Association Of Medical Device Reprocessors Release: Proposed Massachusetts Legislation On Reprocessed Devices At Odds With Views Of Medical Professionals And Surgery Patients, Study Finds

WASHINGTON, May 22 /PRNewswire/ -- Doctors and other medical professionals overwhelmingly support the use of reprocessed medical devices, according to market research data made available today by the Association of Medical Device Reprocessors (AMDR). Nevertheless, proposed legislation in Massachusetts would make it more difficult for hospitals to use these devices. Passage of this legislation would increase cost pressures on Massachusetts hospitals because using reprocessed devices typically saves a hospital fifty percent of the cost of a new device. If enacted, this legislation would also increase the amount of medical waste that enters the waste stream, creating a significant burden on the environment.

The legislation was introduced by Senator Susan Tucker, whose district includes Smith & Nephew, one of the largest original equipment device manufacturers in the world. The bill is being considered by the Joint Committee on Health and Finance, and similar language is now part of the Senate Budget Bill.

A panel of surgeons, operating room nurses and hospital purchasing managers from among the top 20 hospitals in Massachusetts and New Jersey participated in a focus group panel on the issue of medical device reprocessing. Separately, recent surgery patients participated in a similar focus group. In both groups, participants filled out brief opinion surveys before and after an educational presentation and focus group discussion took place.

The research showed that, when given the facts about the reprocessing of "single-use" devices, including the safety record of the reprocessing industry, the regulatory scheme and the environmental impact, medical professionals and patients overwhelmingly believe reprocessing to be a safe practice and an appropriate way for hospitals to save money. Moreover, medical professionals on the panel viewed the current anti-reprocessing legislation pending before the Massachusetts legislature as a tactic of original device manufacturers to eliminate the reprocessing industry. More information about each survey and the results can be found at

Participants in both groups recognized that Massachusetts S.B. 2433 is not a patient protection measure. Indeed, some panelists in the medical professional group discussion were concerned that original devices may fail more often than reprocessed devices. Said one hospital employee on the panel, "I do think that these reprocessed devices are sometimes 'better.' I have seen this with shaver blades being sharper than the [original equipment]."

Among the provisions of the bill is a requirement that hospitals obtain "informed consent" before using reprocessed devices during surgical procedures. Focus group participants saw this provision as unnecessary and problematic. One patient participant in the panel said, "Patients have to sign enough forms these days. This would just give them something else to worry about. And as I said before, increas[ing] a pre-surgical patient's level of concern, or panic, if you will, does no one any good."

"Reprocessed devices are in many cases subject to more stringent FDA requirements than original devices. They are as safe and effective as original devices, if not safer. There is no legal, medical, or ethical basis for imposing a requirement to seek informed consent for reprocessed devices, but not for original devices," commented Dan Vukelich, Executive Director of AMDR. "As reprocessed devices are considered substantially equivalent to original devices by FDA and pose no increased risk over original devices, informing a patient that a reprocessed device, rather than an original device, will be used during his procedure would be on par with informing him that 'Brand X' will be used instead of 'Brand Y.' Informing a patient of real risks is the purpose of informed consent and, as many of our panelists pointed out, requiring consent to use a reprocessed device may only serve to cause undue panic because of incorrectly perceived risk."

What did medical professionals say about reprocessing?

* "The reduced cost is a key advantage. We have experienced price decreases in the 50 percent range on the few items that we reprocess. ... The money saved can be used for other supplies, to offset product categories that are over budget, or in the case of our facilities, positive results on the operational bottom line are used to fund capital equipment acquisition."

* "We are all under pressure to take costs out of our system. In difficult times, reprocessing is one of the best ways to cut supply costs and this helps us to preserve some jobs."

* "The reprocessor my institution [uses] has been very open about all aspects of their operation. Quality of returned items has been consistently good. Personally, I would have no issue if reprocessed items were used on me during a hospital stay."

What did recent surgical patients say about reprocessing?

* "The advantages of reprocessing medical devices are so obvious that I cannot imagine why this practice should be controversial, unless, of course, you consider the economic incentive for the device manufacturers to increase their revenues tremendously by turning everything into a 'disposable.'"

* "Based on the supporting data it appears to me that reprocessing makes sense from both a cost saving perspective and an opportunity to minimize waste. The key to the safety is the guidelines established by the FDA and the checks and balances to make sure that there is no risk of infection. The costs of many of these devices are quite significant so if they can be reused safely it makes quite a bit of economic sense."

* "We all know that medical costs are exorbitant and we all want exceptional care with minimal cost. This is a very concrete way to pass on saved money to other areas that will eventually benefit us [the patient]. Having worked in a hospital for nearly thirty years and witnessed the budget cuts that are made to keep a small hospital afloat, a 50 percent reduction in any aspect of medical care is remarkable and desirable. This is a very appealing part of the concept."

About the study

The focus groups were organized and moderated by MedPanel, an online medical market research firm based in Cambridge, Mass. Before being educated about the benefits of reprocessing and the safety record of the industry, participants had mixed views about the practice. After the educational slideshow and focus group discussion, all participants reported that they would feel comfortable if a reprocessed device were used on themselves or a family member during surgery.

"Although the study is not statistically significant, the results confirmed what we've known all along -- that the medical community supports reprocessing, and patients support it when they have all the facts about it," said Mr. Vukelich. "These facts should certainly be a primary consideration as this issue continues to be debated."

About AMDR

AMDR member-companies reprocess medical devices for 15 of the 16 "Honor Roll" hospitals identified by U.S. News & World Report in its 2005 edition of "Best Hospitals." Today, third-party reprocessing is a small but expanding industry. Approximately 95 percent of the third-party reprocessing done in the United States is performed by two companies, which comprise the membership of the Association of Medical Device Reprocessors (AMDR). AMDR members have collectively reprocessed tens of millions of devices. Though numerous devices labeled for "single use" can be safely reprocessed, it is AMDR's view that not every device should be. AMDR member companies reprocess only a small percentage of the medical devices in the marketplace.

Association of Medical Device Reprocessors

CONTACT: David Sheon, +1-202-518-6321,, forAssociation of Medical Device Reprocessors

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