CE ONLINE
Instructions for Use –
An Important Aspect of
Patient Safety
An Online Continuing Education Activity
Sponsored By
Grant Funds Provided By
Welcome to
Instructions for Use –
An Important Aspect of Patient
Safety
(An Online Continuing Education Activity)
CONTINUING EDUCATION INSTRUCTIONS
This educational activity is being offered online and may be completed at any time.
Steps for Successful Course Completion
To earn continuing education credit, the participant must complete the following steps:
1. Read the overview and objectives to ensure consistency with your own learning
needs and objectives. At the end of the activity, you will be assessed on the
attainment of each objective.
2. Review the content of the activity, paying particular attention to those areas that
reflect the objectives.
3. Complete the Test Questions. Missed questions will offer the opportunity to reread the question and answer choices. You may also revisit relevant content.
4. For additional information on an issue or topic, consult the references.
5. To receive credit for this activity complete the evaluation and registration form.
6. A certificate of completion will be available for you to print at the conclusion.
Pfiedler Enterprises will maintain a record of your continuing education credits
and provide verification, if necessary, for 7 years. Requests for certificates must
be submitted in writing by the learner.
If you have any questions, please call: 720-748-6144.
CONTACT INFORMATION:
© 2015
All rights reserved
Pfiedler Enterprises, 2101 S. Blackhawk Street, Suite 220, Aurora, Colorado 80014
www.pfiedlerenterprises.com Phone: 720-748-6144 Fax: 720-748-6196
OVERVIEW
Understanding and following device and equipment manufacturers’ instructions for use
(IFU) are key to providing the surgical team with instruments and items that are safe for
use on patients undergoing surgery or other invasive procedures. The IFU that accompany
newly purchased, loaned, or refurbished devices or equipment must be accessible,
readily understood, and followed by personnel responsible for processing devices for
use in surgery. IFUs may be put in a drawer, filed in a cabinet, entered into a binder or
located in a computer program. Unfortunately IFU that are not located within a computer
program are often misplaced and seldom, if ever, reviewed to determine currency. Even
when computerized and locatable they are seldom used as a tool to measure processing
personnel competency. There is growing recognition however of the importance of IFU
and the responsibility for ensuring they are current and are implemented. Beyond the
fact that surveyors may ask to see a particular instruction for use and observe to see if it is
implemented, is the fact that not following the IFU can result in inadequate processing of
a device, failure of a device to function as intended, and even patient injury. This program
will explain what a validated IFU is, the information that should be contained in an IFU, and
why it is so important to follow the IFU. Information will also be presented as to what action
should be taken when an IFU is not clear, is incomplete or vague, or cannot be located.
LEARNER OBJECTIVES
After completing this continuing education activity the learner should be able to:
•
Describe the relationship between device and equipment manufacturers’ written
IFU and patient safety.
•
Identify key components of device and equipment manufacturers’ written IFU
•
Explain the difference between validation and verification
•
Discuss responsibilities of processing personnel relative to device and equipment
manufacturers’ written IFU.
INTENDED AUDIENCE
This continuing education activity is intended for perioperative nurses, technologists and
central processing personnel who want to learn more about manufacturer’s instructions for
use of instrumentation and devices and how they impact patient safety.
Credit/Credit Information
State Board Approval for Nurses
Pfiedler Enterprises is a provider approved by the California Board of Registered Nursing,
Provider Number CEP14944, for 2.0 contact hours.
Obtaining full credit for this offering depends upon attendance, regardless of circumstances,
from beginning to end. Licensees must provide their license numbers for record keeping
purposes.
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The certificate of course completion issued at the conclusion of this course must be
retained in the participant’s records for at least four (4) years as proof of attendance.
IACET
Pfiedler Enterprises has been accredited as an Authorized Provider by the International
Association for Continuing Education and Training (IACET).
CEU Statements
•
As an IACET Authorized Provider, Pfiedler Enterprises offers CEUs for its programs
that qualify under the ANSI/IACET Standard.
•
Pfiedler Enterprises is authorized by IACET to offer 0.2 CEUs for this program.
Note: 0.2 CEU is equivalent to 2 contact hours of credit
Release and Expiration Date:
This continuing education activity was planned and provided in accordance with accreditation
criteria. This material was originally produced in April 2015 and can no longer be used after
April 2017 without being updated; therefore, this continuing education activity expires April
2017.
Disclaimer
Pfiedler Enterprises does not endorse or promote any commercial product that may be
discussed in this activity.
Support
Funds to support this activity have been provided by One Source
Authors/Planning Committee/Reviewer
Cynthia Spry, MA, MS, RN, CNOR
Clinical Consultant/Author
New York, NY
Aurora, CO
Judith I. Pfister, RN, BSN, MBA
Program Manager/Planning Committee
Pfiedler Enterprises
Aurora, CO
Aurora, CO
Julia A. Kneedler, RN, MS, EdD
Program Manager/Reviewer
Pfiedler Enterprises
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Disclosure of Relationships with Commercial Entities for
Those in a Position to Control Content for this Activity
Pfiedler Enterprises has a policy in place for identifying and resolving conflicts of interest for
individuals who control content for an educational activity. Information below is provided to
the learner, so that a determination can be made if identified external interests or influences
pose potential bias in content, recommendations or conclusions. The intent is full disclosure
of those in a position to control content, with a goal of objectivity, balance and scientific rigor
in the activity. For additional information regarding Pfiedler Enterprises’ disclosure process,
visit our website at: http://www. pfiedlerenterprises.com/disclosure
Disclosure includes relevant financial relationships with commercial interests related to
the subject matter that may be presented in this continuing education activity. “Relevant
financial relationships” are those in any amount, occurring within the past 12 months
that create a conflict of interest. A commercial interest is any entity producing, marketing,
reselling, or distributing health care goods or services consumed by, or used on, patients.
