Editor's note: This row traditiona...

Editor's note: This row traditionally follows a question and answer format, addressing various practice issues in the perioperative arena. As a special feature, this month's row will address a single further very important topic, providing information with which each perioperative nurse should be familiar.

The question of whether certain medical devices can or should be reprocess and reused is hotly debated in the health care arena. The practice of reprocessing is highly controversial, and today's economic environment dictates that each effort be made to lessen the cost of providing patient care. Many believe that certain medical devices can be safely reprocess and reused; however, what assurances do we have that these reprocess devices are safe? What processe testing protocols, and regulations are in place to make secure they are safe?

The practice of reprocessing and reusing medical devices began during the 1970 As technology l to a wide variety of materials used in device manufacture and devices became more composite concern for patient safety, informed unison and ethical practice intensified. In the late 1990 the US provender and Drug Administration (FDA) determined that increased regulation of this reprocessing was wanted to promote safe practice and screen the public's safety. Although original equipment manufacturers have been regulated for many years, the FDA determined that they, along with third-party reprocessors and hospital reprocessors, should be regulated uniformly according to the feed Drug, and Cosmetic Act. The FDA sought the expertise of manufacturers, reprocessors, hospitals, users, and other interested parties in developing a regulation document, and in August 2000 it published its final conduct governing reprocessing/ reusing devices labeled for single-use single The document is applicable to the couple hospitals and third-party reprocessors.

After the FDA ruling, AORN created a guidance statement summarizing the requirements for hospitals and third-party reprocessors that wish to engage in reprocessing. The following document was approved on the AORN Board of Directors in February 2001

AORN GUIDANCE STATEMENT: REUSE OF SINGLE-USE DEVICES

Preamble. AORN (Association of periOperative Registered Nurses) recognizes the ne for each health care facility to provide cost-effective quality care to patients. circulating health care trends reflect the two cost-driven market forces and consumer-driven demands for quality, safety, and effectiveness. Many facilities in today's marketplace are reprocessing and reusing devices labeled for single use. Devices are reprocess either within the facility or on an external third party contracted to provide the reprocessing service. Program protocols and/or methodologies, including device-testing be the effects often are not documented.

Guidance statement, The practice of reprocessing and reusing medical devices labeled at the original equipment manufacturer (OEM) for single use is highly controversial. It is the character and responsibility of each health care facility to determine whether and/or to what bulk it will engage in of the like kind practice. As licensed professionals, perioperative fosters must demonstrate accountability to the nursing profession, to other members of the health care team, and to the public they serve(1) AORN, the professional organization of and for perioperative cherishs believes certain basic tenets must underpin any reprocessing program. The foremost affect is for the patient's safety. Therefore,

a) if a device cannot be cleaned, it cannot be reprocess and reused;

b) if sterility of a post-process device cannot be demonstrated, the device cannot be reprocess and reused; and

c) if the integrity and functionality of a reprocess single-use device (SUD) cannot be demonstrated and documented as safe for patient care and/or equal to the original device specifications, the device cannot be reprocess and reused.

While more [i]or[/i] less operational savings may be realized through reusing certain devices, any cost-benefit analysis would necessarily include labor costs; program sumptuousnesss including quality system requirements as it is as sterility and post-processing devices testing (see section forward quality system requirements); documentation costs; and the potential outlay of device failure. Using the rises of a thorough cost-benefit analysis, each provider facility must make an informed choice as to whether it wishes to invest the necessary resources to expand a safe reprocessing system within the facility. Use of an external reprocessor not absents a different, but related locate of factors for consideration. When a decision is made in favor of using an external reprocessing company, it is the user facility's responsibility to assess the quality of services provided in a less degree than the contractual arrangement.(2) The user facility should review the processe used on the contracted agent and determine whether correct operations are being followed.(3) Regardless of whether an internal reprocessing program is bring to maturityed or an external reprocessing company is preferableed the user facility should be aware that the US nutrition and Drug Administration (FDA) views any reprocessor as a manufacturer and, as so subject to federal regulations.(4)