FDA summarizes 150 comments on reuse

Risk scheme was considered too subjective

In revising its proposed scheme for reprocessing single-use devices, the Food and Drug Administration (FDA) considered more than 150 written comments on its November 1999 and February 2000 draft documents. In issuing its final guidance, the FDA listed the following summary of the major comments received:

• strong support for the agency’s decision to actively regulate third-party and hospital reprocessors;

• concern that the risk prioritization scheme lacked clarity and was too subjective. To demonstrate that point, several stakeholders used the scheme to evaluate their products. In all cases, the stakeholders’ risk category for their devices ranked higher or lower than FDA’s risk category for the same devices;

• concern that FDA was imposing burdensome regulations on hospitals;

• concern that many hospitals are not prepared to comply with the agency’s premarket requirements due to their lack of experience in this area or to their limited financial resources;

• support for FDA’s decision to exclude "opened but unused" single-use devices (SUDs) from the enforcement strategy. The agency will examine its policy further with respect to opened but unused products. In the meantime, FDA’s current policy remains unchanged;

• several stakeholders identified additional SUDs they were reprocessing or considering reprocessing in the future that were not on FDA’s current list of frequently reprocessed SUDs.

[Editor’s note: A copy of the comments may be obtained by contacting the Dockets Management Branch, HFA-305, Food and Drug Administration, 5600 Fishers Lane, Room 1061, Rockville, MD 20857.]