Activity Authors/ Planning Committee/Reviewer
Cynthia Spry, MA, MS, RN, CNOR
No conflict of interest
Judith I. Pfister, MBA, RN
Co-owner of company that receives grant funds from commercial entities
Julia A. Kneedler, EdD, RN
Co-owner of company that receives grant funds from commercial entities
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contact us at:
Phone: 720-748-6144
Email:
registrar@pfiedlerenterprises.com
Postal Address: 2101 S. Blackhawk Street, Suite 220
Aurora, Colorado 80014
Website URL:
http://www.pfiedlerenterprises.com
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INTRODUCTION
Joint Commission standard IC 02.02.01 requires healthcare facilities to reduce the
risk of infections associated with medical equipment, devices and supplies. Despite
this mandate Joint Commission surveyors found this standard was one of the top five
non-compliant standards across hospitals, ambulatory facilities and office based surgery
facilities.1 In November 2014 the ECRI Institute published Top 10 Health Technology
Hazards for 2015. Number 4 on the list is “inadequate processing of endoscopes
and surgical instruments.”2 Articles about inadequately cleaned endoscopes are also
appearing in the popular press. In January of 2015 an article titled Deadly Bacteria on
Medical Scopes Trigger Infection was published in USA Today. It was reported that
seven patients in Seattle may have died from infections associated with contaminated
duodenoscopes that had been processed and were considered “patient ready.”3
Although direct correlation between improperly processed surgical instruments/devices
and the incidence of surgical site infection is not always known or identifiable, there is
a growing recognition that improperly processed devices can be the cause of patient
injury including surgical site infection. In 2009 seven organ space surgical site infections
following arthroscopic surgical procedures were determined to be related to a surgical
instrument contaminated with Pseudomonas aeruginosa during instrument processing.
This occurrence was reported in professional journals, in the popular press, and featured
on nightly television news.4 Another incidence was reported in the popular press when
surgical site infection was attributed to retained tissue on an instrument that was used on
5 patients who became infected following anterior cruciate ligament surgery.5 In addition,
thousands of patients have received notices advising them that they may have been
exposed to pathogenic microorganisms when an endoscope that was not processed
in accordance with the manufacturer’s IFU was used to perform a procedure on them
and they were therefore advised to return to the facility for further testing. 6 Breaches in
device processing can result in outbreaks of HIV, Hepatitis B and C and transmission of
other infectious agents such as E coli and Methicillin resistant Staphylococcus aureus
(MRSA). It is not uncommon for a breach to go undetected for a long period of time and
only when there is an outbreak and the CDC becomes involved that the true scope of
the problem is brought to light. Most instances of surgical site infection do not make the
nightly news and because there are so many variables that can contribute to surgical
site infection often it is difficult or impossible to determine the cause of infection or
attribute it to improper or inadequate instrument processing. We cannot see pathogenic
microorganisms but if allowed to remain in an instrument that is considered “patient
ready” can be deadly to the patient. The best defense against sending a contaminated
instrument to surgery for use during a procedure is to strictly adhere to the device
manufacturer’s written instructions for processing. In response to a growing concern
over lapses in instrument processing the Association for the Advancement of Medical
Instrumentation (AAMI) published a list of 10 things that an organization should/could do
to improve instrument processing. Number 1 is to clean, disinfect, and sterilize according
to the manufacturer’s written instructions for use. Number 2 is to have the IFU readily
available in all processing areas.7
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Historically surgical instruments were made from stainless steel, cleaning was relatively
standardized and simple, and sterilization was accomplished in a gravity steam
autoclave. Written instructions for cleaning and sterilizing were not mandatory and in
absence of manufacturers’ IFU individual institution policies for preparing instruments for
surgery were what guided practice. Cleaning was accomplished in the operating room
and was accomplished manually; sterilization equipment varied little and it was relatively
easy to transfer knowledge of processing from one instrument to another without a
written IFU from the manufacturer. Today’s instruments are made of many different
materials, designs are often highly complex and present unique challenges for cleaning
and sterilization, and there is much variety in processing equipment. Referring to and
adhering to manufacturers’ IFU is critical to proper processing and what is appropriate for
one instrument is not necessarily appropriate for another.
Key Points
• Surgical instruments have evolved from being relatively simple and
easy to clean and sterilize to being complex and challenging to
process.
• Improperly or inadequately processed instruments used on patients
undergoing a surgical or invasive procedure have been associated
with patient injury – i.e., surgical site infection.
• Strictly adhering to the instructions for use e.g., the processing
instructions, is the best way to ensure that a device is truly patient
ready.
• Instructions for use must be readily available to all personnel who
share responsibility for instrument processing.
FOOD AND DRUG ADMINISTRATION (FDA) AND MEDICAL DEVICES
The FDA is responsible for protecting and promoting public health through regulation and
supervision of a variety of categories of products including medical devices. The FDA
was empowered by the United State Congress to enforce the Food Drug and Cosmetic
Act which was enacted in 1938 following the sulfanilamide elixir disaster in which more
than 100 people died after using a drug that was unsafe.8 Under this Act medical
devices must have clearance from the FDA before they can be marketed. In order to
obtain clearance, device manufacturers must demonstrate that the product is effective
and safe and must submit technical data to support product claims regarding safety and
effectiveness. FDA requirements to obtain clearance to market vary according to the
classification of the device. Classifications are based on the Spaulding classification
system which is as follows:9
Critical devices: Instruments or objects that are entered into normally sterile areas of the
body. Examples include surgical instruments and cardiac catheters. Critical items require
sterilization.
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Semi-critical devices: Instruments or devices that contact but do not penetrate intact
mucous membranes. Examples include laryngoscope blades, GI endoscopes, and
thermometers. Semi-critical items require at least high-level disinfection and may be
sterilized.
