May 2011 udy s for sterile processing

Self-study serieMay 2011 Self-study series Sponsored by

The self-study lesson on this central service topic was The importance of IFU
developed by STERIS. The lessons are administered by for sterile processing
KSR Publishing, Inc. quality management

Earn CEUs by Michele McKinley, LVN, CRCST and Richard Schule, MBA, BS, CST, CRCST, CHMMC, FCS

The series can assist readers in maintaining their CS ANSI/ASQ/ISO 9001:2008 provides processing instructions for the user. The
certification. After careful study of the lesson, com- a model for quality management requirement includes:
plete the examination at the end of this section. Mail that has been used in dozens of • Detailed cleaning instructions, including
the complete examination and scoring fee to Health- healthcare facilities and departments
care Purchasing News for grading. We will notify you across North America. Facilities that have disassembly
if you have a passing score of 70 percent or higher, implemented a quality model such as • Detailed disinfection and sterilization
and you will receive a certificate of completion within ISO 9001 have gained many advantages,
30 days. Previous lessons are available on the Internet including a better understanding of what instructions with specific sterilization
at www.hpnonline.com. to do and how to do it and an ability to parameters
assure that their work meets requirements. • Expected end of life and how this can be
Cer tification Applying this model has also provided determined by the user
the ability to react faster and to adjust • Roles and responsibilities
The CBSPD (Certification Board for Sterile Processing processes when results are not meeting • 21CFR 820.30 Design Controls
and Distribution) has pre-approved this in-service for specified requirements, and the ability • 21CFR 820.70 Production and Process
one (1) contact hour for a period of five (5) years from to develop and acquire resources to help Controls
the date of original publication. Successful completion solve problems. From an organizational • 21 CFR 820.75 Process Validation
of the lesson and post test must be documented by perspective, the ISO 9001 model has also Manufacturers of products must provide
facility management and those records maintained yielded an understanding of how to com- cleared labeling for all medical devices in-
by the individual until re-certification is required. DO municate problems in a nonthreatening tended for patient care. These documents
NOT SEND LESSON OR TEST TO CBSPD. way by focusing on process issues, and has should include, but not be limited to IFU,
For additional information regarding certification con- provided a nurturing working environ- cleaning, sterilization, and preventative
tact CBSPD - 148 Main Street, Suite B-1, Lebanon, NJ ment in which staff is not blamed for issues maintenance instructions. (Figure 1)
08833 • www.sterileprocessing.org. For more infor- that can only be resolved by management. IFU are typically packed with new items
mation direct any questions to Healthcare Purchasing and should be removed from the packag-
News (941) 927-9345, ext 202. Under this model, there are eight qual- ing and saved in some type of archive or
ity management elements that can help to file for staff reference. They may be needed
Learning guide your organization toward improved in the future to provide the necessary
Objectives performance: customer focus; leadership; information for training on the device,
involvement of staff; process approach; equipment repairs, or for purchasing
1. Identify the components of a sound system approach to management; con- replacement parts, for example.
quality management system tinual improvement; factual approach to Methods of storage should be organized
decision-making; and mutually beneficial for easy access. For example, IFU can
2. Discuss instructions for use supplier relationships. be stored in a system of filing such as a
(IFU), how to use them, and the three-ring binder with tabs indicating the
ramifications of not following them As an integral part of the staff involve- location where the device resides. They
ment, process approach and continual can also be filed in hanging folders in a
3. Identify when IFU supersedes improvement elements, a sound quality filing cabinet and alphabetized and/or
current standards and recommended management system also requires the col- color coded by location. The point here
practice lecting and archiving of product instruc- is the physical collection and control of
tions for use (IFU) and the use of IFU for documented information for future use.
Sponsored by: educating staff and auditing departmental If IFU are brought to the facility on a
processes. Unlike the user’s manual for per-case basis with loaner instrument sets,
your television or coffee maker, these the facility should require the instrument
documents are extremely thorough and manufacturer to provide the IFUs before
detailed because they have a direct impact the instruments are cleaned and sterilized.
on the health of human beings. If the facility owns medical devices that
are missing their IFU, the manufacturer
Collecting, reviewing and should be contacted to send a set to the
archiving IFU facility.
Once the manufacturers’ IFU are ob-
The U.S. Food and Drug Administration’s tained, they need to be reviewed for
510(k) and pre-market approval (PMA) each device’s required processes. This is
guidance documents for medical devices especially important for instruments that
require manufacturers to document re-

