Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Part2

V.     General Considerations for Reprocessing Instructions

in Device Labeling   

A.     Overview of Reprocessing

Reprocessing is defined as validated processes used to render a medical device, which has been previously used or contaminated, fit for a subsequent single use. These
processes are designed to remove soil and contaminants by cleaning and to inactivate microorganisms by disinfection or sterilization. Reprocessing of reusable devices encompasses appropriate steps that begin in close proximity to the point of use of the device and, in general, involves the following three steps in sequence:

1.  Point-of-Use Processing: Reprocessing begins with processing at the point of use
      (i.e., close proximity to the point of use of the device), to facilitate subsequent

cleaning steps. We define this as point-of-use processing, which includes prompt, initial cleaning steps and/or measures to prevent drying of soil and contaminants in and on the device.

2.  Thorough Cleaning: The device should be thoroughly cleaned after the point-of-
      use processing. Generally, thorough cleaning is done in a dedicated cleaning area.

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.

3.  Disinfection or Sterilization: Depending on the intended use of the device, the
      device should be disinfected or sterilized, and routed back into use.

A simple overview of reprocessing is presented in Figure 1. A more detailed overview of each reprocessing step is provided in Appendix B.

FIGURE 1. PROCESS OVERVIEW
                            Use

Point-of-Use Processing

(prompt, initial treatment to remove and/or
prevent drying of soil and contaminants)

Thorough Cleaning

(and return to use, or)

Disinfection         Sterilization

(Low, Intermediate,
    or High Level) 

   

It is important to note that cleaning, disinfection, and sterilization are distinctly different
processes.

Cleaning is the physical removal of soil and contaminants; the methods and agents used for cleaning should be designed to remove such soil and contamination effectively. Effective cleaning should:

§   minimize the soil transfer from one patient to another or between uses in a single
      patient;

§   prevent accumulation of residual soil throughout the product’s use life; and §   allow for successful, subsequent disinfection/sterilization steps.

In comparison, disinfection and sterilization processes are intended to kill

microorganisms; the methods and agents employed for disinfection and sterilization

should be designed to achieve appropriate microbicidal effects.  Please see Appendix A for the definitions of disinfection and sterilization, and Section VI. Criterion 3 for
specific information on appropriate microbicidal processes.

Accordingly, cleaning steps should be validated separately and independently from disinfection or sterilization steps.

An overview of reusable medical device processing is found in Appendix B of this document.

B.      Resources for Developing Reprocessing Instructions

The following are resources to consider when developing reprocessing instructions for reusable medical devices.

1.   You should follow the labeling recommendations in device-specific guidance,

when available. Device guidance may be found by searching FDA’s Guidance Document Database available at

http://www.fda.gov/RegulatoryInformation/Guidances/default.htm.

2.   The following Technical Information Reports (TIRs) developed by the

Association for the Advancement of Medical Instrumentation (AAMI) provide technical information for manufacturers and users and may be helpful when developing labeling instructions for reusable medical device:

a.  AAMI TIR12, Designing, testing and labeling reusable medical devices for
      reprocessing in health care settings: A guide for medical device

manufacturers.

2.  AAMI TIR30, A compendium of processes, materials, test methods, and
      acceptance criteria for cleaning reusable medical devices.

3.   We recommend you refer to the current FDA-recognized version of AAMI/ANSI

ST81, Sterilization of medical devices - Information to be provided by the
      manufacturer for the processing of resterilizable medical devices.
 4. We recommend you use current FDA-recognized test methods available from

standards developing organizations (SDO). A searchable database of FDA-

   

recognized consensus standards is available at:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.
5. You should also consult any relevant clinical practice guidelines and
      recommendations for infection control published by professional societies and

associations, standards developing organizations, and government agencies (for

example, the “Guideline for Disinfection and Sterilization in Healthcare Facilities,
2008” from the Centers for Disease Control (CDC), available at
http://www.cdc.gov/hicpac/pdf/guidelines/disinfection_nov_2008.pdf).
Clinical practice guidelines, however, do not always consider or correctly address
all FDA regulatory requirements. As an example, some professional organizations
may recommend using disinfectants in ways that may not necessarily comply with
FDA regulations. Compliance with FDA regulations is required.

C.      Human Factors in Developing Reprocessing Instructions

You should consider the following recommendations regarding human factors in developing your reprocessing instructions:

1.   We recommend that you develop consistent reprocessing instructions across each

of your product lines. Labeling that provides consistent methods and terminology, and utilizes the same document layout for all devices of a type, may help improve the user’s comprehension and adherence to the instructions.

2.   You should address any known post-market human factors issues known to exist

for reprocessing your device or similar devices. Examples of human factors issues
include, but are not limited to, actions requiring substantial dexterity or strength,
good visual acuity, or familiarity with uncommon practices. Information on post-
market issues may be found by reviewing your internal user complaint files, the
published literature, the FDA’s Medical Device Reporting (MDR) system, and
FDA Safety Alerts and Public Health Notifications. We recommend that you refer
to the following sources for additional information on human factors:

a.  FDA’s guidance “Medical Device Use-Safety: Incorporating Human Factors
      Engineering into Risk Management”

(http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidan
ce/GuidanceDocuments/ucm094461.pdf).

b.  FDA’s guidance, “Human Factors Principles For Medical Device Labeling”

(http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidan
ce/GuidanceDocuments/UCM095300.pdf).

c.  The current FDA-recognized version of IEC Standard 62366, “Medical
      Devices - Application of usability engineering to medical devices.”

d.  The current FDA-recognized version of ANSI/AAMI HE75, “Human Factors
      Engineering - Design of Medical Devices.”

3.   For devices that are subject to design controls under 21 CFR 820.30, you should

validate your reprocessing instructions to ensure that users will be able to

successfully understand and follow them.  FDA recommends considering the following:

a.   Your validation study participants should be representative of the professional

staff that would perform these actual reprocessing procedures. If users would
be wearing personal protective equipment (PPE), such as goggles, full-length
face shields, heavy-duty utility gloves or liquid-resistant covering with

sleeves, then the validation study participants should wear them as well.

b.   Participants may use the instructions to perform an actual or simulated

reprocessing procedure or verbally describe what they would do as they read the instructions.

c.   If attributes of the use environment might affect use of the instructions and

reprocessing of the device, they should be represented in the study.

d.   Observing and documenting participant behavior during testing will allow you

to assess the participants’ adherence to the instructions and to identify and understand the nature of any errors or problems that occur.

e.   After using the instructions independently, you should ask the participants if

they had difficulty in performing the reprocessing, and allow them to describe their experience. You should ask specifically about any errors, problems or hesitations that were observed. The participants should provide subjective
feedback regarding any wording in the instructions that they found confusing, misleading, or incomplete. The participants’ responses and comments should be documented.   If you make significant changes to the instructions after
testing them, you should validate the success of the changes at eliminating or reducing the problems previously identified.