Federal enforcement is coming soon to a little-known niche of the medical waste industry. In February, the Food and Drug Administration (FDA), Washington, D.C., opened for public comment in the Federal Register two documents about proposed guidance that will regulate reprocessors of single-use medical devices (SUDs), items such as forceps and catheters.
At press time, the public comment period was nearing its end, with a final rule expected by July. Under the proposal, hospitals or third parties that reprocess medical devices must obtain FDA approval that their methods are safe and effective.
The documents impose the same standards on third-party and hospital reprocessors that original equipment manufacturers (OEMs) already follow. "We are not issuing new regulations at this point. We have all of the regulatory authority we need to cover implementation of the requirements listed in those guidances," says FDA's Larry Spears, director of the Division of Enforcement, Office of Compliance, in FDA's Center for Devices and Radiological Health, Rockville, Md.
"We're no longer using enforcement discretion - we're now saying we will be imposing [the requirements], and we state how and when."
Spears says FDA will actively enforce requirements within six, 12, or 18 months after the final guidance is issued. The time depends on the medical device's risk level - high, medium or low - and whether the reprocessor is a third-party or hospital.
Devices that the FDA classifies as high-risk, or Class III, such as guidewires, are difficult to clean or could be damaged by sterilization. Reprocessing Class III items would be subject to enforcement in six months. Class II items, such as orthodontic braces, have 12 months before the rule takes effect. Low-risk Class I devices, such as surgical saw blades, would be subject to enforcement in 18 months. FDA, however, can take immediate action against any product that is deemed harmful.
"We are not banning the practice," Spears says. FDA received a citizen petition asking that reprocessing be banned, but such a move requires proof that the practice endangers public health. "We just don't have that evidence. In the absence of the ability to ban, the next step is to regulate," he says. "If [reprocessors] can meet the regulations, fine. If they can't, they're going to have problems."
The number of reprocessors affected by the rule is unknown. "There are roughly 15 third-party reprocessors," Spears estimates, but the FDA doesn't have a good estimate on how many hospital reprocessors exist. Even the American Hospital Association (AHA), Washington, D.C., doesn't track the information.
Medical device recycling or reprocessing dates back to the late 1970s. Prior to that, most such items were considered "reusable" and were made of glass, rubber or metal. Reprocessing usually involved hand wiping, dipping and soaking devices in disinfection solutions such as hydrogen peroxide.
Plastic Made the Difference The advent of cheap, disposable plastics in the 1970s heralded a new day for medical devices. OEMs began to sell SUDs. And hospitals received products labeled "single-use only" that looked like the medical devices that previously were marked "reusable."
According to the FDA, reprocessing SUDs expanded when hospitals began reusing SUDs to save money.
By reusing SUDs, hospitals reduced the need to buy new items and thus reduced medical waste. Governed by multiple state and federal regulations, discarding medical waste can be costly and complicated. However, the decision to reuse SUDs led hospitals to reprocess more complex products, such as endotracheal tubes and cardiac catheters. Thus, an industry of third-party reprocessors evolved.
Reprocessing now includes wiping visible soil from the device, containing it, and transporting it to a decontamination or sterilization work area. There, it is reprocessed, repackaged and returned to health care facilities.
Because the FDA does not inspect hospitals, the agency has little information about whether they or third-party reprocessors do a better job of medical device recycling. "Reprocessors probably have a more sophisticated system," Spears says. "Their business is reprocessing, whereas hospitals do a variety of things." He notes some hospitals have expressed concerns about reprocessing. "They feel pressured to do it in terms of economic resources," he says. "They feel more comfortable having liability insurance and the other protections from a third-party reprocessor."
Tightening Regulations The new FDA proposal would require reprocessors to meet the same safety standards as OEMs - before they sell equipment. This includes: * Registration and listing;
* Premarket notification and/or premarket approval;
* Medical device reporting;
* Adherence to Quality Systems; labeling;
* Medical device tracking; and
* Medical device corrections and removals. [See "FDA Standards for Manufacturers and Reprocessors on page 84.]
Until now, third-party reprocessors were not required to comply with premarket notification or medical device tracking corrections and removals. A recent FDA letter warns that reprocessors are subject to premarket notification, but the agency did not actively enforce the requirement against third-party reprocessors - nor did it enforce any standards against hospital reprocessors.
