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.)
Washington D.C. personal injury attorneys for insight into your possible case.