• FDA Requests Comments for Possible SUD Guidance Document (AAMI News: Vol. 37, No. 2, February 2002) 02.01.02
• AAMI to Host Virtual Seminar on Reuse of SUDs on March 7 (AAMI News: Vol. 37, No. 1, January 2002, p. 4) 01.01.02
• The Reuse of Single-Use Devices: The Story Continues (BI&T: Vol. 35, Number 5, September/October 2001, p. 307) 10.09.01
• Working Group Formed to Develop Report on Cleaning Reusable Medical Devices (AAMI News: Vol. 36, No. 5, May 2001, p. 3) 05.01.01
• FDA Teleconference for Hospitals Highlights Quality Systems for Reprocessing SUDs (AAMI News: Vol. 36, No. 1, January 2001, p. 10) 01.01.01
• Hospitals Tackle Learning Curve on Reprocessing SUDs at AAMI/FDA Seminar; Teleconference Set for Dec. 13 (AAMI News:
  Vol. 35, No. 11, December 2000, p. 1) 12.01.00
• FDA to Hold Interactive Satellite Teleconference for Hospitals Reprocessing Single-Use Devices (AAMI News: Vol. 35, No. 10, November 2000, p. 10) 11.01.00
• AAMI Press Release: New Requirements for Hospital Reprocessors of Single-Use Devices Focus of AAMI/FDA Seminar 8.21.00
• AAMI/FDA Seminar Will Outline New FDA Requirements for Hospitals (AAMI News: Vol. 35, No. 5, May 2000, p. 8)
• FDA Releases Proposed Guidance for Hospital and Third Party Reprocessors; Comments Due April 11 (AAMI News: Vol. 35, No.3, March 2000, p.1)
• FDA Director Tells Congressional Hearing That Reuse of SUDs Practice Needs Closer Scrutiny, Oversight (AAMI News: Vol. 35, No. 3, March 2000, p. 3)
• FDA Official Urges Interested Parties to Comment on Draft Guidance (AAMI News: Vol. 35, No. 3, March 2000, p. 3)
• FDA Outlines Regulatory Strategy for Suds; Final Guidance on Reuse Due in Summer 2000 (AAMI News: Vol. 35, No. 1, January 2000, p. 1)
• Re-use of Single-Use Devices: FDA Teleconference Participants Support Risk-Based Approach, But Significant Differences Remain (AAMI News: Vol. 34, No. 11, December 1999, p. 1)
• Senate Approves Funding for More Oversight of Reuse of Single-Use Devices ( AAMI News: Vol. 34, No. 8, September 1999, p. 1)
• The Reuse of Single-Use Devices: Are Additional Controls Needed? (AAMI News: Vol. 34, No 4, April 1999, p. 6)
• AAMI/FDA Conference Will Explore Reuse of Single-Use Devices (AAMI News: Vol. 34, No. 1 - January 1999, p. 7)

AAMI Standards

• Link to list of AAMI standards and guidance documents cited by the FDA as being useful in the reprocessing of SUDs.

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Federal Register

• December 20, 2001: Medical Devices; Guidance on Labeling of Reprocessed Single Use Devices; Request for Comments and Information
• October 22, 2001: Agency Information Collection Activities; Announcement of OMB Approval; Survey of Single-Use Medical Device Reuse and Reprocessing in Hospitals
• July 25, 2001: Agency Information Collection Activities; Submission for OMB Review; Comment Request; Survey of Single-Use Medical Device Reuse and Reprocessing in Hospitals
• May 27, 2001: Available Documents Frequently Asked Questions about the Reprocessing and Reuse of Single Use Devices by Third Party and Hospital Reprocessors; Final Guidance for Industry and FDA Staff
• May 24, 2001: Premarket Guidance: Reprocessing and Reuse of Single-Use Devices; Draft Guidance for Industry and FDA Staff
• April 30, 2001: Proposed Collection; Comment Request; Survey of Single-Use Medical Device Reuse and Reprocessing Hospitals (PDF file - 2 pgs.)
• August 14, 2000: Guidance for Industry on Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals; Availability (PDF file - 3 pgs.)
• February 11, 2000: Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme; and Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals (PDF file - 3 pgs.)
• February 8, 2000: Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals (PDF file - 23 pgs.)
• February 2, 2000: Draft Guidance on Reprocessing and Reuse of Single-Use Devices: Risk Categorization Scheme; Availability (PDF file - 2 pgs.)
• November 3, 1999: FDA's Proposed Strategy on Reuse of Single-Use Devices; Availability (PDF file)

