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Contents
UNIT ONE: INSTRUMENT PREPARATION 27 Ureteroscopy, 113
FOR SURGERY 28 Nephrectomy, 115
29 Laparoscopic Nephrectomy, 117
1 Care and Handling of Surgical Instruments, 1 30 Pubovaginal Sling/Anterior Repair, 119
2 Sterilization Container Systems, 24 31 Prostatectomy, 122
32 Laparoscopic Prostatectomy, 127
UNIT TWO: GENERAL SURGERY 33 Transurethral Resection of the Prostate, 128
34 Vasectomy, 130
3 Operating Room Suite/Basic Laparotomy, 31 35 Penile Prosthesis, 133
4 Abdominal Self-Retaining Retractors, 39
5 Small Laparotomy Set, 45 UNIT FIVE: ORTHOPEDIC SURGERY
6 Minor Laparoscopic Set, 47
7 Laparoscopy, 49 36 Basic Orthopedic Surgery, 136
8 Laparoscopic Adult MIS Set, 54 37 Power Saws and Drills, Battery Powered, 139
9 Laser Laparoscope, 60 38 Small Joint Arthroscope Set, 144
10 Laparoscopic Cholecystectomy, 61 39 Arthroscopic Carpal Tunnel Instruments, 145
11 Laparoscopic Bowel Resection, 63 40 Small/Minor Joint Replacement, 146
12 Bowel Resection, 69 41 Total Ankle Prosthesis, 148
13 Sigmoidoscopy, 71 42 Arthroscopy of the Knee/Shoulder, 150
14 Laparoscopic Bariatric Surgery, 72 43 Arthroscopic Anterior Cruciate Ligament Reconstruction
15 The da Vinci ® Surgical System and EndoWrist ® Instruments
with Patellar Tendon Bone Graft Instruments, 154
(Robotic Instruments), 79 44 Total Knee Replacement, 157
16 Breast Biopsy/Lumpectomy, 84 45 Shoulder Surgery Instruments, 164
17 Mastectomy, 85 46 Hip Fracture, 166
47 Hip Retractors, 169
UNIT THREE: FEMALE REPRODUCTIVE SURGERY 48 Total Hip Replacement, 170
49 Total Hip Instruments (Zimmer-VerSys), 174
18 Dilatation and Curettage of the Uterus, 88 50 Spinal Fusion with Rodding, 179
19 Hysteroscopy, 91 51 Long Bone Rodding for Fracture Fixation, 185
20 Vaginal Laser, 94 52 ASIF Universal Femoral Distractor Set, 187
21 Abdominal Hysterectomy, 96 53 Synthes Retrograde/Antegrade Femoral Nail, 188
22 Supracervical Laparoscopic Hysterectomy, 99 54 Synthes Unreamed Tibial Nail Insertion and Locking
23 Vaginal Hysterectomy, 103
24 Laparoscopic Tubal Occlusion, 105 Instruments, 190
55 External Fixation of Fractures, 191
UNIT FOUR: GENITOURINARY SURGERY 56 ASIF Pelvic Instrument Set, 194
57 Universal Screwdriver/Broken Screw Set, 196
25 Cystoscopy, 108
26 Urethroscopy, 112
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Instrumentationfor the
OPERATING ROOM
A PHOTOGRAPHIC MANUAL
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9N I N T H E D I T I O N
Instrumentation for the
OPERATING ROOM
A PHOTOGRAPHIC MANUAL
Shirley M. Tighe, BA, RN, Retired
AD in Applied Science in Photography
Consultant for the Operating Room
Lake Havasu City, Arizona
with over 800 photographs
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3251 Riverport Lane
St. Louis, Missouri 63043
INSTRUMENTATION FOR THE OPERATING ROOM: ISBN: 978-0-323-24315-5
A PHOTOGRAPHIC MANUAL, NINTH EDITION
Copyright © 2016 by Mosby, an imprint of Elsevier Inc.
Copyright © 2012, 2007, 2003, 1999, 1994, 1989, 1983, 1978 by Mosby, Inc., an affiliate of Elsevier Inc.
No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechani-
cal, including photocopying, recording, or any information storage and retrieval system, without permission in
writing from the publisher. Details on how to seek permission, further information about the Publisher’s permis-
sions policies and our arrangements with organizations such as the Copyright Clearance Center and the Copyright
Licensing Agency, can be found at our website: www.elsevier.com/permissions.
This book and the individual contributions contained in it are protected under copyright by the Publisher (other
than as may be noted herein).
Notices
Knowledge and best practice in this field are constantly changing. As new research and experience broaden
our understanding, changes in research methods, professional practices, or medical treatment may become
necessary.
Practitioners and researchers must always rely on their own experience and knowledge in evaluating and
using any information, methods, compounds, or experiments described herein. In using such information or
methods they should be mindful of their own safety and the safety of others, including parties for whom they
have a professional responsibility.
With respect to any drug or pharmaceutical products identified, readers are advised to check the most
current information provided (i) on procedures featured or (ii) by the manufacturer of each product to be
administered, to verify the recommended dose or formula, the method and duration of administration, and
contraindications. It is the responsibility of practitioners, relying on their own experience and knowledge of
their patients, to make diagnoses, to determine dosages and the best treatment for each individual patient, and
to take all appropriate safety precautions.
To the fullest extent of the law, neither the Publisher nor the authors, contributors, or editors, assume any
liability for any injury and/or damage to persons or property as a matter of products liability, negligence or
otherwise, or from any use or operation of any methods, products, instructions, or ideas contained in the
material herein.
Library of Congress Cataloging-in-Publication Data
Brooks Tighe, Shirley M., author.
Instrumentation for the operating room : a photographic manual / Shirley M. Tighe. -- Ninth edition.
p. ; cm.
Includes bibliographical references and index.
ISBN 978-0-323-24315-5 (alk. paper)
I. Title.
[DNLM: 1. Surgical Instruments--Atlases. WO 517]
RD71
617.9’178--dc23
2014048834
Executive Content Strategist: Tamara Myers
Senior Content Development Specialist: Laura Selkirk
Publishing Services Manager: Pat Joiner
Project Manager: Suzanne C. Fannin
Designer: Margaret Reid
Printed in the United States of America
Last digit is the print number: 9 8 7 6 5 4 3 2 1
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Thank you to PeaceHealth Southwest Medical Center and their staff for allowing me to use
their faculties for the photographing to update Instrumentation for the Operating Room: A
Photographic Manual textbook, ninth edition.
It has been a real honor to work with the staff at PeaceHealth Southwest Medical Center
in Vancouver, Washington. First, they were very knowledgeable about the work they were
doing and were so willing to share it (so many new or improved instrumentation) with
my staff who had worked in perioperative nursing. Second, they had their plan of what
needed to be updated and were efficient in assisting us in photographing and labeling the
instruments.
Wendy Weir-Raynor and Denise Reese were definite assets to the entire undertaking of
updating the ninth edition of this textbook. They are clinical educators with over 2 decades
working in the perioperative services. Wendy is located second from the right in the front
row, and Denise is located first on the left in the last row. This photo includes some of the
clinical consultants and many technicians who work in the central sterile processing depart-
ment, where instrumentation processing takes place.
PeaceHealth Southwest Medical Center.
Dedication v
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Left to right: Jack Sanders, Glen Tighe, Shirley Tighe, Pauline Vorderstrasse, Gwen Graham, and Beverly
Burns, all of whom came out of retirement and assisted Shirley in another edition of her textbook. It has
been an honor to work with these friends and many other consultants for over 4 decades on the textbooks.
Sharing their expertise of operating room nursing and the time to complete the textbooks, one should really
call it “their textbook.” Many thanks to all.
Sincerely,
Shirley M. Tighe, BA, RN, Retired, AD in Applied Science in Photography
vi Dedication
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CONTRIBUTORS/CONSULTANTS
CLINICAL EDITOR
Denise A. Reese, RN, CNOR
Clinical Educator─Perioperative Services
PeaceHealth Southwest Medical Center
Vancouver, Washington
Wendy M. Weir-Raynor, BSN, RN
Clinical Educator─Perioperative Services
PeaceHealth Southwest Medical Center
Vancouver, Washington
NURSE/CONSULTANTS
Marcia Frieze, CEO
Case Medical, Inc.
South Hackensack, New Jersey
Cynthia C. Spry, MA, MSN, RN, CNOR(E), CBSPDT
Independent Consultant, Sterilization, Disinfection, and Related Infection Prevention
New York, New York
CLINICAL CONSULTANTS
Kathryn Diane Amer, BSN, RN
Ambulatory Surgery
PeaceHealth Southwest Medical Center
Vancouver, Washington
Joan Blackler, RN, CNOR
RN Surgical Specialist─Orthopedic Surgery
PeaceHealth Southwest Medical Center
Vancouver, Washington
M. Tiffany Brenton, BSN, RN
RN Surgical Specialist─EENT/Plastics/Robotics Surgery
PeaceHealth Southwest Medical Center
Vancouver, Washington
Sheryl A. Bundy, RN
Pediatric Surgical Coordinator
Legacy Emanuel Hospital and Medical Center
Portland, Oregon
Robert L. Nyberg, RN
RN Surgical Specialist─Cardiovascular Surgery
PeaceHealth Southwest Medical Center
Vancouver, Washington
Contributors/Consultants vii
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Katherine Schneider, RN, CNOR
RN Surgical Specialist─Neurosurgery
PeaceHealth Southwest Medical Center
Vancouver, Washington
Jack Som, RN
RN Surgical Specialist─General Surgery
PeaceHealth Southwest Medical Center
Vancouver, Washington
Shannon Young, RN
RN Surgical Specialist─GYN/GU Surgery
PeaceHealth Southwest Medical Center
Vancouver, Washington
Sandy Zarosinski, RN
Open Heart/Vascular Coordinator
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon
CONTRIBUTORS/CONSULTANTS
Beverly I. Burns, RN, CNOR(E)
Clinical Education Specialist, Retired
SurgiCount Medical
Portland, Oregon
Gwendolyn Graham, MN, RN
Associate Professor in AD Nursing Program, Retired
Umpqua Community College, Oregon
Silverlake, Washington
Kia Holmes
Graphic Designer
Case Medical, Inc.
South Hackensack, New Jersey
Christianne C. Mariano, MA
Executive Assistant
Case Medical, Inc.
South Hackensack, New Jersey
Jack W. Sanders, BA
Medical Photography/Videographer
Portland, Oregon
Glen E. Tighe
Photography and Computer Consultant, Retired
Lake Havasu City, Arizona
Pauline E. Vorderstrasse, BSN, RN, Retired
Director/Instructor Surgical Technology, Retired
Mt. Hood Community College
West Linn, Oregon
PeaceHealth Southwest Medical Center
Vancouver, Washington
viii Contributors/Consultants
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Preface
The organization of this edition is the same as in the past editions, starting with the basic
and continuing to the advanced, just as you would progress when working in the periopera-
tive area.
Knowing the history of the instruments and understanding their care and handling,
their classification, and the correct type of sterilization to be used for each instrument will
assist you in any perioperative role, whether you work in central sterile processing, ambula-
tory surgery, or the operating room. In addition, it is important to know the types of ster-
ilization-container systems in which instruments can be sterilized and transported among
departments while maintaining their sterility.
Instrumentation for 114 surgical procedures is shown in this textbook according to the
body systems involved. Each unit begins with a basic set of instruments, or most of the
instruments, required to perform that surgery. Most of the basic units begin with a descrip-
tion of how the instruments are used in those procedures and then continue with photo-
graphs of the sets of instruments. The sets are photographed in groups, showing instruments
that are normally placed in a sterilizing container together. Some instruments are shown
individually, with a close-up photograph of their tips if the tips are not visually clear in the
group photograph. Once an instrument is shown individually, it will not be shown again
as an individual instrument. If you are interested in a specific type of surgery and wish to
learn about or review the instruments for that surgery, check the table of contents. If you are
searching for an individual instrument, check the index, which provides you with the page
on which the individual instrument and the close-up of its tip or tips are found.
Most of the clinical consultants are new reviewers to the textbook. They have years of
experience in the perioperative area, which has added to the textbook. We deleted some
basic sets from the textbook and have them available to you on the Evolve website. If a set-
up or individual instrument is on Evolve, that information will be located on the front page
of that chapter. The information you need to get to Evolve website is available to you on the
Evolve page in the beginning of the book.
I wish to acknowledge all the valuable assistance I received from Cynthia Spry in her
writing of Chapter 1: Care and Handling of Surgical Instruments, and Marcia Frieze, CEO of
Case Medical, Inc., for her writing of Chapter 2: Sterilization Container Systems.
Three of the very important people who are in the background and who are rarely talked
about how valuable they are to the publishing of my textbook are my Elsevier associates:
Tamara Myers, Executive Content Strategist; Laura Selkirk, Senior Content Development
Specialist; and Suzanne Fannin, Project Manager. You are very much appreciated by this
author for all the dedicated work you do to make this textbook available. Thank you very
much.
