Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 87

This is the center that deals with medical devices and radiologic agents. There are three sections in the CDRH website that are worth examining.

The first is the Medical Device Safety section, which covers alerts and notices, recalls, and emergencies. There is a large section on Medical Device Reporting (MDR) of adverse events from manufacturers, importers, and user facilities (e.g., hospitals, nursing homes). Consumer and healthcare professionals report via MedWatch (as with biologics and drugs) using either the 3500- or 3500B-voluntary reporting form. With the introduction of electronic reporting, eMDR was launched and mandatory reports must be sent to eMDR according to CDRH technical specifications.

The second is the Device Advice: Regulations & Guidance section. This is a very useful section that explains the regulations on marketing, standards, guidance, compliance, and post-market requirements. Note that the entire process of approval, marketing, and safety for devices is markedly different from the processes for drugs and biologics.

The third is the section on medical device databases. There are several, but the key one for safety is MAUDE (Manufacturer and User Facility Device Experience). This database contains AE reports involving medical devices. It contains data submitted by mandatory reporters (manufacturers, importers, and device user facilities) and voluntary reporters (healthcare professional, patients, and consumers). Data goes back to 1991 for device user facilities, to 1993 for distributor reports, and to 1996 for manufacturer reports. It is online and searchable by product problem, product, class, manufacturer, event type (death, injury, malfunction, other), brand name, registration number, and time frame. The focus is on medical devices which may have malfunctioned or caused a death or serious injury.

Some of the MAUDE data are downloadable. These files consist of voluntary reports since mid-1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since mid-1996. The searchable portion of the data contains records for the most recent 10 years and is refreshed weekly. Note that MAUDE may not include reports made under waivers, exemptions, variances, or alternative reporting requirements. There also is a separate database for pre-1996 reports from manufacturers. A detailed review of medical device safety or drug-device combination products is not in the scope of this manual.