Medical Device Daily Washington Editor

Of all the problems FDA has, the one that rarely, if ever, that makes the news is the operation of the agency's Freedom of Information (FOI) office, but that part of the agency's operation is clearly bothered by information technology snags. Appearing for a time yesterday on the warning letter page at FDA's web site was an April 14, 1998, warning letter to Paragon Healthcare (Little Rock, Arkansas), which was later bought out by Alliance Medical (Phoenix) at a time when the device reprocessing industry was going through a wave of consolidations.

The January 1998 audit of Paragon disclosed problems with validation of cleaning of reprocessed electrophysiology catheters, but an inspection conducted a year later indicated that Paragon had made headway in getting operations under control. Paragon evidently relapsed, however, as suggested by a warning letter dated July 13, 2001 after the buyout by Alliance. In that warning letter, operations at the former Paragon facility were deemed to be violative due in part to lack of data in support of a validation for the firm's use of an ethylene oxide sterilization procedure for sutures and grafts and a failure to validate the maximum number of times a cardiac catheter could be reprocessed.

FDA's FOI office has routinely posted warning letters well after the dates on the letters, and this week's postings offer no evidence the problem is improving. Along with the Paragon/Alliance warning are letters from the year 2001 to Campbell County Memorial Hospital (Gillette, Wyoming) and Ft. Collins Mammography Center (Ft. Collins, Colorado), both for violations of the Mammography Standards Quality Act (MQSA). At press time, FDA had not responded to contacts for comment.

Maker of teething rings gets warning

The Sept. 11 warning letter to Luv N' Care (Monroe, Louisiana) noted that the firm's plant was not registered with FDA, but the maker of gel-filled teething rings had other issues to overcome. According to FDA, laboratory analysis of samples of teething items retrieved during the May 29 inspection indicated that those products "consist in whole or in part of a filthy, putrid, or decomposed substance." This was determined by FDA to be two species of bacillus bacteria, circulans and subtilis.

FDA asserted further that the company lacked a PMA or 510(k) for the devices. As for the source of the contamination, Joseph Hakim, the company's president, told MDD "we're not sure. We think it was introduced by one of the components, so to alleviate that, we're filing for a special 510(k) for irradiation" of the teething devices. "Hopefully in another 30 to 45 days we hope to start shipping again."

Hakim added that the contamination came from a supplier, but that Luv N' Care is still doing business with the supplier. "We feel it was introduced with one of the materials" purchased by the supplier, and recent tests "showed that the product passed. Evidently it was an isolated incident but we have to make sure it doesn't happen again," he said.

Philips recalls AEDs due to memory chip

Philips Healthcare (Andover, Massachusetts) announced on Monday that it had voluntarily recalled roughly 5,400 HeartStart FR2+ automated external defibrillators (AEDs) due to the possibility that a faulty memory chip could "render the device inoperable." The recall affected four of the firm's HeartStart FR2+ AEDs manufactured between May 2007 and January 2008. The affected models are the M3860A and M3861A, distributed by Philips, and models M3840A and M3841A, which were distributed by Laerdal Medical (Stavanger, Norway).

Philips indicates that the failures arose during unit self-tests rather than during actual use and that there have been no reports of injuries in connection with the faulty memory modules. Philips is offering to replace the chips or the entire unit. The units in question were distributed "globally to fire departments, emergency medical services, hospitals, and other organizations."

The company had responded to a call for comment, but was unable to provide further information on details of the faulty memory chip, and would not comment on the impact of the recall on financial statements due to "the small scale" of the recall. Philips notes that the recall involves "less than 1% of the more than 650,000 units shipped."

CMS not keen on outpatient IV insulin

The Centers for Medicare & Medicaid Services has proposed national non-coverage of intravenous insulin therapy on an outpatient basis in a decision memo posted to the agency's web site yesterday.

Determining that the procedure "does not improve health outcomes," CMS makes the case that studies of animal models led to contradictory outcomes where glycemic control is concerned. As for human studies, CMS states that "patient variables, (e.g., age, diabetes type, disease severity, and co-morbid conditions), or treatment variables, (e.g., pulse parameters, respiratory quotient response, and duration of therapy), which could impact therapeutic utility were not adequately addressed."

CMS points out that a review of nine longer-term studies of such therapy in humans disclosed "significant limitations," including that four of the studies "were based on populations that were subsets of larger study populations," that "none of the studies were blinded" and that "only two were randomized." CMS also notes that none of the nine studies enrolled more than 100 subjects and that the total enrollment from these nine studies was less than 250.

CMS opened the national coverage analysis in March (Medical Device Daily, March 31, 2009) and expects to issue a final determination in December. The agency will accept comments until Oct. 25.

Mark McCarty, 703-268-5690;