Non-critical devices: Devices that contact intact skin: Examples include blood pressure
cuffs, bedpans and crutches. Non critical items require only low-level disinfection.
Devices within healthcare facilities and instrument processing areas that are regulated
by the FDA include surgical instruments, packaging, sterilizers, quality monitors, and
implants. The level of regulation varies according to the nature of the device. A device
may be categorized as Class I - low risk and least regulated, Class II – potential risk and
moderate regulation or Class III – high risk and very stringent regulations. Most of the
items relating to the work of personnel in Sterile Processing departments/areas are Class
II items of a critical or semi-critical nature.
One of the FDA requirements to obtain clearance to market is labeling. Labeling includes
instructions for use which includes cleaning and disinfection or sterilization instructions.
It also requires a package insert that contains supplemental information regarding safe
and effective use of the product. Regulatory reviewers depend heavily on the labeling to
make decisions about safety and efficacy.
A label is generally defined as written, printed, or graphic material that is either on
an article or any of its containers or wrappers or on an accompanying poster, tag,
pamphlet, circular, booklet, brochure, instruction book or direction sheet, etc. The U.S.
FDA requirements relative to labeling are codified in Title 21 of the Code of Federal
Regulations.10 Other countries have additional or other labeling requirements. Labeling
requirements also require that the medical device manufacturer provide a printed or
electronic copy of the most current version of labeling to the end user upon request.
RELATIONSHIP BETWEEN THE DEVICE MANUFACTURER’S
WRITTEN IFU AND PATIENT SAFETY
Labeling includes the IFU and generally describes the features and benefits of the
product, promotes the product for a targeted specialty, and provides information
detailing proper use and care. The implication is that if the product is used and cared
for/processed as indicated in the IFU, the product will be safe and effective. The
information/instruction contained in the IFU is what the device manufacturer has
determined must be followed to ensure effectiveness and safety. If a device is not
used and processed as directed in an IFU and a patient sustains an injury it is very
conceivable that the IFU would factor heavily in subsequent litigation. The IFU protects
the device manufacturer and most importantly, if followed, protects the patient. In addition
to instructions for use the label is used to identify a unit, lot, or batch, and to track a
product and is critical during a recall process.
Labeling should contain information about the preparation of the device in preparation
for use on a patient, the intended use of the product, limitations of the device and its use,
9
associated risks to patient or end user, and any safety precautions. Disposal and reuse
instructions and instructions on adverse event reporting should also be included.
From a health care provider perspective the IFU should serve as a training/teaching tool
for staff that provides information on how to prepare the device for use.
Key Points
• Medical devices must receive clearance from the FDA in order to be
marketed.
• FDA requirements to achieve clearance to market vary according to
the device classification.
• Labeling is one part of the requirements.
• Labeling includes instructions for use.
UNDERSTANDING AN IFU
Definitions and terms necessary to understanding an IFU
Cleaning – The removal of debris or contaminants. Cleaning is accomplished with
a detergent that may or may not contain enzymes, and water. Cleaning may be
accomplished manually or with an automated system.
Disinfection – A process that kills microorganisms through a chemical or thermal
application.
Decontamination – Cleaning followed by disinfection.
OSHA defines decontamination as the use of physical or chemical means to destroy
blood borne pathogens on a surface to a point where they are no longer capable of
transmitting infectious particles and the surface of the item is rendered safe for handling,
use or disposal.11 (Cleaning precedes disinfection)
Washer disinfector/washer decontaminator – automated system for decontaminating
items. Washer disinfector/decontaminator cycles typically include a cleaning phase
followed by a chemical or thermal disinfection phase thereby rendering items
decontaminated.
Sterilization – A process that kills all microorganisms including high numbers of spores.
Sterilizer – An apparatus used to sterilize devices and other items used in surgery.
Sterilizers utilize various modalities. Steam under pressure, ethylene oxide, and
hydrogen peroxide are common sterilization technologies used in health care facilities.
Steam sterilizer – also referred to as an autoclave. Two types of cycles are utilized – gravity displacement and dynamic air removal.
Gravity displacement – air in the chamber is removed through the force of
gravity.
10
Dynamic air removal – air in the chamber is removed though a vacuum pump
or other dynamic action.
Some sterilizers, primarily older ones or some table top sterilizers, can only be
run using a gravity displacement cycle. Many sterilizers that employ a dynamic air removal cycle can also be programmed to run a gravity displacement cycle. Because air removal is more efficient in a dynamic air removal cycle this cycle
is used most often. However there are some medical devices where the IFU indicates that the device should only be sterilized using a gravity displacement cycle. Steam sterilization is appropriate for sterilization of items that are able to
tolerate moisture and high temperatures.
Ethylene oxide and hydrogen peroxide sterilization technologies are
appropriate for devices that are heat and moisture sensitive.
Parameters of sterilization – values that must be achieved for sterilization to occur. For
steam sterilization the critical conditions are temperature, saturated steam, pressure,
and time. A device IFU that recommends steam sterilization may state that the steam
sterilization cycle should reach a temperature of 2700F (1320C) (temperature parameter)
and remain at that temperature for 4 minutes (exposure/time parameter). Knowing what
the parameters are that should be met a person removing items for a sterilizer can check
the printout to see if those parameters have been met. If the parameters have not been
met the cycle must be considered a failed cycle and the items in the failed cycle load
must not be distributed or used.
High-level disinfection – a process that kills all microorganisms with the exception of
high numbers of spores.
