Congress weighs value of expedited approval process for medical devices

Medical device manufacturers are hoping lawmakers sympathize with them and their efforts to put much-needed medical devices on the market sooner for patients in need, rather than with consumer groups who say the approval process for moderate-risk medical devices is flawed and dangerous, and allows products onto the market before they have been proved safe and effective.

The $350 million medical device industry spent a whopping $33 million last year and used 225 lobbyists in an effort to sway federal decision makers in their favor despite records from the Food and Drug Administration (FDA) that show that nearly 5,000 deaths in 2009 were linked to medical devices.

Moderate-risk medical devices, which include products like transvaginal mesh and artificial hips, currently are approved by the FDA through an expedited process that allows them to be cleared without clinical testing if similar products are already on the market. This, consumer advocates say, is a public hazard.

One stellar example of how this process is flawed is the DePuy ASR XL hip replacement and resurfacing systems. The artificial hip, made by Johnson & Johnson subsidiary DePuy Orthopaedics, passed seamlessly through the FDA approval process, but once it hit the market, problems began to arise. The metal-on-metal devices were failing at a higher than expected rate, and were also linked to a type of blood poisoning from heavy metals seeping into patients’ bloodstreams. DePuy had no choice but to recall the devices, affecting nearly 93,000 people worldwide.

Consumer advocates allege that many problems Americans are facing with their faulty medical devices could have been averted if only the federal government had a more efficient way of approving the medical devices. The FDA has proposed raising its fees to medical device manufacturers in order to hire an additional 200 employees over the next five years to help strengthen its oversight for medical devices.

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