A Medical Device Daily

Scientists at FDA who are unhappy with the review mechanism at the Center for Device and Radiological Health (CDRH) have inked another letter to make known their complaints about the product review process, but as was the case with a a letter dated Oct. 14, 2008, addressed to Rep. John Dingell (D-Michigan), allegations of reprisals were not accompanied by specific complaints of dismissal, demotions or other forms of retribution

In this latest letter to the federal government, the signers alleged that "the scientific review process for medical devices ... has been corrupted and distorted by current FDA managers, thereby placing the American people at risk," according to wire service reports. The Jan. 7 letter also alleges that "managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid."

The Associated Press report quotes FDA spokeswoman Judy Leon as saying that the agency is "is actively engaged in a process to explore the staff members' concerns and take appropriate action" in addition to corresponding with the incoming Obama administration on the matter.

The letter to Dingell, who chaired the House Energy and Commerce Committee until being overthrown by Henry Waxman (D-California) late last year, also alleged that upper level staff at CDRH have "corrupted the scientific review of medical devices."

The AP story indicates that the latest letter took issue with computer-aided detection used in mammography as an example of an application that should not have won approval, citing false positives that were said to have led to needless breast biopsies. The Obama team has offered no comment on the matter.

FDA eyes class II for tissue expanders

An advisory committee recommended in 2005 that CDRH reclassify tissue expanders from class III devices, which require a PMA, to class II devices, needing only a 510(k) application, and the agency has finally got around to doing just that.

The Dec. 22 draft guidance, announced in Friday's edition of the Federal Register, notes that tissue expanders, which are "intended for temporary (less than 6 months) subdermal implantation to stretch the skin for surgical applications" and are usually made of "an inflatable silicone elastomer shell filled with normal physiological saline," were seen by the panel as innocuous enough that class II controls "would provide reasonable assurance of ... safety and effectiveness."

Among the special controls for future tissue expanders noted in the draft guidance are materials tests such as tensile strength and degree of elongation, and the draft also notes that for any valves used in the device, "there should be no leakage observable after a normally closed valve is subjected to a retrograde pressure equivalent to" 30 centimeters of water for five minutes and an identical antegrade test. Any expanders with self-sealing patches should be tested for the ability to self-seal "for the duration of intended use."

Other requirements address sterility and biocompatibility, and interested parties have 90 days to respond.

MedPAC urges 5.5% cut for home health

The Medicare Payment Advisory Commission (MedPAC) met for two days last week, and sewed up a couple of recommendations to forward to Congress regarding payment updates for various provider groups. Among those recommendations is a 5.5% cut in the rates paid to home health agencies for 2010, but the advisory group also recommended a freeze for payment rates to inpatient rehabilitation and skilled nursing facilities.

Faring better under the MedPAC watch were long-term care hospitals, which would get a bump of 1.6% in 2010, while dialysis facilities would receive a 1% increase in the composite rate for those services.

The American Health Care Association (Washington) called MedPAC's recommendation on skilled nursing facilities "illogical" and said it would result in "damaging funding cuts" that would hurt patients and cost jobs. Blair Childs, VP for public affairs for Premier (San Diego), the hospital consortium that handles the Part A hospital quality initiative for CMS, said in a Jan. 8 statement that the alliance commends MedPAC "for its recommendation of a full market-basket update in 2010 for both inpatient and outpatient Medicare payments," describing the update as "a minimum step in this difficult [economic] environment."

NIH to fund 'soap opera study'

Acquired immune deficiency syndrome (AIDS) takes a huge toll on sufferers, and a number of means of suppressing the spread of the disease have been tried. The National Institutes of Health will now add to that list a soap opera played on a cellphone.

According to Jan 3 wire service reports, nurse educator Rachel Jones of Rutgers University College of Nursing (Newark, New Jersey), has snared a $2 million grant from NIH to test whether 20-minute soap operas downloaded onto and played on subscribers' cell phones can modify risk-taking behavior and tamp down on the spread of the disease. Jones was quoted in the reports as saying that "women who watched the first pilot were getting upset, angry, [and] exacerbated," and that the videos are "really resonating with urban contemporary themes that we believe are relevant to women."

The study entails a follow-up measurement of risk-taking behavior compared to controls who receive text messages about condom use. Jones made the case that "knowledge alone is not effective at changing behaviors" and that the premise is that "women in the community will so identify with heroines in the story their own behaviors will change as well."