Most countries have some kind of database for gathering adverse event data for medical devices, but most of these databases are not open to the public. The most common question I am asked is, “How do you access the Eudamed database?” for reporting of adverse events in Europe. Unfortunately, you can’t access Eudamed. The Eudamed database is only available to competent authorities at this time.

The latest update is that manufacturers will be responsible for updating the Eudamed database in the future as part of the new European Regulations. This requirement will be implemented during the next years. The database will also become accessible to the public.

The primary publicly accessible database for adverse event reporting is the US FDA MAUDE database:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm

The MAUDE database is also integrated with other FDA databases for 510k submissions and recalls. This combined database is called the Total Product Life Cycle database:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTPLC/tplc.cfm

The Therapeutic Good Administration (TGA) in Australia makes adverse event data publicly available:

http://apps.tga.gov.au/prod/DEVICES/daen-entry.aspx

The TGA also has a national registry for implanted orthopedic devices that publishes an annual report. There are other countries that also have public registries.

Searching for post-market surveillance data should be performed on a frequency that is risk-based. If you have a brand new device, a high risk device or a device that is implanted; post-market surveillance data should be reviewed frequently–either monthly or quarterly. In fact, the new European guidance document for clinical evaluation reports (MEDDEV 2.7/1 rev 4) requires that clinical evaluation reports be updated at least annually for these devices:

http://ec.europa.eu/DocsRoom/documents/17522/attachments/1/translations/en/renditions/native

It is also important that you collect post-market surveillance data for both your device and competitor products. Therefore, you should be reviewing all the publicly available adverse event databases. You should also be reviewing your own complaint data, and you should be searching for journal articles that may include adverse event data–possibly associated with a clinical study.

If you are interested in the full text of this article and future articles, please visit my blog page:

http://www.medicaldeviceacademy.com/blog/

source: https://www.linkedin.com/groups/2070960/2070960-6232439645834084353