Devices & Diagnostics

Device makers prepare for FDA changes: MedCity Morning Read, Feb. 18, 2010

The U.S. Food and Drug Administration is holding an all-day public meeting today with medical device companies, clinicians and consumer advocates. While no big changes are expected for years, the meeting could help lay the groundwork for big changes to the 510(k) process by which devices are approved by the federal government.

By Brandon Glenn on February 18, 2010
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Highlights of the important and the interesting from the world of health care:

A new world on the way for device makers? The U.S. Food and Drug Administration is holding an all-day public meeting today with medical device companies, clinicians and consumer advocates. While no big changes are expected for years, the meeting could help lay the groundwork for big changes to the 510(k) process by which devices are approved by the federal government. Device companies love (or should, at least) the process because it allows for quick and cheap regulatory approval. Here’s how it works: Manufacturers claim that their new device is similar to something that’s already on the market and they’re absolved of the more lengthy and detailed tests required for novel devices. The effects of that system aren’t tough to predict and are borne out in the numbers: About 3,500 devices are cleared every year under the 510(k) system compared with about 50 under the more stringent system, the AP reports.

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That wasn’t the plan when the government began regulating devices in 1976, Minyanville reports. The industry, sensing that stronger regulations are on the way, has proposed some changes, including more detailed safety standards for devices with higher risks. That’s certainly a smart strategy from the device industry: Try to head off any big changes while prescribing small changes of its own all the while projecting a public face of “Nothing to see here!” The question is whether the FDA will demand more, which is likely, and whether the new regulations get watered down by Congressional leaders taking campaign contributions from the industry, which is also likely.

15 key issues facing hospitals: Hospital Review lists 15 factors affecting the long-term outlook for hospitals. At No. 1 on the list is a big effect of the health reform’s failure–hospitals can no longer expect a big influx of paying patients. Other trends include a loss of negotiating strength to insurers, overcapacity of beds in some affluent areas, and more patients switching to high-deductible plans. Perhaps most surprising is No. 15:  Now is a great time to build new facilities with plenty of discounts available due to low demand for construction, materials and contractors.

How healthy is your county? The Robert Wood Johnson Foundation’s county health rankings have been attracting plenty of attention, so check yours out at the above link if you haven’t yet. No shocker here from the press release about why some counties are healthier than others: “The Rankings show that people who live in healthier counties tend to have higher education levels, are more likely to be employed, have access to more health care providers, and have more access to healthier foods, parks and recreational facilities.”

“An unconscionable abdication of responsibility:” The American College of Physicians’ blog features a strongly worded post on the state of America’s health system and our inability to save ourselves from it. The ACP’s president says the U.S. health system is “in decline” and failure to reform the system amounts to “unconscionable abdication of responsibility” by our elected officials. ACP paints a scary economic picture of America’s future without reform: “huge payroll tax increases, cuts in Medicare benefits and eligibility, and reduced payments to physicians and hospitals.”