44 May 2011 • HEALTHCARE Purchasing NEWS • www.hpnonline.com

Sponsored by Self-study series

EndoWrist® Instrument and Accessory Cleaning Disinfection5 Sterilization Equipment Parameters
Cleaning and Sterilization
Compatibility Matrix Enzymatic Ultrasonic da Vinci Medisafe Medisafe Thermal Chemical Autoclave STERIS STERRAD STERRAD EtO Ultrasonic Bath
Cleaning Bath2 SI PCF Niagara SI (Pre-vacuum) System 1E6, 50, 100S, 100NX
NOTE: For complete cleaning and sterilization (pH-Neutral) SonicPro System System (Not V-PRO 1, V- Express • Power Density = 48 watts/gallon or
instructions, precautions and warnings, refer to (For U.S. available in PRO 1 Plus 200 Cycle8 • greater (ultrasonic power output / internal
the Reprocessing Instructions (PN 550875), • the U.S.) • tank volume)
of which this wall chart is a subset, or to the only) Ultrasonic Frequency = 38kHz or greater
applicable Instructions for Use. inst8roumnmlmyents
• • •3 3 •◆4 Sterilization Parameters
EndoWrist® Instruments
• •3 EtO Sterilization
Instrument Arm Cannula • • •3 •◆4
and Cannula with Outlet • • •3 Temperature: 55 ± 2 °C
•◆4 Relative Humidity: 70 ± 5%
Obturator/Reducer • •3 Set Pressure Point: 25.4 PSIA
Ethylene Oxide Concentration:
Instrument Accessories Instrument Sterile Adapter1 • •◆4 600 ± 30mg/L
Gas Exposure Time: 2 hrs.
Instrument Arm Cannula Holder1 • •◆4 Detoxi cation Time: 0 hrs.
Aeration: 12 hrs. at 55 ± 2 °C
PK Instrument Cords • • •◆4 7 7
Autoclave
Wrench, Emergency Grip Release • • •◆4
• Cycle: Pre-vacuum
Snap-Fit Instrument Blade Protector • • •3 •◆4 Temperature: 270-272 °F (132–134 °C)
and Reusable Insertion Tool • Minimum Exposure Time for the U.S.: 4
• •◆4 min.
EndoPass Delivery Instrument • Minimum Exposure Time for countries
Endoscopes Blank Cartridge • • • • •8 following European guidelines: 3 min.
• Dry Time: 20 min.
da Vinci and da Vinci S • •• • •8
8.5 mm and 12 mm Endoscope • WARNING: The use of“ ash”
• sterilization is not recommended.
da Vinci and da Vinci S • WARNING: Donotsterilizeat
5 mm Endoscope temperatures over 285 °F or 140 °C.

da Vinci Si Disinfection Parameters
8.5 and 12 mm Endoscope
• • • •8 Chemical
da Vinci and da Vinci S The following methods are compatible
Light Guide Cable with endoscope disinfection:

da Vinci and da Vinci S •◆4 Cidex® Helipur® H plus N
Light Guide Cable Adapter
Cidex® OPA Gigasept® FF
da Vinci and da Vinci S
Camera Arm Sterile Adapter • •◆4 NOTE: The methods of sterilization
• •3 and the parameters listed are the
Vision Accessories da Vinci and da Vinci S • •3 •◆4 manufacturers’ recommendations.
Camera Sterile Adapter • •3 Sterility is the responsibility of the
• •3 •◆4 person/institution performing
8.5 mm Endoscope Cannula sterilization.
• •3 •◆4
• Legend
Endoscope Cannula Mount1 • •◆4 Validated for e cacy (i.e. process
achieves expected cleaning/sterilization
Endoscope Alignment Target • •◆4 results) AND compatibility (i.e. process
doesn’t damage the product).

◆ Only validated for compatibility (i.e.
process doesn’t damage the product).
Efficacy is not established.

