# Presentation: 704626

## Reuse of Single Use Devices

- CDRH/CBER MDUFMA Stakeholder Meeting

- Presented by:   Barbara Zimmerman

## Sec. 302 – Single-Use Medical Devices (SUDs)

- Certain reprocessed SUDs identified by FDA must include validation data.
- Validation data includes cleaning, sterilization, and functional performance data demonstrating substantial equivalence.

## Requirements of Sec. 302

- For reprocessed SUDs which are exempt from 510(k) requirements, determine which “critical” reprocessed SUDs are no longer exempt
- Federal Register notice- dated April 30, 2003 (List I)
- Federal Register notice- dated June 26, 2003 (added non-electric biopsy forceps to List I)
- Due date for validation data to be submitted to FDA – July 30 and Sept. 26, 2004

## Requirements of Sec. 302

- Determine which non-exempt reprocessed SUDs require validation data
- Federal Register notice- dated April 30, 2003 (List II)
- Due date for validation data to be submitted to FDA – January 30, 2004

## Requirements of Sec. 302

- For reprocessed SUDs which are exempt from 510(k) requirements, determine which “semi-critical” reprocessed SUDs are no longer exempt
- Federal Register notice- dated April 24, 2004 (List I)
- Due date for 510(k)s with validation data to be submitted to FDA – July 24, 2005

## Comments Submitted to Docket

- Bundling of reprocessed SUDs
- Review Prioritization Scheme
- Update of Lists I and II to include additional devices
- Timeliness of FDAs review of validation data

## SUPPLEMENTAL VALIDATION SUBMISSIONS

- for Reprocessed Single-Use Medical Devices (SUDs)
- Ginette Y. Michaud, MD
- Office of Device Evaluation
- November 18, 2004
- Gaithersburg , Maryland

## Supplemental Validation Submissions (SVSs)

- July 2003: guidance on the validation data to be submitted
- June of 2004, updated guidance with information on review timelines.

## Supplemental Validation Submissions

- 53 SVSs anticipated accounting for 1800 device models
- 9 SVSs were not submitted – all NSE
- 44 SVSs received;
- 19 SE
- 12 SE for some models
- 11 NSE or withdrawn
- 2 under review

## Supplemental Validation Submissions

- CDRH accounted for 1800 device models
- 52% found SE - may continue to be legally marketed
- 33% found NSE (no data or inadequate data submitted)
- 15% withdrawn by the reprocessor.

## Supplemental Validation Submissions

- Reprocessed SUDs that were withdrawn or found NSE may no longer be legally marketed.
- Reprocessors of these SUDs may submit new 510(k) premarket notifications to FDA.

## Supplemental Validation Submissions

- In completing MDUFMA mandate, CDRH:
- accounted for 1800 SUD models
- addressed complex scientific issues
- resource intensive and interactive process
- careful and thorough reviews
- timely and scientifically grounded regulatory decisions

## How can users access information on the status of their reprocessed SUDs?

- Users can determine which models are legally marketed and which ones are not.
- The status of previously cleared reprocessed SUDs appears on FDA’s Reuse website, at: (_[http://www.fda.gov/cdrh/reuse](http://www.fda.gov/cdrh/reuse/)__[/](http://www.fda.gov/cdrh/reuse/)_)

## Slide 14

## REPROCESSING OF SINGLE USE DEVICES(SUDS) MDUFMA Stakeholder’s Meeting November 18, 2004

- Steven Turtil, M.S.
- FDA/CDRH/ODE/DAGID/INCB

## 510(k) Data – Reprocessed SUDs

- With each application, data should be submitted and reviewed for:
-   Cleaning Validation
-   Sterilization Validation
-   Functionality Testing

- No Standards

- Standards Available
- Guidance and Standards Available

## How do we want to define “Clean”

- To allow for successful, subsequent sterilization steps.

- To limit to a minimum, the organic soil transfer from one patient to another.

- To prevent accumulation of residual soil (and to prevent the development of biofilms) after multiple cycles.

## FDA Recommended Validation Data, Post-Simulated Use, for Cleaning of SUDs

- DRAFT

## Table of Contents

- _Cleaning Process:_ Instructions for technicians - highly variable between reprocessors.

- _Cleaning Process Validation:_ What is it?

- _Artificial Soils and Simulated Use Protocols:_ How are you going to get the devices dirty?

- _Cleaning Validation Protocols:_How are you going to test the Cleaning Process?

- _Test Protocols and Cleaning Endpoints_And a summary of Sterility, Endotoxin and Detergent Residues

## Cleaning Process

**Cleaning Instructions should specify:**

- Point-of-Use Decontamination

- Disassembly, if possible

- Automated or Manual cleaning, or a combination – 	time, temperature, brushing duration, etc.
- Ultrasound –	time, temperature, setting (high, medium, low)
- Detergents, Enzyme Detergents – 	time, temp., concentration, cycle limit (replenishing)
- Intermediate Rinse Steps – 	time, temp., particular water quality specifications.

## Table of Contents

- _Cleaning Process:_ Instructions - highly variable between reprocessors.

- _Cleaning Process Validation:_ What is it?

- _Artificial Soils and Simulated Use Protocols:_ How are you going to get the devices dirty?

