A Medical Device Daily

Companies that make high-risk implantable devices are acquainted with FDA’s medical device tracking requirements, which the agency rewrote in 2006. The agency now has tweaked those requirements and recently published the “final” version, inviting stakeholders to offer their “written comments and suggestions,” but it has not provided a deadline for that feedback.

The Oct. 25 guidance says that the Safe Medical Devices Act (SMDA) of 1990 added the tracking requirements to regulations, which were then amended by the FDA Modernization Act (FDAMA) of 1997. SDMA required tracking for a specific set of devices even in the absence of an explicit order by FDA, but FDAMA removed the mandatory tracking requirement, making this a discretionary action on FDA’s part.

According to FDAMA, the tracking would apply to only Class II or III devices when the device qualifies under one or more of three conditions: One that the device is for implantation for more than a year; the second that the device is life-sustaining or life-supporting and used outside a facility, such as a hospital. The third condition is that failure of the device would be likely to have seriously adverse consequences.

The agency also has added qualifications for deciding whether to issue an order for device tracking, including the likelihood of a sudden, catastrophic failure, the likelihood of a significant adverse clinical outcome, and the need for “prompt professional intervention.”

Some devices came off the list FDA had assembled in 1998 for high interest for tracking, including intraocular lenses, vascular graft prostheses less than 6 mm in diameter, annuloplasty rings, arterial stents and infusion pumps. It also has added the following device types for possible tracking: temporomandibular joint prostheses; implantable pacemaker pulse generators; permanent implantable pacemaker electrodes; mechanical replacement heart valves; and implanted phrenic/diaphragmatic nerve stimulators.

The tracking methods, according to the guidance, “must provide certain critical information about the location of the device within a short time frame,” specifically three days for devices that have been distributed but not implanted in a patient, and 10 days for devices in use.

Tracking information must include the name, address and phone number of the distributor, and for single-use devices, data must also include lot numbers, date of shipment, the name, address and social security number of the patient, and contact information of the physician who prescribed it or the physician who is overseeing the patient’s care. For multiple-use devices, however, the patient information is not necessary.

The agency says that “manufacturers will have different methods” of tracking devices, and it is not mandating a means of tracking, with the rule allowing third parties to handle device tracking.

Manufacturers, and implicitly any tracking contractors, “must make sure their method of tracking works” by conducting audits twice a year for the first three years. This is followed by annual audits for another three years. FDA states that it recognizes MIL STD 105E as a valid statistical sampling plan, but audits can be handled either through on-site visits “or through some other effective way of communication with the distributors, professionals and patients involved.”

The device must be tracked “for the useful life of the device, even if a patient is lost to follow-up,” but companies can petition for relief from tracking requirements after 10 years. Any company that goes out of business altogether must forward its tracking records to FDA, but should the firm be acquired or simply leave the device business, the acquiring or remaining entity is still liable for tracking.

House takes another shot at HIT

Congress has not yet given up on a bill for healthcare information technology (HIT), and the latest to take up the effort is Bart Gordon (D-Tennessee), chair of the House Committee on Science and Technology. Gordon has introduced H.R. 2406, dubbed the Healthcare Information Technology Enterprise Integration Act, and has moved the bill out of committee onto the House floor.

H.R. 2406 would require the National Institute of Standards and Technology (NIST) to develop standards for interoperability of HIT systems. However, many who have been involved in the process to date claim that NIST’s involvement would duplicate or overlap substantial efforts already taken toward this end.

As a consequence of this feedback, Gordon rewrote the bill so as to authorize NIST to provide technical expertise in the standards development effort, and it calls for an appropriation of $8 million in 2009 and 2010 toward developing interoperable standards.

In a statement on the committee web site, Gordon said he sees a consensus that “fully utilized information technology would ... lower cost and improve patient care,” and that the bill will remedy the healthcare community’s laggardly adoption of IT.

Despite the difficulties faced by an effort several years in the making, Gordon’s bill includes the requirement dthat the director of NIST must “develop technology-neutral information technology infrastructure guidelines and standards, or adopt existing technology-neutral industry guidelines and standards, for use by Federal agencies to enable those agencies to effectively select and utilize healthcare information technologies” within six months of bill passage.