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Reprocessing Medical Devices in Health 

Care Settings:

Validation Methods & Labeling

FDA Final Guidance

Elaine Mayhall, Ph.D.

Scientific Reviewer; Infection Control Devices Branch; Division of Anesthesiology 

General Hospital Respiratory & Infectious Diseases, Office of Device Evaluation

Geetha Jayan, Ph.D.

Senior Science Health Advisor; Office of the Center Director
Background

• Final guidance – published March 2015

• Draft – published in 2011

– 487 public comments

• From various stakeholders including device 

manufacturers, testing laboratories, trade / 

professional organizations, users

– Common theme: additional information / clarification

• e.g., scope of the document, steps in the validation of 

cleaning, the six criteria for reprocessing instructions, 

resources for developing reprocessing instructions, 

device design considerations

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Webinar Outline

2015 Final Guidance

• Purpose & scope

– How it differs from the 1996 guidance

• Overview of reprocessing, reusable devices & recent 

trends

• Formulation of reprocessing instructions

– Six criteria for reprocessing instructions

• Validation of cleaning process

• Summary – key messages

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Purpose of this Guidance

Proper reprocessing of reusable medical devices is 

important to reduce the risk of patient infections during 

reuse

• Provides recommendations to medical device 

manufacturers for developing reprocessing instructions 

that can be easily understood and followed by users

• Outlines current Agency expectations for manufacturers 

to conduct scientifically sound testing to validate their 

reprocessing instructions prior to marketing

5 Continued.....
Purpose of this Guidance

• Also describes new measures the Agency is taking to 

enhance its oversight of reprocessing procedures

– e.g. Appendix E

• Replaces FDA’s 1996 “Labeling Reusable Medical 

Devices for Reprocessing in Health Care Facilities”

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What’s New in this 2015 Final Guidance

(vs the 1996 Guidance)

• Expanded to include information pertaining to 

validation of reprocessing methods and instructions

– Specific emphasis on importance of proper cleaning 

& cleaning validation, importance of worst-case 

testing, importance of device designs that are less 

challenging to reprocess

– Human factors considerations when validating 

reprocessing methods and instructions

7 Continued.....
What’s New in this 2015 Final Guidance

(vs the 1996 Guidance)

• Provides greater clarity on documentation to be 

provided in the different premarket submissions

– 510(k), PMA, de novo, HDE, IDE

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Scope of the Guidance

Recommendations in this guidance are applicable to:

• Reusable devices initially supplied sterile to user & 

requiring user to reprocess after each patient use

• Reusable devices initially supplied non-sterile to 

user & requiring user to process prior to initial use, 

as well as after each use

• Reusable devices intended for reuse by a single 

patient and reprocessed between each use

• Single-use devices initially supplied non-sterile & 

requiring user to process prior to its use

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Reprocessing: 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

(Low, Intermediate, 

or High Level)

FIGURE 1. PROCESS OVERVIEW

Sterilization

Continued.....
Reprocessing: Overview

• Cleaning, disinfection, sterilization:

– Are distinctly different processes

– Should be validated separately and independently 

• Point of use processing: Initial cleaning steps to 

prevent drying of soil on device surface prior 

cleaning

• Cleaning: Physical removal of soil

• Disinfection and sterilization: Intended to kill 

microorganisms

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Reusable Devices: Recent Trends

• Devices with complex designs that are more 

difficult to reprocess

• Significant advances in knowledge and 

technology involved in reprocessing reusable 

medical devices

– Recommendations in this guidance reflect the 

scientific advances in these areas
Formulation of Reprocessing Instructions: 

Device Design Considerations

• Starts in early stages of device design and 

engineering

– Challenging designs: shaft-within-lumen 

configurations, fine channels, seals and mated 

articulating surfaces

– Less challenging alternatives: single-use parts; flush 

ports; dedicated cleaning accessories

• Use designs that facilitate cleaning, disinfection and 

sterilization methods that can be easily & effectively 

implemented by the users

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Formulation of Reprocessing Instructions: 

Ensuring Safety

• Device labeling should:

– Provide instruction on how to prepare the device for 

the next patient use

– Identify materials and equipment that will be needed 

and are readily available to users
Formulation of Reprocessing Instructions: 

Human Factors

• Use consistent format for all devices of a type

– Use consistent terminology and the same document 

layout for all devices of a type

– Improve user comprehension & adherence

• Address any known post-market human factors issues

– e.g., Actions requiring substantial dexterity, strength, 

good visual acuity or familiarity with uncommon 

practices

•

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Validate instructions to ensure that users will 

thoroughly understand and follow them
FDA’s Six Criteria for Reprocessing 

Instructions 

1. Should reflect the intended use of the device

2. Should advise users to thoroughly clean the device

3. Should indicate the appropriate microbicidal 

process for the device

4. Should be technically feasible and include only 

devices and accessories that are legally marketed

5. Should be comprehensive

6. Should be understandable

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1. Intended use of the device

