Healthcare supply-chain experts said they are troubled by two government reports showing the Food and Drug Administration is unable to properly inspect and monitor medical-device manufacturers, but most experts are uncertain what, if anything, group purchasing organizations and supply-chain associations can do to press federal officials to address the problems.
According to a November 2007 FDA Subcommittee on Science and Technology report and congressional testimony given last week by Government Accountability Office Healthcare Director Marcia Crosse, staff shortages and antiquated technology are making it impossible for the FDA to meet its mandate to inspect medical-device manufacturers every two years. Under the current system, FDA officials are only able to inspect domestic manufacturers of high-risk devices, such as coronary stents and pacemakers, every three years and medium-risk devices, such as catheters and intravenous needles, every five years. The frequency is worse for foreign manufacturers shipping medical products to the U.S. Those facilities are inspected every six years for high-risk devices and 27 years for medium-risk ones.
When you read (the reports), its pretty alarming, said Blair Childs, spokesman for GPO Premier. I think hospitals are going to be very anxious to see the government take action here.
The revelationspart of two broad reviews detailing funding problems and a subsequent erosion of the FDAs ability to guarantee safety of the U.S. medical-device, pharmaceutical and food-supply chainshave prompted at least two lawmakers to call for greater funding of the agency (See story below).
While news of the FDAs troubles is still making its way to supply-chain professionalsmany of the GPOs and hospitals called by Modern Healthcare said they were unprepared to comment for this storythose familiar with the seriousness of the inspection gaps feel there is little hospitals and the purchasing industry can do to effect quick improvement.
I dont think that we have any control (over the improvement process), said Jean Sargent, director of materials management for University of Kentucky HealthCare and immediate past president of the Association for Healthcare Resources and Materials Management, an organization representing hospital supply-chain managers. Its a government agency, and it seems that the two areas causing the problems are the lack of staff and outdated technology, and those are things that even if theyre addressed today, it would take two years to see any effects.
Regine Honore, corporate director of supply-chain management for Cooper University Hospital, Camden, N.J., said she hopes the findings will spur action by lawmakers. I hope with this report the FDA is able to reprioritize and make changes, she said.
Curtis Rooney, president of the Health Industry Group Purchasing Association, a GPO lobby group, agreed that the materials-management industry is currently in a precarious wait-and-see position, and he expressed concern over what the FDAs current condition could mean for hospitals. I think the FDA (subcommittee) report is telling, and its a concern because patient safety should always be a priority.
Indeed, the safety of imported medical devices is a particular area of concern, according to the FDA science subcommittee and GAO reports (See table).
The FDA faces challenges in managing its inspections of foreign medical-device establishments, noted the GAO in its assessment of the agency. Two databases that provide (the) FDA with information about foreign medical-device establishments and the products they manufacture for the U.S. market contain inaccuracies that create disparate estimates of establishments subject to FDA inspection.
The science subcommittees report acknowledged that, among other challenges facing the agency, the FDAs imported-products computer system cannot communicate with customs and other government agencies, and it often misses significant product arrivals because it cannot distinguish between such items as table salt and road salt.
The two reports come at a time when many in the healthcare industry believe concerns over medical-device quality are increasing exponentially with swift globalization of manufacturing. For example, cardiac-device makers Boston Scientific Corp. and Medtronic have each grappled with defective implantable defibrillators that caused life-threatening problems for patients.
While its unknown how many, if any, of the defibrillators were manufactured overseas, Boston Scientific manufactures in 45 countries and Medtronic in 14 countries. Companies often manufacture various parts of a single device in different countries. The FDAs inability to monitor and inspect such globalized production practices is at the heart of concerns highlighted by the FDA subcommittee and GAO reports.