European Commission Outlines Key Issues In Device Reprocessing Debate
Full article reprinted from "The Gray Sheet" - June 2, 2008
The European Union is taking its first steps towards determining whether to create a uniform policy on the reprocessing of medical devices labeled for single use.
At this early stage of the process, even the most basic issues - such as how to define reprocessing to distinguish it from refurbishing - are still up for discussion.
Some individual countries in Europe have single-use device (SUD) reprocessing laws, in some cases outlawing it and in others allowing it under regulatory oversight.
A regulatory approach in the U.S. has evolved during the past decade in which reprocessed devices are subject to risk-based pre-market review and post-market requirements, including validation of a reprocessor's sterilization and cleaning processes.
Reprocessing companies, such as the large, U.S.-based Ascent Healthcare Solutions, as well as smaller contractors and individual hospitals that reprocess SUDs, argue that the practice saves money, provides greater access to health care and lessens the impact of medical waste on the environment.
Original equipment manufacturers, meanwhile, see it as a threat to their business and say it unfairly makes them vulnerable to lawsuits. Device firms say SUD reprocessing causes unnecessary safety risks including infections. Several high-profile and graphic accounts of potential safety problems with reprocessing have appeared in the U.S. popular press. Members of Congress have also been critical of the practice (1"The Gray Sheet" Oct. 2, 2006, p. 15).
Report Summarizes Stakeholder Positions
On May 27, the European Commission released the first round of public comments from stakeholders in a 31-page document outlining key reprocessing issues ranging from health and safety concerns to economics and liability.
No individual respondent is identified in the document, and the Commission does not take a stand on policy.
Last year's revisions of the European Union's Medical Device Directive require the Commission to submit a report to the European Parliament by September 2010 analyzing whether an EU reprocessing policy is necessary (2"The Gray Sheet" April 9, 2007, p. 19).
"This is probably not going to be a rapid process," John Wilkinson, CEO of Eucomed, told "The Gray Sheet," adding that the medical devices trade group would not want a speedy process because the issue warrants "serious consideration."
Eucomed is "firmly in the camp that [single-use medical device reprocessing] should not happen," he said.
The European Association for Medical Device Reprocessing (EAMDR), on the other hand, argues that prohibition sends the practice underground, leading to a "gray market" for reprocessing. The group instead supports regulation that allows for validated reprocessing methods to ensure reprocessed devices are hygienic and functional.
EAMDR estimates the EU health care system could save "several billion euros per year" and reduce "hazardous hospital waste" through reprocessing of SUDs.
In the Commission's May 27 synthesis document, some respondents noted that the potential hidden economic impact of reprocessing includes the cost to the health care system of keeping patients hospitalized longer if they acquire an infection from a reprocessed device, as well as the societal impact from such patients' lost work.
"The issues surrounding this are far from simple," Wilkinson said.
The category of SUDs was created to address the risk of hospital acquired infections, he said. "That was the driving force behind disposables."
Hazards arise when microbiological matter remains on a device after its first use, running the risk that it would later infect another patient or a clinician, he explained.
Sterilization Procedures Can Damage Devices
Wilkinson added that many SUDs are made of plastic, which can degrade over time as it is exposed to heat, light or other environmental stimuli common in the device sterilization process.
Especially in devices designed only for a single use, Wilkinson said, the more often they are exposed to high temperatures, the more likely there will be some sort of product failure, "which has the potential to be catastrophic."
Respondents to the Commission's inquiry suggested that in addition to the possibility of corroding a device, cleansing agents could harm patients on contact if the cleanser had not been thoroughly removed in reprocessing.
Other respondents noted that certain devices are inherently difficult to clean.
Eucomed Seeks Ban First, Conditions Otherwise
In the event the Commission does not enforce a ban on reprocessing of SUDs, Wilkinson said, patients should give informed consent before they are exposed to the reprocessed devices.
"It is particularly important the patient's voice is heard in these processes," Wilkinson said, noting that the International Association of Patients Organizations also provided comment to the Commission.
According to the Commission's document, clinicians may be unaware that they are using reprocessed devices in some instances.
Eucomed wants to see that original equipment manufacturers are protected against liability if a device fails after it has gone through reprocessing.
A spokesman said Eucomed wants "any hints of branding of the original manufacturer" to be removed before a reprocessed device is returned to patient use.
"It's all about traceability," Wilkinson said. "If you don't have that information when you're trying to evaluate adverse incidents, then you're compromised."
The debate in the EU mirrors the discussion that has taken place in the U.S., where device manufacturers have lobbied for stricter oversight, if not an outright ban, of reprocessing for the past decade.
In 2005, industry succeeded in getting the U.S. Congress to pass legislation requiring reprocessors to mark a reprocessed SUD or, in some cases, its packaging, with updated branding identification (3"The Gray Sheet" Aug. 22, 2005, p. 12). Further, individual states have passed or are pursuing legislation that transfers liability to the reprocessor or mandates informed consent when reprocessed SUDs are employed.
Canada does not regulate medical device reprocessing on a nationwide basis, although some provinces enforce their own policies. In the May issue of the journal Infection Control and Hospital Epidemiology, a survey of Canadian hospitals reveals that 28% use reprocessed medical devices.
Until the European Commission comes up with its own set of standards, individual countries govern medical device reprocessing in the EU. Some, like France and Spain, condemn the practice, while others, such as Germany and Denmark, allow it under regulated conditions. Several, including Greece and Poland, have no official policy.
"While not hugely widespread, we are seeing what appears to be an increase in the hospitals that seem to be prepared to reprocess and reuse products that weren't designed for this purpose," Wilkinson said.
But just because it is already happening, Wilkinson said, it should not necessarily be endorsed with legislation.
"The Commission's view of the issue is very important," he said. "The issues need to be laid out very carefully before you go anywhere with this."
- Monica Hogan
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