Sincerely,
Shirley M. Tighe, BA, RN, Retired, AD in Applied Science in Photography
Preface ix
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Contents
UNIT ONE: INSTRUMENT PREPARATION FOR SURGERY Contents xi
1 Care and Handling of Surgical Instruments, 1
2 Sterilization Container Systems, 24
UNIT TWO: GENERAL SURGERY
3 Operating Room Suite/Basic Laparotomy, 31
4 Abdominal Self-Retaining Retractors, 39
5 Small Laparotomy Set, 45
6 Minor Laparoscopic Set, 47
7 Laparoscopy, 49
8 Laparoscopic Adult MIS Set, 54
9 Laser Laparoscope, 60
10 Laparoscopic Cholecystectomy, 61
11 Laparoscopic Bowel Resection, 63
12 Bowel Resection, 69
13 Sigmoidoscopy, 71
14 Laparoscopic Bariatric Surgery, 72
15 The da Vinci® Surgical System and EndoWrist ® Instruments (Robotic Instruments), 79
16 Breast Biopsy/Lumpectomy, 84
17 Mastectomy, 85
UNIT THREE: FEMALE REPRODUCTIVE SURGERY
18 Dilatation and Curettage of the Uterus, 88
19 Hysteroscopy, 91
20 Vaginal Laser, 94
21 Abdominal Hysterectomy, 96
22 Supracervical Laparoscopic Hysterectomy, 99
23 Vaginal Hysterectomy, 103
24 Laparoscopic Tubal Occlusion, 105
UNIT FOUR: GENITOURINARY SURGERY
25 Cystoscopy, 108
26 Urethroscopy, 112
27 Ureteroscopy, 113
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28 Nephrectomy, 115
29 Laparoscopic Nephrectomy, 117
xii Contents 30 Pubovaginal Sling/Anterior Repair, 119
31 Prostatectomy, 122
32 Laparoscopic Prostatectomy, 127
33 Transurethral Resection of the Prostate, 128
34 Vasectomy, 130
35 Penile Prosthesis, 133
UNIT FIVE: ORTHOPEDIC SURGERY
36 Basic Orthopedic Surgery, 136
37 Power Saws and Drills, Battery Powered, 139
38 Small Joint Arthroscope Set, 144
39 Arthroscopic Carpal Tunnel Instruments, 145
40 Small/Minor Joint Replacement, 146
41 Total Ankle Prosthesis, 148
42 Arthroscopy of the Knee/Shoulder, 150
43 Arthroscopic Anterior Cruciate Ligament Reconstruction with Patellar Tendon Bone Graft
Instruments, 154
44 Total Knee Replacement, 157
45 Shoulder Surgery Instruments, 164
46 Hip Fracture, 166
47 Hip Retractors, 169
48 Total Hip Replacement, 170
49 Total Hip Instruments (Zimmer-VerSys), 174
50 Spinal Fusion with Rodding, 179
51 Long Bone Rodding for Fracture Fixation, 185
52 ASIF Universal Femoral Distractor Set, 187
53 Synthes Retrograde/Antegrade Femoral Nail, 188
54 Synthes Unreamed Tibial Nail Insertion and Locking Instruments, 190
55 External Fixation of Fractures, 191
56 ASIF Pelvic Instrument Set, 194
57 Universal Screwdriver/Broken Screw Set, 196
UNIT SIX: EYE, EAR, NOSE, AND THROAT SURGERY
58 Basic Eye Set, 198
59 Clear Corneal Set, 201
60 Corneal Transplant, 205
61 Deep Lamellar Endothelial Keratoplasty, 210
62 Glaucoma, 212
63 Eye Muscle Surgery, 214
64 Retinal Detachment, 217
65 Vitrectomy, 219
66 Oculoplastic Instrument Set, 221
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67 Eye Enucleation, 223
68 Basic Ear Set, 224
69 Tympanoplasty, 225
70 Tonsillectomy and Adenoidectomy, 234
71 Transoral Surgery, 237
72 Tracheotomy, 238
73 Septoplasty and Rhinoplasty, 240
74 Nasal Polyp Instruments, 244
75 Nasal Fracture Reduction, 245
76 Sinus Surgery, 246
UNIT SEVEN: ORAL, MAXILLARY, AND FACIAL SURGERY
77 Facial Fracture Set, 251
78 Orthognathic Surgery, 254
79 Titanium 2.0-mm Microfixation System, 257
UNIT EIGHT: PLASTIC SURGERY
80 Minor Plastic Set, 258
81 Micro Plastic Set, 260
82 Plastic Miscellaneous, 262
83 Skin Graft, 266
UNIT NINE: PERIPHERAL VASCULAR, CARDIOVASCULAR,
AND THORACIC SURGERY
84 Endarterectomy, 268
85 Artery Bypass Graft, 269
86 Endovascular Abdominal Aortic Aneurysm Repair, 271
87 Abdominal Vascular Set (Open Procedure), 274
88 Thoracoscopy, 277
89 Thoracic Instruments, 280
90 Cardiac Surgery, 283
91 Open Heart Microinstruments, 287
92 Sternal Saws and Sternum Knife, 289
93 Open Heart Extras, 291
94 Cardiovascular Instruments, 296
95 Open Heart Valve Extras, 299
96 Return Open Heart Set, 301
97 Vein Retrieval Instruments, 304
98 Radial Artery Harvest Set, 306
UNIT TEN: NEUROSURGERY
99 Craniotomy, 307
100 Neurologic Bone Pan Instruments, 314
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101 Neurologic Retractors, 317
102 Medtronic Midas Rex Electric Drill, 320
103 Rhoton Neurologic Microinstrument Set, 322
104 Ultrasonic Handpieces, 325
105 Neurologic Shunt Instruments, 326
106 MINOP Neuroendoscopy Set, 328
107 Intracranial Pressure Monitoring Tray, 330
108 Yasargil Aneurysm Clips with Appliers, 331
109 Synthes Low-Profile Cranial Plating Set, 332
110 Laminectomy, 334
111 Williams Laminectomy Microretractors, 338
112 Minimally Invasive Spine Surgery, 339
113 Anterior Cervical Fusion, 341
114 ASIF Anterior Cervical Locking Plating Instruments, 344
UNIT ON PEDIATRIC SURGERY (ON EVOLVE WEBSITE)
xiv Contents
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UNIT ONE: INSTRUMENT PREPARATION FOR SURGERY CHAPTER 1
Care and Handling of Surgical Instruments*
Although evidence exists that stone knives were used to perform surgery as early as Additional images are available at:
10,000 bc, modern surgical instrumentation began with the introduction of stainless steel evolve.elsevier.com/Tighe/instrumentation
in the early 1900s. Approximately 85% of all surgical instrumentation is now made of stain-
less steel. Although stainless steel continues to compose the bulk of instrumentation used in
surgery today, there have been dramatic changes over the past several decades. One has been
the addition of new materials. In addition to stainless steel, titanium, Vitallium, and vari-
ous polymers are also used. The introduction of minimally invasive surgery coupled with
the availability of space-age materials have wrought instrumentation once only dreamed
of. Cameras, flexible and rigid endoscopes, minimally invasive surgical techniques, and
advanced imaging technology now make it possible to explore almost every crevice within
the human body without having to perform open surgery and without requiring a hospital
stay. Instrument design has focused on enhancing the surgeon’s ability to visualize, maneu-
ver, diagnose, and manipulate tissue using minimally invasive surgical techniques. It is pos-
sible to repair an aortic aneurysm, perform a coronary artery bypass, and operate on a fetus
without making a major incision. Advances in instrumentation design have contributed
significantly to improved patient outcomes, early discharge, reduced recuperation time,
and less physical trauma and pain. In contrast to the general surgery instruments that have
not changed markedly, minimally invasive and interventional procedure instrumentation
has become more complex and delicate and requires special care and handling techniques.
For example, the working channel of a flexible endoscope can be as small in diameter as
0.1 mm and as long as 2200 mm. The consequence of improved instrument design is higher
cost, less inventory of like instrumentation, and greater cleaning, decontamination, and
sterilization challenges. When surgical volume increases without a corresponding increase
in inventory, instruments will experience increased utilization, handling, and processing.
This in turn increases the risk of damage, which can lead to expensive repair costs and pos-
sible cancellation of a surgical procedure. In today’s environment of cost consciousness,
proper care and handling of surgical instrumentation is more critical than ever.
In addition to improvements in instrument design, advances have occurred with regard
to cleaning, packaging, and sterilization technologies. Standards, guidelines, and recom-
mended practices related to instrument processing are continually updated to reflect new
evidence-based knowledge. As a result, the required knowledge base of the person respon-
sible for the care and handling of instruments has expanded significantly. The person caring
for instruments must know the intended uses, functions, and compatibility of instruments
with various cleaning, disinfecting, packaging, and sterilizing methods. This person must
also have an understanding of the equipment used to clean, decontaminate, package, and
sterilize instruments. In recognition of the skill required to process surgical instruments
properly, certification of processing personnel is required in many facilities and is a require-
ment for employment in at least two states, with other states to soon follow. Although the
care and handling of surgical instrumentation is not revenue producing, appropriate and
meticulous care and handling can result in lower overall costs for a surgical department by
preventing damage and consequently reducing expenditures for repair and replacement.
*This chapter was written by Cynthia C. Spry.
CHAPTER 1 Care and Handling of Surgical Instruments 1
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However, the primary concern should be that the instrument be truly patient ready (i.e.,
safe for use on a patient in surgery). Instruments must be thoroughly cleaned and decon-
taminated, and then properly packaged and sterilized in preparation for surgery. Instru-
mentation that malfunctions or is not sterile can result in extended surgery time, poor
technical results, patient infection, patient injury, and even death. Since the publication of
the November 1999 report, “To Err is Human: Building a Safer Health System” issued by the
Institute of Medicine in which it is stated that as many as 98,000 injuries to patients occur
each year in hospitals, many other reports of patient injury have appeared in professional
journals as well as the popular press.1 In a 2014 report from the staff of Senator Barbara
Boxer of California it is estimated that between 210,000 and 400,000 patients die each year
as a result of medical errors and other preventable harm at hospitals.2 In this same report
that lists the most common events that result in patient injury, surgical site infection is
number 7. A heightened awareness of the risk of harm to patients and the resulting eco-
nomic impact has led to a focus on patient safety and financial initiatives to prevent harm.
Several payors such as Medicare, Medicaid, and some private insurance companies will
no longer pay a facility for the costs associated with care for a patient who sustains certain
adverse events, such as some surgical site infections, that with proper care are preventable.3
There is an ongoing intense focus on patient safety throughout the health care industry.
Proper care and handling of surgical instruments are critical components of patient safety
(e.g., prevention of surgical site infection).
In summary, the proper care and handling of surgical instrumentation is not a simple
rote task; it requires specialized knowledge, competence, critical thinking, judgment, and a
commitment to excellent patient care.
EVOLUTION OF SURGERY AND SURGICAL INSTRUMENTATION
Surgery was practiced long before the development of sophisticated surgical instruments.
Stone knives and sharpened flints and animal teeth were the instruments of choice for
trephination, circumcision, and bloodletting in prehistoric times. In Corpus Hippocraticum,
Hippocrates (460-377 bc) wrote of the use of iron and steel in instrument making; however,
there are no existing examples of surgical instruments before the early Roman period. Exca-
vations begun in 1771 in the city of Pompeii reveal surgical instruments that bear amaz-
ing resemblances to contemporary instrumentation. Among the instruments found were
a foreign-body remover, a speculum, retractors, probes, a periosteal elevator, forceps, and
hooks. Metal analysis indicates three materials: copper, bronze, and iron.
Until the 1790s, surgery was not a strict discipline, and surgeons were not afforded equal
status with physicians. Instruments were made by blacksmiths, cutlers, and armorers. How-
ever, as surgery evolved into a scientific discipline and achieved a measure of status, the
specialty of instrument making also emerged. Surgeons employed coppersmiths, steelwork-
ers, silversmiths, wood turners, and other artisans who handcrafted instruments to indi-
vidual specifications. Instruments often had ornate ivory or carved wooden handles and
were cased in velvet.
The introduction of anesthesia in the 1840s and the adoption of Lister’s antiseptic tech-
nique in the 1880s greatly influenced the making of surgical instruments. The use of anes-
thesia enabled the surgeon to work more slowly and accurately and to perform longer, more
complex procedures. The variety of surgeries performed increased, as did the demand for
specialized instruments. The ability to sterilize instruments also had an impact on instru-
ment design. When steam sterilization became a standard process, carved wood or ivory
handles were replaced with all-metal instruments made of silver, brass, or steel. Velvet-lined
boxes were replaced by trays that could be lowered into steam sterilizers.
MANUFACTURE OF STAINLESS STEEL INSTRUMENTATION
The development of stainless steel in the 1900s provided a superior material for the man-
ufacture of surgical instruments. Subsequently, instrument making evolved into a highly
skilled occupation. Shortly thereafter, crafters from Germany, France, and England were
2 UNIT 1 Instrument Preparation for Surgery
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brought to the United States to instruct apprentices in their craft. Even today, many of the 3
delicate, high-quality, stainless steel instruments are manufactured in Europe. Germany is
often considered the home of high-quality surgical instruments. Other metals like Vital-
lium and titanium are used today, but the bulk of surgical instrumentation is made of stain-
less steel and is manufactured in the United States. Many surgical instruments are made
from plastic polymers as well.
Stainless steel is a compound of varying amounts of carbon, chromium, and iron. Small
amounts of nickel, magnesium, and silicone may also be incorporated. Varying the amount
of these materials produces a variety of qualities, such as flexibility, temper, malleability, and
corrosion resistance. There are more than 80 different types of stainless steel. The American
Iron and Steel Institute uses three-digit numbers to grade steel based on its various qualities
and composition. The most commonly used steel alloys for the manufacture of heat-stable,
reusable surgical instruments are stainless steel series 300 and 400, with 400 being the most
common. The 300 series is generally used for noncutting surgical instruments requiring
high strength, such as speculums and large retractors. The 400 series is used for both cut-
ting and noncutting instruments. Both series resist rust and corrosion, have good tensile
strength, and will retain a sharp edge through repeated use. The chromium content in stain-
less steel provides the stainless quality. Stainless steel is really a misnomer. The degree to
which the steel is stainless is also determined by the chemical composition of the metal, the
heat treatment, and the final rinsing process.
The first step in the manufacture of stainless steel instruments is the conversion of raw
steel into sheets that are milled, ground, or lathed into instrument blanks. These blanks are
then die-forged into specific pieces and, where appropriate, male and female halves. Excess
metal is trimmed away and the pieces are milled and hand-assembled. Jaw serration and
ratchet and shank alignment are achieved, after which the instrument is hand-assembled
and then ground and buffed. It is then heat-treated to reach its proper size, weight, spring,
temper, and balance. Following testing for desired hardness, jaw closure, and ratchet and
locking action, a finish is applied.
