Reprocessing single use devices - Letters

AORN Journal,  May, 2002  by Marion Sachs

• E-mail
• Print
• Link

As a clinical specialist/educator for the third-party reprocessing industry since 1998 and as a presenter on this topic at AORN's 2000 Congress, I found the recent article, "Reprocessing single-use medical devices," by Barbara Cohoon, RN, MSN, (March 2002, page 557) to be erroneous and misleading.

Of the 49 references listed by the author, more than half the referenced documents were written before publication of the US Food and Drug Administration's (FDA's) final guidance document in August 2000. When addressing a high profile topic such as reprocessing of single use devices (SUDs), timely and fact-based information is of the utmost importance in keeping AORN colleagues accurately informed. Making educated decisions regarding possible changing standards of practice in relation to reprocessing of SUDs is best served by accessing the FDA's web site at http://www.fda.gov/cdrh and links to the FDA's August 2000 final guidance. The General Accounting Office's report on reprocessing and frequently asked questions and AORN's "Guidelines for single use reprocessing" are other resources for accurate and unbiased information.

The first paragraph of the article sets a tone of subjective opinion by quoting a US News Online article that was published in early 2000 at the height of the debate between original equipment manufacturers, the FDA, and the Association of Medical Device Reprocessors. Having experienced first-hand the power of editorial license, I believe AORN members may use subjective articles such as the author's to begin discussions regarding reprocessing, but by no means should we use this article as a road map for investigation of such a program.

For the author to imply that reprocessors and the FDA would jeopardize patient safety for the almighty dollar is ludicrous. I am passionate about proper, methodical, fact-based education on the reprocessing of selected SUDs and what that may mean to our standards of perioperative practice. Cost-savings realized from reprocessing of Class I and II SUDs may, in fact, be one way to keep all nurses where they need to be--at the patient's bedside.

Despite this article being out-dated and biased, I would like to thank AORN for addressing the topic of reuse. I have been educating on the reprocessing of SUDs for four years, and I still find many perioperative nurses hesitant or unwilling to voice personal concerns or question publications in an open forum for fear of jeopardizing a position in their OR or health system. This article has given them an opportunity to begin communication on this issue. Any open dialogue regarding reprocessing offers health care workers a venue to address misconceptions and misinformation.

I look forward to offering facts and resources to colleagues who are investigating third-party reprocessing programs as an alternative to spending money on noncritical devices labeled for single use. Let's spend our limited health care dollars on innovative capital equipment, retention of experienced perioperative practitioners, and training pro grams for nurses interested in the perioperative setting.

MARION SACHS
RN, MSN, CNOR
DIRECTOR CLINICAL SERVICES
STERILMED, INC

Author's response. I have been a perioperative nurse for more than 20 years, and I worked on Capitol Hill from 1999 to 2001. It is very common for there to be a time lapse between the submission, acceptance, and final publication of an article. Given this scenario, I made a point to revisit the authorities I relied on to make sure they were still valid. I also encouraged readers to visit the FDA's web site at http://www.fda.gov for updates on the status of proposed changes.

The article was a historical and legislative approach to the subject of reprocessed SUDs. I made a point of telling both sides of the story, including the issue surrounding the cost savings of reprocessed SUDs.

Finally, perioperative nurses decide every day which medical devices to select for an upcoming procedure or to open onto their back table. This article was written to raise awareness about the reprocessing of SUDs and to encourage nurses to ask questions about the subject.

BARBARA D. COHOON
RN, MSN
DOCTORAL STUDENT
GEORGE MASON UNIVERSITY
ARLINGTON, VA

COPYRIGHT 2002 Association of Operating Room Nurses, Inc.
COPYRIGHT 2002 Gale Group