In the wake of several high profile, device-related public health disasters–such as faulty surgical mesh that rips into women’s organs, metal-on metal hips that seep cobalt poisoning into people’s bloodstreams, and cardiac defibrillators that unnecessarily shock patients—we need Congress to make some common sense changes to the device regulatory system to ensure the safety of medical devices and protect the public health. Unfortunately, the medical device industry has been pressuring Congress to get the medical device user fee package passed as soon as possible, even though both bills do not address one glaring safety problem with the way most medical devices are approved by FDA.

Currently, over 90% of device applications are OK’d for sale through a “fast track” that does not require the companies to show that the devices have been clinically tested for safety. As long as they show that this new device is similar to one already on the market, the FDA has to “clear” it for sale – this is even the requirement when the old device has been recalled for safety reasons. The FDA can’t even ask the device maker if its new device has fixed the flaws of the recalled device to which it compares itself. The device industry says it is “unnecessary” to change this FDA approval process but we say that is not the case. The industry has been misleading Congress on this issue.

What: Twitter chat on medical device safety

Host: Consumers Union’s Safe Patient Project [@CUsafepatient]

When: Thursday, May 17, 1-2pm EST / 12-1pm CST / 10am-12pm PST

Where: Twitter (hashtag #sppchat)

Consumers Union’s Safe Patient Project has been working to protect consumers from legislative changes that would weaken the current system to give medical device manufacturers more leeway to push potentially unsafe devices on the market. Check out our first Twitter chat transcript on medical devices here.

May 7, 2012

Dear Chairman Pitts and Ranking Member Pallone:

As you get set to mark-up the Medical Device User Fee Act (MDUFA) reauthorization bill, I urge you to keep consumer safety issues in mind.   In the wake of several high profile, device-related public health disasters–such as faulty surgical mesh, metal-on metal hips, and cardiac defibrillators—it is incumbent upon Congress to make some common sense changes to the device regulatory system to ensure the safety of medical devices and protect the public health.

While the Health Subcommittee bill has improved over the previous discussion draft, it fails to address the underlying foundation of the current system for reviewing new medical devices that continues to put patients at risk by allowing too many high-risk devices to be cleared without clinical testing for safety. Further, it fails to create an effective system to monitor devices and notify patients and doctors when there is are safety problems.

Congress is out of step with the public on a number of key issues of medical device safety. A recent national poll by Consumer Reports shows that consumers overwhelmingly support common sense measures that would improve the safety and efficacy of the device regulatory system. Eighty-two percent of the poll respondents believe that preventing safety problems is more important than limiting safety testing in order to prevent delays and encourage innovation. Ninety-one percent believe that each implant should be safety tested before being sold even when similar implants were in use — 68 percent of them thought they “definitely should” be safety tested.

We offer the following specific comments regarding the current House subcommittee bill:

• The bill continues to allow new devices to be cleared for sale based on their similarity to a predicate that has been recalled for safety reasons and even fails to require manufacturers of new devices to show how they have fixed the flaw present in a predicate device that has been recalled for safety reasons. FDA should have the authority to deny 510(k) clearance when predicates have been recalled for safety reasons or if the safety flaw is not corrected.
• The bill does not streamline the FDA’s ability to upclassify devices, as is done in the Senate bill, in order to require more thorough review of high-risk devices through the premarket approval process.
• While the bill maintains important disclosure requirements for FDA advisory panelists, it removes key protections against conflicted experts such as the directive to the Secretary to try to find non-conflicted experts and removes caps on the number of conflicted experts allowed on panels.
• The bill has been improved to expand the Sentinel program to include medical devices and creates a timeline for the promulgation of a final guidance on the Unique Device Identifier system that was created five years ago. However, Congress should adopt language in the Senate draft, which would create an implementation timeline so UDIs for devices that are implantable, life sustaining or high risk are in place quickly.

Consumers Union, the advocacy arm of Consumer Reports, looks forward to working with you to improve patient safety as the reauthorization process moves forward.

Sincerely,

Lisa McGiffert

Director, Safe Patient Project

Consumers Union

lmcgiffert@consumer.org