The Manufacturer and User Facility Device Experience Database (MAUDE), which contains information about medical devices that have caused problems for patients, has a number of interesting facets - particularly for reporters on the health beat.
MAUDE replaced the older MDR (Medical Device Reporting) dataset, which did not require user facilities to report their information about defective medical devices. NICAR recently updated this dataset and now has data from August 1996 through March 1999, which includes voluntary reports, user facility reports, distributor and manufacturer reports.
Some of the fields included in the database:
The problem with the device. The outcome of the event (patient injury, death, etc.). The brand name and type of device, its age, expiration date and shelf life. Name and addresses for the device manufacturer and distributor. The location the incident occurred (patient's home, health clinic, etc.).
In 1992, U.S. News and World Report did a story on dangerous implants (breast, penile, testicular) and other medical devices of concern to the FDA. The MAUDE dataset can provide information for similar stories - although no identifying patient information is included, the frequencies of device failure and resulting injury offer a good starting point. Which manufacturers produce the highest number of defective devices could prove to be another interesting topic. Old or expired devices, particularly when compared with the dates that authorities became aware of the problem, may be worth looking into, as well. Because the format has changed, NICAR is providing the 1996-1998 data and the older information separately. Costs for the 1996-1998 MAUDE is $100 for under 50,000 circulation (50-200 market), $125 for 50-100,000 circulation (25-50 market) and $150 for above 100,000. The older MDR data, 1984-1995, is $75, $100 and $125 respectively. To order this dataset or others available from NICAR, call (573) 884-7711. Jessica Larson can be reached by e-mail at jessica@nicar.org