WHAT TO LOOK FOR IN AN IFU
Although a lot attention is now focused on instructions for use the fact remains that
many IFU leave much to be desired. There is no standardized template or format
for IFU. Many IFU do not include some standard processes such as the use of a
washer/disinfector, sonication or lubrication. Like instruments may also have different
instructions, processes and tools. Instructions can range from a page to more than
70 pages. Some IFU have so many steps as to be unreasonable to expect staff to
have time to read all pages. Human factors are often not taken into consideration
when IFU are developed. Graphics are either not present when they would be helpful
or are such that they oversimplify the process by omitting verbiage. Instructions such
as “sterilize according to routine hospital practice,” “clean with an appropriate sized
brush,” “disassemble as appropriate” and “rinse thoroughly” are some of the inadequate
instructions that can be found in an IFU. For example, what is “routine hospital practice”
in one facility may not be the same as routine practice in another facility and what
is the correct routine? “Clean with an appropriate sized brush” does not inform the
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reprocessor as to the necessary length, diameter, bristle material type – all very important
to the cleaning process. “Rinse thoroughly” does not indicate what the end point should
be - (until rinsate runs clear?) nor does it specify the type of water that should be used
to rinse. “Disassemble as appropriate” – the IFU should specify what needs to be
disassembled and should provide disassembly instructions necessary to disassemble
safely. Some IFU do not include processes that are standard in most facilities such
as use of a washer/disinfector or sonication. These processes are addressed in AAMI
ST79 Comprehensive guide to steam sterilization and sterility assurance in health care
facilities, the recognized guideline for instrument processing in the USA, yet they are
not included in some IFU. It is apparent that much improvement is needed with regard
to written IFU; however, IFU followed in combination with ST79 are the best tools we
have for ensuring a device is properly processed. In 2011 The FDA and AAMI together
convened a summit to address IFU and in particular to address the complex issue of
cleaning and the lack of objective methods to determine whether or not a device is clean.
It was recognized that with regard to IFU much progress has been made but along with
the development of more complex devices, greater understanding of the significance
of various processing practices and the growing data base of patient injuries related
to improper processing that more needs to be done. It is anticipated that the FDA will
refine the requirements for device labeling and will capitalize on opportunities to improve
instrument processing through regulation. AAMI standards committees will continue to
develop and update documents using the most current research to support processing
guidelines.12
The basic and critical steps in instrument processing are cleaning, inspection, packaging
sterilization and storage. The IFU should include instructions for cleaning that indicate
whether or not the device must be cleaned manually or if it can be cleaned in an
automated cleaning system or whether either process is acceptable.
Processing information that may be included is as follows:
Cleaning
Point of use cleaning – instructions for preventing adherence of debris during procedure
and treatment, typically with an enzyme spray, immediately following procedure
•
Disassembly instructions
•
Type of detergent and temperature or instructions to follow the detergent
manufacturer’s IFU for temperature and concentration
•
Equipment/tools necessary to clean – specifications for cleaning cloths and
brush characteristics
•
Whether or not sonication should be used
•
Water temperature and quality
•
Rinse process – number of rinses, required water pressure, desired end point
•
Drying requirements
•
How to inspect for cleanliness – eg. use of a borescope to inspect lumen for
cleanliness
•
Lubrication – type of lubricant
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Packaging
•
Instructions on how to check function prior to packaging
•
Whether device must be processed in containment device supplied with the
device
•
Type of packaging that is appropriate to the sterilization technology that will be
used – eg. Tyvek/Mylar, Paper/plastic, polypropylene wrap, rigid sterilization
container
•
Whether any assembly is required
•
Devices necessary to protect items during further processing, eg. tip protectors
•
Desired positioning or orientation within package
Sterilization/disinfection
•
Sterilization technologies that may be used (steam, ethylene, hydrogen
peroxide– including cycle type, e.g., gravity or dynamic air removal for steam
•
Sterilization technologies that should not be used
•
Sterilization parameters for the acceptable technologies e.g. time and
temperature
•
Dry time
•
Instructions for immediate use steam sterilization if acceptable – wrapped,
unwrapped
Storage
• Environmental conditions – temp, humidity
•
Other
•
•
Useful life if appropriate
Dangers and cautions
Maintenance
Key Points
• Instructions for use are sometimes vague, confusing, or
oversimplified and are not presented in a standardized template.
• Initiatives by the FDA are ongoing in an attempt to improve labeling
(IFU).
• Detailed information regarding, disassembly, cleaning, packaging,
sterilization, and storage should be part of the IFU.
• Dangers, cautions, and maintenance requirements should be
included in an IFU.
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VALIDATION AND VERIFICATION
Validation - Oftentimes sterile processing personnel will speak of validating the
processing of a device. This is incorrect use of the term validation. Sterile processing
personnel in healthcare facilities do not validate because for the most part the facility
does not have the resources or equipment needed for validation. Verification however is
possible in healthcare facilities. There is a difference between the two.
Understanding the difference between to these two terms is necessary to appreciate the
importance of an IFU. The Association for the Advancement of Medical Instrumentation
defines validation as a “documented procedure for obtaining, recording, and interpreting
the results required to establish that predetermined specifications have been met.”13
Validation is a process performed by the device manufacturer in accordance with
guidelines that can be found in AAMI TIR 12:2010 Designing, testing and labeling
reusable devices for reprocessing in healthcare facilities.14 A device manufacturer
wanting to bring a device to market must obtain FDA “clearance to market.” The
device manufacturer must submit validation studies that will be reviewed by the FDA
to determine whether or not clearance to market will be granted. When a facility is
considering purchasing a medical device, one of the criteria should always be that the
product has been cleared by the FDA. Validation studies require specialized equipment
not readily available in health care facilities. To validate sterilization of a device the device
is inoculated with a 106 (approximately a million) population of spores in the most difficult
to sterilize locations (e.g. a narrow lumen or crevice) and then subject to a half cycle
sterilization process. A half cycle is an exposure time of one half the time that would
ordinarily be found on the IFU and that a health care facility would employ. For example
if an IFU calls for a steam sterilization cycle of 2700 F with 4 minute exposure time that
cycle efficacy was actually validated at 2 minutes or at half cycle. Health care facilities
do not have specialized sterilizer equipment programmed to sterilize at half cycles. In
this instance by validating at a half cycle of 2 minutes and stating a 4 minute cycle in the
IFU the healthcare facility will be running a cycle that is actually twice as long as it was
proven or validated to be effective. Other FDA requirements of validation may require
internal temperature mapping, testing with fractional cycles or incremental critical process
parameters and use of spore strips, inoculated threads, or liquid spore suspensions.
