By Heather Mayer and Brendon Nafziger, DOTmed News reporters

A report by the European Commission questioned the safety, economic savings and environmental benefits of reprocessing single-use medical devices in Europe, saying there wasn't enough data to make an informed decision and calling for deeper scrutiny into the matter.

"[T]he reuse of single use medical devices may not be without risk from a public health point of view," the group warned in the report, published Aug. 27.



The commission submitted the report to the European Parliament as it prepares for the coming "recasting" of the Medical Device Directives, the rules that govern much of the medical device trade throughout the European Union.

The report itself is the fruit of several years of work, hosting public workshops and charging experts, including the Scientific Committee on Emerging and Newly Identified Health Risks, or SCENIHR, to look into the subject.

According to the report, SCENIHR's take was largely: need more input.

While not arguing one way or the other, the committee identified potential risks to the patient from reusing devices only meant by the manufacturer for one use before the trash heap. These include changes to the device that could result in mechanical failure and the presence of toxic chemicals used to sterilize the device that could remain on the product after processing.

Also of concern was that germs and other infectious agents could survive on disinfected equipment, especially prions, rogue proteins that can cause disease. Prions are known to cause bovine spongiform encephalopathy, or mad cow disease.

"[O]nly aggressive cleaning methods, not compatible with the commonly used materials, can ensure complete prion inactivation," the commission wrote in the report.

In the United States, neurological devices are prohibited from being reprocessed, making prion concerns moot for U.S. reprocessed devices.

Because of the possibility of an increased risk to the patient, using reprocessed devices also represents an ethical issue, the commission said, as patients might need informed consent.

The group also questioned some of the touted economic and environmental benefits. The commission said economic studies had largely focused on hospital supply savings and not on broader costs to the hospital or even to public health, such as greater liability in the event of device failures and transport and insurance costs.

And while reusing devices can reduce waste, environmental studies have not taken into account the total impact from "transport, resources and energy consumption, as well as the use of chemical disinfectants."

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