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Presentation: 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"

http://www.fda.gov/cdrh/reuse/1168.html

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

• 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
  • August 14, 2001, registration and listing

  August 14, 2002, rest of non-premarket req.

  * All other reprocessed class III SUDs may only be available under Investigational 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

http://www.fda.gov/cdrh/devadvice/365.html

Regulatory Requirements

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

http://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)

http://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)
http://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

http://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 ….
    

http://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

http://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

http://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 http://www.fda.gov/cdrh/devadvice/11.html
• CDRH website has:
  • Quality System Inspection Technique (QSIT) Handbook
  • Design Control Guidance
  • Medical Device Quality Systems Manual

http://www.fda.gov/cdrh/dsma/cgmphome.html
http://www.fda.gov/cdrh/index.html

Reuse Website

http://www.fda.gov/cdrh/reuse/index.shtml
(graphic of the Reuse Website)

Updated 8/29/2001

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