The Food and Drug Administration and reprocessing of single-use medical devices: A revised policy and new questions

Journal of Vascular and Interventional Radiology

Volumn 13, Issue 12, 2002, Pages 1179-1182

  Smith, John J ^a,c,d   Henderson, Jennifer A ^d   Baim, Donald S ^b,c,d  

^a MASSACHUSETTS GENERAL HOSPITAL   (United States)

^b BRIGHAM AND WOMEN S HOSPITAL   (United States)

^c HARVARD MEDICAL SCHOOL   (United States)

^d Center for Integration of Medicine and Innovative Technology   (United States)

Author keywords

Catheters and catheterization; Medical devices

Indexed keywords

DEVICE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; NOTE; PRACTICE GUIDELINE; PRIORITY JOURNAL; RECYCLING; STANDARD;

EID: 0036899375     PISSN: 10510443     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1051-0443(07)61962-9     Document Type: Note

References (24)

1. Food and Drug Administration. Draft Guidance, Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme, February 8, 2000. Available at: http://www.fda.gov/cdrh/reuse/1156.html. Accessed March 6, 2002.
2. Feigal DW. Statement Before Subcommittee on Oversight and Investigations, Committee on Commerce, U.S. House of Representatives; February 10, 2000. Available at: http://www.fda. gov/ola/2000/suds.html. Accessed March 6, 2002.
3. United States General Accounting Office. Single-Use Medical Devices: Little Available Evidence of Harm from Reuse, But Oversight Warranted; Final Report. United States General Accounting Office, Health Education and Human Services Division; June 2000. Available at: http://www.gao.gov. Accessed March 6, 2002.
4. Hazards in Reuse of Disposable Dialysis Devices: Staff Report to the Senate Special Committee on Aging. SEN. REP. 99-K (October 1986).
5. Food and Drug Administration and Center for Disease Control. Public Health Advisory: Infections from Endoscopes Inadequately Reprocessed by an Automated Endoscope Reprocessing System; September 10, 1999. Available at: http://www.fda.gov/cdrh/safety/ endoreprocess.html. Accessed March 6, 2002.
6. Hogan JM, Colonna TE. Products liability implications of reprocessing and reuse of single-use medical devices. Food and Drug Law Journal 1998; 53: 385-402.
7. Food, Drug and Cosmetic Act. Pub L No 75-717, 52 Stat 1040 (1938). Codified as amended at 21 USC §301 et seq, 1994.
8. Medical Device Amendments.§Pub L No 94-295, 90 Stat 539 (1976). Codified at USC 55 and scattered sections of 21 USC, 1976.
9. Safe Medical Devices Act. Pub L No 101-629, 104 Stat 4511. Codified in scattered sections of 21 USC, 1990.
10. Food and Drug Administration Modernization Act. Pub L No 105-115, 111 Stat 2295, 1997.
11. Center for Devices and Radiological Health. Deciding When to Submit a 510(K) for Changes to an Existing Device. Rockville, MD: Food and Drug Administration, 1997.
12. Food and Drug Administration. Compliance Policy Guide 300.500; September 24, 1987. Rockville, MD: Food and Drug Administration, 1987.
13. Medical devices; refurbishers, rebuilders, reconditioners, servicers, and "as is" remarketers of medical devices; review and revision of compliance policy guides and regulatory requirements; request for comments and information. 62 Fed Reg 67011 (December 23, 1997).
14. Establishment registration and device listing for manufacturers and initial importers of devices. 21 CFR §807 (1999).
15. Medical device reporting. 21 CFR §803 (1999).
16. Medical device tracking requirements. 21 CFR §821 (1999).
17. Medical devices; reports of corrections and removals. 21 CFR §806 (1999).
18. Quality system regulation. 21 CFR §820 (1999).
19. Labeling. 21 CFR §801 (1999).
20. Food and Drug Administration. Draft Guidance, Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals; February 8, 2000. Available at: http://www.fda.gov/ cdrh/reuse/1029.html. Accessed March 6, 2002.
21. Food and Drug Administration. Guidance on Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals; August 14, 2000. Available at: http://www.fda.gov/ cdrh/comp/guidance/1168.pdf. Accessed March 6, 2002.
22. Feigal DW. Center for Devices and Radiological Health. Executive Briefing; October 2000. Available at: http:// www.fda.gov/cdrh/present/RAPS-Brief-mod.pdf. Accessed March 6, 2002.
23. Food and Drug Administration. Change in Enforcement Deadline Associated with Reprocessing of Class II Single-Use Devices; February 14, 2002. Available at: http://www.fda.gov/ cdrh/reuse/reuse-important.shtml. Accessed March 6, 2002.
24. Food and Drug Administration. Changes in Enforcement of FDA's Requirements on Reprocessing of Single-Use Devices; September 25, 2001. Available at: http://www.fda.gov/cdrh/reuse/ reuse-letter-092501.html. Accessed March 6, 2002.