1 For da Vinci System only. Headquarters European O ce
2 Refer to Ultrasonic Bath Equipment Parameters listed at upper right. 1266 Kifer Road Intuitive Surgical Sàrl
3 Refer to the validated list of instruments for da Vinci SonicPro and Medisafe SI PCF/Niagara SI System on www.intuitivesurgical.com. Building 101 1, chemin des Mûriers,
4 Thermal disinfection through washer/disinfector system only. Sunnyvale, CA 94086-5304 USA 1170 Aubonne Switzerland
5 This is an optional step. All Intuitive Surgical reusable product must be sterilized prior to patient use. The hospital policy and regional guidelines www.intuitivesurgical.com Customer Service (in Europe): +800.0821.2020
www.daVinciSurgery.com
should dictate whether the product must be disinfected after cleaning and prior to sterilization. Customer Service: 800.876.1310
6 STERIS system 1E is a liquid chemical sterilant processing system cleared by FDA under special usage guidelines. Please contact STERIS Inc. for complete details.
7 Not validated with STERRAD 50 or 200. Refer to speci c sterilization parameters for PK instrument cords in Reprocessing Manual (P/N 550875) for complete details. Copyright © 2011 Intuitive Surgical, Inc. All rights reserved. 550721-03 Rev B
8 Contact Advanced Sterilization Products (ASP) for availability in your region. Intuitive®, Intuitive Surgical®, da Vinci® and EndoWrist® are registered trademarks of Intuitive Surgical, Inc.
Other brand and product names are trademarks or registered trademarks of their respective holders.

Figure 1: Sample wall chart, subset of IFU (Courtesy of Intuitive Surgical Inc.)

require special handling, such as disas- In addition, a form that lists pertinent structions. As you obtain and review these

sembly, channel flushing, and any special information can be a useful tool (Figure 3). instructions, you may find that some of the

sterilization processes or parameters. Once the information is provided to the staff, information is rather vague; for example, “…

Next, the IFU must be shared with the having them sign or initial an acknowledge- follow AAMI guidelines or sterilizer manu-

staff that will be performing the processes. ment will also enable supervisors/managers facturer’s guidelines…” If this is the case, it

It is important to have a systematic process to hold them accountable for each process. is the facility’s responsibility to contact the

for providing this information to staff, to Once the information has been reviewed manufacturer for clarification when develop-

ensure that everyone understands and to with the staff, it is helpful to post the new ing their process.

provide resources the staff can use when instrument form in a central area for a des-

they need to confirm any of the processes. ignated period of time as a resource. After The ramifications of not
If there is a computer system in the sterile the designated period, the forms should be following IFU

processing department, a database can be removed and placed in a binder as a perma- Manufacturers are required to validate clean-

created that includes an area for special nent resource. ing processes for reusable medical devices.

instructions and alerts. Any item that It is very important to obtain, store, and The validation testing should address not

requires special handling should be identi- be able to provide IFU to inspectors when only cleaning and sterilization efficacy, but

fied in the database, along with any special asked, but it’s also critical that staff under- also the process’ compatibility with the

package labeling. If there is no computer stands and follows them. Joint Commis- component materials of the device. The vali-

system for archiving this information, a sion, CMS and other regulatory agencies dation documents confirm that the devices

process flow form should be in place that are asking to see IFUs when they inspect continue to function safely and effectively

enables supervisors/managers to dissemi- facilities. They will read the IFU and observe after many cleaning/disinfection/steril-

nate the information in a manner that will staff performing the functions to see if they ization cycles. The cleaning process must
See Self-Study on page 46
ensure staff compliance (Figure 2). are compliant with the manufacturer’s in-

Self-Study Test Answers: 1. B, 2. A, 3. C, 4. C, 5. A, 6. D, 7. E, 8. E, 9. E, 10. B

www.hpnonline.com • HEALTHCARE Purchasing NEWS • May 2011 45

sELf-sTudy sERiEs Sponsored by

Self-Study from page 45 changes in the type of packaging or wrap- The key to successful cleaning and steril-
ization of these complex instruments is to
remove blood, protein, fat, carbohydrates, per material. study the IFU and learn the manufacturer’s
validated reprocessing method for each
endotoxins and microorganisms from all When the IFU supersedes device. This should happen automatically
joints, lumens and crevices. Manufacturers current standards and when a device is new to the department,
must also ensure that the cleaning procedure recommended practice but it is also important that managers utilize
can be duplicated in healthcare facilities. IFUs as ongoing in-service resources and for
annual competency assessments. In addition,
The instructions provided by the manu- If there is a discrepancy between the two, IFUs should be used to conduct regular
process audits to keep the department in a
facturer assure proven results. However, it IFU will override professional standards and continual state of readiness. Quality audits
can be performed by reviewing the IFU for
is the responsibility of the healthcare facility recommended practice, as long as a patient’s a particular instrument and then observing
that the staff is compliant to the manufactur-
to adhere to these proven parameters. If a safety is not in jeopardy. Typically, standards er’s instructions. The audits should be docu-
mented and used as criteria for additional
facility chooses not to follow the manufac- and recommended practices are developed education and process improvement plans.

