# Presentation: 823047

## FDA’s Final Policy on Single-Use Devices Reprocessed by Hospitals and Commercial Reprocessors

- Lily Ng, RN, MSN, MPH
- Office of Surveillance and Biometrics, CDRH
- Presented at: FDA’s Medical Device Reuse Workshop
- Orlando - May 10, 2001
- Phoenix - May 30, 2001

## Objectives

- Background information on FDA’s reuse
-         policy
- SUD Enforcement Guidance - Overview
- Important dates for reprocessors
- Some technical concerns
- Vision for the future

## Background information or “how we got where we are”

- Reuse practiced in hospitals since the late 1970’s
- _1999_
- Apr 5-6  AAMI/FDA co-sponsored meeting on
-                   reuse of SUDs

## Background continued ...

- Aug 5    Sen. Durbin introduced *Reprocessed*
*                  **Single Use Medical Device Patient *
*                  **Safety Amendments of 1999 (S.1542)*
- Oct 26    Reps. Eshoo & Upton introduced
-                   *Reprocessed Single Use Medical *
*                  **Device Patient Safety Act of 1999*
*                  **(H.R. 3148)*

## Background continued ...

- Nov 3     FDA released proposed regulatory
-                    strategy
- Nov 10   Satellite teleconference
- Dec 14   Open public meeting

## Background continued ...

- _2000_
- Feb 10   House Committee on Commerce
-                   hearing on reuse policy
- Feb 11   FDA released 2 draft guidances -
- _	__	_       - *Reprocessing and Reuse of SUDs: Review                           **	**         Prioritization Scheme *
- 		and
- 		       - *Enforcement Priorities for SUDs Reprocessed by*
*               **Third Parties and Hospitals*
*                  *

## Background continued ...

*Reprocessing and Reuse of SUDs: Review Prioritization Scheme*
- Purpose: to assess the risk of a reprocessed SUD
-          via 2 flowcharts
- 		- risk of infection
- 		- risk of reprocessing on SUD’s functionality
- SUD rated:  *high, moderate, or low*

## Background continued ...

*Enforcement Priorities for SUDs Reprocessed by Third Parties and Hospitals*
- Purpose: to identify FDA’s enforcement priorities and time line based on the level of risk of a reprocessed SUD as determined by the *Review Prioritization Scheme*

## Background continued ...

- Jun 27    Senate Committee on Health,  Ed.,
-                    Labor & Pensions’ hearing on the
-                    General Accounting Office (GAO)’s
-                    report *Reprocessing and Reuse of*
*                   **Devices Labeled Single Use*
*    **(www.gao.gov)*

## Enforcement Priorities for Single-Use Devices Processed by Third Parties and HospitalsAugust 14, 2000

- www.fda.gov/cdrh/comp/guidance/1168.pfd

## SUD Enforcement Guidance - Overview

**Basis of FDA’s Authority**
- The Federal Food, Drug, and Cosmetic Act
- Title 21 Code of Federal Regulations (CFR)
-        Parts 800 to 1299 (*www.gpo.gov)*

## SUD Enforcement Guidance continued ...

*Underlying principles of FDA’s reuse policy:*
- Reprocessing is a manufacturing activity.
- FDA will regulate original equipment manufacturers (OEMs) and all SUD reprocessors in the same manner.
- FDA’s primary goal is to protect public health by assuring that reprocessed SUDs are as safe and effective as new SUDs.

## SUD Enforcement Guidance continued ... 

- Does not apply to:
- Permanent pacemakers;
- Hemodialyzers;
- Health care facilities that are not hospitals; or
- Opened-but-unused SUDs.

## SUD Enforcement Guidance continued ...

*Working Definitions*
- Hospital = an acute health care facility
- SUD      = a disposable device; intended to be
-                      used on one patient during a single
-                      procedure

## SUD Enforcement Guidance continued ...

- Reuse = the repeated or multiple use of any
-                   medical device (whether labeled
-                   SUD or reusable) with reprocessing
-                   (cleaning, disinfecting and/or
-                   sterilization) between patient uses

## SUD Enforcement Guidance continued ...

- Opened-but-unused = a SUD that has not been used on a patient (no contact with blood or bodily fluids) whose sterility has been compromised

## SUD Enforcement Guidance continued ...

*Regulatory Requirements*
- 1. Registration & Device Listing (21 CFR Part 807)
- 2. MDR Regulation (21 CFR Part 803)* *
-         (www.fda.gov/cdrh/osb/guidance/1334.pdf)
- 3. Medical Device Tracking (21 CFR Part 821)

## SUD Enforcement Guidance continued ...

- 4. Medical Device Corrections & Removals
-          (21 CFR Part 806)
- 5. Quality System Regulation (21 CFR Part 820)
- 6. Labeling Requirements (21 CFR Part 801)
- 7. Premarket Notification & Approval Requirements
-         (21 CFR Parts 807 & 814)

## Important Dates for SUD Reprocessors

*February 14, 2001*
-      =>  Deadline for submission of premarket
-             submissions (PMA or 510(k)) for
-             class III SUDs

## Important Dates continued ...

*August 14, 2001*
-       => Deadline for hospital reprocessors to
-              comply with non-premarket requirements
-        => Deadline for submission of 510(k)s
- 		  for non-exempt class II SUDs

## Important dates continued ...

*February 14, 2002*
- =>  Deadline for submission of 510(k)s
- for non-exempt class I SUDs

## Some Technical Concerns

- Control of “raw material”
- Defining specifications
- Identification of changes to OEM devices
- Cleaning, disinfecting, & sterilization procedures
- Functionality of reprocessed SUDs
- Labeling of reprocessed SUDs

## Vision for the Future   or “where we need to go”

- Review premarket submissions within regulatory timeframes (180 days for PMAs ; 90 days for 510(k)s)
- Implement an inspection program for hospital reprocessors
- Continue to inspect all commercial reprocessors

## FDA Reuse Home Page

- www.fda.gov/cdrh/reuse/index.shtml