Devices found to be problematic in another country are occasionally still approved for use in the United States by the U.S. Food and Drug Administration (FDA), according to a November 27, 2018, article from NBC News. The problem highlights a "chaotic global system that too often leaves physicians without essential safety information that is readily available in a nearby country," the authors said. NBC found at least five devices that have had safety warnings issued by other countries and yet not from the FDA. The devices included a knee implant that had a high failure rate; a pregnancy test prone to false results; and dental drills that could cause nerve damage. The authors found further instances in which FDA's warnings came months after those issued by other countries. The article detailed specific cases of patients who had received devices in the United States after they had been banned in other countries. Included among these devices was a metal-on-metal hip implant that currently has about 400 pending lawsuits, including one from former Olympic gymnast Mary Lou Retton, who at one point was a spokesperson for the product. During the extensive litigation process, the authors said, it was unclear why the device maker had not recalled its product in the United States. According to one patient's attorney, "it's because no one was forcing them."

HRC Recommends: The vast array and complexity of medical devices available to clinicians allow for greater treatment options, but use of medical devices is never without risk. Every year, FDA receives hundreds of thousands of reports concerning suspected device-associated deaths, serious injuries, and malfunctions. By the time a manufacturer voluntarily recalls a device or FDA acts to remove a device from the market, many patients may have suffered injuries. Patients injured by medical devices may sue manufacturers and healthcare providers who supplied and used the devices. Manufacturers are typically sued under a theory of strict product liability; physicians who may be codefendants in these cases risk liability for negligence or lack of informed consent. A few courts have broken with traditional jurisprudence, finding that hospitals may be considered distributors or suppliers of medical devices. Risk managers should ensure that staff are educated about FDA's reporting requirements, encourage voluntary reporting to the agency, and ensure that an effective system is in place to manage product alerts and recalls.