Reprocessing single-use medical devices

AORN Journal,  March, 2002  by Barbara D. Cohoon

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National concern became apparent when compelling language was included in HR 3148, sec 524, cosponsored by Rep Anna Eshoo (D-Calif) and Rep Fred Upton (R-Mich), and S 1542, which was sponsored by Sen Dick Durbin (D-Ill). These bills cite government findings saying,

   The Food and Drug Administration has information indicating that some
   reprocessed medical devices labeled for single use have been associated
   with serious injury and that reprocessed medical devices labeled for single
   use have the potential to cause injury. (22)

STATE AND FEDERAL ACTIONS

Concern about patient safety when reprocessed devices are used was raised in both California and Illinois. (23) On Feb 26, 1999, California assemblyman Thomas Calderon (D-Montebello) introduced AB No 1359, which prohibits the reuse of any SUD, because, "AB 1359 will put a stop to this Russian roulette with medical equipment." (24) The bill was referred to committee where it died on Feb 3, 2000. (25)

The 90th General Assembly for the State of Illinois passed SB 80, which amended the Illinois Food, Drug, and Cosmetic Act prohibiting the "reuse, recycle, or refurbish for reuse, or provide for reuse of a single-use surgical device" (26) On March 9, 1999, Illinois state senator Evelyn Bowles (D-Edwardsville) introduced SB 1217. (27) The bill was assigned to the rules committee, where it died on May 26, 1999.

Federal concern about patient safety in regard to reprocessed and reused SUDs also has been increasing steadily. On Aug 4, 1999, the US Senate approved the amendment introduced by Sen Durbin. This amendment gave an additional $1 million to the FDA to provide additional resources for overseeing reprocessing and reuse of SUDs. (28) On Aug 5, 1999, Sen Durbin introduced S 1542 to amend the Federal Food, Drug, and Cosmetic Act. It established mandatory registration by the FDA of all individuals and organizations that reprocess instruments. It also requires that every individual or organization reprocessing instruments demonstrates the safety and effectiveness of reprocessed SUDs and that they honor the requirements of section 510 and 515, which refer to premarket requirements. The S 1542 amendment died in the Health, Education, Labor, and Pension (HELP) committee and has not been reintroduced in the 107th Congress. (29)

On Oct 26, 1999, Rep Eshoo and Rep Upton introduced HR 3148. This bill amends the Federal Food, Drug, and Cosmetic Act and contains language identical to Sen Durbin's bill (ie, S 1542). House Bill 3148 was assigned to the Commerce and Government Reform Committees. The Subcommittee on Oversight and Investigations held a hearing on Feb 10, 2000. (30) The subcommittee wanted more information on reprocessing and reuse of SUDs to determine whether there is a safety issue for patients and to discover the FDA's plans for overseeing and regulating this practice. The bill died in committee and has not been reintroduced in the 107th Congress.

On June 27, 2000, the HELP Committee held a hearing to gather information regarding the practice of reprocessing and reusing SUDs, and it included the formal release of the Government Accounting Office's (GAO's) findings, which were that the number of facilities and the type of SUDs reprocessed are unavailable and that reprocessing SUDs does pose a health risk; however, clinical evidence has shown selected devices can be reprocessed safety. The GAO also found that there has been a significant cost savings directly related to reprocessing SUDs, the FDA's regulation of SUD reprocessing has not been consistently enforced, and the revised regulation will provide information that will allow the FDA to effectively monitor the reprocessing of SUDs. (31) Rep Eshoo, who was the first witness, stated she would remove the requirement of an informed consent from patients if the FDA adequately oversaw and effectively enforced the reprocessing and reuse of SUDs. This was viewed as a major stride toward a possible bipartisan solution.