The final two processes are passivation and polishing. Passivation is the immersion of
the instrument in a dilute solution of nitric acid that removes carbon steel particles and
promotes the formation of a coating of chromium oxide on the surface. Chromium oxide
is important because it produces corrosion resistance. When carbon particles are removed,
tiny pits are left behind. These are removed by polishing to create a smooth surface upon
which a continuous layer of chromium oxide may form. Passivation and polishing effec-
tively close the instrument’s pores and prevent corrosion.
There are three types of instrument finishes: highly polished, satin or dull, and ebony.
The highly polished finish is the most common, but it does reflect light and can cause glare
that may interfere with the surgeon’s vision. The satin finish does not reflect light and elimi-
nates glare. The ebony finish is black and also eliminates glare. The ebony finish is suitable
for laser surgery, in which it is critical that the laser not be accidentally reflected, creating
the potential for burn or fire.
QUALITY OF STAINLESS STEEL INSTRUMENTS
Stainless steel instruments may appear to be of uniform quality when they are new. How-
ever, there are various grades of quality, ranging from high quality and premium grade to
operating room and floor grade. Some instruments appearing to be stainless steel are of
such poor quality that they are sold as single-use instruments. In the United States, there is
no agency that sets standards for instrument quality. Quality is determined by the manu-
facturer. In addition, an instrument labeled Germany may have been forged in Germany
but actually assembled in a country where quality standards are minimal or nonexistent.
Because instruments represent a substantial portion of the budget of a surgical suite, it
is important to be knowledgeable about buying and selecting products with the desired
quality. Many factors affect quality. Two major factors are a balanced carbon-chrome ratio
and the process of passivation. A balanced carbon-chrome ratio is important for instru-
ment strength and long life. Instruments that are classified as premium have the correct
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balance. The passivation process is important to create a protective coat on the outer layer
of an instrument to prevent corrosion and extend its life. Electropolishing is sometimes
substituted for passivation. The result is a less expensive instrument but one that will not
last as long. When purchasing stainless steel instruments, it is best to deal with a reputable
manufacturer who will explain the variation in quality of the products available.
It is important to verify that an instrument manufacturer has clearance from the U.S.
Food and Drug Administration (FDA) to market its products. Instruments manufactured
in some countries outside the United States have been known to enter the American market
without this clearance and without providing adequate instructions for use and processing.
Another reason to deal with a reputable instrument manufacturer is authenticity. When an
instrument that usually sells for $150 is being offered for $50, the buyer should beware and
should check for FDA clearance before considering purchase.
Instruments manufactured of materials other than stainless steel present an additional
set of factors to consider before purchasing. These include their ability to be disassembled,
cleaned, and reassembled; their life expectancy; and their compatibility with the existing
resources within the sterile processing department (e.g., cleaning chemistries, disinfecting
agents, and sterilization modalities) available within the institution.
CARE AND HANDLING OF BASIC SURGICAL INSTRUMENTS: OVERVIEW
A well-made, properly cared for instrument can be expected to last 10 years. The most
important considerations in extending the life of an instrument are appropriate use, careful
handling, and proper cleaning, decontamination, and sterilization. Other considerations
are disinfection, packaging, and storage. Every instrument is designed for a specific pur-
pose. Using it for an unintended purpose is a sure method of damaging an instrument.
Examples of misuse include securing surgical drapes or bending a wire with an instrument
designed to grasp tissue.
RESOURCES
Three must-have resources for personnel responsible for instrument processing are the
Association for the Advancement of Medical Instrumentation’s (AAMI’s) Comprehensive
Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities, the Asso-
ciation of periOperative Registered Nurses (AORN) Recommended Practices for Steriliza-
tion, for Care and Cleaning of Surgical Instruments and for Selection and Use of Packaging
Systems for Sterilization, and the Centers for Disease Control (CDC) 2008 Guideline for
Disinfection and Sterilization in Healthcare Facilities.4,6 The other must-have resources are
the instructions for use (IFUs) for all devices. The IFUs are those processes the manufac-
turer has determined are necessary to obtain outcomes to render a device safe for use. The
IFUs should contain explicit instructions for disassembly, cleaning and/or decontamina-
tion, inspection, function testing, packaging, high-level disinfection, and sterilization as
appropriate to the device. IFUs should be routinely reviewed. Instructions may change
when manufacturers make modifications to their devices, when new regulatory require-
ments become effective, or when new processing technologies come to market. In fact, in a
statement relative to ambulatory surgery facilities, the Centers for Medicare and Medicaid
Services (CMS) have issued the statement, “If manufacturers’ instructions are not followed,
then the outcome of the sterilizer cycle is guesswork, and the Ambulatory Surgical Center’s
practices should be cited as a violation of 42 CFR 416.44(b)(5)” (CMS, 2009).7
In addition to IFUs for devices, IFUs for cleaning chemistries, cleaning and steriliza-
tion equipment, packaging materials and equipment, and quality monitors should also be
reviewed before processing. In instances in which instructions are not compatible with each
other, the vendor(s) should be contacted in an attempt to reconcile the incompatibilities.
When it is not possible to reconcile instructions, product testing (see Sterilization section
later in this chapter) should be performed.
Everyone responsible for instrument processing should have ready access to all neces-
sary IFUs and should refer to them routinely. Surveyors, such as those from accrediting
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agencies, have indicated that they will be asking to see IFUs and will be checking to see if 5
personnel are adhering to them. Many facilities contract with a document management
system to ensure ready availability and access to current IFUs. When a computerized docu-
ment management system is in place, staff must be competent to operate the program.
PREPARING INSTRUMENTS FOR PROCESSING
Point of Use
The first steps in preparing an instrument to be processed in the sterile processing area
should begin at the point of use. During surgery, instruments contaminated by blood or tis-
sue should be wiped, rinsed, or irrigated in the sterile water at the sterile field. This should
be accomplished in a manner that prevents splashing and aerosolization and can generally
be done by wiping the device with a moistened lap pad and/or syringe. A syringe should
be present on the sterile field for the purpose of flushing lumens throughout the procedure
as appropriate. Flushing a lumen should be done below the surface of the water to prevent
the aerosolization of debris. Saline should not be used for wiping or irrigating instruments.
Prolonged exposure to saline can result in corrosion and can eventually lead to pitting of
stainless steel. Pitting can cause entrapment of debris, interfere with sterilization, and result
in destruction of the instrument. Blood and foreign matter that are not removed or are
allowed to dry and harden may become trapped in jaw serrations, between scissor blades,
or in box locks, making final cleaning more difficult and the sterilization or disinfection
process ineffective. It can cause instruments to become stiff and eventually break.
Instruments should be handled carefully and gently, either individually or in small lots,
to avoid possible damage caused by their becoming tangled, dented, and misaligned. They
should be placed, not tossed, into the basin. In preparation for transport to the decon-
tamination area, all disposable blades and sharps should be removed and placed in a des-
ignated sharps container. Heavy instruments should be placed on the bottom of the pan,
container, or basin, with the lighter, more delicate and fragile ones on top or protected in
another manner. Care should be taken to ensure that instruments are not tangled or piled
high. Rigid endoscopes and fiber optic cables should also be placed on top or separated.
Fiber optic cables should be loosely coiled, never tightly wound. Instruments that can be
disassembled should be disassembled. Ratchets should be opened. Instruments should be
returned to their respective containers or baskets to prevent sets from becoming incomplete
and should be contained or covered for transport to the decontamination area. The con-
tainer for transport should be labeled with a biohazard symbol. A red bag or red container
may be used instead.8 Delicate instruments, endoscopes, and other specialty instruments
may need to be separated and transported to the decontamination area in containers spe-
cifically designed to prevent damage. Instruments with cutting edges, pointed tips, or other
sharp components should be placed in such a manner that sharp edges are protected and
personnel responsible for cleaning and decontamination are not injured when reaching
into the container.
CLEANING AND DECONTAMINATION
The AAMI defines cleaning as “removal of contamination from an item to the extent nec-
essary for further processing or for the intended use.” AAMI further notes that, “In health
care facilities cleaning consists of the removal, usually with detergent and water, of adherent
soil (e.g., blood, protein substances, and other debris) from the surfaces, crevices, serra-
tions, joints, and lumens of instruments, devices, and equipment by a manual or mechani-
cal process that prepares the items for safe handling and/or further decontamination.”4
Decontamination is defined by the Occupational Safety and Health Administration
(OSHA) as “the use of physical or chemical means to remove, inactivate, or destroy blood-
borne pathogens on a surface or item to the point where they are no longer capable of
transmitting infectious particles and the surface or item is rendered safe for handling, use,
or disposal.”8
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Decontamination consists of cleaning and a disinfection process. Mechanical washing
machines typically follow the washing phase of the cycle with a thermal or chemical disin-
fection application that renders a device safe to handle.
AFTER SURGERY: CLEANING
Whenever possible, instruments should be taken apart at the point of use. Unless other-
wise specified in the device manufacturer’s IFUs, anything that can be disassembled must
be disassembled before cleaning. After surgery, instruments are transported in leak-proof
containers or trays encased in plastic bags to a designated area for cleaning and decon-
tamination. Instruments should not be transported in basins containing water because the
water may spill. Instruments should be cleaned away from patient care areas or areas where
clean activities are performed. The decontamination area may be within the operating suite
or, more commonly, in the Central Processing Department, also referred to as the Sterile
Processing Department. Instruments that can tolerate immersion and cannot be cleaned
immediately should be treated with an enzymatic foam or gel to prevent debris from drying
and adhering to the device and to prevent formation of biofilm. Another option is to sub-
merge the instruments completely in a warm, noncorrosive enzymatic solution and allow to
soak until cleaning can be performed. The foam or gel may be applied prior to transport to
the dedicated decontamination area. Generally, instruments should be placed horizontally
beneath the water; however, some types of lumened instruments may have to be soaked
vertically, with the entire shaft submerged. Horizontal soaking of lumens can cause air
bubbles to form that can prevent the solution from traveling the length of the inner lumen.
All instruments placed in the sterile field for use in a surgical procedure are considered
contaminated and should be cleaned whether or not they were actually used. Blood, saline,
or debris can be splashed or inadvertently deposited on any of the instruments; therefore,
they all require decontamination and processing.
There are several methods of decontaminating instruments, but all begin with thorough
cleaning. The usual steps in the decontamination process include sorting, soaking, rinsing,
washing, rinsing, drying, and lubricating.
Cleaning is the removal of visible adherent soil from the surfaces, crevices, serrations,
joints, and lumens of instruments. Cleaning may be manual or automated and is accom-
plished with detergent, water, and friction. Proper use of the detergent is essential. Deter-
gents should always be mixed according to the proportions indicated on the label or in
the manufacturer’s IFUs. Enzymatic detergents that are over or under concentrated or
have been improperly rinsed can interfere with subsequent disinfection and sterilization.
Regardless of how heavily soiled instruments appear to be after use, adding more detergent
to the water is inappropriate. To ensure proper detergent concentration, it is advisable to
obtain an exact measuring device for the detergent and to mark the sink with a piece of
tape or a nontoxic, permanent marker to indicate the correct water level. For example, if
the instructions call for a mix of 1 oz of detergent to 1 gal of water, a 1-oz container should
be obtained and kept next to the detergent bottle or sink. A 1-gal container should be filled
with water and poured into the sink in which instruments are washed manually and where
the water level is marked. Commercially prepared labels indicating desired water level that
may be affixed to the sink are readily available. The presence of the 1-oz container and the
mark in the sink should help to ensure the correct preparation of the detergent solution. In
addition to concentration requirements, cleaning agents have temperature and contact time
requirements. A thermometer and timer should be used to determine temperature and to
set contact time. Instructions for rinsing are also important. Some products call for multiple
rinses. When a choice is made to switch to an alternative detergent, it is important to ensure
that all personnel responsible for instrument processing receive the appropriate notification
and information as requirements for use may change.
When possible, mechanical cleaning is preferred. However, some instruments cannot
tolerate immersion, high temperatures, or pressures of mechanical cleansing units and
must be cleaned manually. Instruments that are washed manually should always be com-
pletely immersed and allowed to soak in a cleaning agent intended for manual cleaning of
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surgical instruments. Instruments should be disassembled and box locks, hinges, and joints 7
should be opened. Serrations, box locks, crevices, and lumens must be brushed to remove
imbedded particles. Scouring pads, stiff brushes, abrasive powders and soaps, and sharp
implements should not be used to remove debris because they can destroy the protective
coating on surgical instruments.
Instruments that are washed manually should always be washed one at a time beneath
the surface of the water to prevent the aerosolization and splashing of debris.
The final rinse in the cleaning process, whether manual or mechanical, should be with
treated water (e.g., distilled, deionized, reverse osmosis). Water quality varies by geographi-
cal location and untreated water (tap water) may contain endotoxins. Endotoxins are essen-
tially dead bacteria cells. When found on instruments used in surgery, endotoxins can cause
a pyrogenic (fever) reaction in a patient.
Some instruments, because of their design, may require manual cleaning followed by
mechanical cleaning. Debris and tissue can easily become trapped in complex devices,
and mechanical cleaning alone may not be sufficient to remove the debris. Soaking in an
enzymatic detergent can help to break down organic soil. Reamers with many crevices
tend to trap debris and may have to be soaked and manually brushed before automatic
cleaning. Much will depend upon the capability of the mechanical cleaners in the decon-
tamination area. Lumened instruments should be flushed and brushed. Flushing can be
achieved by attaching a Luer-Lok syringe filled with an enzymatic detergent solution to
one of the ports on the instrument. Brushing must be carried out using a brush that is
appropriate to the device (e.g., a brush made of the appropriate bristle material), intended
for cleaning surgical instruments, and long enough to exit the distal end of the shaft and
wide enough in diameter to cause friction on the walls of the lumen so soil is loosened.
Brushes should be either single use disposable or, if reusable, should be cleaned and disin-
fected at least daily. Mechanical washers and ultrasonic irrigators specifically designed for
lumened devices do an excellent job of cleaning and are preferable for cleaning lumened
devices.
