Lobbying For Labels:
Congressional Committee Discusses Legislation on SUD Reprocessing
By Kathy Dix
Pushing for equality among manufacturers and reprocessors, lawmakers face a new debate in the Senate over specific verbiage for labels on reprocessed medical devices. On Oct. 2, 2002, the House of Representatives' Committee on Energy and Commerce approved language regarding the labeling of reprocessed single-use devices (SUDs). The language was reviewed in a markup session, during which the legislative bill was put into final form before being referred to the House for floor consideration. The House approved HR 3580 on Oct. 9 as amended; the proposed legislation was then received in the Senate.1
The proposed law would require reprocessed SUDs to bear a prominent label stating "Reprocessed device for single use. Reprocessed by ____," with the reprocessor's name inserted. HR 3580 also proposes the creation of an Office of Combination Products and Product Jurisdiction that will "be responsible for designating the center with primary or exclusive responsibility for the premarket and postmarket regulation of drugs, devices and biological products."
HR 3580 would also grant exceptions for certain humanitarian devices and certain devices sponsored by federal or state government, and allow the Secretary of Health and Human Services to waive one premarket application or report if the applicant is a small business submitting its first premarket application or report. It even provides for reduced fees for small businesses.
"We've been working very hard trying to get FDA to treat reprocessors the same way our companies are treated," says Larry Holden, president of the Medical Device Manufacturers Association (MDMA). Reprocessors are currently required by the FDA to provide the same kind of information that original equipment manufacturers (OEMs) must, including registration and listing, medical device reporting, medical device tracking, medical device corrections and removals, Quality System Regulation (QSR), labeling and premarket requirements.2
"We want them to be treated like a medical device company," Holden adds. "What the reprocessors say is they can't do that because they don't have the data from the original manufacturer and the manufacturer won't give it to them." Holden stresses two points: first, that the FDA should know whether a device can be reprocessed or not, and second, if it can be reprocessed, how often that should be done before the device is discarded.
"The FDA is fully regulating this industry -- there's clearly a level playing field already, and there's not a public health issue with reprocessing," says Mark Salomon, senior vice president of corporate development at Vanguard Medical Concepts, Inc. "In some senses, this HR 3580 will create an un-level playing field from the manufacturer's standpoint. In the final analysis, we can live with everything in 3580. What's good about this is that some of the changes will provide more access to more products on the reprocessing side."
"(Reprocessors) need to do their own clinical trials for the FDA on their own time and their own dime," Holden says. OEMs argue that they have invested significant funding in researching a device and launching it; thus, a third-party reprocessor should be obligated to do the same research at its own expense, rather than reaping the benefits of the OEMs' work.
"There is language in here that allows for a class resubmission that would not require a right of reference, so I don't have to describe the manufacturing process of the OEM. In other words, I have to describe my manufacturing process, and those materials are my raw materials," Salomon explains.
Obviously, with the existing rift between OEMs and third-party reprocessors, reprocessors were not likely to be given access to the manufacturers' original manufacturing process or other details. So, says Salomon, "(H.R. 3580) allows third-party reprocessors to open to new products and provide another level of enhanced regulation."
The MDMA asks that a reprocessed device be labeled as such, so physicians and patients know whether they are using a brand-new device or a reprocessed one. "At the end of the day, you almost get to the common sense position, which is, it's either a single use device or not. We should not be reprocessing single use devices; it either should be used again or it should not be," Holden says. "But if we're going to reprocess devices, we have to make sure (the process is) safe. The FDA's entire mission is safety and efficacy."
Reprocessors, however, emphasize that reprocessed devices -- if sterilized properly -- are no riskier than brand-new devices. Thus, labeling a product as reprocessed or new may not be necessary.
If HR 3580 becomes law, the requirement of labeling devices as reprocessed would only apply to devices introduced or delivered for introduction as of Oct. 1, 2002.