Food and Drug Administration/ Center for Devices and Radiological Health/Reuse

• January 30, 2002: FDA-Cleared Sterilants and High Level Disinfectants with General Claims for Processing Reusable Medical and Dental Devices
• January 17, 2002: FDA Important Notice: FDA Intends to Enforce Deadlines Associated with the Reprocessing of Single Use Devices
• November 5, 2001: Presentation: Reuse of Single Use Devices: FDA's Regulatory Requirements for Third Party and Hospital Reprocessors
• September 25, 2001: Changes in Enforcement of FDA’s Requirements on Reprocessing of Single-Use Devices
• September 16, 2001: FDA Talk Paper: FDA Actions on Reprocessed Single-Use Devices
• August 16, 2001: FDA Talk Paper: An Extension of Enforcement Dates
• July 31, 2001: Presentation: Reprocessing of Single-Use Devices (Suds) by Hospitals and Third-Parties
• July 30, 2001: Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals; Final Guidance for Industry and FDA
• July 13, 2001: User Facility Reporting Bulletin
• July 6, 2001: Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors; Final Guidance for Industry and FDA Staff
• July 5, 2001: Presentation: Premarket Review Considerations for Reprocessed Suds
• June 29, 2001: Sterilants and High Level Disinfectants Cleared by FDA in a 510(k) as of June 29, 2001 with General Claims for Processing Reusable Medical and Dental Devices
• April 24, 2001: Guidance on Adverse Event Reporting for Hospitals that Reprocess Devices Intended by the Original Equipment Manufacturer for Single Use (PDF - 21 pgs.)
• April 23, 2001: Available Documents Letter to Hospitals Re: Reprocessing of Single Use Devices
• April 23, 2001: FDA and the Reuse of Single-Use Devices: Policy Now Established (PDF - 21 pgs.)
• April 20, 2001: Letter Requesting Hospitals to Volunteer for FDA Site Visits as Part of a Pilot Program
• April 13, 2001: Reusing Disposable Medical Devices (Article taken from the NAPS publication Featurettes/News To Use)
• November 13, 2000: FDA/CDRH: List of Suds known to be reprocessed
• November 1, 2000: Teleconference: Reprocessing Single-Use Devices in Hospitals: A Primer on FDA Requirements
• October 31, 2000: FDA Brochure: Reprocessing of Single-Use Medical Devices by Hospitals (html)
• October 31, 2000: FDA Brochure: Reprocessing of Single-Use Medical Devices by Hospitals (pdf)
• October 3, 2000: Presentation: FDA’s Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals (pdf)
• September 28, 2000: Letter to Hospitals Re: Reprocessing of Single-Use Devices
• September 12, 2000: FDA and the Reuse of Single-Use Devices: Policy Now Established (pdf)
• August 18, 2000: Reusing Medical Devices: Ensuring Safety The Second Time Around (FDA Consumer Magazine, September-October 2000)
• August 14, 2000: Guidance: Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals
• August 2, 2000: Talk Paper: FDA Issues Final Guidance on Reuse of Single-Use Medical Devices - August 2, 2000
• June 27, 2000: Statement by David W. Feigal, MD Director, CDRH/FDA/HHS before the Senate Committee on Health, Education, Labor and Pensions
• May 15, 2000: FDA's Proposed Strategy to Regulate Reprocessing and Reuse of Devices Labeled for Single Use: Lily Ng, RN, MSN, MPH, Nurse Consultant, Office of Surveillance and Biometrics, CDRH, FDA (PDF file - 30 pgs.)
• May 6, 2000: FDA and the Reuse of Single Use Devices: Policy Moving Forward by Larry Kessler, ScD, Director, Office of Surveillance and Biometrics, CDRH/FDA
• February 10, 2000: Statement by David W. Feigal, MD Director, CDRH/FDA/HHS before the Subcommittee on Oversight and Investigations, Committee on Commerce, House of Representatives
• February 8, 2000: Guidance: Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals (superseded by August 2, 2000 document) (PDF file - 1 pg.)
• February 8, 2000: Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme (Draft)
• December 14, 1999: Speaker List from Public Meeting on Reuse of Single Use Devices - FDA's Proposed Strategy: 12/14/99
• December 14, 1999: Executive Summary Open Meeting: FDA’s Proposed Strategy on Reuse of Single-Use Devices Tuesday, December 14, 1999
• December 14, 1999: FDA Public Meeting Reuse of Single Use Devices: FDA's Proposed Strategy - December 14, 1999
• November 10, 1999: FDA Satellite Teleconference: Proposed FDA Strategy for Reuse of Single Use Medical Devices - November 10, 1999
• November 1, 1999: FDA's Proposed Strategy on Reuse of Single-Use Devices
• July 13, 1998: Letter Re: Commercial Reprocessors of Disposable Medical Devices
• April 1996: Labeling Reusable Medical devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance (PDF file - 30 pgs.)
• December 27, 1995: Letter Re: Policies That May Apply to The Reuse of Single-Use or Disposable Medical Devices
• September 24, 1987: Compliance Policy (CPG 7124.16) Section 300.500 Reuse of Medical Disposable Devices (PDF file - 1 pg.)