• Appropriate reprocessing instructions depend on: 

– Physical design of device

– Intended use of the device

– Direct or indirect contact with patient

– Soiling and contamination exposure during clinical 

use

– Use of toxic chemicals on the device

– Any specific or unique risks to patient or user

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2. Thoroughly clean the device

• Cleaning is the first step in reprocessing

• Adequate sterilization or disinfection depends on 

the thoroughness of cleaning

• Details of the cleaning procedure will vary 

depending on the complexity of the device

– Disassembly

– Use of protective covers to reduce soiling

– Flushing

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3. Appropriate Microbicidal Process

• Spaulding Classification Scheme

– Critical devices

– Semi-critical devices

– Non-critical devices

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3. Appropriate Microbicidal Process: 

Spaulding Classification Scheme

Critical devices: Introduced directly into the 

bloodstream or contact a normally sterile tissue or 

body-space during use

– e.g., Surgical instruments, irrigation systems for sterile 

instruments in sterile tissues, endoscopes used in sterile body 

cavities (laparoscopes, arthroscopes and intravascular 

endoscopes), all endoscope biopsy accessories

– Likelihood of microbial transmission and risk of infection if the 

device is not sterile

– Disassemble (if applicable), thoroughly clean, and sterilize 

after each use

20 Continued.....
3. Appropriate Microbicidal Process: 

Spaulding Classification Scheme

Semi-critical devices: Contact intact mucous membranes 

or non-intact skin; do not ordinarily penetrate tissues or 

otherwise enter normally sterile areas of the body

– e.g., Endotracheal tubes, bronchoscopes, laryngoscope blades 

and other respiratory equipment, esophageal manometry

probes, diaphragm fitting rings, and gastrointestinal 

endoscopes, such as duodenoscopes

– Intact mucosal surfaces are relatively resistant to small 

numbers of spores

– Thoroughly clean and then reprocess by sterilization or, if 

sterilization is not feasible, by high level disinfection

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3. Appropriate Microbicidal Process: 

Spaulding Classification Scheme

Non-critical devices: 

• Contact only intact skin and do not penetrate it

– e.g., Blood pressure cuffs, stethoscopes, skin electrodes

• Devices that have no direct patient contact but may become 

contaminated with microorganisms and organic soil (blood, 

body fluids) during patient care

– e.g., Infusion pumps, ventilators

• May not be visibly contaminated

• Thoroughly clean, then intermediate or low level 

disinfection depending on the nature and extent of 

contamination.

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4. Feasible to implement & include only legally 

marketed devices and accessories

• Intended use location

– Health care setting or home use

• Equipment and accessories needed to implement 

the instructions should be readily available to users

– e.g., Type of brushes and detergents for cleaning

– Type of sterilizer, manufacturer-validated 

sterilization cycle parameters and sterilization 

accessories 

• Sterilization methods and parameters should be 

technically feasible for the user to implement

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4. Feasible to implement & include only 

legally marketed devices and accessories

• Extended cycles 

– Specifications that deviate from those found on 

commonly used, FDA-cleared sterilizers

– Limited or no FDA-cleared sterilization accessories

– Typically include longer exposure times and/or higher 

or intermediate temperatures

– Pose serious technical challenges in health care 

settings

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5. Instructions should be comprehensive

A. Special accessories and any special protection during 

reprocessing

– Valves, plugs or stoppers to prevent ingress of harsh chemicals 

or water; special tools, sizes and types of brushes; flush port 

connectors and connector size specifications

B. Point-of-Use Processing

C. Disassembly and Reassembly – step-by-step instructions 

with visual aids; reassembly before or after sterilization

D. Method of Cleaning - Detailed validated method of 

cleaning; list of parameters, including duration of each 

processing step, temperatures, water quality

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5. Instructions should be comprehensive

E. Cleaning Agents – agents or class of agent used in 

validation testing; preparation and use

F. Rinsing – to remove processing chemical residues; type and 

quality of water, duration, temperature

G. Lubricating Agents – validate reprocessing methods using 

the lubricating agent

H. Visual Inspection – if not visually clean, then repeat 

cleaning or dispose of device

I. Method of Disinfection or Sterilization

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5. Instructions should be comprehensive

J. Reduction of Sterilant Residues – eg. rinsing or aeration

K. Drying – Devices should be thoroughly dried after 

processing and before storage

L. Reuse Life – How many times the device can be reused or 

method to ascertain if exceeded use life

M. Additional Labeling Recommendations

N. Patient or Lay Use

O. Reference to Guidelines or Accessory Labeling

P. Manufacturer’s Contact Information

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6. Instructions should be understandable

