Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Part3

VI.   FDA’s Six Criteria for Reprocessing Instructions

Your labeling should address the six criteria below for clear reprocessing instructions, which will ensure users understand and correctly follow the reprocessing instructions.

Criterion 1. Labeling should reflect the intended use of the device.

Your labeling should include instructions for a reprocessing method that reflects the physical design of the device, its intended use, and the soiling and contamination to which the device will be subject during clinical use. Appropriate reprocessing
instructions depend on whether the device will:

§   contact only intact skin;

§   contact intact mucosal surface;

§   contact normally sterile tissues, blood, or bodily fluids such as cerebrospinal fluid,
      peritoneal fluid, aqueous humor, etc.;

§   be subject to splatter or splash of body fluids or blood because of proximity to the
      patient, although it is not in direct contact with the patient;

§   be subject to contamination during use from contact with soiled hands of patient
      caregivers or patients; (note that both unwashed and gloved hands can carry

organic soil as well as microorganisms to the surfaces they touch);

§   be subject to contamination by unexpected or accidental events (e.g., patient
      bleeding, incontinence, vomiting, wounds leaking through dressings);

§   be subject to reprocessing with disinfectants or other chemicals that might leave
      harmful residues, or adversely affect device materials or performance, if

inadequately rinsed; or

§   present specific or unique risks to the patient or user.

Criterion 2. Reprocessing instructions for reusable devices should advise users to thoroughly clean the device.

Cleaning is the first step in reprocessing and should be described in the labeling as part of
the overall reprocessing instructions. Adequate sterilization or disinfection depends on
the thoroughness of cleaning. Instructions to the user should clearly communicate how to
achieve thorough cleaning. Details of the cleaning procedure will vary depending on the
complexity of the device.

Devices with features that may result in soil retention or have features that make them difficult to clean, may need to be disassembled in order to be completely cleaned, unless the manufacturer can validate effective cleaning without disassembly (i.e., data should be obtained from testing soiled devices cleaned with and without disassembly for
comparison). For such devices, instructions/diagrams for adequate disassembly should be included in the cleaning instructions (see Criterion 5.C. for details).

Directions for use of the device may include the use of protective covers and sheaths to
try to reduce the extent of cleaning needed before the device can be reused (e.g.,
bronchoscopes). If you recommend the use of protective covers, your labeling should
include the recommendation to use only legally marketed protective covers. However, the
cleaning instructions for your device should assume the worst-case where the device is
used uncovered, because of the potential for loss of cover integrity during use. Unnoticed
loss of cover integrity may result in degrees of soiling that are difficult to see but will
present a risk to the health of the next patient unless the device is properly reprocessed.

Flushable devices (e.g., endoscopes, laparoscopic instruments and other devices with
flush ports) are prone to debris accumulation and should have instructions/diagrams to
ensure proper flushing during cleaning procedures. Proper flushing of the device is
important to remove retained soil from inside of the devices during these procedures.
Flushing instructions/diagrams should include information on how to properly flush the
device, the specific accessories to be used including proper size connectors for the flush
ports, and the type and volume of flushing agent to be used to ensure thorough and
effective cleaning of the device.

Criterion 3. Reprocessing instructions should indicate the appropriate microbicidal process for the device.

Your instructions should be consistent with current infection control principles. The microbicidal process recommended should be sterilization or disinfection (high, intermediate, or low level), depending on the intended use of the device.

Note that whichever reprocessing method(s) is/are recommended, the compatibility of the device with the method(s) and the ability of the method(s) to successfully reprocess the device features should be validated and then stated in the instructions for use. The
validation should demonstrate that soil and contaminants have been effectively removed and that the device is free of viable microorganisms.

FDA uses the Spaulding Classification² scheme described below for critical, semi-critical and non-critical devices to describe the potential risk of infection caused by the device and the appropriate microbicidal processes. Because the Spaulding classification does not address all clinical device uses and reprocessing needs in detail, we have modified it
accordingly as described below.

A. Critical Devices

Critical devices are devices that are introduced directly into the bloodstream or which contact a normally sterile tissue or body-space during use. There is a likelihood of microbial transmission and risk of infection (subclinical or clinical) if the device is not sterile. Users should be instructed to disassemble (if applicable), thoroughly
clean, and sterilize critical devices after each use.

