In many cases, that might simply mean good feedback so they can improve their systems. A published list of previously reported device problems in FDA's database, Gardner says, would enable facilities to benchmark their own experiences. Newsletters could discuss important medical device issues. And strategies could be suggested to avoid potential pitfalls in using a medical device. With devices, more than with drugs, it can be difficult to determine if an adverse event was a preventable error or an unexpected reaction, Gardner says.
Devices sometimes require specific knowledge and training to use the product correctly.
In the agency's Center for Biologics Evaluation and Research, the lack of reporting is characterized by consumer safety officer Sharon O'Callaghan as one of the biggest problems where medical errors are concerned. She says that while manufacturers of biological products, such as blood components and vaccines, must report to FDA certain errors that occur during manufacturing, companies are not sufficiently aware of reporting requirements. For biological products, manufacturing errors can lead to mistakes in treatment that are potentially serious and even deadly. In blood banks, for example, a blood product that is mislabeled can present a serious threat to a patient if the wrong type of blood is transfused. We want to increase reporting so we can assess what's happening in the industry.