Reuse of kidney dialysis equipment

Reuse of Kidney Dialysis Equipment

FDA has denied a petition by six U.S. senators thatasked the agency to regulate the reuse of disposable kidney dialysis devices. The petition stemmed from the senators' concern that the growing practice of reuse to save money might be hazardous.

The Senate Special Committee on Aging held hearingsin March 1986 on reuse of the disposable equipment used to cleanse kidney patients' blood. The petition, filed in May 1986 by committee chairman Sen. John Heinz, R-Pa., and five other committee members, requested FDA to apply its Good Manufacturing Practices (GMP) authority to medical facilities that reprocess dialysis components for reuse. It also called for studies to determine if reuse was a safe practice.

In the denial, FDA Commissioner Frank E. Young,M.D., Ph.D., ruled that applying GMP regulations to the nation's 1,400 dialysis clinics would constitute regulating medical practice, an area over which FDA does not have authority. Young noted that GMPs are designed to ensure quality control in manufacturing and are not intended to apply to how devices are used in medical facilities.

Young said that other federal agencies are takingsteps to ensure safe reuse practices. For example, the Public Health Service has developed guidelines for proper reuse and reprocessing. These guidelines essentially endorse others issued in October 1986 by the Association for the Advancement of Medical Instrumentation (AAMI), a private sector, standard-setting organization. The association's guidelines were developed with input from FDA, the federal Centers for Disease Control, experts in hemodialysis, kidney patient groups, and dialysis equipment manufacturers.

Young added that the best way to ensure safe reuseis for the Health Care Financing Administration to adopt the PHS guidelines as part of its conditions for reimbursement under the Medicare End-Stage Renal Disease Program.

Reuse of dialysis equipment does not appear to beless safe than single use, although ways are needed to ensure that reprocessing and reuse are performed properly. FDA is urging manufacturers of hemodialyzers and blood tubing to revise their product labeling to include specific instructions for reuse.

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