Examples of critical devices include surgical instruments, irrigation systems for

sterile instruments in sterile tissues, endoscopes used in sterile body cavities (such as
laparoscopes, arthroscopes, intravascular endoscopes) and all endoscope biopsy
accessories.

B. Semi-Critical Devices

Semi-critical devices are devices that contact intact mucous membranes or non-intact
skin. They do not ordinarily penetrate tissues or otherwise enter normally sterile areas
of the body. Intact mucosal surfaces are relatively resistant to small numbers of
spores. However, these devices should be reprocessed to be free from all
microorganisms. Users should be instructed to thoroughly clean these devices and
then reprocess them by sterilization. If the device design does not permit sterilization
(e.g., device materials cannot withstand sterilization), then high level disinfection
should be used.

Examples of semi-critical devices include duodenoscopes, endotracheal tubes,

bronchoscopes, laryngoscope blades and other respiratory equipment, esophageal
manometry probes, diaphragm fitting rings, and gastrointestinal endoscopes.

Heat-stable devices (e.g., rigid endoscopes) should be processed by steam

sterilization. For heat-labile devices, available “low temperature” reprocessing

² Spaulding, EH The role of chemical disinfection in the prevention of nosocomial infections. In: Brachman PS, Eickoff TC, eds Proceedings of the International Conference on Nosocomial Infections, 1970. Chicago: American Hospital Association, 1971:254-274

technologies include hydrogen peroxide (H₂O₂) sterilization, ozone (O₃) sterilization,
ethylene oxide (EO) sterilization³ (including device aeration) and liquid chemical
sterilant/high level disinfectant chemical systems used to provide either liquid
chemical sterilization or high level disinfection. High-level disinfection methods used
in health care settings include liquid chemical sterilants used at high level disinfection
conditions and hot water pasteurization (often used for respiratory and anesthesia
equipment reprocessing).

C. Non-Critical Devices

Non-critical devices are instruments and other devices whose surfaces contact only
intact skin and do not penetrate it. Non-critical devices also include devices that do
not directly contact the patient but may become contaminated with microorganisms
and organic soil during patient care (e.g., blood, body fluids); such devices may not
be visibly contaminated. FDA recommends thorough cleaning, then intermediate or
low level disinfection for non-critical devices depending on the nature and extent of
contamination.

Examples of devices that contact only intact skin include blood pressure cuffs,

stethoscopes, and skin electrodes. Examples of devices that have no direct patient
contact, yet may become contaminated during patient care, include infusion pumps
and ventilators.

Note that some disinfectants are fairly effective cleaning agents while others are not.
Always consider the worst-case microbes to which the device may be exposed during
clinical use, the likelihood of significant organic soiling of the device during use, and
the ability of the device material to repeatedly withstand disinfectant contact when
selecting a disinfectant to validate and then recommend for use with your device.
Also consider the products that are frequently used in health care settings when
selecting a disinfectant to study and validate. If a product or class of products can
damage the materials in your device, your device label should include a warning not
to use that product or class of products to reprocess your device.

Items contaminated with blood or body fluids, which may contain blood-borne

pathogens, should be cleaned and then receive intermediate level disinfection with a product having an EPA-registered claim for activity against hepatitis B.⁴ Blood
glucose meters used in healthcare settings are an example of a blood-contaminated device which has been a source of hepatitis B transmission during patient-to-patient use when not properly cleaned and disinfected after each patient and not used in strict compliance with glove use and hand washing after glove removal.

Be aware that in some clinical situations (e.g., patients with Norovirus or Clostridium difficile infections, drug-resistant organisms, etc.), isolation precautions

³ EO sterilization may not be ideal for certain device types, such as duodenoscopes.

⁴ Center for Disease Control and Prevention (CDC), “Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008.

recommended for use by CDC may include the use of specific disinfectants and should be followed.  You should instruct the user to follow the specific EPA label disinfectant contact times when using the disinfectant as well as the instructions specified in the medical device labeling.

Devices that will likely not become contaminated with pathogens during use (e.g.,

room vital signs monitor) may not require disinfection, and therefore may be suitable for use after cleaning only.

