Crimson Audit & Review

Content Audit, Review & Consulting for Medical Device Makers

New Online Service Provides Consumer Access to FDA’s Recall Database

Posted by crimsonlanguage on 2012/01/31

Today, the Wall Street Journal reported on two new websites that provide consumer access to FDA’s drug (AERS) and device (Maude) adverse event reporting databases. The story is here.

The site that reports on device events is Clarimed. According to Clarimed’s founder, Nora Iluri, the site’s purpose is to empower consumers and promote quality-based competition among manufacturers.

Although this information is interesting, I have my doubts about it’s ultimate usefulness in the device arena. Unlike drugs, physicians often have the ultimate say-so about which device they are using…my hip replacement is a Stryker because that’s what my doctor uses and was trained on…consumer preference is a secondary consideration. Will consumers start educating themselves about scalpels and IV pumps? Even if they did, would they be able to influence what gets used? That decision is largely in the hands of the hospital purchasing department. While some device decisions may be open to consumer input (e.g. hip, heart valve, pacemaker), the large majority are going to be beyond the patient’s immediate control. However, the launch of websites like Clarimed are interesting because they illustrate the democratization of information on the web…and a growing consumer awareness of the risks associated with medicines and medical devices.

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