Personnel responsible for cleaning must wear personal protective attire to prevent con-
tact with blood or with fluid that might contain blood and/or other body fluids. Protective
attire consists of a fluid resistant face mask and eye protection such as goggles or a full-
length face shield, heavy-duty cuffed decontamination gloves, and a liquid-resistant gown
with sleeves that cover the scrub suit underneath. Aprons are not acceptable. Masks are
recommended when cleaning items that can create aerosols (e.g., lumened devices). Fluid-
resistant shoe coverings or waterproof boots are appropriate when fluid may be expected to
pool on the floor.4,5,8
Ultrasonic cleaning is another component of instrument cleaning. Ultrasonic cleaners
should be used only on devices that can tolerate this process and only after gross debris
has been removed. Ultrasonic washers use a process called cavitation to remove fine soil
from difficult-to-reach areas of a device that manual cleaning may not remove. High-fre-
quency sound waves are captured and converted into mechanical vibrations in the solution.
The sound waves generate microscopic bubbles that form on the surfaces of the instru-
ments. These bubbles expand until they become unstable and collapse or implode (col-
lapse inwardly), creating minute vacuums that rapidly disrupt the bonds that hold debris
to instrument surfaces. The tiniest particles are rapidly drawn from every crevice in the
instrument. Ultrasonic cleaning is especially effective for box locks and instruments with
serrations and interstices that are not easily accessible.
Ultrasonic cleaning does not kill pathogens; it only removes them and deposits them in
the ultrasonic bath. The energy created in an ultrasonic cleaner is not biocidal, and unless
the solution is changed frequently, the bioburden on instruments can actually increase. To
prevent this, ultrasonic solutions should be changed between cycles and according to the
ultrasonic IFUs. The cover of the ultrasonic cleaner should be closed during operation to
prevent the spread of microorganism-containing aerosols that are created during the clean-
ing process and that may be harmful to personnel.
Both the device manufacturer’s IFUs and the ultrasonic IFUs should be reviewed before
using ultrasonic cleaning.
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Instruments made of dissimilar metals can be damaged if sonicated together in the ultra-
sonic cleaner. The electroplating of the more active metal onto the less active metal can
result in permanent discoloration of the less active metal (e.g., brass plating on stainless
steel turns the steel a golden color) and will eventually weaken the instrument from which
the metal is being removed. In addition, some instruments cannot tolerate the energy waves
of the ultrasonic cleaning process, and manufacturers of some instruments, such as lensed,
in which the sonication process can loosen adhesives, may specifically state not to use ultra-
sonic methods for cleaning.
There are a variety of ultrasonic cleaners on the market and some of them are designed
and intended to be used for specific instruments such as robotic instruments. These may
include attachments or ports that connect lumens to the cleaner and are especially efficient
at removing debris from difficult to access locations on the device.
At the completion of the ultrasonic cycle, the instruments are placed in a mechanical
washer or rinsed and dried.
The performance of ultrasonic cleaners should be tested periodically using monitors
specifically designed and intended for this purpose. There is no nationally recognized stan-
dard for frequency of testing, however some IFUs may recommend specific testing inter-
vals. Weekly or daily testing is common.
The most common mechanical cleaning machine in use is the washer-decontaminator/
disinfector. These machines offer a variety of cycles, including cool-water rinse, enzyme
soak, wash, sonication (ultrasonic cleaning), hot-water rinse, germicide rinse, and dry.
For lumened devices, washers with connection ports that facilitate cleaning lumens
should be utilized.
Instruments should be placed in a mesh bottom or perforated tray prior to placement
within mechanical washing systems. Detergent should be selected according to the type of
debris, the tolerance of the instrument, and recommendations from the device and washer
manufacturers. The pH of a detergent can be alkaline, neutral, or acidic. A mildly alkaline
or neutral detergent is generally preferred. Acidic or heavily alkaline detergents should not
be used routinely because they can destroy the passivation layer and promote corrosion.
When high-alkaline detergents are used, they must be completely and thoroughly neutral-
ized. To accomplish this, some mechanical washers employ a high-alkaline detergent wash
followed by an acid rinse.
Enzymatic detergents usually consist of a detergent base with a neutral pH in combi-
nation with one or more enzymes and a surfactant. Surfactants lower the surface tension
of water and allow the detergent to more easily penetrate into crevices and serrations.
There are many enzymatic detergents on the market. Some formulations contain only one
enzyme; others contain multiple enzymes. There are enzymatic detergent products suit-
able for ultrasonic cleaners, mechanical washers, and manual cleaning. Some can be used
for manual and mechanical cleaning. Some enzymatic cleaners are intended for specialties
such as orthopedic or ophthalmic procedures. Some target blood, fat, or organic soil. As a
general rule, a low-foaming detergent with a neutral pH is preferable. High-foaming deter-
gents may not be completely rinsed off and can leave spots and stains on instruments. In
areas where the water is hard, a water softener should be used to minimize scum and scale
formation.
Placement of instruments within mechanical washers must be such that cleaning agents
and water can make contact with all surfaces of the instrument.
Mechanical cleaning equipment should be tested at least weekly, and preferably daily.
There are commercially available products that can be used to test the ability of the
washer to clean effectively. These should be used according to the manufacturer’s written
IFUs.
As a final step before inspection and packaging for sterilization, instruments should be
lubricated with a nonsilicone, water-soluble lubricant. Mechanical washers often include a
lubrication process as part of the cycle. In manual lubrication, instruments are dipped into
a milky-white solution or bath. The manufacturer’s instructions for dilution of the lubricant
should be followed, and the expiration date after mixing should be noted and indicated on
the instrument milk bath.
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SPECIALTY INSTRUMENTS 9
Specialty instruments require exceptional handling. Instruments used in microscopic sur-
gery should be handled separately from those used for general surgery. They easily become
tangled or misaligned when the heavier instruments used in general surgery are placed on
top of them. Other specialty instruments, such as powered hand pieces and telescopes, will
be destroyed if subjected to ultrasonic cleaning or to a washer-decontaminator and should be
meticulously cleaned by hand. Other specialty instruments may have instructions that spec-
ify steps not common to general surgery instruments (e.g., attachment of accessories, use
of special cleaning tools, and use of pressurized water). The device manufacturers provide
instructions for cleaning that are determined as necessary to obtain the desired outcome. The
manufacturers’ instructions for care and handling of instruments should always be followed.
Eye Instruments
Toxic anterior segment syndrome (TASS) is an acute anterior segment inflammation that
can lead to impaired vision. TASS has been associated with inadequate cleaning of ophthal-
mic instruments following cataract and anterior segment surgery.9-14 Detergent residues,
viscoelastic solution used in surgery that can quickly harden on instruments, preservatives,
and foreign material can induce TASS. Irrigation ports of phacoemulsion hand pieces, tips,
small-diameter tubings, and cannulated instruments coupled with viscous solutions used
in eye surgery present unique challenges to cleaning eye instruments. Instruments used
for cataract surgery are among those that are most commonly subjected to immediate use
steam sterilization (IUSS). Although IUSS, if carried out properly, is safe and effective, the
resources to process IUSS correctly may be less than ideal (see section on IUSS) and can
lead to shortcuts that negatively impact the outcome of the processing.
Following surgery, eye instruments should be immediately immersed in sterile water, and
lumens should be flushed with sterile water. The aspiration and irrigation ports and tubings
on phacoemulsion hand pieces should be flushed prior to being disconnected. Instruments
should then be cleaned with a detergent recommended by the instrument manufacturer.
Enzymatic detergents should not be used unless indicated in the device manufacturer’s
IFUs. Detergent concentration and water quality should also comply with the device manu-
facturer’s instructions. The final rinse should be done with sterile, distilled, or deionized
water. Lumens should be dried with compressed air. Personnel responsible for processing
ophthalmic instruments should refer to the AORN Recommended Practice for Cleaning
and Care of Surgical Instruments and to the American Society of Cataract and Refractive
Surgeons for recommendations specific to cleaning and processing of ophthalmic instru-
ments.5,13
Flexible Endoscopes
Flexible endoscopes contain long, narrow lumens and are inherently difficult to clean. A
failure to process properly has been reported in a number of studies. Thousands of patients
who have undergone gastrointestinal (GI) endoscopy procedures have been sent letters
advising them to return to the facility for testing to determine if they were infected from
an improperly processed flexible endoscope.14-17 Instructions for cleaning flexible endo-
scopes are quite detailed and specific and are beyond the scope of this review. In 2003, The
Society of Gastroenterology Nurses and Associates released The Multisociety Guideline for
Reprocessing Flexible Gastrointestinal Endoscopes,18 which provides detailed cleaning and
disinfection protocols for flexible endoscopes and their accessories. The guideline, which
was revised in 2011,19 has been endorsed by 11 agencies including the Joint Commission,
professional nurse and physician endoscopic societies, and the Association for Practitioners
in Infection Control and Epidemiology. In 2005, the American College of Chest Physicians
and the American Association for Bronchology published an article entitled Prevention of
Bronchoscopy-Associated Infection that provides recommendations for cleaning, disinfecting,
and postprocedure processing of flexible bronchoscopes.20
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Adherence to these guidelines is critical to proper processing. The endoscope manu-
facturers’ guidelines should always be consulted for design features specific to the scope in
question. Manufacturers usually provide in-service education in the cleaning and steriliza-
tion of these devices. Personnel responsible for cleaning and processing these devices must
have thorough knowledge of the process and must have demonstrated competence as well.
Competence should be demonstrated for each model and type of scope.
Proper cleaning of flexible scopes should begin immediately after their use. The biopsy
and suction channel should be flushed with an enzymatic detergent solution and the out-
side wiped to remove gross soil. Debris must not be allowed to dry within the channel,
and the scope should be delivered to the decontamination area as soon as possible after
use. Meticulous cleaning must precede exposure to disinfecting or sterilizing agents. The
lumens and internal channels should be cleaned using an appropriately sized brush and
then rinsed. It is important that endoscope cleaning agents be mixed and used precisely
according to the label. Following manual cleaning, the scope may then be processed in
an automated endoscope reprocessor (AER) designed specifically for this purpose. The
compatibility of the endoscope with the AER, the detergent, and the disinfectant must be
determined. In the absence of an automated system, additional meticulous manual cleaning
according to the manufacturer’s recommendations is required. Strict adherence to manu-
facturers’ instructions concerning use of the disinfectant and the AERs is critical to achieve
adequate cleaning and disinfection. As a final step, all channels should be flushed with 70%
alcohol to facilitate drying. Some AERs include an alcohol flush. Storage in an appropriate
drying cabinet that has humidity and temperature control is an additional method to facili-
tate drying. Pathogenic microorganisms found in rinse water can colonize in a relatively
short time (overnight) in an endoscope that has not been adequately dried. In addition, it
is possible for a biofilm to form in a lumen that has not been sufficiently dried. A biofilm
is an assemblage of microbial cells that forms when bacteria attach to a surface and then
exude an extracellular polysaccharide that acts as a glue and a protective layer of slime
in which the bacteria proliferate. The extracellular polysaccharide film prevents antibiotic
penetration. Biofilms can be removed only by mechanical action. If a biofilm breaks from
the surface and enters a patient, the consequences can be deadly because of the especially
large number of bacteria in a biofilm. It can require more than 100 times the normal dose of
an antibiotic to treat an infection caused by a biofilm. Biofilms have been found to form in
moist endoscope lumens as a result of inadequate drying. An alcohol flush can prevent the
growth of water-borne microorganisms and biofilms.
CONSIDERATIONS FOR INSTRUMENTS CONTAMINATED WITH PRIONS
A prion is an infectious proteinaceous particle that is responsible for causing Creutzfeldt-
Jakob disease and several other fatal degenerative neurological diseases. Because prions are
resistant to routine disinfection and sterilization processes, instruments that have come
into contact with prions require treatment according to special processing protocols. Infor-
mation about appropriate processing protocols is not always consistent and continues to
evolve. In February 2010, the Society for Health care Epidemiology of America (SHEA)
published an article entitled Guideline for Disinfection and Sterilization of Prion-Contami-
nated Medical Instruments.21 AORN and AAMI also provide recommendations and guide-
lines related to processing prion-contaminated instruments. These guidelines as well as the
most current literature should be consulted when developing a policy and procedure for
processing prion-contaminated instruments.
Research on best practices related to processing instruments suspected or known to
have been exposed to prions is ongoing. In addition, processing protocols are evolving and
cleaning chemistries are increasingly being recognized as a critical factor in processing
these instruments.22 Institutional policies and procedures for prion-contaminated instru-
ments should be reviewed at least annually and revised accordingly. Processing protocols
are based on the presence or suspected presence of a prion disease in a surgical patient,
the type of tissue that comes into contact with the instruments used during the surgery,
and whether the device is critical. Critical devices are those that enter sterile tissue or the
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vascular system. High-risk patients are those with a known prion disease or those with 11
rapidly progressive dementia consistent with prion disease. High-risk tissue includes brain,
spinal cord, posterior eye, and pituitary. Critical instruments used on high-risk patients
undergoing surgery on high-risk tissue require special processing protocols. Each health
care facility should have policies and procedures for screening patients to determine the
presence or possible presence of a prion disease, identifying and tracking the instruments
used in these patients, and establishing protocols for processing these instruments.
SPOTTING, STAINING, AND CORROSION
Although stainless steel is highly resistant to spotting, staining, rusting, and pitting, these
conditions can occur for many reasons. Understanding the cause of the specific problem
usually provides an effective solution.
Minerals in the water may cause light and dark spots. Instruments processed in health
care facilities in which the water supply has a high concentration of minerals may show
spotting. When water droplets condense on the instruments and evaporate slowly, mineral
deposits in the water can remain and leave spots. Sodium, calcium, and magnesium miner-
als are particularly problematic. Using treated water (e.g., demineralized, reverse osmosis,
and filtered) for rinsing and pure steam for sterilizing may solve the problem. After the
sterilization cycle, the door to the autoclave should remain closed until all the steam in the
chamber has been allowed to exhaust. This reduces the amount of condensate remaining on
the instruments. Vigorous rubbing with a cloth or cleaning with a soft brush may be suffi-
cient to remove mineral-deposit spotting. If spotting remains a problem, the autoclave may
need servicing. Leaky or faulty gaskets may be the cause of the problem.