Criterion 4. Reprocessing instructions should be technically feasible and include only devices and accessories that are legally marketed.

Reprocessing instructions should be technically feasible in the intended location (e.g.,

health care setting or home use). The equipment and accessories needed to implement the instructions should be clearly defined (including detailed descriptions and part numbers, if applicable) and readily available for the users to obtain.

The type of sterilizer, and the manufacturer-validated sterilization cycle parameters and accessories should be available to the users. For example, radiation sterilization is
generally only used in manufacturing facilities. Steam sterilization is the most common method of sterilization used in health care settings. EO, H₂O₂, O₃ and liquid chemical sterilization processes are also available in some health care settings. Dry heat and
chemical vapor sterilization are less common.

FDA recommends that the instructions specify sterilization methods and parameters that
are technically feasible for the user. That is, sterilization cycle parameters specified in the
labeling for reprocessing a device should be consistent with validated sterilization cycle
parameters for commonly available, legally marketed sterilizers. Examples of cycle
parameters commonly found on health care steam and EO sterilizers at the time of this
guidance are provided in Appendix C. Designing your reprocessing instructions in
accordance with the conventional parameters represented in Appendix C provides
assurance that your reprocessing instructions are compatible with existing essential FDA-
cleared reprocessing equipment. Information on other methods may be found in AAMI
TIR12.

FDA’s recommendation that sterilization methods and parameters be technically feasible
for the user has direct application to sterilization accessories. Many sterilization
accessories used in reprocessing reusable devices in health care settings are class II
medical devices subject to FDA premarket notification requirements. These accessories
include sterilization wraps, pouches, cassettes, and containers; biological indicators and
chemical indicators; and liquid chemical sterilants and disinfectants. These products
typically receive FDA-clearance for specific process parameters or sets of parameters,
which appear in the “Intended Use” sections of FDA-cleared sterilization accessories.
Your reprocessing instructions should match these specific process parameters.
FDA maintains a list of FDA-cleared liquid chemical sterilants and high level
disinfectants, which is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofReus
ableMedicalDevices/ucm437347.htm. Designing validation protocols in accordance with
the conventional parameters represented in this document provides assurance that your
device is compatible with existing FDA-cleared liquid chemical sterilants and high level
disinfectants.

Extended Cycles

The expression “extended cycle” has gained common usage to describe any

sterilization cycle that includes specifications that deviate from those found on

commonly used, FDA-cleared sterilizers, and for which there are limited or no FDAcleared sterilization accessories. Extended cycles typically include longer exposure times and/or higher or intermediate temperatures, which may also deviate from more conventional sterilization cycles. Implementation of extended cycles poses serious technical challenges in health care settings.

Extended cycles are typically developed to achieve sterilization of complex devices
or larger loads.  Recommending the use of extended cycles for larger loads or more
complex devices in reprocessing instructions may be appropriate provided the
appropriate accessory devices have been cleared for use with such extended cycles.
While many sterilizers are designed with manual over-ride controls for time and
temperature, FDA generally evaluates physical and microbiological performance
validation data and product labeling claims for discrete cycle parameter specifications
as part of the premarket review process for sterilizers and their accessories, including
biological indicators, chemical indicators, and sterilization packaging.

FDA recommends that “ranges” not be used for defining sterilization cycles (for example, 121°C-132°C temperature and greater or lesser than 4 minutes exposure time), as this implies that all intermediate values have been validated, and that there are FDA-cleared accessories for all the intermediate cycles.

The Agency has accepted validated drying time specifications in the labeling that exceed those found on FDA-cleared sterilizers and that require manually setting the drying time controls.

Criterion 5. Reprocessing instructions should be comprehensive.

Comprehensive instructions enable the user to understand precisely how to implement the entire reprocessing procedure safely and effectively. There may be several acceptable formats for instructions.

To ensure the reprocessing instructions are comprehensive, they should include all of the elements below. If any element is not applicable to your device, then you should state this in your premarket submission and provide a justification.

