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DEVICE TRACKING EXEMPTION/VARIANCE REQUESTS: FDA TO RESPOND BY OCT. 31

This article was originally published in The Gray Sheet

Executive Summary

DEVICE TRACKING EXEMPTION/VARIANCE REQUESTS: FDA TO RESPOND BY OCT. 31, Kathleen Shanahan, consumer safety officer in the device center's office of compliance, said at a Sept. 29 tracking seminar sponsored by the Health Industry Manufacturers Association in Washington, D.C. "We are working on [responses to requests for exemptions and variances] right now and we anticipate that the responses will be out by the end of October," she said, adding that the agency will continue to accept additional requests. Shanahan said the agency had not responded earlier to the pending requests because it was waiting for publication of the final tracking regulation. The final rule issued on Aug. 16 and went into effect Aug. 29 ("The Gray Sheet" Aug. 16, p. 5). The regulation, which implements tracking provisions of the Safe Medical Devices Act of 1990, lists 26 types of devices that must be tracked. The reg spells out tracking requirements for manufacturers, distributors and "final distributors." Requests for exemptions or variances have been submitted to FDA by several firms over the past year, including Physio-Control and Marquette Electronics for external defibrillators ("The Gray Sheet" Aug. 2, p. 11) and TMJ Implants, Inc. for its temporomandibular joints. In addition, a number of firms, including Abbott, Baxter, Sandoz Nutrition and Sherwood Medical, have sought exemptions for certain infusion pumps ("The Gray Sheet" Sept. 13, p. 20). The Health Industry Manufacturers Association submitted an exemption request for certain infusion pumps in May 1993 ("The Gray Sheet" May 24, I&W-12). In addition to addressing manufacturers' concerns over timely responses to requests for exemptions and variances, FDA officials discussed several other tracking issues of concern to industry at the seminar. Explaining the agency's position on defibrillator tracking requirements, Joseph Sheehan, regulations staff director at the device center's office of standards and regulations, stated: "a defibrillator needs only [to] be tracked down to the emergency medical service or the ultimate user...you do not have to keep information about each individual patient." In its petition, Physio-Control had expressed concern that defibrillators might have to be tracked to the patient level ("The Gray Sheet" Aug. 2, p. 9). FDA staffers at the seminar also were asked whether signed shipment invoices would fulfill the requirement that manufacturers verify distributor receipt of products subject to tracking. Shanahan said FDA would accept a signature acknowledging receipt of a package only if the signer verified that the serial numbers of the devices in the package matched those on the invoice listing. "If you have a system that you think would work, we are amenable to taking a look at it," Shanahan said, adding that the distributor would have to request a variance for the method. At the meeting, industry reps expressed concern that confidentiality of patient data will not be protected and will be vulnerable to discovery by plaintiffs' lawyers in product liability suits. Sheehan acknowledged the concern, but said FDA does not "have a lot of control over the privacy of records that are in the hands of manufacturers." Moreover, "whether or not a court can get [patient information] or a lawyer can get them for class action may be out of [FDA's] control." Several manufacturers discussed problems they are experiencing in implementing tracking systems. Barbara Fisher, a biologist and quality assurance associate with W. L. Gore & Associates, told seminar attendees that "of all the [tracking] reports received so far" by the company, "1O to 20 percent of them are complete -- that's all." Marge Foss, Director, Quality Management for the IV Systems Division of Baxter Healthcare, said that "with infusion pumps at Baxter, [in] the first 30 days...less than 5% of our shipment has been verified."
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