Orthodontics. Adolescent angst. Two seemingly endless years of contorted expressions that ultimately keep many a teen's mouth clamped shut in a perpetual scowl. Some may regard this behavior as a small price to pay for the rite of passage that braces represent, especially when the impact of the future investment is so dramatic--a set of perfectly straight pearly whites. But for all their misery, let alone their parents' money, at the very least kids deserve a fresh set of braces that haven't been glued onto someone else's teeth first.
It's a thought that would leave a bad taste in anyone's mouth, but under today's economic health-care constraints, and in a disposable society, the medical and dental professions have found that recycling pays.
Until recently, the advent of cheap, modern plastics and the risk of infectious diseases led doctors and dentists to use a device once and then toss it. It was cheaper, more convenient, and safer. Recycling single-use products became more attractive as devices became more complex, as prices went up, and as new sterilization methods allowed a wider variety of products to be sterilized. As a result, a new industry sprang up to reprocess medical devices intended for disposal after one use--and with it came some new worries for the Food and Drug Administration. This new industry of third-party reprocessors increased FDA's concern for patient safety and raised questions about how to regulate the original manufacturers and reprocessing firms equitably.
The idea of reusing a medical device is not a new one. Decades ago, everything was reused. Medical manufacturers made tools from durable materials like glass, rubber and metal, and early reprocessing of reusable devices, such as probes and surgical instruments, involved little more than hand wiping, dipping and soaking in a disinfectant, and a trip through the autoclave--a giant pressure cooker that scalded infectious organisms into oblivion.
But market demand for disposable equipment and the development of new plastics influenced manufacturers to make and sell single-use devices (SUDs). The practice of reprocessing SUDs expanded when an increasing number of hospitals decided that reuse was a cost-saving measure and when the amount of medical waste generated by disposable devices became noticeable. If, for example, a cardiac catheter--a tube that snakes its way from the femoral artery in the groin to the coronary arteries of the heart--costs a considerable amount for a single patient, the hospital could cut the cost almost in half by using it on two patients.
Sounds reasonable, but cleaning and sterilizing devices intended for a single use appears to be more difficult than sterilizing old-style devices designed to survive autoclaving. Between August 1996 and December 1999, FDA's Medical Device Reporting (MDR) system documented 245 adverse events associated with the reuse of SUDs, including seven deaths, 72 injuries, 147 malfunctions, and 19 "other" incidents, as reported by manufacturers. The reports listed 70 different types of products, but FDA could not discern a pattern of failures with reused SUDs that differs from those observed with their initial use.
"When you reuse single-use devices, such as orthodontic products, the risk increases for both infection and product failure," says Tim Ulatowski, director of FDA's Division of Dental, Infection Control, and General Hospital Devices. But the MDR reports do not allow an accurate assessment of the failure rates, since device failures in general are underreported. Also, it would be hard to trace infections that may have resulted from improperly reprocessed SUDs back to the reused devices.
"Despite a lack of clear data that suggests that many injuries are occurring due to reprocessing practices," says David W. Feigal, M.D., director of FDA's Center for Devices and Radiological Health (CDRH), "FDA has concluded that the practice of reusing single-use devices needs additional attention and regulatory controls."
In an effort to provide closer oversight of the growing recycling practice, FDA conducted research and developed a new regulatory approach for hospitals and third-party device reprocessors.
First, CDRH implemented a research program to explore the safety and effectiveness of reprocessing SUDs. From that, the center gleaned information on the difficulty of cleaning the devices, the effect of sterilization and resterilization on materials, and changes in device performance. SUDs were examined after one-time use and compared both to devices that had never been used and to those that were reused in simulated laboratory studies. The research turned up several problems, including the loss of elasticity in inflatable balloons, breakdown of products because of repeated use, and loss of original lubricants.
The agency's current policy requires that a medical device be safe, effective, and manufactured in accordance with a quality control system. If a SUD is prepared for reuse by cleaning, repairing or refurbishing, it is in fact being remanufactured, but until recently SUDS haven't been subject to the same regulations that original equipment manufacturers are required to follow.
That policy changed in August, when FDA issued a final guidance that requires third-party reprocessors and hospitals to follow the same regulations as those required by original manufacturers. This includes premarket notification and approval requirements, registration and listing of firms, submission of adverse event reports, manufacturing and labeling requirements, tracking of devices, and correcting or removing from the market unsafe medical devices. FDA's enforcement of the premarket clearance requirements for SUDs will be phased in based on the traditional device classification scheme (i.e., Class I, II and III, with Class III having the most rigorous premarket requirements). The agency intends to enforce premarket submission requirements within six months for all Class III devices (requiring submission of safety and effectiveness data), within 12 months for all Class II non-exempt devices, and within 18 months for all Class I non-exempt devices. (Manufacturers of Class I and II non-exempt devices need only prove that the device is "substantially equivalent" to one already on the market.) Third-party reprocessors are already subject to enforcement of the other, non-premarket regulatory requirements, and will continue to be under the new guidance. However, the FDA intends to phase in enforcement of these non-premarket requirements for hospital reprocessors within the next year, and will use this time to educate hospitals about the requirements.
The FDA believes that such a phased-in approach for enforcement of regulatory requirements for third-party and hospital reprocessors is appropriate because:
- The health risk associated with reprocessing SUDs varies with each device.
- It may avoid any unintended and unpredictable consequences, such as potential shortages, in certain hospitals.
- Establishments such as hospitals may be unfamiliar with FDA regulations and a phased-in approach will allow those facilities time to learn about the requirements.
- The agency's limited resources do not permit immediate enforcement of all regulatory requirements.
It should be stressed, however, that nothing in the new policy, including the phased-in enforcement approach, precludes the agency from taking immediate action against any particular product that is causing harm.
The primary goal of the new policy is to ensure a program for regulating device reprocessing and reuse that is based on good science and that protects the public health, while ensuring that its regulatory requirements are fair to all parties.