With Medical Devices, minimizing risk for users and improving product safety and usability is paramount. The new AAMI TIR50, “Post-market surveillance of use error management,” is geared to help anyone involved in the MedDev space learn how to best collect, review and act on post-market use error data to improve their products or processes. It helps the reader develop a process for handling complaints based on usage errors of any kind. Since these types of problems aren’t necessarily covered by regulatory requirements, this presents an opportunity for companies to improve customer satisfaction both short and long term.
What caused the interest in producing such a standard? The FDA gets about 100,000 Medical Device Reports (MDR) annually. Of those, one-third mention “error” in the filing. Currently, there’s no clear data on what exactly all those “errors” are. They may be user error of course. But they might also stem from inadequate instructions or unclear markings on the devices themselves. And AAMI was also concerned that there may be under-reporting issues due to the natural tendency to avoid a situation in which the party doing the reporting might risk being blamed in “near-miss” situations.
The Technical Information Report 50 guides you, the user, in developing a protocol and system for capturing use errors. It describes process flow, training and scalability for your data capture and analysis efforts, including sample questions you might include in your database.
Interestingly enough, the Report approaches this issue from two distinct viewpoints — that of the manufacturer and that of the user. This means that a clinician can find this document has helpful as a medical device manufacturer. Why would the authors want to include both audiences? Certainly both groups have a vested interested in assuring the proper use of medical devices, and in improving both processes and products to facilitate that goal. So Section 7 of the document provides process recommendations for manufacturers while Section 8 covers the topic from the clinical perspective.
The document has 2 Annexes as well. One covers suggested questions as I noted above. The other has information that will help a manufacturer link customer complaints to usage errors. This is intended to be part of your Usability Engineering effort, perhaps when designing a second generation product, or to forecast potential issues when designing a new product. The Report is completed by a bibliography containing 19 citations to provide further reading on this topic.
Of course, you’ll need to get a copy of the new TIR50. You can go to Document Center’s webstore, www.document-center.com, and order it in either paper format or for pdf download. Or you can contact our staff by phone (650-591-7600), fax (650-591-7617) or email (firstname.lastname@example.org). AAMI is an important contributor to the medical device standardization effort and Document Center is proud to be an authorized distributor of the AAMI publications.