A. Special Accessories

The instructions should describe any accessories that are needed for safe

reprocessing. If the device requires any special protection during reprocessing (e.g., valves, plugs or stoppers to prevent ingress of harsh chemicals), they should be
described in detail. The instructions should also identify any special tools, sizes and types of brushes (including custom brushes), flush port connectors and connector size specifications, trays, test kits, specific types of sterilization wraps or containers, and part numbers, if appropriate.  The instructions should also provide sufficient detail so that the user can purchase the correct items, including any custom cleaning
accessories, or identify a source for the purchase of such items.

B. Point-of-Use Processing

As needed, labeling should include applicable instructions for point-of-use

processing. For example, instructions for prompt, initial cleaning steps and/or

measures to prevent the drying of soil on the device surface prior to cleaning may be appropriate, as this will facilitate subsequent cleaning steps.

In general, reprocessing procedures should minimize or eliminate delays between steps. Delays may create conditions favorable to microbial growth, which may increase the challenge to subsequent steps such as cleaning and
disinfection/sterilization. Organic contamination may inactivate or prevent full penetration of a disinfectant or sterilant.

C. Disassembly and Reassembly

If the device has removable parts, then reprocessing instructions should include stepby-step instructions for disassembly and reassembly of the device to facilitate
cleaning by the user. The equipment needed to perform these activities should be identified. Diagrams, photographs, illustrations and/or videos are recommended. In addition, the instructions should indicate the location where the user should perform the step (e.g., at the point of use, at the designated cleaning area).

Disassembly and reassembly instructions should be explicit, device-specific, and

reflect the validation activities. Expressions such as “disassembly, if applicable” leave
the determination of “applicability” to the discretion of the user; such ambiguous
language should not be used. If a device must be disassembled for cleaning, the
instructions should be validated to assure that proper reassembly can be performed at
the appropriate point in reprocessing. The labeling should provide the user with a
validated method to verify that reassembly has been properly performed; this is to
assure that the device is in operable condition for the next use.  Instructions should
also specify whether to reassemble before or after sterilization. Additionally,
disassembly and reassembly instructions should include information to visually
inspect the device and components for wear and tear of components that cannot be
assessed in the fully assembled configuration.

If reassembly is to be performed by the surgeon and is described in the surgeon’s
manual, then reference to this should also be made in the reprocessing instructions.

D. Method of Cleaning

The labeling should provide a detailed, validated method of cleaning. The method

may be manual or mechanical (e.g., washer, washer/disinfector, ultrasonic washer) or may combine the two. However, manufacturers should be aware that some small health care settings may not have automated cleaning equipment; therefore, validated manual cleaning instructions may be needed.

Cleaning instructions should include a list of the appropriate parameters for each recommended method.

For manual cleaning, the labeling should specify the duration of each processing step, as well as temperatures, water quality, and other necessary conditions. Repeated
actuations, flexures, and manipulations should be specified, where appropriate, based on device design and validation activities.

Similarly, for automated cleaning, the labeling should specify all processing

conditions. The instructions should recommend equipment settings such as time, temperature, and maximum device load size.

Whether the cleaning method is manual, automated, or a combination of the two, the labeling should contain comprehensive directions, including photographs and/or
diagrams, if appropriate, for each cleaning, rinsing, and drying step so that users can accurately follow the steps or program them into the device washer or
washer/disinfector. Recommendations for the use of detergents, enzymatic cleaners, and automated cleaning cycles should be consistent with the manufacturer’s
directions for use for those products.

Labeling should include surface cleaning instructions for medical devices that are at risk of becoming contaminated with patient materials through routine handling by health care workers. Even when only simple surface cleaning is recommended, the label should identify the suggested method, any cautions for specific locations or materials, any disassembly needed, and any subsequent steps.

For a device whose internal components are not contaminated during clinical use but
could be damaged by contact with liquids (e.g., cleaning agents, disinfectants),
surface cleaning instructions should describe how to adequately clean the device and
prevent contact with internal device components that are not designed for contact
with liquids.

E. Cleaning Agents

The instructions should recommend only cleaning agents or classes of agents (e.g.,
detergents such as quaternary ammonium compounds and enzymatic detergents) that
were used during the cleaning validation studies, that have been demonstrated to be
compatible with the device, and are effective in cleaning the device. Labeling should
include instructions for the preparation and use of those agents (e.g., mix one ounce
of detergent per gallon of water), or refer to the cleaning agent labeling for

preparation and use instructions (e.g., according to the detergent manufacturer’s

instructions). Labeling for use on specific medical devices should be consistent with the cleaning agent manufacturer’s instructions for use of the product.