Hospitals will have six months longer than third-party reprocessors to register with the FDA. Many health care facilities may be unfamiliar with these reprocessing regulations and will need time to learn them and develop programs to comply, Spears says. "We feel [six months] gives us some time to do outreach to hospitals so they understand what is expected."
Premarket notification, also known as 510(k), is a multi-part requirement. Unless devices are exempt, such as surgical saw blades or laparoscopy scissors, reprocessors must fill out a 510(k) submission for Class I and Class II devices.
Class III devices may require either a 510(k) or a premarket approval application (PMA).
For 510(k) clearance, FDA must determine the device is as safe and effective as a legally marketed equivalent device. FDA's basis for approval of a PMA is that the device has a "reasonable assurance of safety and effectiveness on the basis of valid scientific evidence."
More information is available at the FDA website, www.fda.gov
The Subcommittee on Oversight and Investigations of the Commerce Committee held a hearing on SUD reprocessing on February 10. Rep. Fred Upton, R-Mich., who called the meeting, says there was a "significant and perhaps even dangerous gap in FDA's procedures."
Congressional Oversight But David Feigal, FDA's director of the Center for Devices and Radiological Health, says no clear data confirms that reusing disposable devices is riskier than using new medical equipment. In fact, he adds, brand new devices can malfunction the first time they are used.
Little problem exists with reuse of non-critical devices - ones that do not penetrate but may touch the patient's skin, Feigal says. The FDA has concluded, however, that SUD reuse requires additional attention and controls. FDA's website acknowledges reports of patient injuries. In 1996 and 1998, several incidents of apparent patient-to-patient transmission of infections following a bronchoscope examination are listed. The bronchoscopes may have been inadequately reprocessed.
FDA states that of 300,000 medical device reports received from Aug. 19, 1996 through Dec. 7, 1999, 464 adverse events could be attributed to SUDs. The reports mention approximately 70 different products.
The AHA supports FDA's proposed regulations. Testifying at the congressional hearing on AHA's behalf, Walter Maurer, a physician and director of quality management at the Cleveland Clinic Foundation, Cleveland, noted that in some cases, a device never touches a patient. Almost every day, a surgery is canceled or postponed, sometimes after the operating room has been prepped for the procedure, he said. That preparation may include assembling trays that contain many open SUDs, such as needles, scalpels, sponges and syringes.
"What becomes of these devices when the surgery is canceled? Most of it unfortunately would be wasted as 'medical trash,' but because of increased environmental concerns and cost reduction initiatives, we have found that we can safely sterilize, inspect and repackage many devices for later use," Maurer said.
AHA has an interest in reducing medical waste. For example, its member hospitals agreed in 1998 to eliminate hazardous chemicals and mercury use. The hospitals are working toward a one-third reduction in waste volume by 2005, with a 50 percent reduction goal by 2010.
Maurer called for the FDA to reevaluate what the term "single-use" means. Some manufacturers ship SUDs to hospitals with separate sterilization instructions, which indicate that the device can be reused, he says. OEMs also have financial incentives to self-designate devices as "single-use" as a means to increase sales, he adds.
Industry Reps Weigh-In Manufacturers developed SUDs to respond to the needs of hospitals, according to Stephen Northrup, executive director of the Medical Devices Manufacturers Association (MDMA), Washington, D.C. "They're always looking for ways to control costs and control cross infections," he says.
SUDs replaced materials that previously were reusable. "These are devices that can't and don't need to withstand steam heat in the sterilizing process."
Hospitals also have financial incentives to reuse SUDs, he says, adding, "The problem is now hospitals want to have their cake and eat it, too."
Undoubtedly, hospitals save money by reprocessing SUDs. In fact, according to the Association of Medical Device Reprocessors (AMDR), Washington, D.C., medical devices that are reprocessed offer, on average, a 50 percent cost savings. But the savings probably are not being passed on to patients or federal programs. "Medicare payments are lump sum payments based on diagnoses or procedures," Northrup says. "Medicare does not pay separately for devices that are used or for time in the operating room. In effect, taxpayers are getting ripped off."
MDMA is encouraging FDA to regulate hospitals and third-party reprocessors in the same way as OEMs, Northrup says, noting, "We'd much prefer to see hospitals use the devices only once - they're intended for only one use. But we don't want reprocessing to continue the way it's currently going on with no oversight."
