When a new medical device hits the market, there’s typically still some uncertainty about whether it works.
Device makers generally do not have to submit as much, or as rigorous, clinical data to the Food and Drug Administration as their biotech counterparts. Once FDA regulators decide a device is safe and effective, companies and researchers then attempt to track how the device performs in the real world.
But tracking devices is tricky. The FDA requires that manufacturers tag each of its devices with a unique code, or identification number, but the Centers for Medicare and Medicaid Services and insurance companies do not require that physicians mark these numbers on reimbursement forms. This makes it incredibly difficult for researchers to observe device performance trends in claims data, and for hospitals to reach out to patients when specific devices are recalled. Because of this, comprehensive medical device databases are rare.
Click this link for the original source of this article.
Author: Lizzy Lawrence
This content is courtesy of, and owned and copyrighted by, https://www.statnews.com and its author. This content is made available by use of the public RSS feed offered by the host site and is used for educational purposes only. If you are the author or represent the host site and would like this content removed now and in the future, please contact USSANews.com using the email address in the Contact page found in the website menu.