Certain products (e.g., some quaternary ammonium compounds and alcohols) may be used for both cleaning (removal of soil) and disinfection (inactivation of microbes). Other products are capable of only performing one of these two functions. The
instructions for use should address both cleaning and disinfection if both are intended, and should be clear regarding the difference between cleaning and disinfection, and the products used for each step.

F.  Rinsing

The labeling should recommend specific directions for rinsing to remove chemical

residues used during reprocessing; rinsing steps should be included after cleaning and after use of liquid chemical sterilants/high level disinfectants. Rinsing may be manual or mechanical. The rinsing instructions should include the type and quality of rinse water, duration of rinse (or, for flushes, the volume and number of repetitions), and temperature. You may refer to the detergent manufacturer’s labeling to assist in
developing your validated rinsing instructions.

Rinsing instructions should be validated to show that residual cleaning agents and

liquid chemical germicides are reduced to levels that will not interfere with

subsequent reprocessing steps and to levels that are non-toxic. Additionally, for some devices, the final rinse water specifications should be sufficient to remove bacterial endotoxins. (Note that tap water may contain endotoxins.)

We recommend that you refer to the current version of AAMI TIR34 “Water for the
reprocessing of medical devices” for more information on final rinse water quality
and to establish the optimal water quality for final rinses, based on the intended use of
the device. We also recommend that you refer to FDA’s guidance “Pyrogen and
Endotoxins Testing: Questions and Answers”

(http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/UCM310098.pdf).

FDA generally does not recommend saline solutions as the final rinse because saline
solutions may interfere with subsequent disinfection or sterilization steps. Saline
rinses may also lead to corrosion on certain devices and build-up of inorganic
residues.

G. Lubricating Agents

Use of lubricating agents is an effective way of extending the use life of some

medical devices. Lubricants may reduce the friction commonly associated with metalon-metal movements and thereby reduce device wear and corrosion.

If applicable, the reprocessing instructions should recommend lubricating agents, or a class of lubricating agents (e.g., water soluble lubricants) that are compatible with the medical device, its intended use, and with any subsequent processing steps such as sterilization. Also, labeling for the reusable device should refer to the lubricating agent labeling for preparation and use instructions of those agents.

If your reprocessing instructions specify the use of lubricating agents, you should validate the device reprocessing methods using the lubricating agents under the conditions of use of the device.

Caution should be exercised when using oil-based and silicone-based lubricants, as they may coat and protect surface microorganisms and reduce the effectiveness of certain sterilization methods, including steam and EO. They may even provide nutrients for microbial growth.

H. Visual Inspection

All routine cleaning instructions should include instructions for visual inspection, which may include use of magnification and adequate lighting. The instructions should advise the user that if the device is determined not to be visually clean at the end of the cleaning step, the user should either repeat the relevant previous cleaning steps or safely dispose of the device.

Additionally, the visual inspection instructions should identify acceptance or failure criteria related to device performance (e.g., unacceptable deterioration such as
corrosion, discoloration, pitting, cracked seals), as well as instructions to properly dispose of devices that fail.

I.          Method of Disinfection or Sterilization

For reusable devices intended to be disinfected or sterilized, reprocessing instructions
should specify at least one validated microbicidal method for disinfection or
sterilization.

The type of microbicidal method would depend on the type of device to be

reprocessed. Please refer to Criterion 3 for general considerations when selecting the type of microbicidal method. Specifications for sterilization equipment and sterilization cycle parameters vary with manufacturers and models. Labeling for reprocessing should identify the particular sterilization method and type, and list the validated cycle parameters.

Traditional sterilization processes such as steam and EO are sufficiently well-

standardized among sterilizer manufacturers such that sterilization cycles may be

identified by the critical cycle parameters. Accessories for these sterilization

processes also may be identified using only the critical cycle parameters. Refer to

Appendix C for typical parameters of sterilization cycles currently used in health care
settings.