Josephine Torrente, president of the Association of Medical Disposable Device Manufacturers (MDDM), Washington, D.C., agrees. "Overall, we're enthusiastic about the FDA documents," she says. "All other medical devices have to be proven safe and effective. This is just leveling the playing field."
The upcoming FDA guidance goes a long way toward putting appropriate regulations in place, although according to Torrente, MDDM thinks it requires some fine-tuning.
For example, some devices that are exempt from FDA regulation, such as biopsy forceps, probably shouldn't be. This device is a narrow plastic tube with scissors at the end that ranges in length by several feet. Inside the tube is a coil that operates the scissors. The biopsy forceps' structure appears to make it difficult to clean. "I don't think that it can be done," Torrente says.
She adds that the incentive driving medical device manufacturers is not to sell more SUDs, but rather to protect patients' safety and to protect themselves against lawsuits. "Some of our members, such as Johnson and Johnson, [New Brunswick, N.J.], are huge, trusted household names."
AMDR's Executive Director Pamela Furman says that reprocessors are very much in favor of FDA regulation. "We think that strong, rational FDA oversight is critical," she says. Reprocessing SUDs is in the best interests of patients and hospitals, she notes. "It allows hospitals to conserve resources so they can better serve patients."
Furman agrees that some SUDs probably should not be reused. But she argues that reprocessing does not necessarily serve the economic interests of OEMs. "Hearing opposition from OEMs - that's telling. It's a good way [for them] to sell more devices," she says.
The Medical Waste Institute (MWI), a component of the Environmental Industry Associations, Washington, D.C., wrote to FDA but focused its comments only on reprocessing single-use sharps containers. MWI believes FDA's proposal does not consider the healthcare risks that employees face in reprocessing single-use sharps containers. Such products are not designed to be reopened.
In addition, the proposed rule does not address overlapping jurisdiction between federal agencies.
MWI recommends that FDA work closely with the Occupational Safety and Health Administration (OSHA), Washington, D.C., and the Department of Transportation (DOT), Washington, D.C., because reusing single-use sharps containers may violate those agencies' rules.
"If you are opening single-use sharps containers and reusing them, where is the package integrity?" asks Jane Rubinstein, director of Environmental Affairs at Biosystems, Farmingdale, N.Y. Biosystems reprocesses reusable sharps containers.
Rubinstein says FDA's focus on regulating reprocessors is misplaced. "The FDA is not looking at the medical waste containers that remove bloody gloves and bandages. There is no standard on the reuse of containers that may hold infectious fluids," she says. "We're elevating the sharps containers to a level of scrutiny that is disproportionate."
A Matter of Perception? As with all medical waste-related items, perception may be the biggest problem. It is safe to say that few patients actually know many medical devices are being reused, rather than being tossed in the trash. There is no requirement to inform patients of medical recycling.
People may think medical device reuse is limited to metal instruments, such as scalpels and scissors. But many non-critical devices made of plastic commonly are recycled. Still, this is one recycling practice that might cause even the most avid conservationist to balk.
Why not simply use new devices all the time? "Hospitals are in control of that decision," Spears says. "They are reprocessing because of economics, but also because they believe products can be safely reprocessed. That very well could be the case."
FDA approval would solve many problems, MDMM's Torrente says. In fact, then informing patients about reprocessed device use would not be crucial, she says. "If the devices are approved by the FDA, that's the government stamp of approval."
"Third-party reprocessors are saying we can reprocess these devices," Spears says. "We're saying, if you do it, do it right."
Class I Breathing mouthpiece Oral and nasal catheters Tracheobronchial suction catheter
Class II Needle Intra aortic balloon catheter Arthroscopy instruments
Class III Angioplasty catheter Endotracheal tubes Implanted infusion pump
1. Registration and listing. Register with the FDA and list each device.
2. Premarket notification/Premarket approval. Reprocessors must demonstrate that the product is safe and effective.
3. Medical Device Reporting. Report adverse events to FDA.
4. Quality System regulation. Follow good manufacturing practice requirements.
5. Labeling. FDA requires the name and place of manufacture and directions for use.
6. Medical Device Tracking. This establishes tracking systems that enable prompt location of devices in distribution.
7. Medical Device Corrections and Removals. Reprocessors must report corrections and removals to FDA and maintain records.