turer’s IFU, they will not be able to provide by professional bodies and consortiums to As a part of measurement, analysis and
continual improvement, the audit or sur-
assurance that the device is clean. Therefore help guide policy and safe practice within vey process should include the review of
IFU. The audit should identify the facility’s
they are assuming liability for the use of a their respective specialties. This guidance system for organizing these documents and
more importantly, assess how these docu-
potentially non-clean, non-sterile device. is more general in scope and is developed ments support the daily work performed
in the departments or locations where these
This places patients at risk along with the through evidence-based practice. devices are used. IFU should be used to
develop a linear progression; a step-by-step
healthcare facility. In contrast, medical device IFU are vali- process for performing a task, such as the
introduction of a new surgical/medical
dated for a specific device and are included device for reprocessing.

Review of Item to Purchase in that device’s regulatory registrations. IFU are a rich resource for sterile processing
department managers. Once a complete IFU
↓ However, advances in device develop- library is in place, it will provide much of the
Request Instructions for Use ment or medicine can sometimes information needed to run the department’s
equipment and process all necessary medical
↓ create a situation in which a prac- devices in compliance with manufacturers’
Review IFU for Facility Ability to Clean & Sterilize tice becomes necessary even instructions. But the library itself must also

MANUAL COMPUTER though an IFU may not include FACILITY NAME SPD
that practice. For example, con- NEW INSTRUMENT/TRAY BULLETIN
↓ ↓ sider what often happens in DATE: ________
Complete New Instrument – Tray Form Add Special Instructions to sterile processing departments.
Medical device and steam ITEM DESCRIPTION: ________________________
↓ Set Sheet sterilizer manufacturers cre-
Review New Instrument-Tray Form ate thorough IFU documents __________________________________________
↓ detailing sterilization param-
with Staff Add pertinent Information to ITEM VENDOR: _____________________________

↓ Set Label ITEM CATALOG #: __________________________
Have Staff Sign an Acknowledgement
↓ ITEM SPECIALTY: ___________________________
of Receipt Form Flag Set with identifier to no-
tify staff to check instructions ITEM LOCATION: ___________________________
↓
Post New Instrument-Tray Form in eters, but the instructions for CLEANING METHOD:
Department for Designated Time
figure 2: sterilizing a particular medical device Manual  Sonic  Washer  Other
↓ Process flow form may not exactly match those for the
Place New Instrument-Tray Form in a sterilizer. The question becomes; STERILIZATION PARAMETERS: _________________
___________________________________________
Log Book For Staff Reference
SPECIAL INSTRUCTIONS: ______________________
which IFU should be followed? ___________________________________________
___________________________________________
Trial Item to Verify Ability To Clean & Sterilize In situations like these, the health- ___________________________________________
___________________________________________
Process verification care facility must apply scientific
judgment to make the best medical decision figure 3: New instrument form

The AAMI ST79: 2010 document recom- that promotes the safety of patients. The

mends that documentation of the manufac- analysis should be documented and the

turer’s validation test methods and results practice justified. Justification may include

should include information verifying that a review of scientific literature, internal or

sterilization efficacy has been qualified in contracted testing, or communication with

standard hospital sterilization cycles. AAMI manufacturers. The documentation pack-

also recommends that quality testing of age is essential in demonstrating that the

routinely processed items representing a decision to not follow an IFU is sound and

product family be performed on an ongoing reasonable.

basis. A program should be established to

periodically test routinely sterilized prod- IFU as education/auditing tools

ucts. Before newly purchased or loaner sets As surgical procedures continue to evolve at

are placed into routine use, they should a rapid pace, so too, do surgical instruments.

be evaluated to determine if the existing What was once a one-size-fits-all type of

product testing is applicable to these sets. cleaning and sterilization for basic stainless

Whenever changes are made to a product steel tools has had to change. Devices are

family’s composition or designated master now motorized, cabled, robotic and very

product, or when written sterilization complex technologies, many with a host of

instructions are changed, product testing accessories or components made of a mix

should be repeated. In addition, product of substrates. Cleaning and sterilization

testing should always be performed when methods and guidelines have had to evolve

major changes are made to packs, wrapped with each new item, and be validated by

items, or load configurations, such as the manufacturer for each specific device

dimensional changes, weight changes, or to assure effective disinfection.

