# Presentation: 775122

## Reprocessing of Single-Use Devices (SUDs)by Hospitals and Third-Parties

## Why is reuse of SUDs a concern?

- The public is concerned.
- FDA research shows reuse may be feasible, but
- difficult and
- possibly dangerous.
- Minimal evidence of problems does not mean that reuse is safe and effective.

## Enforcement Priorities Guidance

- "Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals"
- www.fda.gov/cdrh/comp/guidance/1168.pdf

## Scope of SUD Enforcement Guidance

- Applies to third-party & hospital SUD  reprocessors.
- Does not apply to:
- permanently implantable pacemakers,
- "open-but-unused" SUDs,
- healthcare facilities that are not hospitals, and
- hemodialyzers.

## Time Table for Enforcement(revised as of 8/14/01)

- Premarket Requirements
**February 14, 2001**, for all class III devices*
**August 14, 2001**, for class II non-exempt devices
**February 14, 2002**, for class I non-exempt devices
- Non-premarket Requirements (hospital reprocessors)
**August 14, 2001, **registration & listing
**August 14, 2002, **rest of non-premarket req.
******All other reprocessed class III SUDs may only be available under Investigation Device Exemption (IDE) regulation.*

## Examples of SUDs

- Surgical saw blades
- Balloon angioplasty (PTCA) catheters
- Laparoscopy scissors
- Endotracheal tubes
- Electrosurgical electrodes and pencils
- Biopsy forceps

## FDA Authority:Federal Food, Drug, & Cosmetic Act as amended (FD&C Act)

- Medical Device Amendments of 1976 & 1992
- Safe Medical Devices Act of 1990
- Food and Drug Administration Modernization Act of 1997
- Regulations implementing FD&C Act
- Title 21 Code of Federal Regulations Parts 800-1299
- www.fda.gov/cdrh/devadvice/365.html#cfrindexes

## Regulatory Requirements

- Premarket Requirements
- Premarket Notification (510(k))
-     (21 CFR Part 807)
- Premarket Approval (PMA)                         (21 CFR Part 814)

## Regulatory Requirements (continued)

- Non-premarket requirements (Gen. Controls)
- Registration & Device Listing (21 CFR Part 807)
- Medical Device Reporting (21 CFR Part 803)
- Tracking (21 CFR Part 821)
- Corrections & Removals (21 CFR Part 806)
- Quality System (QS) Regulation 	(21 CFR Part 820)
- Labeling (21 CFR Part 801)

## Classification

- Three classes based on risk:
- Class I  (least risk):  General controls
- with exemptions
- without exemptions
- Class II:  Special controls
- with exemptions
- without exemptions
- Class III (greatest risk):  Premarket Approval
- www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm

## Types of Premarket Submissions

- Premarket Notification (510(k))
- 		substantial equivalence (SE) to a legally 		marketed device
-  Premarket Approval (PMA)
- 		a new device not previously marketed or an 		existing device seeking a new intended use

## Premarket Notification 510(k)

- What is it?
- Section 510(k) of the FD&C Act
- Marketing clearance submission
- Application submitted 90 days before marketing (no form)

## Premarket Approval (PMA)

- Class III:  the most stringent regulatory category
- Devices for which insufficient information exists to assure safety and effectiveness by General or Special Controls
- Not substantially equivalent through 510(k) process

## SUD Premarket Submission Requirements

- If SUD is a:
**class I** or **class II exempt** device, **no **premarket submission
**class I** or **class II non-exempt** device, a **premarket notification **submission (510(k))** **
**class III** **device, **generally a** premarket approval **application (PMA) but few by 510(k)

## SUD Premarket Notification (510(k))

**510(k)** must demonstrate reprocessed SUD is as _safe & effective_ as a legally marketed device for which a PMA is not needed by comparing to
- original equipment manufacturer (OEM) device, or
- another reprocessed device that is found substantially equivalent.

## PMA vs. 510(k)

- PMA
- Valid scientific evidence
- Risk/benefit analysis
- 510(k)
- Substantial equivalence

## Non-premarket Requirements

- Registration & Listing
- Medical device reporting (MDR)
- Medical device tracking
- Reports of corrections and removals
- Quality System (QS) regulation
- Labeling

## Registration & Listing(21 CFR Part 807)

- Owners and operators of establishments that manufacture devices, including reprocessing of SUDs, must:
- register their establishments with FDA
-    (FDA Form 2891), and
- list each reprocessed SUD (FDA Form 2892)
- www.fda.gov/cdrh/dsma/rlman.html

## Manufacturer Reporting Requirements under MDR (21 CFR Part 803)

- Report device-related deaths, serious injuries, & malfunctions
- Report within 30 calendar days after becoming aware of event
- Report within 5 working days after becoming aware if event involves a remedial action
- Submit baseline reports and annual updates
*Note:  hospital must also report device-related deaths and serious injuries under the *_***user facility***_* reporting provisions (shorter time frames)*
* *www.fda.gov/cdrh/osb/guidance/1334.html

## Tracking(21 CFR Part 821)

**Purpose**:  to promptly locate specific devices in commercial distribution in the event corrective action or notification about the device is necessary
**Triggered** by a specific FDA tracking order to the manufacturer/reprocessor
- www.fda.gov/cdrh/devadvice/353.html

## Corrections & Removals(21 CFR Part 806)

- Must submit within 5 working days a written report to FDA of corrective action or removal of a  device that poses a public health risk
**Correction** - the repair, modification, adjustment, relabeling, destruction, or inspection of a device ....
**Removal** - moving the device to another location for the purpose of repair, modification, adjustment, relabeling, destruction, or inspection ....
**www.fda.gov/cdrh/devadvice/51.html**

## Quality System(21 CFR Part 820)

- Governs the methods used in, and the facilities and controls used for the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices
- Process validation
- www.fda.gov/cdrh/devadvice/32.html

## Labeling(21 CFR Part 801)

- General labeling requirements for medical devices
- Not limited to adequate directions for use
- www.fda.gov/cdrh/devadvice/33.html

## Where To Go For Help

- Division of Small Manufacturers Assistance (DSMA):
- Phone (301) 443-6597; (800) 638-2041
- Facts-On-Demand (800) 899-0381 or
- 	(301) 827-0111
- Device Advice website www.fda.gov/cdrh/devadvice/11.html#start

## Where To Go For Help(continued)

- CDRH website has:
- Quality System Inspection Technique (QSIT) Handbook
- Design Control Guidance
- Medical Device Quality Systems Manual
- www.fda.gov/cdrh/dsma/cgmphome.html
- www.fda.gov/cdrh/index.html

## Reuse Website 

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