Reprocessing single-use devices—regulatory roles

AORN Journal,  July, 2002  by Debra Dunn

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NOTES

(1.) ECRI, Special Report: Reuse of Single-Use Medical Devices: Making Informed Decisions (Plymouth Meeting, Pa: ECRI, 1997).

(2.) "FDA issues final enforcement priorities for reprocessed medical devices," Hospital Outlook 3 (September 2000) 7, 12.

(3.) "GAO/HEHS-00-123--Single-use medical devices: Little available evidence of harm from reuse, but oversight warranted," US General Accounting Office, June 2000, http://www.gao.gov/new.items /he00123 (accessed 24 April 2002).

(4.) M Reichert, "Reuse of single-use devices: A program model," Nursing Clinics of North America 28 (September 1993) 697-709.

(5.) "GAO/HEHS-00-123--Single-use medical devices: Little available evidence of harm from reuse, but oversight warranted."

(6.) Ibid; Center for Devices and Radiological Health, Guidance for Industry and for FDA Staff: Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals, Center for Devices and Radiological Health, US Food and Drug Administration (Rockville, Md: August 14, 2000).

(7.) Reichert, "Reuse of single-use devices: A program model," 697-709; "GAO/HEHS-00-123--Single use medical devices: Little available evidence of harm from reuse, but oversight warranted"; Center for Devices and Radiological Health, Guidance for Industry and for FDA Staff: Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals; "Reuse of single-use devices," (Clinical Issues) AORN Journal 73 (May 2001) 957-966; N English, "Reprocessing disposables: One strategy to balance cost reduction and quality patient care," Today Surgical Nurse 18 (July/August 1996) 23-26; "FDA issues reuse requirements," OR Manager 16 (September 2000) 7.

(8.) Center for Devices and Radiological Health, Guidance for Industry and for FDA Staff: Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals.

(9.) M Parsons, "The dilemma over the reuse of `single-use' medical devices: A risk manager's perspective," Today's Surgical Nurse 19 (May/June 1997) 17-21, 31-32.

(10.) "Survey: ORs are split on reuse of single-use items," OR Manager 15 (September 1999) 1-16.

(11.) "Agencies seek discussion about reuse--No silence, please!" Materials Management in Health Care 6 (May 1997) 38.

(12.) R Radford, "Reprocessing single-use devices: Choosing a third-party reprocessor for a given single-use device," Infection Control Today 5 (January 2001) 27-29; Reichert, "Reuse of single-use devices: A program model," 697-709.

(13.) N Weinberg, "Staying healthy blood money--Hospitals are reusing devices they shouldn't. How safe can that be?" Forbes (March 22, 1999) 123-126.

(14.) "Survey: ORs are split on reuse of single-use items," 1-16.

(15.) A M Cofiell, "The issue that won't go away: Reuse of single-use medical devices," Infection Control and Sterilization Technology 30 (October, 1999) 1, 13.

(16.) Ibid.

(17.) D Hawkins, "Risky recycling: That `disposable' catheter may have been used before," US News World Report 127 (Sept 20, 1999) 62-64; R Haugh, "Reuse pow-wow resolves little," OR Manager 15 (July 1999) 9-10.