46 May 2011 • HEALTHCARE PuRCHAsing nEWs • www.hpnonline.com

Sponsored by Self-study series

become part of the department’s Continuing education test • May 2011
quality systems process; it is a living
archive that must be updated regu- The importance of IFU
larly, as new devices are introduced for sterile processing quality management
or removed from service. hpn
Circle the one correct answer:
References:
1. If instructions for use are not clear, what is the 7. Which organization recommends periodic quality
1. ANSI/AAMI ST79:2010 Comprehensive guide to facility’s responsibility? testing of routinely processed items?
steam sterilization and sterility assurance in health care A. Process the items like you do everything else A. FDA
facilities. Association for the Advancement of Medical B. Contact the manufacturer for clarification B. AORN
Instrumentation, www.aami.org April, 2011. C. Ask the sales rep C. AAMI
D. Ask for clarification in writing D. APIC
2. ANSI/ISO/ASQ Q9001-2008 American National E. Both b and c
Standard Quality management systems – Require- 2. Instructions for use should be obtained for:
ments. American Society for Quality, www.asq.org A. Every item you process 8. When should instructions for use be utilized?
April, 2011. B. Only the new items A. Teaching tool for staff
C. Everything but loaners B. A part of annual competencies
3. Conditions for Coverage. Centers for Medicare and D. Specialty items C. Quality audits
Medicaid Services, www.cms.org D. As part of a checklist
3. If the vendor delivers an item for processing E. All of the above
4. Wall Chart – EndoWrist® Instrument and Acces- without IFU, what do you do?
sory Cleaning and Sterilization Compatibility Matrix. A. Ask your coworker if they know how to process 9. What is included in the cleared labeling for all
Intuitive Surgical, 2009. B. Stick it in the washer medical devices?
C. Request the instructions for use in writing from A. Cleaning specifications
Michele McKinley, LVN, CRCST is a the vendor B. Sterilization parameters
clinical education specialist at STERIS D. Leave it for the next shift C. IFU
Corporation, and is responsible for D. Preventive maintenance instructions
customer education, clinical support, 4. Which government agency requires the manufac- E. All of the above
troubleshooting, and issues concern- turer of medical devices to document reprocess-
ing sterilization and infection control. ing instructions? 10. When is the healthcare facility accepting liability
McKinley has been in healthcare for 30 A. OSHA B. CMS for patient safety?
years, and was a site manager, interim C. FDA D. CDC A. The sterile processing department is following
manager and consultant with STERIS instructions for use
Corporation’s SterilTek process im- 5. When do IFUs not supersede current standards B. The sterile processing department is using a prac-
provement team for eight years. She and recommended practice? tice not listed in the manufacturer’s instructions
is a licensed vocational nurse and has A. When patient safety is at risk for use
also been trained as an operating room B. When AAMI, AORN and CDC say so C. The sterile processing department is inspecting the
technician. She has worked as a materials C. When CMS states this is not a measurable event surgical device according to the manufacturer’s
coordinator for the operating room (OR) D. None of the above instructions for use
and was responsible for OR purchasing, D. All of the above
inventory control, capital budget, charge 6. Which element is not found in the ISO 9001
master, maintenance and clean-up of OR model? Presented by
supply inventory lists, instrument tray A. Customer focus
lists and preference cards. McKinley has B. Continual improvement Sponsored by
led effective team building and process C. Leadership
improvement efforts in total CS reor- D. Avoid changes
ganization and improvement and has E. Factual approach to decision-making
supervised specific areas of Joint Com-
mission and state mandated inspections, Request for Scoring Detach exam and return to:
flash sterilization reduction, loaner tray Continuing Education Division
programs and tray reorganization. o I have enclosed the scoring fee of $10 per test KSR Publishing, Inc.
submitted. (Payable to KSR Publishing, Inc. We 2477 Stickney Point Road, Suite 315B
Richard Schule,  MBA, BS, CST, regret that no refunds can be given. Multiple sub- Sarasota, FL 34231
CRCST, CHMMC, FCS is the director missions may be paid with a single check.) PH: 941-927-9345 Fax: 941-927-9588
of clinical education at STERIS Corpo-
ration. In this role, he is responsible for Please print or type. Return this page only.
a team of experienced clinical profes- Name
sionals and a portfolio of surgical and Title
sterile processing continuing education
and in-service programs for healthcare Hospital Name
providers. He has extensive experience Mailing Address
at standardizing and rebuilding educa-
tional programs for sterile processing Apt/Suite
staff at hospitals to help them achieve na- City, State, Zip
tional certification. He has also assisted Daytime Phone
with the writing and implementation of
equipment work instructions, depart- E-mail
ment policies, procedures and guidelines
supporting an ISO quality management
system for sterile processing.

www.hpnonline.com • HEALTHCARE Purchasing NEWS • May 2011 47