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This article was originally published in The Gray Sheet

Executive Summary

DEVICE TRACKING SYSTEM BASED ON EQUIFAX DATABASE encouraged by the Health Industry Manufacturers Association in a recent memorandum to device manufacturers. Equifax Government and Special Systems, Inc., HIMA says, "can serve as a facilities manager for those companies who wish to pool their resources with other companies in order to accomplish cost- effective device tracking compliance." Although HIMA cites Equifax in particular, it notes that it has a list of other firms that can provide device tracking services. Device tracking requirements mandated by the Safe Medical Devices Act of 1990 take effect on Aug. 29. FDA's implementing reg, published in May 1992 ("The Gray Sheet" June 1, 1992, p. 8), requires that manufacturers of 21 designated devices "keep current records...on each tracked device released for distribution for as long as such device is in use or in distribution for use." The manufacturers must be able to furnish data on tracked patients within 10 days of an FDA information request. Among the devices subject to tracking are vascular grafts, silicone-gel filled implants, annuloplasty rings and replacement heart valves. The basic components of a tracking registry, including "tracking, explant, and followup forms, audits and quality control, can be linked by Equifax to its electronic patient tracking system," HIMA says. Atlanta-based Equifax, the parent organization of Equifax Government and Special Systems in McLean, Virginia, stores detailed information on over 165 mil. people "in a multiplicity of databases," HIMA tells manufacturers. The information firm, which was recently selected as registrar for the national voluntary breast implant registry, uses databases such as the U.S. Postal Service National Change of Address System to locate patients. Equifax can provide device manufacturers with differing degrees of service. A manufacturer might pass along all patient data to Equifax, which would then oversee the maintenance of the database. A manufacturer also could maintain its own database and periodically download to Equifax, which could then update information such as mailing addresses. HIMA highlights savings manufacturers could realize in the device-tracking area by using services such as those available through Equifax. For example, tracking system costs "can be significantly reduced if manufacturers work together to develop a common audit system performed by Equifax operating in the role of facilities manager," says HIMA. Rather than each medical device manufacturer performing its own biannual database audit, as stipulated in the rule, Equifax could satisfy the requirement through an audit of an aggregate medical device database it maintained for the device firms. Important tracking system components were solidified at meetings between representatives of Equifax, HIMA and the American Hospital Association. At the meetings, which were funded by 20 HIMA companies, the group devised a standard followup form that hospitals could use to send device recipient information to the manufacturer. The informational meetings also resulted in a "booklet of helpful hints" on tracking. Participating manufacturers, some of which do not make devices for which tracking is required, included makers of pacemakers, orthopedic implants, spinal implants, vascular grafts, pacemaker leads, heart valves, annuloplasty rings, implantable defibrillators and breast implants. In the memo, HIMA also updates manufacturers on the progress of its proposal to simplify tracking through the use of patient Social Security numbers ("The Gray Sheet" May 18, 1992, p. 8). The association says that "it is unlikely that an SSN-based tracking system can be used by manufacturers in the near future." Before FDA can "begin to consider the acceptability of this system," the Social Security Administration would have to change its policy to allow it to release information. The Internal Revenue Service code would also have to be altered. HIMA says it "has been working over the past several months to effect such changes."

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