Validation also requires demonstrating that the same results are achieved with repeated
cycles. In addition to sterility validation, functional validation is required. Tests must be
performed to demonstrate that the device will function safely and as intended through
repeated cleaning and sterilization processes. Based on validation studies and results,
the device manufacturer will develop an IFU as part of its labeling. When the user follows
those instructions they are performing verification.
Verification – AAMI ST79 defines user verification as “documented procedures,
performed in the user environment for obtaining, recording, and interpreting the results
required to establish that predetermined specifications have been met.”15 Verification
is performed to determine if it is possible to obtain the desired results by following the
IFU. When a device is sterilized according to the IFU and monitored in accordance with
established policies and procedures, e.g., using chemical and biological indicators, and
the desired results are obtained then verification has been accomplished.
Understanding the difference between validation and verification is important especially
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when it comes to preparation and packaging for sterilization. For example, if sterile
processing receives a request to combine two sets with different materials into one or to
move the contents of a set into a container made of material that is different from the one
originally supplied with the device, it is probable that neither the package manufacturer
or the device manufacturer has validated this new combination and the cycles or
processes stated in the individual IFU for each set or container may differ from each
other. Without validated instructions that permit this new configuration or package, it is
not possible to know whether this change is effective or safe. An instrument set that is
sold with a dedicated container was probably validated using that container and placing
those instruments into a different container made of materials that are different from the
original or whose IFU call for a different cycle is risking sterilization efficacy and or device
functionality.
The Centers for Medicare and Medicaid (CMS) released a memo to state survey
agencies directors in 2008 stating that “If manufacturer’s instructions for use are not
followed then the outcome of the sterilizer cycle is guess work, and the ACS (ambulatory
surgery center) practices should be cited as a violation of 42 CFR 416.44(b).16
Processing using a cycle that is not validated for the device could potentially result in
a citation. In addition to the potential of putting patients at risk, facilities that receive
Medicare and Medicaid reimbursements could put their funding in jeopardy when not
following the IFU or when using a technology that is not indicated in the IFU.
Product testing – Product testing is a quality assurance process established within
sterile processing department to periodically test routinely sterilized products. It is a form
of verification. Medical device manufacturers are able to strictly control the contents of
the loads used for validation so that loads are identical. Unlike device manufacturers,
sterile processing personnel sterile loads vary throughout the day according to case
scheduling, demand, volume and through-put capacity. Product testing is performed
within a healthcare facility to determine if desired results e.g., negative BI results,
acceptable chemical indicator readings and absence of moisture, following a sterilization
cycle, can be obtained with existing equipment and resources and under conditions of
instrument processing usual for the department in which the testing is being performed.
Product testing is accomplished by seeding a product (a set) with multiple BIs and
CIs in the most challenging locations within that product, labeling the set (product) as
“product testing” so as to alert personnel that this set should not be distributed, running
the product within a typical challenging load, and evaluating the monitoring results.
Medical device manufacturers may assist in identifying the most challenging instruments
or locations within a set. Not every set is product tested. Rather product representing
categories of devices are chosen for testing. For example, lumened devices or powered
devices are two classifications for which product testing would be appropriate. By testing
the most challenging of lumened device sets or most challenging powered device set and
obtaining desired monitoring results it can be assumed that the conditions for sterilizing
these types of instruments is appropriate. Product “families” might be chosen according
to density, type of material, size, or device configurations. Product testing should always
be performed when major changes are made in packaging, wraps or load configurations.
Product testing should be performed before newly purchased or loaned sets are placed
15
into routine use.17 Following a validated IFU is critical to a successful cycle; however,
because conditions may vary within facilities it is important to perform product testing as
a form of verification.
Key Points
• Validation is testing performed by the device or equipment
manufacturer using equipment and techniques not found in
healthcare facilities.
• Validations studies must demonstrate sterility and functionality, that
the device can be sterilized, and that it will function as intended.
• The IFU, which includes instructions for processing, are based on
validation studies.
• Users follow the IFU to obtain the desired results which are based
on the validation studies.
• Product testing is performed to periodically test routinely processed
items under conditions and with resources found in the sterile
processing department.
RESPONSIBILITIES OF PERSONNEL RESPONSIBLE FOR
PROCESSING DEVICE AND EQUIPMENT
Joint Commission and AAMI response to non-compliance with IC.02.02.01
The Joint Commission’s Office of Quality Monitoring issued a report of the findings
by surveyors who noted an increase in non-compliance with standard IC.02.02.01
which requires that organizations reduce the risk of infection associated with medical
equipment, devices and supplies. Among the findings that relate to IFU are the following:
•
Staff lack the knowledge or training required to properly sterilize or high-level
disinfect equipment.
•
Staff does not have access to or lack knowledge of evidence-based guidelines.
•
The time frames for proper sterilization or high-level disinfection are not
followed.
•
There is no dedicated staff person to oversee the proper sterilization of highlevel disinfection of equipment.