A rust-colored film on instruments may be the result of high iron content in the water
or foreign material within steam pipes. Yellow-brown to dark-brown spots are sometimes
mistaken for rust; the eraser test can be used to determine whether it is rust. If the stain
disappears when it is rubbed with a pencil eraser, it is not rust. In some instances, the instal-
lation of a steam filter may help prevent this type of stain.
Brownish staining can occur when the detergent used for cleaning contains polyphos-
phates that dissolve copper elements in the sterilizer. The result is that a layer of copper is
deposited on the instruments by electrolytic action. If this happens, a different detergent
should be used and the manufacturer’s instructions followed.
Brownish-orange stains can be caused by a high pH level in the detergent used to clean
the instruments.
Black spots are the result of exposure to ammonia, which is found in many cleaning
agents. The problem can be resolved by using a different detergent and rinsing thoroughly.
Black stains can also be caused by amine deposits that can be traced to the autoclave steam.
Amines are used in the boiler to prevent mineral salt deposits on the walls of the boiler
and steam pipes. Some of the amines are carried with the steam into the autoclave and by
means of electroplating are deposited on the instruments, causing staining to occur. Adding
amines to the boiler must be done in a controlled and gradual manner to minimize the risk
of concentrations high enough to cause spotting on items to be sterilized.
A blue-gray stain can result when cold liquid sterilants are used beyond their recom-
mended time limit.
Rusting of stainless steel is unlikely, and what often appears to be rust may actually be
organic residue in box locks or mineral deposits baked onto the instrument surface. Unless
the cause is remedied, corrosion may occur.
Actual corrosion is a physical deterioration of the stainless steel. Pitting is a severe form
of corrosion in which small pits form on the surface of the instrument. Corrosion and
pitting can occur when instruments are exposed to saline for extended periods of time
and when organic debris such as blood and tissue is left in difficult-to-clean areas such as
box locks, serrations, and ratchets. Detergents that are either too alkaline or too acidic can
also cause corrosion and pitting. Detergents with a chlorine base or an acid pH should be
avoided. Exposure to carbolic acid, calcium chloride, ferrous chloride, potassium perman-
ganate, and sodium hypochlorite can cause severe pitting. To avoid electrolysis, stainless
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steel instruments should not be mixed with instruments containing aluminum or copper.
Improperly cleaned wraps can also create a corrosive environment. The detergent can leach
from the wrap during exposure to heat and steam and remain on the instrument.
Measures that can be taken to avoid instrument corrosion and pitting include soaking or
spraying instruments with an enzymatic foam or spray after use to prevent debris from dry-
ing and hardening; scrubbing hard-to-clean areas; using a neutral pH detergent; thoroughly
rinsing with treated water; and routinely cleaning the sterilizer according to the sterilizer
manufacturer’s IFUs. Water and vinegar can also be used to remove impurities.
It is sometimes difficult to identify the cause of stains. Both the instrument manufacturer
and the sterilizer manufacturer should be consulted when the cause is unclear.
In summary, the following steps should be taken to prevent spotting, staining,
and corrosion:
1. Clean as soon as possible after use to prevent debris from drying on instruments.
(Cleaning begins at point of use.)
2. Apply enzyme spray or gel designed and intended to prevent debris from hardening
on instruments after use in surgery.
3. Clean well; remove all soil.
4. Rinse well. Use treated water for the final rinse.
5. Do not place instruments of dissimilar metal in the ultrasonic cleaner. Remove gross
debris prior to placement within the ultrasonic cleaner.
6. Select only detergents and disinfecting solutions that are recommended for
instruments. Check with the instrument and washer-decontaminator/disinfector
manufacturers.
7. Mix and use detergent solutions exactly as indicated by the manufacturer’s IFUs.
8. Dry instruments before wrapping. Ensure adequate drying following exposure to
sterilization. Check autoclaves for proper functioning to ensure drying of packs.
9. Perform sterilizer maintenance according to the sterilizer manufacturer’s IFUs.
10. Periodically have the steam lines and boiler inspected and serviced to prevent boiler
additives from being discharged into the steam.
INSPECTION AND TESTING
Prior to packaging, instruments should be inspected for cleanliness, proper functioning,
and absence of defects. An inadequately cleaned, improperly functioning, or damaged
instrument is a source of frustration to the surgeon, can cause critical delays in surgery, and
can contribute to patient infection or serious injury.
Instruments should be inspected for cleanliness and absence of defects under lighted
magnification.
Box locks, serrations, crevices, and other hard-to-clean areas should be examined for
cleanliness. Deposits left on instruments may prevent sterilization from being achieved and
may dislodge in the patient.
Box locks should be inspected for minute cracks. Cracks are an indication that break-
age is imminent. Other common areas where cracks may appear include hinges, lumens,
and the base of needle jaws. Jaw movement, jaw alignment, and ratchet function should
be checked on all hinged instruments. Joints should work smoothly, and jaws should be
in perfect alignment and not overlap. Ratchets should close easily and hold securely. Joint
movement can be tested by opening and closing the instrument several times. The instru-
ment should close and release with ease. Stiff joints can be caused by inadequate cleaning,
resulting in minute particles remaining in the joint. Stiffness can also result when water
used to clean instruments contains impurities that collect in the joint. Joints that are stiff
should be recleaned if necessary and lubricated with a water-soluble lubricant before they
are packaged for sterilization.
Jaw alignment can be tested by lightly closing the instrument and inspecting the jaws.
Any overlap indicates lack of alignment and need for repair. If there are serrations or teeth
on the jaws, they should meet and mesh perfectly. This can be tested by closing the instru-
ment and holding it up to the light. Light should not be visible through the jaws. Instruments
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with misaligned jaws can damage tissue and will not effectively occlude bleeders. Misalign- 13
ment of hemostatic clamps is a common problem most commonly caused by improper use
of the instrument. Hemostatic clamps should not be used as towel clips, needle holders, or
pliers or for purposes other than those for which they are designed and intended.
Ratchets may be tested by clamping the instrument on the first ratchet, holding it at
the box lock, and lightly tapping the ratchet portion against a solid object. The instrument
should remain closed. Instruments that spring open are faulty and require repair.
The edges of cutting instruments should be inspected for nicks, burrs, and broken tips.
Dull, nicked, or dented cutting edges can cause trauma to tissue. Delicate knives, kera-
tomes, needles, and rongeurs can be tested for burrs and rough edges by passing them
through kidskin. The sensation of a slight drag is an indication of a burr or a rough edge.
Scissors should be tested for cutting ability. Heavy scissors such as Mayo scissors should
cut easily through four layers of gauze. The tips of Metzenbaum and other more delicate
scissors should cut easily through two layers of gauze. One of the most frequent complaints
regarding instruments is that scissors are not sharp. One solution is to create a preventive
maintenance schedule for sharpening scissors before edges become dull and problematic.
Scissors are most often damaged when used to cut material other than that for which they
were designed. One example is the use of Metzenbaum scissors to cut suture material.
A needle holder must hold a needle securely without permitting it to slide or slip during
suturing. Needle holders can be tested by grasping a needle in the jaws and locking on the
second ratchet. If the needle can be turned easily by hand, the instrument should be tagged
for repair or replacement. Inappropriate use is a common cause of damage. Needle holders
should be selected to match needle size. Using a large needle with a delicate needle holder
can spring the jaws of the holder and reduce its holding ability. If the needle holder has
tungsten jaws, identified by gold handles, the jaws can be replaced when worn, thus extend-
ing the overall life of the instrument.
Fiber optic light cords are checked by holding one end up to a light and looking through
the other. Broken glass fibers will appear as black dots. The cord should be replaced if more
than 20% of the area is affected.
Rigid endoscopes, once used only for diagnostic purposes in gynecology, are now used
routinely in every surgical specialty. A rigid endoscope is one of the more expensive instru-
ments used in the operating room. It is also easily damaged, and costly repair can be a
frequent occurrence. Many operating rooms spend more annually for the repair of rigid
endoscopes than for the purchase of new ones. Rigid endoscopes may be damaged in many
ways: during surgery, such as during an arthroscopy procedure when the distal tip is nicked
by an intraarticular shaver; by placement under heavy instruments that can cause a dent or
bend in the shaft and subsequent damage to one or more of the glass rods inside the shaft; by
sterilization using an incorrect cycle; and by careless handling of or dropping of the scope.
Many companies offer scope repair services. It is important to ensure that only original parts
are used during repair. Some third-party repair companies use replacement parts that can
cause the endoscope to fail shortly after repair. The best assurance that the original parts
will be used for repair is to use the original manufacturer’s repair services. Rigid endoscopes
should be checked to ensure that the lens is not cloudy or otherwise occluded. Telescopes
are checked by holding the scope up to the light and observing the lens image at the distal
end. The image should be clear and easily visualized. The light source used in the operating
room should not be used for this test because the high-powered light can cause eye damage.
A more precise test of optical resolution is to use a resolution chart. These can be obtained
at low cost from an optical imaging company. A resolution chart consists of identical sets
of increasingly small bars printed on a circular chart. A set is printed at five locations on
the chart: in the center and at the circumference edges to the left, right, top, and bottom of
the center. The bar sets are numbered. For example, a set of the largest bars is numbered 75
and a set of the smallest bars is labeled 450. The number represents the number of bars that
can be seen if they were lined up across the image. The user should look through the scope
and line up the chart so that it fills the field of view. The number in each of the five locations
should be recorded. The lower the number is, the poorer the resolution. An optical resolu-
tion chart is useful in determining the quality of repair. Measurements should be taken
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when the scope is new (i.e., before the first use), between each use, and after each repair. If
the resolution is lower after repair than before damage, the quality of the repair should be
questioned. This is one way to hold repair companies accountable.
Each time they are processed, insulated instruments (i.e., laparoscopic and robotic)
should be inspected for breaks in the insulation and for areas where the insulation has sepa-
rated from the instrument shaft and appears loose. Both situations are indications that the
insulation is not intact. Multiple studies have shown that insulation failures are not always
detected with visual inspection.23 In addition to visual inspection, an insulation test device
should be used to test insulation integrity. Reusable and single-use insulation testers are
available. Testers are also available that may be used from the sterile field in the operating
room allowing testing just prior to use rather than only prior to packaging. If either defect
is observed, the instrument should be removed from service. Loose or nonintact insulation
is a serious defect and can result in an unintended burn inside the patient at the point where
the insulation is not intact. Insulated instruments are used in endoscopic surgery where the
field of vision is limited by the scope’s distance from the operative site. The site of the burn
may not be within the surgeon’s field of vision and can go unnoticed. The patient may even
be discharged before a complication is noted. In the case of a burn that causes bowel per-
foration, the patient can develop peritonitis, which in turn can lead to additional surgery,
extended recovery, and even death caused by infection.
Microscopic instrumentation should be examined under a microscope to check for
burrs or nicks on tips and to check alignment. Some of the teeth on microscopic forceps are
very difficult to see with the naked eye, and forceps alignment should be inspected under
a microscope.
PREPARATION FOR STERILIZATION OR DISINFECTION
Classification of Surgical Instruments
In 1972, Dr. E. Spaulding classified medical devices and instruments into three categories
based on the risk of infection involved in their use. The categories are critical, semicritical,
and noncritical. This classification was accepted by the Centers for Disease Control and
Prevention and is used today to determine the processing strategy for surgical instruments.
Critical devices are the devices that penetrate mucous membranes and enter normally sterile
areas of the body. Examples of critical devices are instruments used in surgery, needles, and
scalpels. Critical devices must be sterile. Semicritical devices contact, but do not penetrate,
intact mucous membranes and must be high-level disinfected, at a minimum. Examples of
semicritical devices are bronchoscopes, thermometers, and endotracheal tubes. Noncritical
items contact intact skin and require low-level disinfection or cleaning with soap and water.
Examples of noncritical devices are crutches and blood pressure cuffs.
Instruments classified as critical are packaged prior to sterilization. Packaging used for
sterilizing instruments includes paper-plastic pouches, Tyvek/mylar, rigid sterilization con-
tainers, polypropylene wrap, and nonwoven fabric. All packaging should be used in accor-
dance with the manufacturer’s written IFUs.
Packaging
In preparation for sterilization, instruments should be carefully arranged in containers or
baskets with wire mesh or perforated bottoms or in other trays that are compatible with
the intended sterilization method and that may be wrapped in reusable or single-use wrap-
ping material. Alternatively, instruments can be arranged within rigid instrument contain-
ers made of plastic or metal that are compatible with the intended sterilization method.
Rigid containers do not require outer wraps. They offer the advantage of greater protection
to the instruments during handling and transport and can be stacked for efficient storage
after sterilization. Containers should not be stacked within the sterilizer unless indicated in
writing by the manufacturer of the container. Stacking can interfere with sterilization and
drying. Personnel responsible for packaging should refer to the container manufacturer’s
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written IFUs for instructions for cleaning, inspection, replacement of filters and valves, ster-
ilization methodologies, and sterilization exposure times.
15
The combined weight of an instrument set and its containment device should be no
more than 25 lb.4,24,25 Sets weighing more than 25 lb increase the risk of injury to workers
who must lift them during processing and increase the risk that a set will retain moisture
after sterilization. Whenever practical, contents of instrument sets should be standardized.
Standardization reduces the need for inventory, facilitates instrument replacement, and
makes it easier to identify and locate sets needed for a surgical procedure.
Placement
Instruments should be placed so that joints and hinges are in the open position. Instru-
ments with multiple parts should be disassembled. Retractors and other heavy instruments
should be placed on the bottom or at one end of the basket, with lighter instruments strung
open and placed alongside or on top. Sharp edges should be protected. Delicate, fragile, and
lensed instruments should be protected from collision with other instruments in the set.
