A recent spate of infections caused by defective medical scopes has led U.S. lawmakers, federal officials, and experts in health policy to tackle a complex question: how can medical devices be regulated more effectively in order to prevent serious harm?
Leaders in all three areas agree that the Food and Drug Administration (FDA)’s current procedures for medical devices aren’t enough to protect public health, according to a recent CNN article. But opinions are split on how to best solve the problem or even where to start.
The FDA’s current system relies on manufacturers to demonstrate that a new medical device is “substantially similar” to an existing device to justify allowing the new device to enter the market with less testing. An updated set of procedures would likely focus on increasing scrutiny before a new device goes to market and on shortening the time between when an injury occurs and when the FDA notifies the public and responds to prevent similar harm to future patients.
But changes to the FDA’s policies and procedures face an uphill battle. Partisan divides in Congress, the need for more government funding, and the time required to create a workable plan and put it in place all weigh against prompt changes from the agency.
In the meantime, however, patients may suffer. Infections caused by defective duodenoscopes that could not be properly cleaned led to at least 19 outbreaks of treatment-resistant bacterial infections that harmed nearly 200 patients in recent years. The scopes had been placed on the market without thorough testing by the FDA, which might have caught the problem before anyone was harmed. (Learn more: Patients Suffer Serious Infections from Defective Scopes.)
Call our Washington D.C. personal injury attorneys for insight into your possible case.