•
Equipment is spread throughout the facility and may be processed or stored in
numerous locations, making it difficult to track the equipment for documentation
purposes.18
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In response to the recognition that more must be done to mitigate the risk of infection
associated with the processing of medical equipment, devices or supplies AAMI published
an article describing actions to take to improve reprocessing.19
These include but are not limited to the following:
•
The basics: Cleaning and disinfection/sterilization or reusable medical devices
are separate, equally important processes and must be performed before each
patient use according to the device manufacturer’s written instructions for use.
•
The right tools: Have the IFU as well as all cleaning implements and equipment
required by the IFU readily available in all the reprocessing areas.
•
Purchasing: Central sterile processing should be included in purchasing
decisions for medical devices to provide input on whether the device can be
reprocessed appropriately with the facility’s existing resources.
•
Assessment: Conduct an audit of compliance with standards and regulations,
using any number of available tools and resources.
Additional considerations
Prior to purchase
A representative from the sterile processing department should participate in decisions
regarding purchasing of reusable medical equipment or devices that are intended to
be reprocessed within the institution. The decision to purchase must be based on the
organization’s ability to reprocess the device with existing equipment or its willingness to
invest in equipment that will be required. The IFU may call for a sterilization technology
the organization does not have or may require additional time to process that cannot
be accommodated with existing staff. A penny saved on the purchase price may result
in wasted dollars when sterile processing is not consulted with regard to whether the
organization has the resources to process as outlined in the IFU. The IFU should be
requested and reviewed before purchasing any device or system that is not similar to
existing inventory. Receiving and reviewing the IFU prior to purchase rather than upon
delivery is a proactive action to prevent purchase of a device that is not appropriate to the
facility.
Assignment of responsibility for managing IFU
In facilities that perform few surgical procedures or where procedures are limited to one
specialty, the number of IFU may be relatively small and can easily be managed by
existing staff. However in large facilities where thousands of instruments are processed
daily and where a variety of loaner sets are received almost daily, the management of
IFU can be very time consuming. Done correctly and managed in house it is conceivable
that at least a part-time position be allocated for this purpose. Responsibilities within this
position include the following:
•
Ensuring that IFU for all devices are present
It is not unusual for IFU to be placed in a forgotten drawer or cabinet or to get
lost among a stack of papers on someone’s desk. Even where a filing system
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of some sort exists, the sheer volume of IFU can often lead to misplaced or
missing instructions. It is not surprising that a IFU may go missing when one
considers the possible journey of an IFU when it arrives at a health care facility.
The IFU typically goes through receiving and then transport to the sterile
processing department where it goes to the manager and then gets filtered
down to the hands-on staff. The first step to organizing IFU is to make sure
they are all present.
In addition to IFU for instruments, IFU for the equipment and tools needed to
reprocess instruments must be available. These include but are not limited to
the following:
o Mechanical cleaning equipment - washer/disinfectors, washer/
decontaminators, cart washers, ultrasonic cleaners, automated
endoscope reprocessors
o Soaking solutions
o Detergents
o Cleaning implements – brushes, titrating equipment
o Dosing systems
o Water treatment equipment
o Packaging products – wrap, pouches, rigid sterilization containers
o Package sealing equipment
o Sterilizers
o Monitoring tools – Biological indicators, chemical indicators, washing
equipment efficacy testing products
o Incubators
o Non-contact temperature gun
•
Ensuring the right tools
Before any device or equipment is put in service it should be reviewed to
identify the resources that are required for its processing. These may include
soft cloths, a specific detergent, a dedicated cleaning brush, water of a specific
quality, pressurized air or water delivery, etc. If these materials or equipment
are not available they should be obtained before the device is processed.
•
Creating a system for management/accessibility of IFU
An IFU management system must include a mechanism to access the
desired IFU. Filing by manufacturer, device name or catalog number are
all appropriate means, however accessibility via more than one category is
advisable. In addition when a tracking system is utilized within the department
there needs to be integration of the IFU with the tracking system. Assistance
from the tracking company, the device manufacturer and the information
technology department may be required to achieve desired integration.
In many facilities, part or all of the instrument processing for a specific clinic
or department may take place within that department and not within the main
sterile processing department. When this is the case, the IFU for devices
18
processed in satellite locations must be readily available where they are
processed. Without a computerized process hard copy duplicate IFU will be
required.
Once a system is created it is critical that the information be readily accessible
to all staff with reprocessing responsibilities. For example, it is not appropriate
to locate the IFU within an office that is locked when the occupant goes home
for the evening. It is also important that operating room staff have ready
access to IFU. IFU include operating instructions which could be critical to
access in the event of a problem with the device while being used in surgery.
•
Managing updates
One of the more daunting tasks associated with IFU management is ensuring
that the most current IFU are on file. This is made difficult by the fact that
when a device manufacturer revises an IFU they should notify the customer
who has purchased that device. However notification does not always reach
the appropriate department or person and the information gets lost. It is also
possible that the vendor may not be aware that there had been an update.
Whoever is responsible for managing IFU should periodically review the
manufacturer’s web site and/or contact the device manufacturer to determine if
there has been an update. It is not always easy to locate the person within the
company who is responsible for providing this information and time must be provided for this activity.
•
Extracting the processing information from the IFU
Depending upon whether or not a computerized system is used, it may be
possible to create a tab that directs the user to the critical information for
processing thereby eliminating the need to scroll through extensive operating
instructions. Creating a manual system for rapidly accessing the processing
instructions would be more challenging and time consuming.
•
Creating and evaluating competencies
An IFU is only valuable if it is followed. Competency checklists or audits
should be created to determine staff ability to access a specific IFU and to
follow it. They should be developed for categories of instruments, loaner sets
and new equipment and devices – unlike existing equipment and devices
and categories of instruments. Compliance audits should be performed on
a scheduled basis. All staff who share responsibility for processing should
be have their competency to access and comply with IFU evaluated and the
evaluation should become part of their personnel file.