The proprietary characteristics of sterilization processes using newer low-temperature
chemical sterilization methods (e.g., H₂O₂ and O₃) vary from one device
manufacturer to another. Therefore, for these sterilization processes, the manufacturer
of the device, the sterilizer model, and the specific cycle identification (name or cycle
parameters) should be explicitly identified in the reprocessing instructions.
Accessories for these sterilization processes should be labeled by the accessory
manufacturer to specify sterilizer manufacturer, sterilizer model, and sterilizer cycle
name and/or cycle parameters.

For all methods, complete cycle specifications should include all critical cycle

parameters and other pertinent information that identifies the cycle. For example:

§   Moist Heat/Steam - Type of cycle (dynamic air removal vs. gravity),
      exposure time, temperature, drying time

§   EO - EO concentration (and gas composition), exposure time, relative
      humidity, temperature, aeration time

§   H₂O₂ and O₃ - Manufacturer, model, specific cycle identification per model
      either by name or specific cycle parameters

§   Dry heat - Exposure time, temperature

Additionally, specification of device design, packaging, and load characteristics should be addressed to the greatest degree possible in the labeling for the load for sterilization. For example:

§   Weight - Labeling should specify a maximum weight of loaded trays. You

should follow the recommendations in the current FDA-recognized version of
AAMI ST77 “Containment devices for reusable medical device sterilization”
and the health care sterilizer specifications.

§   Materials - Labeling should warn against including incompatible materials
      within the sterilization load (e.g., cellulose incompatibility with H₂O₂

sterilization).

§   Device Design - Labeling should recommend sterilizing only devices with
      dimensions or characteristics (e.g., lumen specifications, powered hand-

pieces) that are compatible with the labeling of the specified sterilizer and sterilization cycles.

§   Chamber load - Labeling should describe the chamber load; for example, if
      the validation was conducted in an empty load or in a full worst case load. §   Drying - Labeling should indicate that devices should be dry before they are

packaged for sterilization.

§   Sterility Maintenance - Labeling should identify packaging that is FDA-

cleared and designed to allow adequate sterilant penetration as well as

maintenance of sterility. Sterilization packaging should be cleared and labeled
for the same sterilization parameters as those recommended for the devices it
is to contain.

J.   Reduction of Sterilant Residuals

Labeling should include instructions for reducing sterilant residuals (e.g., by

aeration), after processes such as sterilization by EO, hydrogen peroxide, or other sterilization processes that may leave sterilant residuals on the device.

For example, for devices intended to be sterilized by EO, the labeling should

recommend an aeration time that results in reduction of EO residuals to acceptable
levels. For more information on EO aeration recommendations, and to establish the
optimal aeration process specification based on the intended use of the device, we
recommend that you refer to the current FDA-recognized version of AAMI ST41

“Ethylene Oxide Sterilization in Health Care Facilities: Safety and Effectiveness.”

For more information on acceptable levels of EO residuals, we recommend that you refer to the current FDA-recognized version of ANSI/AAMI/ISO 10993-7

“Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization
Residuals.”

K. Drying

Active device drying may reduce or eliminate recontamination of unwrapped devices
after high level disinfection/liquid chemical sterilant reprocessing, because the
devices will be wet at the end of reprocessing. Labeling should recommend the
procedures that should be used to thoroughly dry the device, after processing and
before storage, to eliminate moisture that can support the survival of contaminating
microorganisms.

Labeling should also recommend a validated minimum drying time specification for terminal sterilization methods for wrapped/contained devices. Moisture remaining on wrapped/contained products after sterilization could compromise the package
integrity and performance by impairing the sterile barrier properties of the packaging materials and the effectiveness of the seals.

Mid-process drying (i.e., drying after cleaning) is another important consideration, as moisture remaining on devices may interfere with subsequent microbicidal processes. If complete processing is delayed, labeling should recommend an intermediate and effective drying step before any delayed sterilization.

L. Reuse Life

The labeling should either 1) inform the user how many times the device can be

reused, based on testing; or 2) provide the user with a mechanism or method to

ascertain whether the device has exceeded its use life. In the latter case, the labeling
should identify a method to establish that the device is still within performance
specifications, as well as instructions for appropriate disposal of devices that fail. For
example:

§   labeling that refers to a device design feature, such as a built-in, automatic
      pre-check function;

§   labeling that identifies a performance test that should be passed prior to reuse; §   labeling that recommends visual inspection along with acceptance or failure
      criteria (e.g., unacceptable deterioration such as corrosion, discoloration,

pitting, cracked seals).