The legislative language proposed by OEMs includes more than just a recommendation to label reprocessed SUDs. It also sets forth requirements regarding the following:3
- Facility inspection by nongovernment inspectors
- Outside expert review (accredited third parties) of applications for devices subject to premarket notification
- Designating priority devices for the treatment of serious diseases or conditions
- Manufacturers and importers reports only for types of devices requiring malfunction reporting
- Labeling for intended use of devices found substantially equivalent to legally marketed devices
- Notification of false or misleading proposed labeling
- Approving supplements to approved applications seeking to add a specification of a subpopulation under an approved condition of use
- Using the least burdensome scientific evidence required to demonstrate a device's effectiveness
- Investigational plans examining the safety, effectiveness or substantial equivalence of a device
- Notification of deficiencies
- The guidance development process utilizing nongovernmental employees
- Modular review of applications
- Electronic labeling
One element of HR 3580 is the inclusion of a user fee; this, says Salomon, is included as something of a common-sense tax, as a way for the industry to pay for the FDA's efforts. "In essence, what they're doing is applying a user fee like a tax on automobiles -- that tax just gets funneled back to the agency that would use it for enforcement, so it provides money back into the FDA and to the various different elements of the FDA."
But how will this automatic fee affect reprocessors? "It'll have some overall effect on our overhead but it won't skew it immensely," Salomon answers.
HR 3580 gave the Association of Medical Device Reprocessors (AMDR) and the MDMA the opportunity to openly discuss some of the issues dividing the two groups. "It was an effort between reprocessors and OEMs to sort of table some of the issues and get them resolved, because of some of the common goals in this legislation, on both sides," adds Salomon. It allowed the two sides to obtain closure in some volatile areas. "There was some give and take," Salomon recalls. "It's a good sign."
HR 3580 is "all about the patient and public health, and ensuring that we can deliver a good product to the patient and a solution to the rising cost of medical devices in the public health sector," Salomon adds. This, he says, can be done through reprocessing "and with tenets that we can certainly live with that are in this law."
"AMDR members have always been supportive of the process and of regulating this industry where it's appropriate," he adds. "We have gone along with every set of terms and requirements that have been thrown at us, all of this without the issue of public health; there has never been an issue with the public health."
Currently, he emphasizes, reprocessors are regulated at the same level as OEMs. "(To regulate reprocessors) there's not much more we would have to do," he says. "It ultimately provides more stability for the entire industry ... expanding access to the practice of reprocessing."
HR 3580, Salomon says, is a "tremendous solution" for the industry. "I see nothing but tremendous growth. Right now, you're seeing the number of reprocessors shrink as these guidelines come into play; so, if anything, the AMDR companies are getting larger. There's consolidation in the industry." And, he adds, over time more companies will probably enter the reprocessing field. Overall, he says, HR 3580 has strongly impacted both OEMs and third-party reprocessors. "This is tremendous for the stability of this entire industry."
Despite the impact of HR 3580, Salomon does not anticipate a substantial change in the number of hospitals that reprocess devices. Gradually, they have been phasing themselves out of reprocessing. "Some of the largest hospitals in the industry are openly saying they're not going to reprocess anymore, that their mission is to take care of patients, not to be a manufacturer," Salomon affirms. "There are fewer and fewer hospitals doing reprocessing. I don't know that you're going to see any massive switch; I think most of it has been driving toward third-party reprocessors, and the business is growing nicely. There are no fewer disposable instruments being manufactured today, and that provides a rich environment in driving down health care costs. If you look at the cost of the services from the provider side of the thing, it's amazing that you can start to bring (in) some level of stability. Is reprocessing the only answer to that? No, but it is clearly one of the solutions."
HR 3580, which was modified slightly before reaching the President, was signed into law as HR 5651 on October 26. An issue close to the hearts of many, the law flew through Congress to the President's desk with lightning speed. "This one was kind of near and dear to my heart because I was invited to participate in the drafting of the legislation," recalls Don Selvey, the vice president of regulatory affairs and quality assurance at Alliance Medical Corporation. "It was pretty neat to sit there and watch how the process came together."
In September, the House Committee on Energy and Commerce brought together representatives from many different backgrounds: original equipment manufacturers, reprocessors, the American Hospital Association, the FDA. Staffers for the Committee then locked the door and informed the participants that no one was leaving until a consensus was reached.
With that incentive, the parties fell to work and drafted language that was signed into law only a month later. Of course, it is too early to tell how the new legislation will affect the industry long-term. But, says Selvey, OEMs and reprocessors have already begun building bridges. "What we've been seeing over the last year and a half or two years is manufacturers saying, 'Can we work together to make a device that has some limited reprocessing (capability)?'" Selvey recounts. There is, perhaps, some middle ground for the two factions. "I think the new law and collaborative effort we went through to develop this law might help that a little bit -- we hope," he speculates.