APIC: Stricter regs needed only on critical devices

Higher level of risk associated with reuse cited

While generally taking a neutral stance on the controversial issue of reprocessing single-use devices, the Association for Profes sionals in Infection Control and Epidemiology (APIC) has submitted a position paper to the Food and Drug Administration (FDA) favoring more agency oversight on reusing disposable critical care devices. (See related story, p. 133.)

"Although critical, semi-critical and non-critical devices are currently being reprocessed with minimal FDA oversight, APIC believes that stricter regulation is necessary only for critical devices (devices that come into contact with sterile tissue or the vascular system)," the APIC position paper said. "Critical devices have a significantly higher level of risk associated with their reuse than do non-critical or semi-critical devices. For this reason, health care providers and consumers must be assured that a reprocessed critical device offers the same structural and mechanical soundness as the original device."

For example, disinfection of devices prior to reprocessing can cause problems because disinfectants can coagulate proteins and bind debris, making removal of these foreign substances more difficult, APIC noted. There is a need for independent evaluation of that effect and other issues, APIC added. "It is vitally necessary to thoroughly evaluate the cleaning, disinfection and sterilization processes for reprocessing disposable devices," APIC advised the FDA. "It is equally imperative to determine the efficacy of functionality after reprocessing."

The APIC position paper expressed a neutral position on the overall issue of disposable device reuse, however, noting that "we neither recommend nor discourage the reuse of single-use items, since there is not enough significant scientific data to make global recommendations."

The risk of nosocomial infections — not all of which are preventable — is dependent upon multiple factors, including the procedures performed, devices used, treatment provided, and the patient’s underlying condition, APIC reminded the FDA. Safe reprocessing of approved reusable devices has been performed in hospitals when there is strict adherence to sterilization guidelines promulgated by APIC and other clinical groups. "The existing standards that apply to reusable devices should also be applied to reprocessing of disposable devices," APIC noted.

In addition, APIC urged the FDA to design unbiased studies to answer the following questions so facilities that choose to reprocess disposable devices can do so with confidence and assurance:

• How do we determine that a device can safely be reused?

• How does a manufacturer decide a device is safe only for a single use?

• What is the effect of sterilization on device material, glue, and overall integrity of a device?

• How can we promote prudent use of both fiscal and environmental resources to provide safe, high-quality patient care?