Congressmen Tom Davis and Henry Waxman are pulling out their magnifying glasses to examine reprocessed medical devices. As chairman and ranking member of the House Committee on Government Reform, the two men have asked the Government Accountability Office to investigate the safety of reprocessing and reusing medical devices designated by their manufacturers as "single-use." They also want the GAO to determine whether the FDA is regulating the reprocessing business adequately. "In addition, we would like GAO to examine how the safety and oversight of reprocessed devices compares to the safety and oversight of single-use devices," the letter states. Meanwhile, the congressmen requested from the FDA a list of information about the industry and the FDA's oversight of it. In a letter addressed to Acting Commissioner Andrew von Eschenbach, Davis and Waxman asked for information about reported problems with both reprocessed and new single-use devices, and about any regulatory actions the agency has taken against reprocessors, among other things. The committee's dual requests come on the heels of a Washington Post series examining the reprocessing industry. That series prompted Congresswoman Rosa DeLauro, whose House Appropriations Agricultural Subcommittee oversees the FDA's budget, to call for "rigorous oversight" of reprocessed medical devices and for improved pre-market scrutiny and post-market surveillance of medical devices. She contended in a statement that "a small number of reprocessing facilities" are operating completely outside FDA oversight. The GAO last looked at medical device reprocessing in 2000, and that report concluded that some devices could be reprocessed safely. It also noted that farming devices out to reprocessors can cut the cost of each device in half, and reprocessing in-house can slash that price down to as little as 10 percent of the price of a new one. But it said that some devices were improperly reprocessed and not fully sterilized, and it recommended that the FDA improve its oversight of the practice. Not surprisingly, medical device manufacturers have been among the loudest critics of the practice. "This reprocessing industry that seems to be growing has disregarded the safety issues and has gone forward and are reselling these devices to hospitals," says Mark Leahey, the executive director of the Medical Devices Association. "These devices were never intended for multiple use. The reprocessors haven't been able to produce the validation data that they can be safely reproduced." Beginning in 2002, Congress passed legislation that required the reprocessors to produce validation data demonstrating the devices hadn't been compromised in the reprocessing phase. But even after reprocessors' assurances that they were safe, half of the devices characterized as high risk had to pulled from the market after reprocessors failed to produce the data. Under a new federal law scheduled to take effect August 1, adds Leahey, these devices will have to carry the symbol of the reprocessor. "The truth of the matter is this is more of a liability concern," says Leahey, "because these products are manufactured for single use only. After single use, if they're put on the market, it's (the original manufacturers) that can be on the hook. One of the other issues is patient care, making sure the patient is aware. If I'm a patient, I don't want to have a single-use device being reprocessed contrary to FDA safeguards." In 2004, the Advanced Medical Technology Association, which represents device manufacturers, sent a letter to the FDA complaining that doctors were reporting problems with reprocessed devices to the devices' original manufacturers, citing several harrowing cases, including one in which a reprocessed cardiac-surgery device caused a doctor to cut his patient's heart during surgery. The group also claimed that two of its members had tested reprocessed devices and found contamination. The Association of Medical Device Reprocessors maintains that equipment manufacturers have been trying to "eliminate" the reprocessing industry by complaining about reprocessing to the FDA. The MDRA also contends that many devices are only labeled as "single-use" to induce hospitals to buy more of the new ones. "There is no evidence that third-party, FDA-regulated reprocessing increases the risk faced by patients," the association said in a statement. "In fact, it may be that reprocessing makes medical procedures safer, because if an original device fails when it is first used, it is not reprocessed. And because every reprocessed device is inspected or tested prior to use, the strong likelihood is that the device will again work properly. The same cannot be said for original devices, which are subject only to sample-testing."