A Medical Device Daily

The Centers for Medicare & Medicaid Services released information last week on how doctors will be measured for quality performance under the voluntary 2007 Physician Quality Reporting Initiative (PQRI). The 74 measures include aspects of treatment and screening for Medicare patients with diabetes, heart disease, depression, stroke, glaucoma, cataracts, osteoporosis, melanoma, end stage renal disease, asthma and pneumonia. CMS said it may expand specifications later to include additional eligible professionals.

According to a law passed last December, doctors who measure and report their performance from July 1-Dec. 31 of this year, based on the measures, will receive a bonus payment of 1.5% of total allowed charges under Medicare.

Medicare officials have made it clear that though physician pay for performance (P4P) is only in the voluntary stages now, CMS may one day make it a permanent aspect of Medicare.

As early as July 2005, Herb Kuhn, director for the CMS Center for Medicare Management testified before the Senate Finance Committee of the Bush administration's plans "to explore and advance" P4P as a method of lowering Medicare costs.

Chris Weiss, president and CEO of Dynamic Clinical Systems, said he is encouraged to see signs of CMS's progress. He remains skeptical, however, as to whether clinicians at even the larger institutions will be able to accurately measure, track, and report on the breadth of the measures. "Certainly, without the help of robust healthcare IT, smaller offices will have no practical way to either stay abreast of the measures or to address them in an efficient way," Weiss said. "The net impact will be to continue to keep too many clinicians and their patients on the sidelines."

Trial issues dot latest warning letters

Ample funding for devices means a large number of clinical trials, and the latest round of warning letters posted at the FDA web site suggest that clinical trial management is no cakewalk. The agency released warning letters to three companies last week for a range of clinical trial violations and two for quality systems reporting (QSR) requirements, including one to Abbott Laboratories (Abbott Park, Illinois).

Bentec Medical (Woodland, California), received a March 21 warning letter that commenced with a citation for shipping the study article to three clinical investigators prior to FDA and institutional review board (IRB) approval. The letter indicated the firm acknowledged "no monitoring of the clinical trial."

Lack of documented procedures was also the reason that FDA gave for not accepting the company's proposed fix for having shipped investigational devices to investigators who had not signed investigator agreements. FDA also charged that Bentec, whose web site indicates that it sells latex-free surgical supplies, failed to "conduct an evaluation of any unanticipated adverse effects," one involving a deep-vein thrombosis. Lack of detail doomed the company's response to this and the other finding on the 483.

BSD Medical (Salt Lake City, Utah), maker of hyperthermic treatments for cancer and other diseases, was cited in a Feb. 27 warning letter for enrolling four subjects who did not meet the eligibility criterion of tumors of the pelvis. Two of the four had breast tumors, one had a tumor of the esophagus and the fourth a sarcoma in "the left posterior chest."

The agency also cited BSD for failure to perform pre-treatment X-rays on four subjects. It was not clear whether these were the four improperly enrolled patients.

BSD responded that it had repeated training for the clinical staff at the site in 2005 and 2006, and that in the interim, the sponsor had dismissed the study coordinator. However, the November 2006 inspection said that "the interventions you have taken appear unsuccessful," suggested by lack of documentation of various pre-treatment protocols for a patient who enrolled last August. BSD also drew a citation for failing to submit a progress report in 2004 to the agency and to the IRB responsible for trial oversight.

A March 14 letter addressed to KSM (Bellaire, Texas) indicated that FDA had previously notified the company "in a letter dated July 1, 2002, that the [redacted words] is classified as a class III device" and that studies of the device are subject to investigational device exemption rules. The devicen — the name redacted throughout the letter — was used to treat two HIV-positive patients without IRB approval and one patient in an attempt to provide "symptomatic relief of upper and lower extremity complications associated with diabetes." Open-label uses of the device were said to have included treatment of arthritis, paralysis, carpal tunnel, hyperthyroidism and fractured vertebrae.

FDA also cited the company's IRB because "three of the five members of your IRB . . . have conflicting interests." KSM promised to suspend "all clinical trials" until it put in corrective actions.

BTI Filtration (Edmond, Oklahoma) received a Feb. 27 warning letter for deviations from QSR requirements, including a citation for failure to follow cleaning procedures for tanks used in the company's remanufacture of deionization (DI) tanks used to produce hemodialysis water.

BTI's procedures referred to an American National Standards Institute standard, but the warning said that the company did not "have a complete copy" of that standard.

Another citation demonstrated the hazards of mixed-use facilities. FDA cited the firm for mixing resins of DI tanks with those from tanks "used for automobile washing . . . into one big batch of exhausted resins" for reprocessing. Another of the 19 violations was lack of procedures to track incoming products "during all stages of receipt, production, distribution and installation to prevent mix-ups."

Employee training was also said to be deficient since the company could not document training for regeneration and testing of the mixed-bed DI tanks." The company's responses to all citation were deemed inadequate due to lack of written procedures.

A March 13 letter to Abbott Labs said that "some of the current inspectional observations were repeats from inspections in 2003 and 2004." The October-November 2006 inspection disclosed that Abbott's management controls lacked "corrections for global quality control."

Management review procedures were deemed lax due to the company's use of "dollar value as the alert level for parts replacements as a measure of malfunctions of the analyzers." The letter indicated that this finding included c8000, i2000 and i2000SR analyzers, an unspecified number of which "were found DOA (dead on arrival) upon installation in each month" between October 2004 and September 2006.

In a later citation, the warning letter noted that only 76% of the i2000SR analyzers shipped and installed between November 2004 and October 2006 "arrived alive." FDA's third citation was for failure to collect and analyze all quality data for the errant analyzers, and the letter stated that Abbott had responded to this finding to the effect that it would examine critical components of the analyzers, at a period that was redacted from the warning letter. However, Dallas district director Michael Chappel wrote in the letter that the agency wanted to see "analyses of all quality data on a more frequent basis."

Chappel warned Abbott that FDA is "not satisfied with the pace and results of your firm's past corrective actions as they have not been effectively, timely and globally implemented." The agency mandated that Abbott hire an outside consultant to conduct audits and certifications in August 2007 and in May 2008 and 2009. FDA indicated it would conduct follow-up inspections at "any time between August 2007 and May 2009." At press time, none of the warning letter recipients had responded to calls for comment.