Whichever method is chosen, labeling should recommend how to evaluate

deterioration in difficult to see areas of complex devices, especially those with lumens (e.g., leak testing).

Reuse life may also be addressed by validating the number of times the product can
be reprocessed and reused, and providing this specification in the labeling. If the
reuse life of a device is limited to a specific number of use/reprocessing cycles, the
labeling should also describe a specific tracking method for the number of reuse
cycles. It may be appropriate for labeling to remind the user that the specific number
of reuse cycles is dependent on full compliance with the directions for use of the
device.

M. Additional Labeling Recommendations

Devices that are initially supplied non-sterile to the user and require the user to

sterilize the device before use should be prominently labeled "Non-sterile" directly on the individual device label (e.g., as opposed to only on the shipper carton) to ensure the non-sterile product is sterilized before use.

Labeling should include any special warnings or precautions about the reprocessing
procedure, when warranted. These may be related to user safety or emphasize
conditions that could significantly alter the safety or effectiveness of reprocessing or
the performance of the device. For example, some devices may have unsealed
seams/crevices through which excessive liquid disinfectant could reach the interior of
the device and damage it. In such cases, the labeling should caution users about this
potential hazard and provide specific use instructions to prevent it, such as avoiding
the application of excess liquid to the device.  It may also be appropriate to note
situations where damage to the device may affect the reprocessing procedure.

N. Patient or Lay Use

Devices that are intended to be maintained by a patient or lay care provider (e.g.,
family member or other) should have reprocessing instructions that are
understandable to a lay person and can be performed at home. The equipment and
accessories needed to implement the instructions should also be readily available in
the intended location of use. Please also refer to FDA’s guidance document
“Guidance on Medical Device Patient Labeling”

(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocu
ments/ucm070782.htm).

O. Reference to Guidelines or Accessory Labeling

In addition to all of the recommendations set forth in this guidance, the reusable
device labeling should also refer the user to the following for the purpose of
additional education but not in lieu of validated reprocessing instructions:
professional organizations’ clinical practice guidelines or clinical guidelines of the
CDC. Please note that clinical practice guidelines, however, do not always consider
or correctly address all FDA regulatory requirements and compliance with FDA
regulations is required.

Referencing the labeling of devices used in reprocessing, such as an endoscope

washer-disinfector, may be acceptable as long as the referenced labeling is relevant and consistent with the reusable device’s labeling. For example, labeling for an endoscope may refer, in part, to endoscope washer-disinfector labeling for certain details on scope reprocessing (e.g., placement in chamber).

P.  Manufacturer’s Contact Information

The manufacturer of the reusable device is the appropriate contact for user questions
about the reprocessing procedures. The instructions for reusable devices should
include a telephone number, email address, and web page address to obtain additional
information about reprocessing the device, including questions on infection control
procedures for the device.

Customer service representatives of device manufacturers are often the initial point of contact when a device user has a question about device reprocessing. The training of these persons should include information on the reprocessing of devices for which they are responsible and the provision of information resources that they can access rapidly in order to provide assistance to device users.

Criterion 6. Reprocessing instructions should be understandable.

Reprocessing instructions should be clear, legible (i.e., reasonable font size), and

provided in sequential order from the initial processing step through the terminal

processing step (e.g., point-of-use processing, disassembly, cleaning, rinsing, reassembly,

disinfection or sterilization, final rinsing after disinfection or liquid chemical sterilization,
and post-process handling). The instructions should be written in simple language to the
greatest extent possible. They should also be sufficiently detailed to explain the correct
procedures for all steps. Charts, diagrams and/or device reprocessing instructions with
pictures that can be posted in work stations, are helpful in ensuring adherence to
reprocessing instructions. Web-posted pictures/diagrams of devices can also be helpful in
answering user questions directly or through customer service representatives.

Where applicable, instructions may include technique diagrams or other graphic

representations designed to communicate recommended practices. However, any graphics should be accompanied by explanatory text. The instructions should be validated to
ensure that users will be able to understand and to follow them.