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Note from the Editor


Published: April 1, 2010
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An Inconvenient Truth about Reprocessing Single Use Devices


Sometimes, what may seem like the right thing to do is just plain wrong. A commentary titled “A Call to Go Green in Healthcare by Reprocessing Medical Equipment,” published in the March 2010 issue of Academic Medicine, argues that the reprocessing of medical equipment, including single-use devices (SUDs), should be encouraged. “Healthcare can contribute to creating a livable planet by reducing the . . . amount of medical waste it produces,” write Gifty Kwakye, final-year medical student at Yale University School of Medicine; Peter J Pronovost, MD, PhD, professor at Johns Hopkins University School of Medicine and Bloomberg School of Public Health; and Martin Makary, MD, PhD, also at Johns Hopkins. “Reprocessing is one strategy to accomplish this,” they add.
 
Noting that the healthcare sector is the second largest landfill donor after the food industry, the authors of the report laud reprocessing of medical devices as a commonsense strategy for achieving waste reduction. “More than 25% of US hospitals . . . are using reprocessing as a means of decreasing the tons of disposable waste generated annually. The result has been significant waste reduction and cost savings,” they write. “However, uptake of such green practices by hospitals has [been] slow, because of a misunderstanding of the process and concerns about patient safety.” Really? A white paper on the reuse of SUDs published by Eucomed tells a different story. It cites several ways in which refurbishing them elevates risk for the user. These include:
  • Potential cross infection. The refurbishment process may be unable to completely remove viable micro-organisms from devices designed for single use because of narrow lumens or the type of material used. A study conducted at the University of Tübingen in Germany found that none of the refurbished instruments they tested were adequately cleaned, disinfected or sterilised.
  • Possible leaching of disinfectants. Some materials used to manufacture devices can absorb or adsorb chemicals, which may leach over time.
  • Material alteration. Reprocessed plastics may soften, crack or become brittle after having been exposed to elevated temperatures or pressure, for example.
  • Potential mechanical failure. Reusable devices have been designed to withstand stress that occurs each time the device is used. This is not the case for single-use devices, which may be subject to unpredictable fatigue-induced failure and fracturing following refurbishment.
Eucomed submitted the white paper in reply to a call for information from the Scientific Committee on Emerging and Newly Identified Health Risks. The European Commission currently is analysing this and other submissions and will issue a report on the reprocessing of medical devices by September 2010. I am confident that the Commission will rally around a position that recognizes SUDs for what they are—single-use devices.
 
Links
  • A PDF of the Eucomed white paper can be downloaded from this link. 
  • The Academic Medicine commentary on reprocessing medical equipment is available on their website.
  • The Association of Medical Device Reprocessors "takes strong issue" with this editorial. Read its response here.
  

Published in European Medical Device Technology, April 2010, Volume 1, No. 4



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Many “single-use” medical devices are suitable for reprocessing

Submitted by dvukelich on April 13, 2010 - 6:26pm.

The Association of Medical Device Reprocessors (AMDR), the trade association representing third-party reprocessors in the United States, takes strong issue with Norbert Sparrow’s recent editorial disparaging the reprocessing of “single-use” device (SUDs).  Specifically, we find it quite troubling that the Editor of EMDT conveniently left out so many truths on the subject of SUD reprocessing.

Basing all of his conclusions on a white paper from EucoMed (the trade group representing the European medical device manufacturers), Mr. Sparrow neglected to check his facts:
 
Fact:    Unlike Europe, in the United States, the Food and Drug Administration (FDA) regulates the reprocessing of so called “single-use” medical devices and has determined that “reprocessed SUDs that meet FDA’s regulatory requirements are as safe and effective as a new device.”
 
Fact: The “single-use” label is a designation chosen by the medical device manufacturer, not by FDA. In fact, some manufacturers simply shifted the labels on certain devices from “reusable” to “single-use,” or provided cleaning instructions to hospitals so they could reuse SUDs and some manufacturers have even marketed “remanufactured” or “recycled” “single-use” devices to hospitals -- all behavior that has eroded the credibility of the single-use label.
 
Fact: EucoMed, the trade association representing medical devices manufacturers in Europe, has a vested financial interest in making sure devices are not reprocessed, thereby forcing hospitals to buy more “single-use” devices. By failing to consider the science on both sides of reprocessing, EucoMed’s white paper on the subject blatantly furthers this economic agenda. 
 
Fact:    In the U.S. where SUD reprocessing is regulated (and contrary to EucoMed’s assertions), independent sources have noted the absence of any evidence, from any source, indicating an increased risk to patients from the reprocessing of SUDs.  FDA and the Government Accountability Office (GAO), an independent arm of the U.S. Congress, have found “no causative link between reported injuries or deaths and reprocessed SUDs;” “[n]one of the experts… cited the use of reprocessed single-use devices as a factor contributing to [hospital acquired infections];” and “studies have shown both that reprocessed procedures can be safely accomplished and that patient outcomes are not adversely affected by the use of SUDs.”
 
These facts are indeed inconvenient for those, such as EucoMed’s members, who stand to gain economically from preventing the adoption of third-party reprocessing. AMDR is confident that, after evaluating all the facts and evidence, the EU Scientific Committee working group studying the reprocessing of SUDs will conclude that the practice - when appropriately regulated - is safe, effective, lowers healthcare costs and reduces medical waste. 
 
AMDR will make this response available on its website, along with citations and web links to those sources noted above. For more information on third-party reprocessing, visit www.amdr.org.