Reprocessing single-use devices—the equipment connection - Home Study Program

AORN Journal,  June, 2002  by Debra Dunn

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The article "Reprocessing single-use devices--the equipment connection" is the basis for this AORN Journal independent study. The behavioral objectives and examination for this program were prepared by Rebecca Holm, RN, MSN, CNOR, clinical editor, with consultation from Susan Bakewell, RN, MS, education program professional, Center for Perioperative Education.

A minimum score of 70% on the multiple-choice examination is necessary to cam 3 contact hours for this independent study. Participants receive feedback on incorrect answers. Each applicant who successfully completes this study will receive a certificate of completion. The deadline for submitting this study is June 30, 2005. Send the completed application form, multiple-choice examination, learner evaluation, and appropriate fee to

AORN Customer Service
c/o Home Study Program
2170 S Parker Rd, Suite 300
Denver, CO 80231-5711
or fax the information with a credit card number to (303) 750-3212.

BEHAVIORAL OBJECTIVES

After reading and studying the article on reprocessing single-use devices (SUDs), the nurse will be able to

(1) explain the steps involved in reprocessing SUDs,

(2) discuss the steps involved in evaluating whether an SUD can be included in a reprocessing program,

(3) identify the benefits of reprocessing,

(4) discuss the risks of reprocessing, and

(5) describe the components of a reuse program.

This program meets criteria for CNOR and CRNFA recerfification, as well as other continuing education requirements.

Reprocessing Single-use Devices--the the Equipment Connection

Numerous, complex activities must take place to ensure positive outcomes with a reprocessing program. The reuse of devices intended for single use is not a practice that should be implemented casually. As a central principle, a reuse program must demonstrate that reprocessing used or previously opened but unused items is as safe as reprocessing medical devices that are reusable. (1) Table 1 contains a list of terms pertinent to resterilization and reuse of single-use devices (SUDs).

Fiscal restraint, budget cutbacks, and managed care have been the driving forces behind the burgeoning industry of reprocessing SUDs. (2) In fact, reprocessing has resulted in the birth of a $20 million per year industry. (3) One source found that if health care facilities took full advantage of the practice of reuse, they could save $700 million per year because the typical reused device costs approximately one-half that of a new device, including reprocessing costs. (4) One group of health care facilities that reuses SUDs estimates their annual savings per facility to be $44,000 for sequential compression devices, $17,000 for pulse oximeter sensors, and $115,000 for electrophysiology catheters. Other health care facilities that actively perform electrophysiology procedures state their savings from reprocessing range from $200,000 to $1 million annually. (5)

One researcher makes no apologies for reprocessing supplies. He states that the electrophysiology laboratory where he works has reused more than 50,000 catheters without a single problem. His laboratory carefully tracks each device and reprocesses only simple, less intricate catheters. These devices cost between $200 and $900 each; therefore, he estimates that his laboratory has saved $9 million during the past 20 years. (6)

Facilities that reprocess SUDs use sophisticated methods for cleaning and sterilizing. Although some critics claim this practice is not worth the savings, the potential exists for cost savings if reprocessing is performed correctly and the patient's safety needs are considered the first priority. (7) In many situations, therefore, the practice is safe if employed with a conservative approach.

OVERVIEW OF REFUSING SUDS

The first recycled devise in the United States was the hemodialysis filter, which remains the most commonly reused disposable medical device. (8) The practice of recycling these filters patients used only their own filters; therefore, patient-to-patient transmitted infections were not an issue. This practice has become accepted, but it is not risk free. Although studies have not found death rates to be increased related to hemodialysis filter reuse, the Centers for Disease Control and Prevention (CDC) has investigated 12 outbreaks of pyrogenic reactions or bacterial infections, primarily as a result of inadequate reprocessing. (9) Dialysis centers now are required to meet the Association for the Advancement of Medical Instrumentation (AAMI) standards, and in 1995, the US Food and Drug Administration (FDA) required dialysis filter manufacturers to specify the procedures necessary to reprocess dialysis filters as part of their labeling and to replace "single use" with "multiple use" on the labels. (10)

In general, most of the savings of reprocessing SUDs comes from high-cost devices. For example, electrophysiology catheters (ie, devices inserted into the heart to measure and correct cardiac rhythm disorders) have been reprocessed for 20 years, even though some models were approved for single use only. Electrophysiology procedures typically require the use of several catheters, which range in price from $100 to $1,500. (11) Approximately 30% of US health care facilities routinely reuse single-use electrophysiology catheters. (12)