An MD&DI November 1997 Column
Manufacturers of 12 types of devices are urged to file summary reports instead of MDRs, and no MDRs are required for IDE exports.
- HIMA Urges FDA Action against Reuse of Single-Use Devices
- FDA's Phantom Two-Year Rule
- FDA Document Leak Revisited
- FDA, Senate Seek Foreign-Facility List
Device manufacturer reporting under FDA's medical device reporting (MDR) regulation will be cut by up to 27,000 reports annually through allowing makers of certain products to record routine device malfunctions under a summary reporting system (a quarterly tabular count of the aggregate malfunctions).
A recent FDA letter to industry urged manufacturers of 12 types of devices to request permission to submit only summary reports of well-known and expected events in lieu of routine MDRs (3500As).
The devices eligible for summary reporting are:
- Intravascular administration sets.
- Intravascular catheters.
- Implanted subcutaneous intravascular catheters.
- Mechanical/hydraulic incontinence devices.
- Urological catheters.
- Endosseous implants.
- Diagnostic intravascular catheters.
- Mechanical/hydraulic impotence devices.
- Mechanical heart valves.
- Silicone gelfilled internal inflatable breast prostheses.
- Saline-filled internal inflatable breast prostheses.
- Permanent pacemaker electrodes.
Some manufacturers already have experience in summary reporting--for example, makers of breast implants, heart valves, and pacing leads already report in this way. Another group of about 15 devices will fall under summary reporting near the end of the year, according to Mary Weick-Brady, FDA Center for Devices and Radiological Health's Division of Postmarket Surveillance team leader. Eventually, some events may be dropped from the reporting requirement altogether, Weick-Brady speculates. However, this could be years down the road and is likely to be a tough sell for many at the agency.
In addition, medical devices under an approved FDA investigational device exemption (IDE) that are exported and sold overseas are now exempt from MDR adverse event filings. FDA's Office of General Counsel recently ruled that if the device is not in commercial distribution within the United States, the agency cannot enforce the MDR regulation. However, events required to be reported under the IDE must still be reported, whether the device is exported or not.
The big savings from these changes for industry will be in the time and resources recouped from not having to complete and file FDA's MedWatch 3500A forms for each reportable event. Weick-Brady says one manufacturer estimated that 60% of its reporting staff was dedicated to filling out MedWatch forms. Although FDA estimates that the total time necessary for completion of a 3500A is roughly one hour, the Health Industry Manufacturers Association recently characterized this as a "gross underestimate," contending that completion could take as long as five hours when time to compile the required information for the form is considered.
Although many manufacturers may no longer need to fill out the 3500A, a complete investigation, including maintaining a separate file and performing necessary follow-up and analysis of the malfunction/failure, will still be expected--and FDA field investigators will probably pay closer attention to these areas in the future.
Manufacturers that are interested in summary reporting are encouraged to contact CDRH's Reporting Systems Monitoring Team, HFZ-533, 1350 Piccard Dr., Rockville, MD 20850.
After simmering in the background of industry-FDA relations for years, the issue of reusing single-use devices has finally boiled over. HIMA filed a petition in September asking FDA to regulate the reuse industry and subject it to good manufacturing practices. The number of commercial third-party reprocessors of single-use devices has risen from a mere handful to about 15 in recent years, HIMA says, and each second and subsequent sale of a manufacturer-designated single-use device represents a lost sale to the manufacturer.
One indication of this new industry's growth is the burgeoning sales to hospitals of a $395 book, Reuse of Single-Use Medical DevicesMaking Informed Decisions, published by ECRI (Plymouth Meeting, PA). This comprehensive guide describes the operational, ethical, legal, regulatory, and financial issues surrounding device reuse and names specific devices that can be reworked in-house or by third-party commercial reprocessors. ECRI says the book is intended to be an objective aid, mainly for hospitals, and the publisher takes no position, pro or con, on device reuse.
Although HIMA says it doesn't know whether or not reworked single-use devices are inferior, it contends that they present potential product liability issues for their original manufacturers. Only some reprocessors have promised to carry liability.
A phantom is haunting the orthopedic device worldFDA's alleged two-year rule for clinical follow-up data supporting a premarket approval (PMA) application. The rule doesn't really exist, making it difficult for a company with an approved device on the market to use it to keep out a competitor.
Nevertheless, United States Surgical Corp., maker of the Ray Threaded Fusion Cage (RTFC) spinal implant, has filed a citizen petition with FDA that cites the two-year rule as a reason the agency should not approve rival Sofamor Danek's Threaded Interbody Fusion Device (TIFD), currently pending in CDRH's Office of Device Evaluation (ODE). Presumably, the TIFD PMA application presents less than two years of follow-up data. In a formal response to the petition, Sofamor Danek contended that there is no two-year rule and that FDA should not allow a competitor's petition to influence its review of the TIFD data.
In a conversation that did not mention the petition, ODE director Susan Alpert confirmed that there is no two-year rule. Instead, there is simply a perception in the orthopedic community that two years of follow-up data are desirable, especially for spinal fusion devices.
U.S. Surgical's petition draws heavily on comments by members of FDA's Orthopedic and Rehabilitation Devices Advisory Committee to document the importance of having a minimum of two years' follow-up data. The petition also quotes a June 17 telephone conversation between the company's attorney, James Phelps, and ODE Orthopedics Branch chief Mark Melkerson, who "emphasized that FDA will not modify the two-year rule without first resorting to the panel."
Sofamor Danek chairman and CEO Ron Pickard urged FDA to reject U.S. Surgical's petition for several reasons: there is "no legal authority for a third party to participate in the review process or to influence the agency's decision making on a particular PMA," there is no two-year rule at FDA, the agency has accepted PMAs for implantable devices with less than two years of follow-up data, and Sofamor Danek's PMA has been filed by the agency. Pickard said "there are alternative means of assuring adequate long-term safety of a device without two-year follow-up" and argued that his studies were "robust" because they used randomized concurrent controls rather than U.S. Surgical's literature and historical controls, with which FDA had found fault.
Former CDRH reviewer Emma Knight, an "individual of interest to the FBI" in its incomplete investigation of Summit Technology's receipt of confidential FDA files at the end of 1995, has a home office with a modem link to FDA's database. House Commerce oversight and investigations subcommittee chairman Joe Barton (RTX) wants to know why. Knight had reviewed the Visx, Inc., excimer laser submission papers that mysteriously arrived in the mail of David Muller, then president of competitor Summit.
Barton wrote Health and Human Services secretary Donna Shalala on July 30 asking for full documentation on the "flexible workplace agreement" effective last April with Knight, who now works in the human tissue program for the Center for Biologics Evaluation and Research. Barton says he is giving the matter top priority.
Knight's Washington lawyer, John Fleder (Olsson, Frank & Weeda, P.C.), says she had a work-at-home arrangement with FDA before the Summit flap, and he believes FDA officials continue to trust her. He declined to say why Knight works at home rather than at FDA but noted that other FDA employees have similar arrangements with the agency and Knight is not getting special treatment.
A study by FDA's Foreign Inspections Working Group has found that the agency's overseas medical device and drug inspections "are hindered by an incomplete list of foreign facilities" that send products to the United States and by the lack of legal authority to compile such a list. That is only one of the internal problems that would be fixed if the Senate's FDA reform bill, now under final bipartisan negotiation, is passed. Anticipating statutory authority, FDA's working group says a comprehensive list of foreign facilities could be incorporated into the agency's new Field Accomplishment and Compliance Tracking System (FACTS), scheduled to go on-line during the 1998 fiscal year.