The products sterilization business is a growing one, according to a report issued last month by Business Communications Company (Norwalk, Connecticut). The report estimates that contract sterilization services alone generated $160.5 million in 1999, predicting a growth rate of 10% annually over the next five years. And the reprocessing and reuse of single use medical devices (SUDs) "has become an important part of this market," according to the report. That sector could be boosted even further as a result of a new guidance, issued last month by the FDA, outlining what is intended to be stricter enforcement of reprocessing practices.

While medical device manufacturers, the OEMs in the industry and med-tech associations over the past two years have lobbied hard to restrict the process, the new guidance may actually promote the activity, according to Pamela Furman, head of the Association of Medical Device Reprocessors (AMDR; Washington). The new guidance will work to "legitimize" the practice of SUDs reprocessing by underlining reprocessors' claims that the practice is both safe and cost-effective, she told The BBI Newsletter. The guidelines, Furman said, "will once and for all lay to rest the unfounded uncertainty about the practice of proper reprocessing." "The conclusion of government scrutiny is that the safety of reprocessed devices "is as good or better than that of new devices," she said. Furman termed this a "bold statement" but one supported by reprocessing methodology. Reprocessors, she said, normally do "100% functionality testing" of each individual device, as opposed to the manufacturer's approach of batch testing.

Furman said that the only significant difference in the new enforcement rules would be in requiring reprocessors to submit premarket data. "Our position is that premarket review is not necessary from a patient safety standpoint – there's no rationale for it," Furman contended. "But, that said, we feel very prepared to comply with the new requirements and look forward to continue working with the agency as we've always done to assure implementation is reasonable."

The new guidance received praise as well – though with various qualifications – from some representatives of the device industry. The Association of Disposable Device Manufacturers (ADDM; Washington) issued a statement praising the new emphasis on reprocessors having to submit PMA and 510(k) data. But ADDM director Josephine Torrente cited "significant gaps" in the new rules. The first, she told BBI, was the agency's failure to clarify the type of data used in the premarket review applications and the allowance of exemptions from the rules for too many devices. The new guidance rules "are a step forward," Torrente said, but "do not go far enough."

Issuing a similar sort of "good job, but not far enough" statement was the Medical Device Manufacturers Association (MDMA; Washington), which termed the guidance "an important step toward protecting the public health and patient safety." Like the ADDM, the MDMA raised the issue of exempting some devices from the premarket approval process, pointing to patient safety as its main concern in the debate.

Single business issue: HIPAA compliance

The most important business issue facing health care providers over the next two years is compliance with new Health Insurance Portability and Accountability ACT (HIPAA) rules, according to "The 11th annual HIMSS Leadership Survey," generated by participants at the annual conference of the Healthcare Information and Management Systems Society (HIMSS; Chicago, Illinois). About 70% of all survey participants said that compliance with the HIPAA rules – issued last month – is a top business issue for their organizations, and some 55% said that upgrading their systems for HIPAA is a top information technology priority.

The new regulations establish standards for B2B health care e-commerce, but the impact of the regulations on medical device makers will be relatively minimal, according to David Sweigert, director of HIPAA programs at OpenNetwork Technologies (Clearwater, Florida), a company assisting health care firms to comply with the new rules. Sweigert said that the issue for equipment manufacturers that will be "most concerning" will be simple data fields that identify a patient by name and/or social security number, and the way in which that data field is then moved and consolidated with an electronic record. "It's no big deal for a piece of equipment to print out a report or some type of diagnostic that has a name and identifiable data," he told BBI. But it could be a big deal if that information falls into unauthorized hands. "Where a physician could probably run into a lot of trouble is when he starts collecting all this information in the medical record," Sweigert said. ""here are lots of different reports from these machines. As information is put into electronic format, once consolidated like that, the information must be secure. That's the kind of information that starts transferring across web or electronic communication networks. If accessed by someone else, then you could have a problem."

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