19
When an IFU is missing or raises questions
Problems associated with IFU include the following: Instructions
•
cannot be located and are not posted on the manufacturer’s web site
•
from the device manufacturer are in conflict with the instructions from the
sterilizer manufacturer or the packaging manufacturer
•
are vague
•
are incomplete/insufficient
•
are confusing and/or not understood
•
are not the most current
Staff should be empowered to contact the device manufacturer to obtain the missing
information, to gain clarification, or to attempt to reconcile conflicting instructions. It is not
always easy to obtain this information because requests for information are not always
relayed to the department or person who can provide the answer. This information may
come from the regulatory or marketing department or the caller may be referred to the
vendor who may not have direct access to this information either. Although for both the
device manufacturer and the person reprocessing a device the common goal is patient
safety, communication to facilitate this is not always efficient.
Medical device development is primarily driven by the desire to develop an improved or
new diagnostic or treatment tool. The ability to clean that device is often not a priority
and the result many times is a device that is excellent for diagnostic or treatment
purposes but one that poses significant processing challenges especially with regard
to cleaning. Processing personnel should explore ways to partner with device
manufacturers on product design to provide information about cleaning challenges
and human factors. Many device manufacturers have begun to reach out to sterile
processing personnel for advice during product development.
Key Points
• Components of a system for managing IFU should include:
◦◦ Sterile processing personnel representation in purchase decision
◦◦ Having the tools identified as necessary to process
◦◦ A dedicated person to oversee the system
◦◦ Competencies developed based on IFU
• When IFU are vague, missing or inadequate the manufacturer
should be contacted.
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Considering purchase of a document management system
Many facilities have chosen to contract with a IFU document management system rather
than invest the time and resources it could take to develop one’s own system. The
greater the inventory of equipment and devices, the more likely the benefit of such an
investment. Purchase of such a system should be based on whether or not the system is
appropriate to the facility. There are several companies that sell document management
systems. For a fee, the management company will provide the user with ready access to
IFU as needed. Some systems are limited to specific types of items such as loaners and
others are more comprehensive with an extensive data base of IFU. When considering
contracting for a document management system the following should be considered:
•
How extensive is the data base?
o Does the data base include the devices processed in the department
considering purchase?
o Does the data base include equipment and device processing IFU or
does it only supply device IFU?
•
When an IFU is not in the data base will the company obtain the IFU upon
request?
•
Does the company periodically request updates from device and equipment
manufacturers and is that information disseminated on a regular basis?
•
What do other customers say about the service?
•
Is the computer program easy to use?
•
Is there a help line?
•
Does the program include a snapshot version of the processing instructions
thereby eliminating the need to scroll an entire IFU including operating
instructions for the processing information ?
•
Is is possible to create a file within the program that permits storage of IFU for
the most commonly processed items within the department?
•
Does the program include suggested competency check lists?
•
Is the cost reasonable versus what it would take to create a document
management system in-house?
Instructions for Use is a “hot” topic. Joint Commission and other surveyors know that one
of the keys to infection prevention is following an IFU when processing or maintaining a
medical device or operating related equipment. It is entirely likely that a surveyor, when
in the sterile processing department, will ask to see an IFU and will observe compliance
with that IFU. Ready access to all IFU regardless of where the processing occurs,
compliance with the IFU and competency documentation will indicate compliance with
21
the Joint Commission standard IC.02.02.01. to reduce risk of infection from equipment,
medical devices and supplies.
BENCHMARKING AND THE IFU
Often times benchmarking productivity in the sterile processing departments centers
on how many of a certain type of tray can be processed in a given time period. The
less time it takes or the greater number of sets that can be turned around the better
the productivity is considered. Proper benchmarking should be based on whether or
not the IFU is followed not on how quickly a set or device can be turned around. The
reality is that if all steps in many IFU are followed, the time required may far exceed
what is currently considered a benchmark for productivity. By reading through an IFU
and identifying time requirements or steps i.e.. soak for 10 minutes in detergent. Rinse
with tap water 3 times, flush port with 50 ml warm water place, in bath of warm water,
repeat process 2 times, place in ultrasonic cleaner for 10 minutes, it is obvious that the
times indicated in the IFU often exceed the times actually carried out. In these instances
benchmarking against times that match the IFU is more appropriate. It is obvious that
with pressure for turnaround, it is almost impossible with existing resources to comply
completely and some steps may be shortened or omitted. It is imperative that sterile
processing personnel present data to management that details time requirements for
processing according to the IFU and to lobby for the resources necessary to follow the
IFU to the letter. It is also imperative that sterile processing personnel partner with device
manufacturer’s to ensure rapid cleaning processes are built in instrument design.
Key Points
• Benchmarking should be based on compliance with an IFU not on
how quickly a set can be processed.
IFU, AAMI and AORN
Instructions for use are critical to processing a device that is truly patient ready i.e., safe
and effective, however they should always be used in concert with other recognized
standards of practice. Both the Association of periOperative Registered Nurses
(AORN) and AAMI have published guidelines for instrument processing and equipment
maintenance that are widely recognized and highly regarded throughout the world. For
example where an IFU for a packaging product such as a rigid sterilization container
may identify how to remove the filter, what product may used to clean the container,
technologies that can be used for sterilization, and the temperature and exposure
time parameters for sterilization; the AORN and AAMI guidelines will provide more
general, but no less important information, such as what criteria to use when selecting
a packaging product, how to label packages, how to load packages within a sterilizer,
and what the general conditions for storage should be. Information in AORN and AAMI
guidelines does not contradict product specific IFU but rather compliments them. Every
sterile processing department should have a readily available current copy of AAMI
Comprehensive guide to steam sterilization and sterility assurance in health care facilities
22
2013 and access to the AORN Guidelines and tools for sterile processing team.20 In
addition to requesting to see an IFU, it is very likely that an accrediting agency surveyor
will ask what standards or guidelines are used to direct practice within the department.
