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ICPs in the middle of a highly polarized debate
In a move that may give infection control professionals much-needed guidance on a thorny issue, the Food and Drug Administration (FDA) is nearing release of a new regulatory position that may strengthen oversight of the controversial practice of reprocessing single-use medical devices for use on additional patients. As this issue of Hospital Infection Control went to press, the FDA planned to publish its new position "by October," possibly in the Federal Register or as a separate guidance document, says FDA spokes woman Sharon Snider.
"We are re-looking at our position on how we regulate companies that reprocess," she tells HIC. "There has been more reprocessing the last few years. But the one problem with the whole reprocessing [issue] is that there isn’t a whole lot of information out there. Who is doing it and how many? [Is it] safe for some products and unsafe for others?"
FDA officials declined to comment on wide spread speculation that the agency is going to "crack down" on the practice. Still, recent public disclosures of adverse outcomes in patients and mounting political pressure for more FDA oversight do not exactly set the stage for the agency to unveil more lenient policies. Thus, while it appears the FDA will increase oversight in some areas, the questions of how far the agency will go — and whether any additional regulation is really needed — are the subjects of a simmering and highly polarized debate.
The FDA’s current policy is that reprocessors — whether independent companies contracted by health care facilities, or hospitals that reprocess in-house — are considered to be "manufacturers," and thus technically subject to a full range of inspection, labeling, and registration requirements, Snider says. However, the FDA has exercised "discretion" in letting reprocessors operate without submitting pre-market product information. In addition, hospitals have largely been given the green light to reprocess as long as they assume full liability for any adverse effect on patients, she adds.
"As long as they take responsibility for the reprocessing and make sure they have procedures in place for reprocessing the equipment, then it is up to them," Snider says. "It is their responsibility. We are looking to see if any of that needs to be changed."
Infection control professionals are somewhat caught in the middle on the subject, as underscored by the Association for Professionals in Infection Control and Epidemiology taking a "neutral" position in a letter to the FDA. At the same time, however, APIC essentially told the agency that heightened regulation and oversight may be warranted for reprocessing single-use critical care items that come into contact with sterile tissue or the vascular system. (See related story, p. 135.)
"Right now, there is not a lot of science for or against it," says Loretta L. Fauerbach, MS, CIC, the principal author of APIC’s position paper and the association representative at meetings with the FDA. "It has to be individually evaluated for the device. Who is going to do it and how you are going to do it? Can it be sterilized using the APIC guidelines for cleaning, disinfection, and sterilization, and safely provide the intended function after it’s been reprocessed?"
The disposable devices currently being recycled include angioplasty balloon catheters, biopsy forceps, pulse oximeters, and a variety of bits and blades on medical devices.
With data scarce, many ICPs seem to share a general consensus that no widespread problems are likely occurring due to reprocessing, but certainly some infections and adverse events could be missed in individual patients because there is little active follow-up focusing on those treated with reprocessed disposables.
"I think the biggest concern in reprocessing from an infection risk [standpoint] is things that have lumens," Fauerbach says. "I would be hard-pressed to recommend reprocessing balloon catheters that have a lumen that can be contaminated inside, like some people do. Those would be really hard to clean because they have really small crevices and crannies. Until we can prove that you can get in there and clean that and sterilize and disinfect it, that is probably not the first item you want to look at reprocessing."
There are many items routinely reprocessed and reused quite safely in hospitals every day, "but they are not labeled single-use only. Therein lies the difference," she adds. Further complicating the issue are items like gastrointestinal biopsy forceps that are available under both "reusable" and "single-use-only" labels, she notes. In addition, some operating rooms reprocess "opened-but-not-used" disposables, but discard single-use items that have been used.
"You have to really evaluate what you can do and how you are going to do it within your organization," Fauerbach says. "And if you are going to outsource them, which is probably better for most people, you need to go visit the [reprocessing] facility and check their quality controls. It is probably better to select a [reprocessing company] by what their expertise is in, and not one that is a jack of all trades."
Farmers and cattlemen
Representatives for reprocessing companies argue that it is a cost-effective, environmentally friendly practice, and little evidence of infections and injuries has been traced back to a reused disposable. On the other hand, manufacturers of single-use devices say such off-label uses of their products may put patients at risk of infections and injuries from contaminated or degraded equipment. With both sides at times implying the other is primarily motivated by its own business interests, the issue has gotten divisive enough that lawyers — rather than clinicians — debated its merits at the 1999 APIC conference in Baltimore.
