Medical Safety Databases and their Use in a Clinical Evaluation Report:
As part of the Clinical Evaluation process for a medical device, manufacturers are required to analyze broadly 2 types of data. One, which is held by the manufacturer, and another one which comes from various external sources, including published scientific literature, which can often form the bulk of this dataset. Apart from literature data, several publicly accessible Medical Device Safety Databases are available which can provide valuable post-market data to monitor device safety and performance.
Defined as a part of a medical device manufacturer’s Post Market Surveillance (PMS) plan, complaints with incidents where the device malfunctioned or caused a death or serious injury are to be reported to the country’s regulatory authority, along with any device recalls or safety notices published by the manufacturer. These then subsequently get published on country-specific medical device safety databases as Reports, Recalls, Safety Alerts or Field Safety Notices. In the United States, the regulatory authority Food and Drug Administration (FDA) maintains several Medical Device Databases. The Manufacturer and User Facility Device Experience (MAUDE), Total Product Life Cycle (TPLC), and the FDA Recall databases are some sources to dip into when finding external PMS data on your device. In this post we’ll discuss the our FDA MAUDE / TPLC Integration and how you can benefit from it.
The FDA MAUDE database contains reports of adverse events involving medical devices marketed in the United States. The data consists of all voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. Incidents in these reports may describe suspected device-associated deaths, serious injuries, and device malfunctions, with a wide range of causes (e.g., from manufacturing to usability issues).
Data can be extracted from MAUDE by three methods:
- Using the Simple Search to search by single words or phrases
- Using the Advanced Search to search by Brand Name, Manufacturer, Event Type, 510K Number, PMA Number, Product Code, or date, or
- Downloading the data and conducting a manual search