AdvaMed Fights Back Against Increased FDA Scrutiny

A report issued Wednesday by the industry's main trade association Advanced Medical Technology Association (AdvaMed) "found that there were 101 of the most serious kinds of recalls of medical devices from Jan. 1, 2005 to May 1, 2010, a record that AdvaMed senior executive vice president David Nexon called 'remarkable' considering the number of devices on the market," CQ HealthBeat reports.

But "[c]onsumer advocacy groups disagreed. ... The release of the report comes in the midst of a battle between the FDA and the industry over changes to the process used to determine whether a device can be sold in the United States. Most medical devices are currently approved through the 510(k) process, a type of regulatory approval process that allows a company to often avoid clinical trials if it can show that its product is similar to one already being sold." (Adams, 9/15).

The Hill: "The FDA is currently debating more than 70 changes to the 510(k) process amid concerns that approval rules are too lax, and will be gathering public input through Oct. 4. AdvaMed supports some changes to the program, such as increased reviewer training, development of additional guidance, and greater communication of reviewer decision rationale to prevent delays and inconsistencies in the program. But the industry argues that the basic expedited review process is sound and should be preserved to help American products get to market quickly and efficiently" (Pecquet, 9/15).

Meanwhile, General Electric Co "is turning its attention to a seemingly simple problem that costs the U.S. healthcare system $10 billion to $15 billion per year -- making sure that physicians and nurses wash their hands," Reuters reports. "That's one of the first things the company's forthcoming 'Smart Patient Rooms' system is intended to track." The new system "relies on technology GE developed for security services, initially to provide automated scanning of large crowds in public places for signs of unusual activity. It can also track how frequently doctors and nurses check in on patients in their hospital beds" (Malone, 9/15).

The Connecticut Mirror reports that doctors in the state are lagging behind in adapting electronic record-keeping. "Among state doctors, 25.8 percent used electronic medical records, and less than a quarter prescribed drugs electronically, according to a 2008 survey by the Connecticut State Medical Society. In a national survey conducted the same year by the National Center for Health Statistics, 41.5 percent of doctors reported using electronic medical records in their office-based practices. Connecticut hospitals fared better. According to a recent study, less than 12 percent of U.S. hospitals used either basic or comprehensive electronic health record systems to track patients in 2009. In Connecticut, 7 of the 28 hospitals that responded to the survey [25 percent] reported using basic or comprehensive systems" (Becker and Shesgreen, 9/15).

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