"The original manufacturers and the reprocessors, I lovingly call them the farmers and the cowmen.’ They can’t be friends," Fauerbach says. "There is just so much confusion. The [manufacturers] say, we know of all of these problems,’ and the reprocessors say, there have been no problems.’ Well, somewhere in there lies the real truth."
Indeed, critics say the FDA is not looking hard enough for evidence of infections and adverse incidents linked to reuse, as the agency does not necessarily clarify in its Medwatch surveillance system whether an adverse event was linked to a reused disposable. Sen. Richard Durbin (D-IL) recently introduced a bill into Congress that would change that. In advocating the need for legislation, Durbin cited reports of the presence of blood or tissue on reused devices, which also can lose integrity and proper functioning through repeated reuse. Durbin cited a widely reported finding that a cardiac catheter tip broke off and lodged in a patient’s heart after it had been reprocessed six times.
The bill calls for patients to give informed consent regarding which reprocessed devices are used. It also would require the FDA to beef up surveillance for adverse outcomes. A staff aide in Durbin’s office confirmed that the political future of the bill is largely dependent on what stance the FDA takes in updating its position, meaning the legislation could wither on the vine if FDA takes sufficient action to address Durbin’s concerns.
While the bill proposes that FDA change its Medwatch reporting forms to require the names of reprocessors, the FDA may only be willing to add guidance language suggesting that reprocessing information be included, according to the staff aide. Noting that the FDA concedes it does not have the mechanisms in place to track injury and infection, the bill would create "a "paper trail" that should reveal whether problems are occurring with reprocessed single-use devices, explained the aide, who declined to comment for attribution. Regardless, the informed consent process could give pause to many patients, who have been largely oblivious to the practice.
"When you go in for heart surgery or these diagnostic treatments, it never crosses your mind to ask the doctor: Incidentally, will all the devices you are going to be using in the course of my treatment be used for the first time only?" Durbin said during committee discussions of the need for legislation. ". . . That never dawns on a patient, but in fact we find a third of hospitals are reusing these devices."
However, an attorney with a trade association for reprocessing companies argues that high industry standards make the process safe and informed consent is not necessary in the absence of increased risk.
"If, as a physician, you are going to use a product or do a procedure that is going to enhance the patient’s risk, then you have an ethical obligation to disclose that, "says Pamela J. Furman, JD, executive director of the Association of Medical Device Reprocessors (AMDR) in Washington, DC. "AMDR’s view is that a properly reprocessed device is as safe and effective as a new device. If, as a physician or a hospital [official], you believe that you are in some way increasing the patient’s risk by using the reprocessed device, then you shouldn’t be reprocessing. This is not about a second tier of substandard devices."
Cents and common sense
Safe reprocessing is a much-needed cost-savings measure for hospitals, and the fiscally strapped health care industry would be hard hit if all single-use-only devices were truly used once and thrown away, Furman notes. Moreover, AMDR reprocessing companies thoroughly test the devices before shipping them back to hospitals, where multidisciplinary committees typically sit to ensure the program has infection control and risk management oversight.
"We are proud of our safety record," Furman tells HIC. "We seek out FDA oversight because we think it helps us and it helps the patient. Clearly, if there are [reprocessing] entities that are not doing what they should do, that doesn’t help the industry or the patient. We think the current regulatory regime — under which reprocessors have to comply with the registration, quality system, and medical device reporting requirements — is adequate."
While common sense suggests that reprocessing some of the more intricate, invasive devices could pose a risk to patients, the bottom line is that the FDA should quit abdicating its responsibilities and clarify whether the process is safe or unsafe for all single-use medical devices, retorts Josephine M. Torrente, MS, JD, president of the Association of Disposable Device Manufacturers (ADDM).
"ADDM’s on a mission to get FDA to look device-by-device and say, this one yes,’ this one no,’" she said at the APIC conference. ". . . That way, you folks will know and won’t have to juggle and try to figure out what is safe and what is not safe. It’s not your job. It’s FDA’s job, and they should be doing that for you."
Regardless of what the FDA decides in amending its regulatory stance on reprocessing, ICPs will likely be called on as key clinical team members to ensure compliance and safety at those facilities that choose to reprocess single-use devices. "One of the big assets that we have is that we are used to working in group dynamics with many different people at many different levels," Fauerbach says. "Hopefully, our expertise would help an organization be able to meet the regulations and do this safely if they chose to do it."