Fingered mats, foam pockets, scope holders, and tip protectors are examples of items that
protect instruments. Some instrument sets are supplied in specialized containers, either to
secure and protect the instruments, as in the case of fine microsurgical instruments, or to
facilitate their location within the set, as with some orthopedic joint replacement sets.
Plastic/paper pouches should not be placed within sets. Instruments should not be dou-
ble pouched unless the pouch manufacturer has validated the plastic pouch for this use.
Loading and operating any sterilizer should be carried out in accordance with the sterilizer
manufacturer’s written instructions.
Sterilization
Steam sterilization is the most commonly used method for sterilizing instruments. Instru-
ments that can tolerate repeated exposure to the moisture and high temperature of steam
should be steam sterilized. Steam sterilization is an economical and reliable method avail-
able in almost every health care facility. Items sensitive to heat and moisture are sterilized
using alternative methods, such as ethylene oxide and hydrogen peroxide gas plasma. Cut-
ting instruments and other instruments with sharp edges, although they can be processed
in steam, will hold their edges longer if sterilized in low-temperature sterilization systems.
Instruments, pans, containers, and any packaging material, as well as any padding or
protective material used in the pan, must be compatible with the sterilization method.
For example, placing a cotton surgical towel in the bottom of a pan or container is use-
ful in steam sterilization to absorb condensate and facilitate drying. However, cotton or
other cellulose-containing materials cannot be used in some low-temperature sterilization
technologies.
Although one sterilization cycle may be appropriate for the majority of instruments,
there are instrument sets that require extended exposure time. Sterilization cycles should be
selected according to the device, the packaging, and the sterilizer manufacturer’s IFUs. Any
discrepancy between the IFUs should be resolved prior to sterilization. In the absence of
resolution, product testing may be appropriate. Essentially, product testing consists of plac-
ing multiple biological and chemical indicators in the areas within the instrument set that
are considered to be the least accessible to the sterilant, exposing the set to the sterilization
process, and evaluating the results of the chemical and biological monitors. If monitoring
results are negative, the instruments may be washed, packaged in the same manner as they
were packaged for product testing, sterilized, and entered into service. Personnel attempt-
ing to perform product testing should refer to the AAMI publication ST79, Comprehensive
Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities,4 for a much
greater detailed explanation of this process.
Because prions, the causative agent of Creutzfeldt-Jakob disease, are resistant to routine
sterilization cycles, instruments known or suspected to have contacted prion-contaminated
tissue require special procedures and extended sterilization cycles. Extended cycles
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recommended by the Society for Health care Epidemiology of America for prion-contam-
inated instruments include:
• Autoclave (sterilize) at 134°C for 18 minutes in a prevacuum sterilizer.
• Autoclave at 132°C for 1 hour in a gravity displacement sterilizer.
• Immerse in 1 N NaOH (1 N NaOH is a solution of 40 g NaOH in 1 L water) for
1 hour; remove and rinse in water, then transfer to an open pan and autoclave
at 121°C in a gravity displacement sterilizer or 134°C in a prevacuum sterilizer for
1 hour.21
Instruments should be dry prior to sterilization. Processing wet instruments by steam
sterilization may cause difficulties in obtaining a dry set. Sterile items that are not com-
pletely dry at the end of the cycle are considered contaminated because the moisture inside
the package can breach the sterile barrier and create a pathway for microorganisms to enter
the package.
Lumens should not be moistened prior to sterilization unless the device manufacturer
specifies this in the IFUs.
Sterilizing wet instruments in ethylene oxide can lead to the formation of ethylene gly-
col (antifreeze), a by-product of water and ethylene oxide. This chemical by-product is not
removed during the aeration process and can harm patients. Wet instruments processed in
hydrogen peroxide gas plasma or vapor will cause the sterilization cycle to cancel.
Immediate Use Steam Sterilization
IUSS, formerly known as flash sterilization, is sterilization that does not include a dry time
or may include a very minimal dry time. Immediate use is defined as the shortest possible
time between the removal of a sterilized item from the sterilizer and its aseptic transfer to the
sterile field. Items subject to IUSS may not be stored for future use nor held from one case
to another.26 IUSS cycles do not include a dry time or may include a very short dry period.
Immediate use is not to be used for purposes of convenience or as a substitute for sufficient
inventory.6 Previously, IUSS was carried out in an open pan and cleaning was often done
in an area not specifically dedicated for decontamination under less than ideal conditions.
Current guidelines call for cleaning to be carried out in a dedicated decontamination area,
that the same critical reprocessing steps (such as cleaning, decontaminating, and transport-
ing sterilized items) must be followed, and that items are sterilized in a container.26
Disinfection
Common liquid chemicals used to disinfect surgical instruments include glutaraldehyde,
hydrogen peroxide, peracetic acid, and orthophthalaldehyde. Each has unique characteristics
and should be chosen in accordance with department needs and instrument compatibility.
Instruments to be disinfected should be cleaned and dried before placement into the
disinfectant. Moisture from instruments that are not dry can dilute the disinfectant, causing
it to lose its effectiveness. The disinfectant solution should be tested for minimum effec-
tive concentration (MEC) according to the manufacturer’s instructions. Testing should be
performed before each use. If the MEC falls below the accepted level as indicated by the
test strip, the solution should be discarded. The immersion time required for high-level
disinfection is indicated on the product’s label and should be strictly adhered to. Follow-
ing disinfection, items should be rinsed with copious amounts of water according to the
manufacturer’s instructions. Disinfected instruments should be allowed to dry and should
be stored in a clean, dry area in a manner that protects the device from contamination.
Personnel responsible for carrying out high-level disinfection should refer to the AORN
Recommended Practices for High-Level Disinfection.27
IDENTIFICATION SYSTEMS
Instrument identification and related instrument-tracking systems are becoming com-
monplace in health care facilities. Instrument identification is used for inventory control,
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reordering, and as a deterrent to theft. Color coding and etching are two methods of coding. 17
Color coding may be adapted for a specific instrument set, specialty, department, or sur-
geon. Most systems use a hard color coating that is permanently fused to the instrument’s
ring handle. For example, a set with green ring handles may indicate that the set belongs
within a specific specialty. If colored tape is used to mark instruments, it is important to
follow the manufacturer’s instructions for proper tape application and to obtain written
verification of tape compatibility with the intended sterilization method. It is important to
inspect the condition of the tape before packaging the instrument. Tapes may peel or flake
over time and harbor microorganisms. Loose, cracked, or flaking tape must be removed,
all adhesive removed, and new tape applied. For these reasons, taping is not a preferred
method of marking instruments.
Another method of instrument identification is etching or engraving the shaft with the
desired information. Vibrating mechanical engravers that scratch the surface should not
be used because they break down the rust-resistant protective coating of the instrument,
potentially allowing corrosion to begin. When a mechanical engraver is used in the area
of the box lock, minute fault lines can be created and can result in premature breakage of
the lock. Newer acid or laser etching processes are preferred because they do not harm the
instruments.
It is important to check with the manufacturer of the instrument to ensure that the
instrument can withstand the desired coding system. Many instrument companies offer
engraving at the time of purchase.
CLASSIFICATION OF INSTRUMENTS
The three broad categories of instruments are handheld, nonpowered surgical instru-
ments; powered tools or devices; and endoscopic equipment and instrumentation.
Handheld, nonpowered instruments are used for cutting, clamping, grasping, retracting,
chiseling, and manipulating tissue and bone. Powered instruments are used for drill-
ing, sawing, or cutting bone and cauterizing tissue. Drills, oscillating and sagittal saws,
and wire drivers are examples of powered devices. They may be powered by electricity,
compressed gas, or battery. Endoscopic equipment and instruments are used to perform
minimally invasive surgery and to examine internal organs through very small incisions.
Examples of endoscopic instruments are rigid and flexible endoscopes along with cam-
eras and light cords.
Interventional procedures under advanced imaging systems are increasingly being per-
formed in the operating room. Many of the devices that are used in these procedures are
single-use disposable and outside the scope of this chapter. These devices should not be
reprocessed within health care facilities.
The following information describes the general classifications of handheld, nonpow-
ered instruments. Descriptions and examples are included. The names of the instruments
may vary with the manufacturer, the geographic location within the country, the surgeon’s
preference, and the health care facility in which they are used. The different instrument
names are used interchangeably by surgeons and staff. In this textbook, the names given for
instruments that appear in the photographs are the manufacturer’s names.
Handheld, Nonpowered General Surgery Instruments
Clamps
Hemostats are used to control the flow of blood. The jaws of a hemostat contain horizontal
serrations designed to close the severed edge of a blood vessel, allowing for minimal tissue
damage. There are several sizes of hemostats: for example, mosquito, Crile, Halsted, and
Mayo-Péan. The larger hemostats are also used to clamp tissue.
Occluding clamps are used to clamp bowel or vessels that will be reanastomosed. The
jaws of occluding clamps used on bowel contain vertical serrations. Occluding clamps
used on blood vessels contain multiple longitudinal rows of finely meshed teeth. Both are
designed to prevent leakage while minimizing trauma to the tissue.
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1-1 Components of a typical clamping Ratchet Jaws
instrument. Box Lock Tip
Ring Shank
Handles
1-2 Scissors. Left to right: Mayo dis-
secting scissors, straight; Metzen-
baum dissecting scissors; iris scissors,
straight; and Westcott tenotomy
scissors, straight.
Cutting Instruments
Knife handles are usually straight handles that hold knife blades of various shapes that are
used for incision and dissection. Examples of knife handles are Bard-Parker and Beaver.
Other knives, such as Fisher tonsil, Smillie cartilage, and myringotomy knives, incorporate
the blade into the structure of the handle.
Scissors exist in many different forms; the two basic types are dissection and suture
scissors. Dissection scissors are manufactured according to their intended purpose. Small,
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delicate scissors, such as iris or Westcott scissors, are used in ophthalmic, plastic, and
microscopic surgery. Metzenbaum scissors are used in intraabdominal and other general
surgeries. More sturdy scissors such as Mayo scissors are appropriate for cutting fascia or
sutures. Metzenbaum and Mayo scissors are found in most general surgery instrument sets.
Curvature, weight, size, and flexibility vary according to intended use.
Retractors
Retractors are used to hold back the edges of a wound to permit visualization of the opera-
tive site. A handheld retractor consists of a shaft to hold and an end piece for retracting. The
end piece may be a hook, a blade, or a rake. Examples of handheld retractors are skin hook,
Senn, Army Navy, Parker, and rake. Self-retaining retractors do not require that someone
hold them in place. Some self-retaining retractors consist of two blades that are held apart
by a ratchet, such as the weitlaner, Jansen, and Gelpi. Larger self-retaining retractors consist
of a series of blades that attach to bars that are held in place by a screw or similar device. The
bars that hold the blades may be attached to the operating table itself. Examples of larger
self-retaining retractors are the O’Sullivan-O’Connor, Thompson, and Balfour.
1-3 Handheld retractors. Top to
bottom: Skin hook and double-ended
Richardson retractor.
1-4 Self-retaining retractors. Top
to bottom: Weitlaner retractor and
unassembled O’Sullivan-O’Connor
retractor.
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Grasping and Holding Instruments
Forceps, also referred to as pickups, are shaped like tweezers and are used to grasp and hold
tissue. The tips of forceps vary according to their intended uses. The tips may be smooth or
serrated or have single or multiple teeth that interlock.
1-5 Grasping and holding instruments. Top to bottom, left to right: Adson tissue forceps without teeth;
Ferris Smith tissue forceps (1 × 2); tissue forceps with teeth (1 × 2). Tips on the right, top to bottom: Fer-
ris Smith tissue forceps (1 × 2); tissue forceps with teeth (1 × 2); and Adson tissue forceps without teeth.
Examples of common clamp-shaped grasping instruments include the Ochsner, Kocher,
Allis, and Babcock. The Ochsner and Kocher forceps have a heavy tooth at the jaw tip and
are used to grasp and hold tissue without concern for trauma. The Allis clamp has multiple
noncrushing teeth and is used to grasp tissue without crushing. The Babcock clamp tissue
forceps has a curved, fenestrated tip without teeth. It is useful for grasping structures such
as the fallopian tube or ureter.
A
A
B
B
1-6 Grasping instruments. Top to bottom: A, Ochsner forceps and tip; B, Allis tissue forceps
and tip.
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A needle holder is a grasping instrument designed to secure a suture needle in its jaws.
A needle holder may be a clamp type with a ratchet handle or may be a spring-action type.
Size and jaw surface vary and are selected with regard to the procedure and the size of the
needle being used.
A towel clamp is a holding instrument that is used to secure towels and drapes in place.
The tip may be blunt or pointed and designed to penetrate.
A sponge holder is a clamplike instrument with rounded jaws that is used to hold a
folded 4 × 4 sponge.
1-7 Grasping instruments. Top to
bottom: Foerster sponge forceps with
sponge in the jaws, and Backhaus
towel forceps.
1-8 Accessory instruments. Top to
bottom: Frazier suction tube with stylet
below; Poole abdominal suction tube
with shield below; and Yankauer suc-
tion tube with tip off.
Accessory Instruments 21
Suction instruments/tubes vary in length, curvature, and lumen diameter and are selected
according to the type of surgery and the amount and depth of fluid to be suctioned. Minor,
delicate surgery and surgery on small vessels require small-diameter suction. Two examples
of small-diameter suction tubes are Frazier and antrum. Abdominal, deep-joint, and other
general surgeries usually require a Yankauer or Poole suction tube. Poole suction tubes are
used in areas where the fluid is deep. Yankauer suction tubes are curved, and the suction
opening is on the tip. Poole suction tubes are straight and have multiple holes along the
length of the shaft.
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REPAIR CONSIDERATIONS
Preventive maintenance coupled with careful handling and proper use are the best ways to
prevent deterioration and equipment failure and to extend the lives of instruments. Regard-
less of the care in handling and use, some instruments will need replacement or repair. The
facility may choose to send the item to the original manufacturer or an outside contractor
or may utilize the services of an independent service manufacturer that repairs instruments
and performs preventive maintenance on site. When selecting a repair facility or service,
the following should be considered:
• Company reputation
• References from other users
• Liability and shipping insurance
• Cost
• Response time
• Turnaround time
• Loaner program
• Repair exchanges: Will your original equipment be returned?
