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Consumers Union Urges Congress to Strengthen Medical Device Oversight
Date:11/15/2011

. For example, the standards for the fuller pre-market approval of devices that require clinical trials are weaker than are used for drug approval. Drugs must show substantial evidence of safety and effectiveness where devices must merely show reasonable assurance of safety and efficacy. 

Furthermore, more than 90 percent of devices are cleared through the 510(k) process, a process that does not require clinical trials but merely a showing that the new device is similar to an existing one called a predicate.  The predicate device upon which a device is cleared may never have been through a clinical trial.  Devices may vary quite considerably from the initial predicate, as each newer model with modifications from the initial predicate can then become the predicate for subsequent models. Once a predicate device has been removed from the market, it is not necessarily removed as a predicate, and subsequent devices approved based on that removed predicate are not automatically reviewed or removed from the market.

Recent high-profile device failures such as those that occurred with metal-on-metal hip implants and surgical mesh-devices that were approved through the 510(k) process- illustrate that lax approval standards for devices are allowing faulty high risk devices to make it to market, where they have caused considerable harm to patients and cost to the health care system. When an implanted device is recalled or removed from the market, patients cannot simply stop using them. Removal of the device requires surgery, sometimes multiple surgeries, and it may take months or years to repair the damage done by the device.  Some patients are permanently disabled or die due to complications from a device.

Below are Consumers Union's recommendations for Congress to improve the safety and effectiveness of devices for consumers:

Improve the pre-market approval process by:

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SOURCE Consumers Union
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