Key words: biomaterials, database, Compendium, medical devices, tech support, research
The Beta test of the compendium data collection software is in progress. Beta Software was sent to 62 manufacturers with the expectation that over 100 records of previously approved devices representing different biomaterials would be completed by the end of March. To date, one response has been received from a manufacturer. OST participated in a series of meetings on the Compendium on March 19-20, 1997, in Memphis, Tennessee, where concerns of the industry were voiced and discussed. Follow-up correspondence was sent to the 62 companies in early April 1997 to encourage greater response. Through this effort, there have been only three additional replies. In addition, OST has entered into discussions with DCRND to have a reviewer extract materials data for previously reviewed PMAs and to use the biomaterials data sheet format to obtain pre-PMA and pre-IDE data on new products. Further, OST has worked with the American Chemical Society (ACS) to obtain a cross-reference listing of CAS (Chemical Abstract Service) numbers to the generic materials listed in the Compendium. A cross-reference list of ASTM and ISO standards to the listed materials is also being generated. Both of these lists will be made available to the review staff through the CDRH MIS system.
During the past year, the Biomaterials Compendium was used to help catalog medical products, including foods, drugs, biologics, and veterinary products regulated by FDA that are derived from a bovine source. This effort was in response to concerns that BSE (Mad Cow) disease might be transmitted to humans through these products. The utility of the Biomaterials Compendium database was such that CVM and CBER are also interested in using it.
Progress is well underway to have the Compendium posted on the Intranet. A query program has been written which will search the database. At present, the BSE database of 260 records is being used as the prototype. A revision of the datasheet program is being done by CB Tech. The system will be built so as to be posted on the Internet.