• Clear and legible 

• Sequential order from the initial processing step 

through the terminal processing step 

• Simple language 

• Sufficiently detailed to explain the correct 

procedures for all steps 

• Charts, diagrams, pictures that can be posted in 

work stations 

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Cleaning Methods Validation

• Worst-case conditions

• Clinically relevant soil

• Pre-determined test endpoints

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Validation of Cleaning Process:

Worst-case Testing

• Artificial Soil

– Represent materials that the device would likely be 

exposed to during actual clinical use, and would 

create the greatest challenge to cleaning

– e.g., During visualization of the larynx, a laryngoscope 

would likely be exposed to both blood and mucus

• The artificial test soil should be a multi-component soil 

that includes substances that simulate both blood and 

mucus

30 Continued.....
Validation of Cleaning Process:

Worst-case Testing

• Inoculation Sites

– Application of test soil should mimic worst-case 

clinical use conditions

– Inoculate the device in all locations likely to contact 

patient materials, especially all locations that are 

difficult to clean (e.g., mated surfaces, lumen, hinges)

31 Continued.....
Validation of Cleaning Process:

Worst-case Testing

• Simulated Use Conditions

– Incorporate multiple full use cycles

– Assess the accumulation of soil over time

– Account for real-world use conditions to mimic 

worst-case clinical use 

–

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e.g., Conduct all functional procedures, such as 

repeated articulations, flexures, manipulations, in 

order to soil the device sufficiently; powered handpieces and electrosurgical instruments need to be 

powered-on to simulate use conditions

Continued.....
Validation of Cleaning Process:

Worst-Case Testing

• Validation Protocols 

– Shortest times, lowest temperatures, weakest 

dilutions, etc., for each step of the cleaning 

instructions

• e.g., If instructions recommend 10-20 min pre-soak, 

the validation protocol should specify 10 min

– Side-by-side comparison of label cleaning instructions 

and cleaning process used in validation protocol

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Validation of Cleaning Process:

Choice of Test Types

• At least two quantitative test methods

– Measure clinically meaningful levels of test soil

– Predetermined cleaning endpoints for residual soil

• Validate the quantitative test methods chosen to 

measure residual soil

– Analytical sensitivity and specificity

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Validation of Cleaning Process:

Extraction Method

• Extraction methods:

– Exhaustive extraction

– Extraction using a known quantity of soil

• Recovery efficiency determined as part of its 

validation

• Sample all surfaces, including internal surfaces (e. g., 

lumens) and mated surfaces

• Use appropriate extraction volume to remove test 

soil from the device

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Validation of Cleaning Process:

Methods Validation

• Appropriate controls

– Negative device control – unsoiled and cleaned

– Positive device control – soiled

– Negative sample control – used as a blank

– Positive sample control – extraction with no device. 

This control addresses interference of the extraction 

fluid and extraction method with soil detection

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Validation of Microbicidal Process

• Disinfection

– e.g., Demonstrate that device can be disinfected to 

the appropriate endpoint(s) using contact conditions 

that are consistent with those specified in labeling for 

legally marketed disinfectant and under worst case 

conditions

• Sterilization

– Validate cycle specifications that are consistent with 

the conventional parameters (Appendix C)

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Pre-market Review

• FDA will review the reprocessing instructions 

included in the labeling when we review premarket 

submissions for reusable medical devices

• All cleaning, disinfection, and sterilization 

procedures should be validated, and validations 

should be completed prior to submission of your 

pre-market application

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Pre-market Review

• PMA, HDE and de novo: Protocols and complete test 

reports of validation of reprocessing instructions

• 510(k): FDA expects manufacturers of a subset of 

devices (Appendix E) to include data in 510(k) 

submissions to validate their reprocessing 

instructions 

– Validation data may also be requested ‘as needed’ 

for substantial equivalence

• IDE: Summary of the validation of reprocessing 

instructions

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Key Messages

• Manufacturers should provide adequate labeling 

that includes instructions for reprocessing and 

reusing devices and device accessories safely

• All cleaning, disinfection, and sterilization 

procedures provided in the labeling should be 

validated

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Key Messages

• The labeling should provide sufficient instructions 

on how to prepare the device for the next patient 

use

– Manufacturers should identify the materials and 

equipment that the users will need to reprocess the 

devices

– These materials and equipment should be readily 

available to users

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Questions?

Division of Industry and Consumer Education: 

DICE@fda.hhs.gov

Slide Presentation, Transcript and Webinar Recording 

will be available at:

http://www.fda.gov/training/cdrhlearn

Under “Specialty Technical Topics” Heading

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