- _Cleaning Validation Protocols:_How are you going to test the Cleaning Process?

- _Test Protocols and Cleaning Endpoints_And a summary of Sterility, Endotoxin and Detergent Residues

## Table of Contents

- _Cleaning Process:_ Instructions - highly variable between reprocessors.

- _Cleaning Process Validation:_ What is it?

- _Artificial Soils and Simulated Use Protocols:_ How are you going to get the devices dirty?

- _Cleaning Validation Protocols:_How are you going to test the Cleaning Process?

- _Test Protocols and Cleaning Endpoints_And a summary of Sterility, Endotoxin and Detergent Residues

## Table of Contents

- _Cleaning Process:_ Instructions - highly variable between reprocessors.

- _Cleaning Process Validation:_ What is it?

- _Artificial Soils and Simulated Use Protocols:_ How are you going to get the devices dirty?

- _Cleaning Validation Protocols:_How are you going to test the Cleaning Process?

- _Test Protocols and Cleaning Endpoints_And a summary of Sterility, Endotoxin and Detergent Residues

## Table of Contents

- _Cleaning Process:_ Instructions - highly variable between reprocessors.

- _Cleaning Process Validation:_ What is it?

- _Artificial Soils and Simulated Use Protocols:_ How are you going to get the devices dirty?

- _Cleaning Validation Protocols:_How are you going to test the Cleaning Process?

- _Test Protocols and Cleaning Endpoints_And a summary of Sterility, Endotoxin and Detergent Residues

## Cleaning Process Validation

- Use of actual clinical contamination as well as simulated organic soil that represents intended clinical exposure.
- Simulation of worst case clinical use conditions:
- Inoculation sites should be most difficult to clean
- Duration of exposure should mimic worst case
- Articulations/Flextures/Manipulations, etc.
- Worst case cleaning conditions.

- Cleaning Validation Protocols should support and confirm the effectiveness of the Routine Cleaning Instructions and should include consideration of:

## Cleaning Validation Protocols

**Should Include **_**WORST CASE**_** consideration of:**

- Automated, Manual or a combination – 	time, temperature, brushing duration
- Ultrasound –	time, temperature, setting (high, medium, low)
- Detergents, Enzyme Detergents – 	time, temp., concentration, cycle limit (replenishing).
- Intermediate Rinse Steps – 	time, temp., particular water quality specifications.

## Cleaning Validation Protocols Compare Cleaning Instructions with Validation Protocols

- If instructions say “Sonication 20 – 25 min.,” then validation should be for 20 min. or less.

**Examples (note set-points, tolerances):**

- If instructions say “Not to exceed 12 devices per cleaning load,” then validation should be performed with 12 devices, or more.

## Test Protocols and Cleaning Endpoints

**Specify the endpoints**** of cleaning, and data should meet them – at the end of its use-life.**
**Visual Inspection**** should be part of both the routine cleaning and the cleaning validation (yet realize the limitations: e.g., ****lumens)****.**
**Extraction method**** should be validated.**
**Test methods**** should be validated.**

## Sterilization

- Standards are available for validation methods.
- ISO 11134 – Industrial Moist Heat
- ISO 11135 – Ethylene Oxide
- Applicants should provide a “summary of the sterilization process design and validation activities.”
- Use of routine methods for evaluation of endotoxins on medical devices, for those devices required to be labeled as such. Testing should be conducted on final, sterilized product (as always).

## Bundling

- Reprocessing a group of closely related device models based on validation data for a “representative” worst case model.
- How was the worst case device selected?
- Were all materials considered?
- All geometric variances?
- Is there validation data to support this?
- Or a scientifically valid justification?
- _An especially tricky issue:_ slight differences in materials may result in different surface characteristics, and unexpected consequences with regard to cleaning effectiveness.
- Bundling between different manufacturers’ products should be validated or scientifically justified, because device designs can be very dissimilar.

## Slide 31

## MDUFMA STAKEHOLDERS MEETING

- Reuse of Single Use Devices Panel – Compliance Update
- November 18, 2004

## Reprocessor Inspection Update - Hospitals

- Over 225 inspections conducted since 8/2000
- Three types of Inspections:
- Routine surveillance, i.e. f/u to hospital registration
- “For Cause” i.e. f/u to informant reports
-  Sample of hospitals based on their responses to a contractor survey
- Findings:
- Most hospitals were either not reprocessing or promised to discontinue
- A few early inspections led to FDA correspondence; one Warning Letter and two untitled letters

## Reprocessor Inspection Update – Third Party Firms

- In the 1990s, there were 15-20 reprocessing firms
- Earlier inspections commonly found GMP problems in validation, purchasing controls & component controls
- 17 Warning Letters have issued
- 2 injunctions were filed; both firms went out of business
- All currently registered firms (5) have been inspected; all  recent inspections found in substantial compliance

## Compliance Follow-up to NSEs and Withdrawals

- Calls made to all applicants (5 firms) to determine withdrawal plans for distributed product
- All applicants have withdrawn/are withdrawing product
- Inspection assignment developed to verify discontinuance of reprocessing
- Inspection to cover special concerns raised by Office of Device Evaluation, i.e. packaging
- Inspection assignments request review of validation for the firm’s key processes