• Quality measures: Is quality measured according to ISO 9000?
• Replacement parts: Are original manufacturer parts provided?
• On-site inspection visits: Are they unrestricted?
INSTRUMENT TRACKING
Several companies offer instrument-tracking software that allows the facility to monitor the
productivity of processing personnel and track the use, inventory, and location of surgical
instrument sets. These programs make it possible to know where any set is within the sys-
tem at any time. Instruments can be tracked by serial number, where appropriate, according
to the patient, surgeon, and procedure. This information would be particularly helpful, for
example, in tracking sets used in neurosurgery when the patient is known, or suspected, to
have Creutzfeldt-Jakob disease and the set must be quarantined until a definitive diagnosis
is made. Bar coding can be used to identify whether a set is complete and what needs to
be ordered when a replacement is necessary. Replacement orders can be made via an auto-
mated procurement system that interfaces with the tracking program. Data from a track-
ing system can be used to identify the costs of acquisition and repair. Information about
repair rates, reasons for repair, and costs is useful when determining where to focus quality-
improvement efforts. Tracking systems also facilitate the optimization of instrument-set
inventory based on actual use.
SUMMARY
Surgical instruments are a major financial investment in every surgical facility, and pro-
cesses should be in place to protect this investment. The life of a surgical instrument is
dependent upon the way it is used and the care it receives. It is the responsibility of the
surgical team and the personnel who process the instruments to handle them carefully, use
them for the purpose for which they were designed, and process and maintain them appro-
priately. The extra time it takes to properly care for instruments is well worth the investment
and is always in the patients’ best interests.
REFERENCES
1. Brennan T, et al.: Incidence of adverse events and negligence in hospitalized patients — results of
the Harvard Medical Practice Study 1, N Engl J Med I, Feb 9, 1991.
2. Medical Errors: A report by the staff of US Senator Barbara Boxer. 2014, http://www.boxer.senate
.gov/en/press/releases/042514.cfm. Accessed May 8, 2014.
3. Agency for Healthcare Research and Quality (AHRQ): Never events, http://psnet.ahrq.gov/prim
er.aspx?primerID=3. Accessed May 8, 2014.
22 UNIT 1 Instrument Preparation for Surgery
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4. AAMI/ANSI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013: Comprehensive guide to
steam sterilization and sterility assurance in health care facilities, Arlington, Va, 2013, Associa-
tion for the Advancement of Medical Instrumentation.
5. AORN: Recommended Practices for Cleaning and Care of Surgical Instruments and Powered
Equipment. In: Perioperative standards and recommended practices, Denver, Colo, 2014, AORN.
6. Rutala WA, Weber DJ, and the Healthcare Infection Control Committee Practices Advisory Com-
mittee (HICPAC): Guideline for disinfection and sterilization in healthcare facilities, http://www.
cms.gov/SurveyCertificationGenInfo/downloads/SCLetter09_55.pdf, 2008. Accessed May 7, 2014.
7. Centers for Medicare and Medicaid Services (CMS): Flash sterilization clarification-FY 2010 Am-
bulatory Surgical Center (ASC) surveys. https://www.cms.gov/Medicare/Provider-Enrollment-
and Certification/SurveyCertificationGenInfo/downloads/SCLetter09_55.pdf US. Accessed May
19, 2014.
8. Department of Labor: Occupational Safety and Health Administration (OSHA) Bloodborne
Pathogens, CFR 29:1030, 1910, https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_
id=10051&p_table=STANDARDS. Accessed May 10, 2014.
9. Holland SP et al: Update on toxic anterior segment syndrome, http://unboundmedicine.com/
medline/. Accessed May 8, 2014.
10. Mathys KC, et al.: Identification of unknown intraocular material, J Cataract Refract Surg 34:
465–469, 2008.
11. Maier P, et al.: Toxic anterior segment syndrome following penetrating keratoplasty, Arch Oph-
thalmol 126(12):1677–1681, 2008.
12. Hellinger WC, et al.: Outbreak of toxic anterior segment syndrome following cataract surgery
associated with impurities in autoclave moisture, Infect Control Hosp Epidemiol 27(3):294–298,
2006.
13. American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Reg-
istered Nurses Recommended Practices for Cleaning and Sterilizing Intraocular Surgical Instru-
ments: Special report, J Cataract Refract Surg 32(2):22–28, 2007.
14. Ofstead CL, et al.: Re-evaluating endoscopy-associated infection risk estimates and their implica-
tions, AJIC: Am J Infect Control 41(8):734–736, 2013.
15. Ofstead CL, et al.: Endoscope reprocessing methods: a prospective study on the impact of human
factors and automation, Gastroenterol Nurs 33:304–311, 2010.
16. Schaefer MK, et al.: Infection control assessment of ambulatory surgical centers, JAMA 303:
2273–2279, 2010.
17. Langlay AM, et al.: Reported gastrointestinal endoscope reprocessing lapses: the tip of the ice-
berg, AJIC: Am J Infect Control 41(8):1188–1194, 2013.
18. Multisociety Guideline on Reprocessing Flexible Gastrointestinal Endoscopes 2011. Ameri-
can Society for Gastrointestinal Surgery, https://www.google.com/search?newwindow=1&
site=&source=hp&q=multi+society+guideline+for+reprocessing+flexible&oq=Multisocie
ty&gs_l=hp.1.0.0i10i30l2.1644.4278.0.5939.13.12.0.1.1.0.259.1845.1j10j1.12.0....0...1c.1.43.
hp..2.11.1456.0.cj_1kvZMURc. Accessed May 9, 2014.
19. ASGE and SHEA: Updated Announcement, http://www.shea-online.org/View/ArticleId/82/ASGE-
and-SHEA-Issue-Updated-Multisociety-Guideline-on-Reprocessing-Flexible-Gastrointestinal-
Endosco.aspx. Accessed May 9, 2014.
20. Moses L, et al.: Prevention of flexible bronchoscopy-associated infection: consensus statement,
Chest 128(3):1742–1755, 2005, http://dx.doi.org/10.1378/chest.128.3.1742.
21. Rutala W, Weber D: SHEA guideline: guideline for disinfection and sterilization of prion-
contaminated medical instruments, Infect Control Hosp Epidemiol 31(2):107–117, Feb 2010.
22. McDonnell G, et al.: Cleaning, disinfection and sterilization of surface prion contamination,
J Hosp Infect 85(4):268–273, 2013.
23. Montero PN, et al.: Insulation failure in laparoscopic instruments, Surg Endosc 24(2):462–465,
2010.
24. AORN: Recommended Practices for Selection and Use of Packaging Systems. In: Perioperative
standards and recommended practices, Denver, Colo, 2014, AORN.
25. AAMI/ANSI ST77: Containment Devices for Reusable Medical Device Sterilization, Arlington, Va,
2013, Association for the Advancement of Medical Instrumentation.
26. AAMI: Immediate-Use Steam Sterilization, https://www.aami.org/publications/standards/ST79_
Immediate_Use_Statement.pdf. Accessed May 10, 2014.
27. AORN: Recommended Practices for High-Level Disinfection. In: Perioperative standards and
recommended practices, Denver, Colo, 2014, AORN.
CHAPTER 1 Care and Handling of Surgical Instruments 23
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CHAPTER 2
Sterilization Container Systems*
Additional images are available at: INTRODUCTION
evolve.elsevier.com/Tighe/instrumentation
Sterilization packaging systems are required to secure instrument sets, provide for sterilant
penetration of contents, and withstand multiple handling events during a prolonged period
of storage and handling. There are two types of containment devices: rigid reusable sealed
containers with filters and valve systems and perforated case trays, which are designed to
be wrapped. Rigid reusable container systems provide an efficient, cost-effective way to
package and protect surgical devices in order to sterilize the contents, maintain the sterility
of the contents until the package is opened at point of use, and to allow for the removal of
contents without contamination; some containment devices can be designed to aid in the
efficiency of the surgical procedure. They are sealed systems and serve as an alternative to
disposable and reusable sterilization wrap. The rigid sides of a sterilization container pro-
tect fragile devices within and eliminate the tears associated with sterilization wrap. Some
containers are cleared for steam sterilization only, others for low-temperature sterilization.
Only one is universal and corrosion resistant, cleared by the FDA for all current sterilization
methods from steam to various low-temperature methods.
Rigid container systems have been used in the United States for over three decades with
the preference for sealed containers instead of wrapped sets increasing in recent years.
The rigid sterilization container systems are intended to be used as packaging for medical
devices before, during, and after sterilization. Sterilization is required to secure instrument
sets, provide for sterilant penetration of contents, and withstand multiple handling events
during a prolonged period of storage and handling.
GENERAL DESCRIPTION
Containment devices for reusable medical device sterilization include perforated trays,
case trays with a lid and base, and sealed container systems. Containers are most typi-
cally constructed from anodized aluminum and have a boxlike structure with removable
lids, base, filter mechanism, and gasket to secure a tight seal. Sealed containers include
tamper-proof locking mechanisms, a location for labeling set name and external indica-
tor/load card, and handles for ease of transport. All sterilization containers have a filter
mechanism designed to permit the sterilant to enter and exit as well as to act as a microbial
barrier. Filters may be disposable and manufactured from cellulosic, polypropylene, or
synthetic materials. Most sealed container systems are designed for terminal sterilization
and extended storage, utilizing a disposable filter secured by a filter retention plate with
a gasket. Some containers have a filter-less system equipped with a pressure-sensitive or
thermostatic valve that opens and closes within the sterilizer. Such devices are cleared for
prevacuum steam sterilization only, and a few may be used for sealed flash sterilization,
including gravity displacement steam.
All sealed container systems require an inner basket or tray to secure the contents of
the load. The basket may contain accessories including instrument brackets, partitions,
and posts to secure, organize, and protect contents. Some may include stackable trays to
*This chapter was written by Marcia Frieze, CEO of Case Medical Inc., South Hackensack, New Jersey.
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separate contents into levels and protect contents from damage during transport. Peel
pouches may not be used within sealed or wrapped container systems as they are not able
to stand on their sides for sterilization. Small highly perforated trays or insert boxes to
ensure adequate air removal are recommended in lieu of pouches. All perforated trays and
case trays may either be wrapped with medical grade wrappers or placed within a sealed
container cleared for the intended purpose. Although the wrapper must be both porous for
sterilant penetration and intact, it must also be free of rips and tears. The perforated basket
should be designed for decontamination, cleaning, and rinsing of contents by means of
manual or automated methods.
2-1 SteriTite Container group with MediTray basket inserts. (Courtesy Case Medical Inc., South
Hackensack, N.J.)
2-2 SteriTite Container.
(Courtesy Case Medical Inc., South
Hackensack, N.J.)
CHAPTER 2 Sterilization Container Systems 25
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2-3 Small, perforated metal case
basket inserts.
2-4 SteriTite container with basket
designed for Solera instrumentation.
(Courtesy Case Medical Inc., South
Hackensack, N.J., and Medtronic,
Louisville, Colo.)
CARE AND HANDLING
Rigid sterilization systems should be cleaned and inspected after each use. The disposable
filter should be discarded and the components disassembled for cleaning, including remov-
ing the lid from the base and removing the filter retention plate and placing it in a perforated
basket. According to AAMI ST79 guidelines, “For all reusable devices, the first and most
important step in the decontamination of medical devices is thorough rinsing and cleaning.
Cleaning primarily removes rather than kills microorganisms.”1 Valve-type closures must
be decontaminated following the manufacturer’s written instructions. Particular attention
should be given to the type of detergent used because alkaline cleaners and those followed
by acid neutralizers can damage the passive layer of sealed systems, creating the oppor-
tunity for corrosion to develop. Validated, pH-neutral cleaners including multienzymatic
detergents can be used for both manual and automated cleaning of containment devices.
If cleaned manually, a dry, lint-free cloth should be used to wipe off additional moisture.
If placed in a cart washer for automated cleaning, ensure that all components are disas-
sembled and placed at an angle to prevent water collection. A chemical disinfectant wipe
26 UNIT 1 Instrument Preparation for Surgery
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should never be used in lieu of a thorough cleaning and rinsing of the container after each
use. Inspection procedures should include verification that gaskets are intact and latches are
properly functioning. If the hardware is riveted to the container, such devices may become
compromised over time as rivets loosen and create pathways for entry of microorganisms.
2-5 Case Solutions pH neutral
cleaning products. (Courtesy Case
Medical, Inc., South Hackensack, N.J.)
Aseptic presentation is important with all sterilization packaging systems. To properly 27
remove the inner basket or tray from the container, the sides of the basket must not touch
the edge of the container or else the contents will be considered contaminated. Neither the
exterior of the container nor the outer wrapping of wrapped trays is sterile. Proper removal
and handling at point of use is required. All containers sterilized in an outside contract
facility should be double wrapped in plastic bags during transport.
Furthermore, the contents of the container system must be dry. Wet packs are consid-
ered nonsterile. The contents of the containment device, if wet, must be reprocessed. The
only exception to this is for flashed items that are properly cleaned, decontaminated, and
sterilized for immediate use only. To manage wet packs, be sure that the contents are dry
prior to sterilization. Preheat the load to reduce the formation of condensation during the
cycle, evaluate the weight and density of the set, and review the manufacturer’s recom-
mendations for processing, including proper cool-down prior to transport to sterile stor-
age. Plastic containers may require additional drying time as they do not have the thermal
conductivity properties of aluminum and other metals. Metal materials used to construct
containment devices must be corrosion resistant or treated to improve their corrosion resis-
tance. These materials must not affect the biocompatibility of the device.