General Accounting Office (GAO)

• June 2000: Single-Use Medical Devices: Little Available Evidence of Harm From Reuse, but Oversight Warranted (PDF file - 37 pgs.)
• June 27, 2000: Reprocessing and Reuse of Devices Labeled Single­Use Statement of Janet Heinrich, Associate Director Health Financing (PDF file 12 pgs.)

House Committee on Commerce

• November 10, 2000: Committee Correspondence: Questions Regarding FDA's Guidance on Reuse of Single Use Medical Devices
• February 10, 2000: Bliley Delivers Statement on Single-Use Medical Devices
• February 10, 2000: Oversight Hearing Reuse of Single-Use Medical Devices Subcommittee on Oversight & Investigations (Real Player required)
• December 8, 1999: Committee Correspondence: Risk of Adverse Health Impact on Patients as a Result of Reusing Some Medical Devices

Office of Senator Dick Durbin (D-IL)

• June 27, 2000: Press Release: Durbin Lauds GAO Recommendation of Oversight of Recycled Medical Devices
• August 5, 1999: Press Release: Senate Approves Durbin Amendment, Takes First Step Toward Curbing Risky Practice of Recycling Single-Use Medical Devices
• July 26, 1999: Durbin Seeks Report on Recycling of Single-Use Medical Devices; Senator Concerned About Infection and Injury

Senate Committee on Health, Education, Labor and Pensions

• June 27, 2000: Full Committee: Medical Device Reuse
• June 27, 2000: Statement of Josephine M. Torrente, M.S., J.D. President Association of Disposable Device Manufacturers before the Health, Education, Labor and Pensions Committee United States Senate
• June 27, 2000: Testimony of the American Hospital Association before the Health, Education, Labor and Pensions Committee of the United States Senate on Reuse of Medical Devices

Advanced Medical Technology Association (AdvaMed) (formerly HIMA)

• HIMA Position Paper on the Reuse of Single-Use Medical Devices

American College of Cardiology

• August 25, 2000: Medical Device Reprocessing
• April 11, 2000: Comments to FDA
• February 10, 2000: Testimony Presented to the United States House of Representatives Commerce Committee Subcommittee on Oversight and Investigations

American Hospital Association

American Medical Association

• September 4, 2000: FDA boosts watch over reuse of disposable devices

American Society for Healthcare Central Service Professionals (ASHCSP)

• ASHCSP Position on Reuse of Single-Use Medical Devices

Association for Professionals in Infection Control and Epidemiology, Inc.

Association of Medical Device Reprocessors (AMDR)

Association of Disposable Device Manufacturers (ADDM)

700 13th Street NW, Suite 1200
Washington, DC 20005-3960
Phone: (202) 737-5600 Fax: (202) 737-9329

Association of periOperative Registered Nurses (AORN)

• January 4, 2001: AORN Guidance Statement: Reuse of Single-Use Devices (PDF - 8 pgs.)

ECRI

Fellows of the American College of Surgeons

• April 10, 2000: ACS Views on Legislative, Regulatory, and Other Issues Single Use Medical Devices

International Association of Healthcare Central Service Materiel Management (IAHCSMM)

• IAHCSMM: The Reuse of Single-Use Medical Devices

MEDEC

• January 1998: The Reuse of Single-Use Medical Devices: Industry Position Paper: Medical Devices Canada

Medical Device Manufacturers Association (MDMA)

• May 20, 1999: Citizen Petition To Ban Reprocessed Single Use Devices

North American Society of Pacing and Electrophysiology

Society of Gastroenterology Nurses and Associates, Inc.

• 2001: Position Statement: Reuse of Single-Use Critical Medical Devices

British Medical Devices Agency

• August 2000: Device Bulletin: Single-Use Medical Devices: Implications and Consequences of Reuse (PDF - 21 pgs.)

Federal Association of the Medical Device Industry in Germany

• July 18, 2001: Statement on Reprocessing of Single-Use Devices

German Medical Technology Association (BVMed)

• 18 July 2001: Statement on Reprocessing of Single-Use Devices
• 22 January 2001: Statement on the Second Amendment to the German Medical Devices Act: BVMed demands that reprocessors fulfil the same requirements as manufacturers of medical devices

Barlow, Dana Rick. "FDA Offers Candid Answers To Expected Questions About Reuse Controversy." News & Analysis @ Hospital Network.com. November 19, 1999.

Hawkins, Dana. "Hospitals' Reused Tools: Reassessing the Risk to You." US News Online. November 29, 1999.

Hawkins, Dana. "Risky Recycling." US News Online. September 20, 1999.

"Risky Reuse of Medical Equipment Is on Rise." Los Angeles Times, Home Edition. August 11, 1999.*

Underwood, Anne. "Do Scopes Spread Sickness." Newsweek. March 1, 1999, pp. 72-73.

Updated:01.31.02