Sermo And FDA Collaboration Brings Real-Time Physician Feedback To Medical Device Safety

Main Category: Public Health
Also Included In: Primary Care / General Practice
Article Date: 24 Oct 2008 - 3:00 PDT

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Sermo, the largest physician-only online community, today released survey results of a collaboration with the Food and Drug Administration (FDA) that offers candid feedback from physicians regarding recent headline-grabbing news, including toxins in plastic products and post-surgical metal remnant leftovers.

Sermo collaborated with the U.S. Food and Drug Administration (FDA) for a successful six-month evaluation by the Center for Devices and Radiologic Health (CDRH). The recently concluded FDA/CDRH relationship included both observational monitoring of physician discussions on Sermo, as well as proactive engagement of physicians to gain insights and observations on clinical practices involving medical device safety and efficacy.

The FDA typically relies on reporters such as physicians, medical manufacturers, hospital risk managers, pharmacists and patients to relay information surrounding adverse events. The accurate collection of adverse event data is an important way for FDA to monitor for any potential problems related to a drug or device. Due to the time and paperwork required, physicians are less likely to report these events to FDA. Accordingly, physicians submit about 3% of adverse event reports to FDA. Sermo helps solves this by providing a platform where physicians anonymously exchange observations with their peers, often in minutes. This real-time interaction means that observations and consensus around important medical topics and trends can be formed quickly by large numbers of physicians. For FDA, this means that thousands of physicians can respond directly to their inquiries in a matter of hours.

One study on Sermo was prompted by numerous healthcare groups - including the American Medical Association and the American Nurses Association - calling for FDA to act on a 2002 warning about widespread presence of a toxic chemical in medical devices made of polyvinyl chloride (PVC). The groups called for mandatory labeling of such devices, and FDA turned to the Sermo physician community for feedback. The chemical in question, di-2-ethylhexyl phthalate (DEHP) is used as a plasticizer of PVC in numerous products including IV bags and tubing for medical procedures. Without DEHP in the plastic, these devices would be hard and brittle, and therefore useless for medical purposes.

The overwhelming response from physicians on Sermo was that more data was needed to show evidence that potential harm outweighs the benefits doctors receive from these products. Physicians on Sermo also pointed out that these plastics often come into contact with patients for only a very short time, and until an alternate product - and an affordable one at that - becomes available, physicians should continue their use of these products without fear of potential harm. Not to mention, merely labeling the products achieves very little since doctors are not typically the ones deciding what hospitals purchase.

-- Within days of posting on Sermo, over 1,000 physicians responded with comments related to their experiences with PVC-plastizers in their own practice.

-- Of the physicians responding to the related question, 85% stated they were previously aware of the 2002 FDA Public Health Notification concerning PVC devices containing the plasticizer DEHP.

-- Of the physicians responding to the related question, 10% stated that their practice or hospital monitors and/or tracks the amount of DEHP a patient is exposed to and have established a "safe" DEHP limit.

-- Of the physicians responding to the related question, 10% stated that their practice or hospital has established a "safe" DEHP limit.

Another standout finding ended with FDA/CDRH issuing a public health notice earlier this year regarding failures to retrieve medical device fragments. FDA advised healthcare practitioners on associated adverse events, and provided recommendations to mitigate them. According to CDRH, nearly 1,000 adverse events are reported each year related to unretrieved post-surgical device fragments.

To inform its position, FDA/CDRH turned to Sermo's community to learn more about how often patients are told about retained metal devices/fragments, particularly when it may be important for the patient to inform future practitioners of the presence of the device, such as during an MRI procedure. From its survey to the Sermo community, FDA/CDRH was able to determine that of the nearly 300 physicians polled:

-- 38% were not aware of all the risks associated with unretrieved medical device fragments.

-- 61% say they always tell patients when they think fragments may have been left behind.

-- Just over 50% of physicians say they explain to patients their need to report the possible fragment leftovers during other medical exams.

-- 63% of physicians document information about fragments in patient medical records.

"Sermo's unique platform brings 90,000 physicians together to exchange the latest in medical thinking anonymously, and represents a new and intriguing model for FDA," said Daniel Palestrant, CEO and Founder, Sermo. "For the first time, FDA can access physicians' perspective on critical medical issues and collect data in hours - not days or months - that help shape public guidance on important healthcare issues."

About Sermo

Sermo is where 90,000 US physicians collaborate on difficult cases, share clinical observations and work together to achieve far more than they could individually. Sermo's technology harnesses this collective insight for healthcare institutions, financial services firms and government agencies. This creates a two-sided marketplace for information exchange. Physicians on Sermo gain a unified voice that allows them to influence healthcare policy. Sermo's clients gain direct access to a fresh stream of actionable information on emerging medical trends - to physicians on the frontlines who put drugs, devices and treatments to the test every day. For more information, visit www.sermo.com