STORAGE AND STERILITY MAINTENANCE
Sterilized items should be stored in well-ventilated, limited-access areas with controlled
temperature and humidity, separated from cleaned items. Sterilized items should not be
stored near sinks or any water source from which they can become wet. Although sealed
containers may be stacked on top of one another for storage and transport, wrapped pack-
ages should not be stacked to avoid tears, crushing, bending, or cramming by other pack-
ages. Perforated or wire shelving is commonly used for storage of containment systems to
avoid dust accumulation. Wire shelving can contribute to torn wrappers when sterile pack-
ages are removed from the shelf. The addition of pull out, perforated shelves can address
the environmental as well as ergonomic concerns when removing heavy items from carts
and shelving.
The shelf life of containment devices may be determined by time or conditions during
storage and handling. Event-related sterility maintenance means that if a package is not
contaminated during storage and handling, it will remain sterile indefinitely. Shelf life is
related to an event that can occur when sterilized items can be compromised or contami-
nated. Proper packaging, storage, handling, and environmental conditions can affect how
CHAPTER 2 Sterilization Container Systems
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long a product will remain sterile. Most facilities have eliminated time dating with expira-
tion dates and have gone to an event-related sterility maintenance program. Items pack-
aged in a sealed container have a longer shelf life than wrapped items. Sealed containers are
not as easily compromised by environmental or handling issues, nor is there an opportu-
nity for tears in the wrapper.
INSTRUMENT PLACEMENT
There are specific guidelines for the placement and organization of surgical instrumen-
tation within sealed containers. Sealed containers must utilize inserts, such as perfo-
rated or mesh instrument baskets or trays to secure the contents. Some sealed container
systems have been cleared for stacking of multiple levels of inserts to distribute the load.
Selecting the correct size container is dependent on the length, height, and volume of the
instrumentation within the set to be containerized. AAMI ST79 states, “If a rigid ster-
ilization container is used, the basket(s) placed in the container system should be large
enough to allow the metal mass of instruments and devices to be distributed equally in
the basket(s). . . Instruments should be positioned to allow the sterilant to come into
contact with all surfaces. All jointed instruments should be in the open or unlocked
position.” Brackets, posts, partitions, and stringers may be used to secure instruments
in place or in an open position. Another important guideline is placing heavy instru-
ments below lighter, delicate instrumentation to avoid damage. The user must refer to
the medical device manufacturer’s written instructions regarding set preparation and
assembly.
Weight and density of the set are integral components to consider during the configu-
ration of the instrument set. If a set is too densely packed or heavy, sterilization efficacy,
degree of dryness, and proper body mechanics may be adversely affected. ST79 recom-
mends that, “The weight of the instrument set should be based on whether personnel
can use proper body mechanics in carrying the set, on the design and density of indi-
vidual instruments comprising the set, on the recommendations of the medical device
manufacturer and on the distribution of mass in the set and sterilizer load.” In some cases
where the set is too heavy and exceeds the AAMI and AORN recommended total weight of
25 lb, the set should be distributed in more than one sealed container. In other cases, a
dense set can be stacked in multiple baskets within the sealed container for better orga-
nization and efficiency. The heavier sets should be placed below the delicate instrumenta-
tion. Sets should be organized to correlate with the procedure. Items used first should be
placed on top or easily accessible.
2-6 Cranial tray with instrumentation.
(Courtesy Case Medical Inc., South
Hackensack,N.J.)
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2-7 Spinal tray with instrumentation.
(Courtesy Case Medical Inc., South
Hackensack, N.J.)
Graphics trays or loaners are offered for specialty sets, primarily for orthopedic pro-
cedures. Some containment devices that are designed for specific instrument sets may
include graphics to locate and identify placement of devices within the tray system. The
specific information may be silk screened, laser etched, or stamped into the tray base.
Custom brackets or inserts included in the tray provide instrument protection and a spe-
cific location for a device to be placed. In the past, such graphic trays were designed to
be wrapped, but recently a number of sets have been placed alternatively in rigid reus-
able, sealed containers. Some sealed containers meet the size requirements of the German
Institute for Standardization (DIN) and have proven to provide seamless integration from
wrap to containerization.
SELECTION AND SPECIAL CONSIDERATIONS
When selecting a container system, it is important to identify the needs of the facility and to
assess what the container system is capable of and for which sterilizers it is compatible. Not
all container systems are compatible with low-temperature sterilization or with lumened
devices. For example, a container cleared for steam sterilization may not be suitable for use
in a different modality. If not provided in the labeling or instructions for use (IFUs), the
user should consult the container system manufacturer for testing and validation confirma-
tion of the container system for a specific sterilization method.
There are numerous factors to consider when selecting a container system. Among
these are options such as container size, estimated life of the container system, asep-
tic presentation of contents, protective accessories for tray customization, ease of use,
maximum load, and cost effectiveness. It is important to review any special instructions
for decontamination and handling. Although manufacturers are required to validate for
efficacy and safety, verification of the packaging within the hospital system is recom-
mended in the guidelines. When verifying containers at health care facilities, biological
indicators and integrators (process indicators) must be placed within the containers in
areas that will provide the greatest challenge. This may include areas such as the opposing
corners of the instrument basket and the underside of the lid away from the perforated
area (vent).
MANUFACTURERS’ INSTRUCTIONS FOR USE
The written recommendations of the device manufacturer should always be followed. The
device manufacturer is responsible for ensuring that the device can be effectively cleaned
and sterilized. It is important that all rigid containers be completely disassembled, washed,
CHAPTER 2 Sterilization Container Systems 29
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and dried after each use. Most sterilization container systems are manufactured from anod-
ized aluminum alloy, which requires cleaning with a pH neutral detergent to maintain
integrity. Thorough rinsing is essential for the removal of all soil and for removal of cleaning
agents. A truly dry container and contents are critical for sterilization. Some low-tempera-
ture sterilization systems will abort if the container and its contents are not properly dried.
Moisture within containers can create wet packs.
An extended reprocessing time may be required when container systems are processed
in gravity displacement steam. In addition, the materials of construction and the design of
the containment device itself may increase either processing time or drying time. Internal
chemical indicators or integrators should be placed in the corner of each inner basket for
routine monitoring. Biological indicators should be utilized for verification of an instru-
ment set and for weekly or daily monitoring of the load. In addition, an external indicator
and tamper-evident seal, which serves as a security lock, should be assembled to the con-
tainer prior to sterilization. Such indicators demonstrate that the set has been processed
when a color change is confirmed.
Containment devices must be placed flat on the sterilizer cart. If wrapped items are
included in the sterilizer load, they must be placed on the shelf above the containment
device to avoid moisture in the load. To minimize the potential for condensate forma-
tion within the sealed container system, a gradual cool down is required. The door of
the sterilizer may be cracked after processing for a minimum of 10 to 15 minutes to
facilitate a gradual cool down and reduce condensate formation. Wet packs are unac-
ceptable for terminal sterilization and storage. Once removed from the sterilizer, the
containers should be placed on a rack in a draft-free area until cool enough for han-
dling and then placed in storage or transported to point of use. The only exception is
when flash sterilization or immediate use sterilization is required in an emergency.
Moisture will most likely occur when items are processed for immediate use without
proper drying.
REGULATORY REQUIREMENTS
All containment devices, whether sealed containers or wrapped trays, are considered Class
II medical devices and must be cleared by the FDA for their intended use. According to the
Association of periOperative Registered Nurses (AORN) recommended practices,2 “Pack-
aging systems should be evaluated before purchase and use to ensure that items to be pack-
aged can be sterilized by the specific sterilizers and/or sterilization methods to be used and
should be compatible with the specific sterilization process for which it is designed.” AAMI
ST773 provides guidelines for manufacturers of containment devices for reusable medical
devices. Many international standards have been adopted into U.S. documents with the goal
of providing minimal labeling, safety, performance, and validation requirements. Manufac-
turers are required to validate their containment devices and provide the data to the FDA
for clearance. Efficacy testing, material compatibility, sterility maintenance, reuse testing,
and whole package microbial testing are examples of the various studies to be presented
to the FDA and required before containment devices may be sold to health care facilities.
However, health care personnel bear the ultimate responsibility for ensuring that the con-
tainment device or sterilization packaging is compatible with, or can be effectively sterilized
within, the health care facility.
REFERENCES
1. ANSI/AAMI ST79: 2008/2010 & A12010: Comprehensive Guide to Steam Sterilization and Steril-
ity Assurance in Health Care Facilities, Arlington, Va, 2010, Association for the Advancement of
Medical Instrumentation.
2. AORN Recommended Practice for Selection and Use of Packaging Systems for Sterilization,
Denver, Colo, 2010, AORN.
3. ANSI/AAMI ST77: 2006/2013: Containment Devices for Reusable Medical Device Serilization,
Arlington, Va, 2013, Association for the Advancement of Medical Instrumentation.
30 UNIT 1 Instrument Preparation for Surgery
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UNIT TWO: GENERAL SURGERY CHAPTER 3
Operating Room Suite/Basic Laparotomy
10 Additional images are available at:
9 evolve.elsevier.com/Tighe/instrumentation
8 3-1 Operating room equipment: 1,
ring stand; 2, back table; 3, Mayo
63 stand; 4, surgical step lifts; 5, sponge
bucket; 6, sponge count bags;
2 7, garbage; 8, timeout briefing/
debriefing poster; 9, nurses’ station/
desk; 10, integration/video equipment
(i.e., printer); 11, stop/start clock;
12, nitrogen regulator.
11
12
45 1
7
3-2 Basic back table setup.
CHAPTER 3 Operating Room Suite/Basic Laparotomy 31
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3-3 Two basic Mayo stand setups
for starting a procedure. The same
instruments and equipment are on
the stands, just arranged differently.
The arrangement is determined by the
individual scrub personnel.
A laparotomy is an incision into the abdominal cavity for the purpose of exploration or the
performance of an operative procedure on organs or structures within.
To start the procedure, a dissection set is placed on the Mayo stand. Possible instruments
needed include:
1. A Bard-Parker scalpel handle #4 with a #20 blade, used for the skin incision.
2. A Bard-Parker scalpel handle #3 with a #10 blade, used for the abdominal layers.
3. 2 Ferris Smith tissue forceps, used for grasping the abdominal layers.
4. A curved Mayo dissecting scissors, used for the dissection.
5. A straight Mayo dissecting scissors, used for cutting the suture.
6. 6 straight Crile hemostatic forceps, used for clamping the bleeders.
7. 6 curved Crile hemostatic forceps, used for clamping bleeders in the deeper abdomen.
8. 2 Army Navy retractors, used for retracting the abdominal layers.
9. 2 small Richardson retractors, used for retracting the abdominal layers.
During the exploration, longer and heavier instruments may be needed. Add the follow-
ing instruments to the Mayo stand:
1. A Bard-Parker scalpel handle #7 with a #10 blade, used for the deeper dissection.
2. A Bard-Parker scalpel handle long #3 with a #10 blade, used for the deeper dissection.
3. A Mayo-Péan hemostatic forceps, used for clamping the deeper bleeders.
4. A Babcock clamp tissue forceps, used for “running the bowel” and retracting structures
without injury to tissue.
5. A tonsil hemostatic forceps, used for clamping the deeper bleeders.
If heavy graspers are needed, add the following instruments: Kocher clamps, regular and
long, used for grasping structures that may be removed; Ochsner hemostatic forceps; and
Allis tissue forceps, regular and long.
For deeper retraction, add the following instruments: a large Richardson retractor;
medium and wide Deaver retractors; Ochsner malleable retractors (ribbons); and a self-
retaining retractor such as a Balfour, O’Sullivan-O’Connor, Harrington, or Thompson.
After the exploration has been completed, remove the instruments from the sterile field,
and bring up the following incision-closing instruments:
1. 4 curved Crile hemostatic forceps, used to grasp the peritoneum.
2. An Army Navy retractor, used to retract the abdominal layers.
3. A Ferris Smith tissue forceps, used to hold the layer being closed.
4. A 7-inch Mayo needle holder with suture and needle, used for suturing the tissue.
5. Straight Mayo dissecting scissors, used for cutting suture.
To close the skin, possible instruments include Adson tissue forceps with teeth used to
grasp the tissue and a skin stapler.
32 UNIT 2 General Surgery
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3-4 Left to right: 2 Mayo-Hegar
needle holders, 7 inch; 2 Ayers needle
holders, 8 inch; 3 Foerster sponge
forceps; 2 Mixter hemostatic forceps,
long, fine-point; 2 Babcock clamp
tissue forceps, long; 2 Allis tissue
forceps, long; 6 Ochsner hemostatic
forceps, long, straight; 4 Mayo-Péan
hemostatic forceps, long, curved; 6
tonsil hemostatic forceps; 2 Westphal
hemostatic forceps; 4 Babcock clamp
tissue forceps, short; 4 Allis tissue
forceps, short; 8 Crile hemostatic
forceps, curved, 6½ inch; 1 Halsted
mosquito hemostatic forceps, straight;
6 paper drape clips.
3-5 Left to right: 2 Bard-Parker knife
handles #4; 1 Bard-Parker knife handle
#7; 1 Bard-Parker knife handle #3, long;
1 Mayo dissecting scissors, curved;
2 Mayo dissecting scissors, straight;
1 Metzenbaum dissecting scissors, 7
inch; 1 Snowden-Pencer dissecting
scissors, curved; 1 Snowden-Pencer
dissecting scissors, straight.
CHAPTER 3 Operating Room Suite/Basic Laparotomy 33
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3-6 Left to right: 2 Adson tissue for
ceps with teeth (1 × 2 teeth); 2 Ferris
Smith tissue forceps; 2 Russian tissue
forceps, medium; 2 DeBakey vascular
atraugrip tissue forceps, medium;
2 DeBakey vascular atraugrip tissue
forceps, long; 2 Russian tissue forceps,
long.
3-7 Left to right: 2 Goelet retractors;
2 Army Navy retractors; 1 Richard-
son retractor, medium; 1 Richardson
retractor, large; 1 Yankauer suction
tube and tip; 1 Poole abdominal shield
and suction tube.
34 UNIT 2 General Surgery
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