Sterile processing personnel should be able to point to the AAMI and AORN guidelines.
SUMMARY
Ensuring that a device is safe for use on a patient undergoing a surgical or invasive
procedure is a complex process. Devices used in surgery have evolved from very simple
and easy-to-clean and sterilize to complex and challenging to clean and sterilize. At the
same time there is increased recognition that an improperly or inadequately processed
surgical instrument used on a patient can contribute to development of a surgical site
infection and in some instances to death. In the early days many devices used in surgery
came without instructions for use. Today an IFU may contain as many as 70 or more
pages. Following the instructions in the IFU in combination with adherence to recognized
instrument processing guidelines is critical to producing a device that is safe for use on a
patient. In a large facility the number of devices and their accompanying instructions for
use can be overwhelming and management of them is often less than ideal. Regarding
IFU, facilities should ensure that:
•
Sterile processing personnel are included in purchasing decisions for devices
that will be processed within the sterile processing department.
•
There is an IFU for all of the products, devices and equipment within the
department that relate to instrument processing.
•
IFU are accessible 24/7 to all personnel who share instrument processing
responsibilities regardless of where any aspect of processing is performed.
•
IFU are current.
•
Competencies related to IFU are in place.
•
Staff competency to follow an IFU is evaluated when new devices or
equipment are obtained.
•
There is a process in place for reconciling conflicting IFU.
•
Management of IFU is considered in staffing formulas if contracting with a
document management system is not implemented.
•
Productivity is benchmarked against meeting IFU requirements.
Finally guidelines from AAMI and AORN along with IFU should be what drives practice.
23
REFERENCES
1. Joint Commission. Quick Safety, Improper sterilization or high-level disinfection of
equipment, May 2014. http://www.jointcommission.org/issues/article.aspx?Article
=OnSN6wB9zLJ4d9rcQg%2fkk23LJ5axbSViQF2x1VoLaKc%3d Accessed Dec 16,
2014
2. ECRI Institute. Top 10 health technology hazards for 2015. ECRI Institute, Plymouth
Meeting, PA, 11/2014.
3. Eisler P. Deadly bacteria on medical scopes trigger infection. USA Today. Jan. 27,
2015.
4. Tosh P, et al. Outbreak of Pseudomonas aeruginosa surgical site infections
after arthroscopic procedures. Infection Control and Hospital Epidemiology 2011
Dec;32(12):1179-86.
5. Parada, S, et. al, Instrumentation-specific infection after anterior cruciate ligament
Reconstruction, Sports Health Nov/Dec 2009 1(6):481-485.
6. Holodniy M, et. al, Results from a Large-Scale Epidemiologic look Back
Investigation of Improperly Reprocessed Endoscopy Equipment, Infection Control
and Hospital Epidemiology, 2012 July: 33(7):649-656.
7. AAMI. Reprocessing 2011 summit: Priority issues from the AAMI/FDA medical
device reprocessing summit. http://www.aami.org/htsi/infusion/jan2012/2011_
Reprocessing_Summit_publication.pdf.
8. U.S. Food and Drug Administration. Sulfanilamide disaster. http://www.fda.gov/
AboutFDA/WhatWeDo/History/ProductRegulation/SulfanilamideDisaster/default.htm.
Accessed December 20, 2014.
9. Rutala W, Weber D. and the Healthcare Infection Control Practices Advisory
Committee, CDC Guideline for disinfection and sterilization in healthcare facilities
2008.
10. FDA: CFR Code of federal regulations Title 21. http://www.accessdata.fda.gov/
scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
11. Occupational Safety and Health Administration. Occupational exposure to bloodborne pathogens. Code of Federal Regulations, Title 29. Part 1910.1030
12. AAMI. A clean start: Priority issues from the AAMI/FDA medical device reprocessing
summit. Arlington, VA. Oct. 2011.
13. Association for the Advancement of Medical Instrumentation (AAMI), AMMI/ANSI
ST79 2013 Comprehensive guide to steam sterilization and sterility assurance in
health care facilities 2013 Arlington VA. Section 2.
14. AAMI. TIR12: Designing, testing and labeling reusable medical devices for
reprocessing in health care facilities: A guide for medical device manufacturers.
Arlington, VA.
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15. Association for the Advancement of Medical Instrumentation (AAMI), AMMI/ANSI
ST79 2013 Comprehensive guide to steam sterilization and sterility assurance in
health care facilities 2013 Arlington VA. Section 2
16. Department of Health and Human Services, Centers for Medicare and Medicaid
Services. http://www.ascquality.org/Library/sterilizationhighleveldisinfectiontoolkit/
CMS%20Flash%20Sterilization%20Memorandum.pdf
17. Association for the Advancement of Medical Instrumentation (AAMI), AMMI/ANSI
ST79 2013 Comprehensive guide to steam sterilization and sterility assurance in
health care facilities 2013 Arlington VA. Section 10.
18. Joint Commission. Quick Safety, Improper sterilization or high-level disinfection of
equipment, May 2014. http://www.jointcommission.org/issues/article.aspx?Article
=OnSN6wB9zLJ4d9rcQg%2fkk23LJ5axbSViQF2x1VoLaKc%3d Accessed Dec 16,
2014.
19. AAMI. 10 things your organization can do now to improve reprocessing. Horizons,
Spring, 2012. http://www.aami.org/publications/HSHorizons/2012/pdfs/Ten_Things_
Improve_Reprocessing.pdf
20. AORN. Guideline and tools for the sterile processing team. Feb. 2015 Available at
www.Aorn.org.
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