Latest Hearing Bodes Well
for Third Party Reprocessors
by Julie E. Williamson

The battle may still be waging between single-use medical device manufacturers and third party reprocessors, but one wouldn’t have known that by the attendance at the September 26, 2006, House Committee on Government Reform Hearing on the U.S. Food and Drug Administration’s regulatory oversight of the single use device reprocessing industry.

Surprisingly absent from the hearing were the original equipment manufacturers, which, historically, have been front and center at such gatherings to weigh in on what they contend are potentially serious safety concerns related to the practice of SUD reprocessing. Although some OEMs were specifically invited to testify, they opted instead to defer to the Advanced Medical Technology Association (AdvaMed) – the trade association representing medical device manufacturers. The OEMs’ noticeable absence disappointed committee chairman, Rep. Tom Davis, who even went so far as to comment on it in his opening statement.

“We have no device makers testifying because they preferred to speak through their trade association, AdvaMed,” Davis noted, while specifically referring to at least one manufacturer that was invited to testify, but declined to appear before the committee. “We would have preferred to have direct testimony from companies so they would be able to provide specific examples and commentary regarding their specific devices.”

That OEM absence proved to be a feather in the cap of the third party reprocessing sector. Both SterilMed and Ascent Healthcare Solutions, the two largest reprocessing companies in the business, testified at the hearing, along with the director of the FDA’s Center for Devices and Radiological Health, Dr. Daniel Schultz. The CDRH is responsible for regulating the practice of SUD reprocessing.

The hearing gave the FDA and the leading reprocessing firms another platform for defending the oversight process and the safety and efficacy of their practices. Although the reprocessing industry took some hits from AdvaMed during the hearing, which continued with its allegations about the risks reprocessed single use devices can pose to patients, Dan Vukelich, executive director of the Association of Medical Device Reprocessors, Washington, said that the committee approached the hearing fairly, and in some regard even favorably, toward the reprocessing industry.

“I felt that for the first time in a very long time, we weren’t on the defensive,” said Vukelich. “I felt that [the committee] was really interested in hearing the facts about safety and how it relates to reprocessing [of SUDs]. That is always good for us because the facts are our biggest strength.”

FDA Under Fire
FDA’s Schultz, however, faced some tough scrutiny from Rep. Henry A. Waxman, the Committee’s ranking minority member, and Rep. Davis – both of whom, after reading a series of articles in the Washington Post that reported many patient injuries related to the use of defective or non-sterile reprocessed devices, wrote to the FDA requesting information on device safety regulations and the adequacy of adverse event data. While the FDA responded that the data in question did not establish a clear causal link between reprocessed devices and subsequent adverse health events, Reps. Davis and Waxman still had lingering concerns.

“We need to know whether [the lack of clear causal link] was because the reprocessed devices are safe or because MedWatch, the adverse event monitoring system, is too passive or insensitive to capture subtle, but potentially deadly, trends,” Davis noted, adding that the purpose of the hearing was to question whether FDA’s MedWatch reporting system is adequate and effective, and whether the agency’s new labeling requirements, under the Medical Device User Fee and Modernization Act, are working to improve the system.

As of August 2006, reprocessed devices are required to be stamped or tagged with a label indicating that they have been reprocessed. Prior to that requirement, only the packaging was required to identify a device as reprocessed.

During his testimony, Schultz promptly assured that the FDA has many tools to ensure the safety, effectiveness and manufacturing quality of reprocessed SUDs. He added that the agency continues to review and assess the practice of reprocessing SUDs.

“FDA believes that reprocessed SUDs that meet FDA’s regulatory requirements are as safe and effective as a new device. The law and regulations in place are designed to protect the public health by assuring that the practice of reprocessing and reusing SUDs is based on sound science,” he stated before the Committee. “FDA continues to monitor the performance of these devices and to assess and refine our ability to regulate these devices appropriately.”

While SUD reprocessing was the focus of the hearing, the reprocessing industry seemed to earn a reprieve from the harsh spotlight when Rep. Waxman stated that safety risks posed by medical devices are by no means limited to reprocessed devices. He referenced one example where an OEM continued to allow brand-new, yet defective, implantable cardiac defibrillators to be surgically implanted, even though the company was aware of the defect.

“The safety concerns with reprocessed devices have to be understood within the broader context of device safety,” Waxman testified, stating that under FDA’s current regulatory scheme for reprocessed devices, the agency assures that a reprocessed device will meet the same exact standards as the original devices.

“So as we question FDA’s ability to ensure that reprocessed devices are safe and effective – as we should – we must recognize that we are, in effect, questioning FDA’s ability to ensure that all devices are safe and effective.”

Economic Issues Addressed
As could be expected, the issue surrounding the economic impact of reprocessing made its way into discussions. Reprocessing’s negative impact on OEMs was promptly addressed by Rep.Waxman.

“I understand that the original equipment manufacturers do not like reprocessing. They have an economic concern about this practice,” he acknowledged in his statement. “The practice of reprocessing cuts into their profits and often forces them to lower their prices to stay competitive. Their agenda, however, should not be our agenda.”

By now, the economic benefits associated with reprocessing have been widely publicized, and SterilMed, Ascent and even Rep. Davis highlighted the savings hospitals can receive by reprocessing.

SterilMed’s director of regulatory affairs, Dennis Toussaint, stressed that reprocessing also exerts competitive pressure on the marketplace, keeping the price of original equipment down. He noted that biopsy forceps previously cost hospitals roughly $49 each, but after hospitals began having them reprocessed, the price of the original devices dropped to about $15. It’s because of that pressure, he said, that OEMs are so eager to put an end to reprocessing.

“The explanation lies in their bottom line: If they are successful in eliminating reprocessing, they will be able to raise the price of those forceps to pre-reprocessing levels,” Toussaint said. He added that reprocessing is also good for the environment, helping hospitals divert more than 4,000 tons of medical waste from the waste stream in 2005 alone.

Ongoing Efforts
Regardless of which side of the reprocessing debate one finds themselves, one thing remains certain: the battle is far from over.

A handful of states have already introduced legislation that would subject hospitals that reprocess and third party reprocessing firms to even more stringent regulatory oversight. Although, to date, no bills have passed, more states are following suit with copycat legislation. New Jersey, for example, is the latest to tackle the issue of reprocessing, representing the fifth state to introduce such a bill.

The Committee of Government Reform is also moving forward with additional efforts to determine whether reprocessing poses any safety risks to patients. Reps. Waxman and Davis have asked the General Accounting Office to update its June 2000 report on SUDs. The original report found little harm from reuse, but the GAO did recommend additional FDA oversight.

“Because FDA regulation of the industry has increased significantly since 2000, the Committee has asked GAO to specifically examine the safety of SUD reprocessing, the adequacy of FDA’s oversight, and how reprocessed SUDs compare to original devices,” Davis said in his statement.

The GAO accepted the request, but as of press time, had not yet initiated work on the latest report. Vukelich anticipates that when the new GAO report is issued (which could take anywhere from nine to 12 months, or longer), the Committee will hold another hearing.

OR Today will continue to report on the developments as they unfold.