Medical Device Daily Washington Editor

There is a more-or-less fine line between a change to a product requiring only a tweak of an existing 510(k) and an entirely new filing, and Kimberly Clark (KC; Roswell, Georgia) found out the hard way that its efforts to turn out a better brand of mousetrap – actually a better sterilization wrap – qualifies as the latter. However, those efforts date back more than a decade.

FDA sent the firm a June 4 warning letter that made the agency's web site only yesterday, which would not be the first time the agency took more than a month to post a warning letter. The letter stated that KC and the agency had been corresponding at least since September 2007 over the question of whether changes to several of the firm's sterilization wraps required a new 510(k) filing.

The letter states that the Spunguard wrap had been cleared for one layer of spun polypropylene with a layer of melt-blown polypropylene, but that KC added a layer of melt-blown polypropylene to the other side of the spun layer. The concern here is the possibility that "three layers could hinder the ability of the sterilant to penetrate through the wrap."

The agency cited KC for lowering the tensile strength specification for two of the Kimguard model wraps, which FDA indicated "could lead to maintenance of package integrity and product sterility issues." In contrast, KC is alleged to have increased the tensile strength for one of the Spunguard line of wraps, which FDA indicated "may hinder sterilant penetration."

Higher tensile strength also was cited in connection with two other wrap products. The warning letter also states that the use of an ultrasonic bonding process could lead to problems with sterilant penetration."

Dave Dickson, director of corporate communications at KC told Medical Device Daily, "We believed that when the changes were made in the mid-1990s, there was not clear guidance on the types of changes that required notification." He said the company will "submit an update by the end of this week," but said "there's no reason to believe that the warning came about as a result of customer complaints or product performance related events."

He added that FDA did not ask KC to stop making or shipping the products.

FDA in import alert for implants

A Feb. 20 warning letter to Cochlear Bone Anchored Solutions (Molnlyeke, Sweden) collected even more dust than the one to Kimberly Clark, but cited the maker of bone conduction hearing systems for fairly typical deviations from good manufacturing practices. Among these was a lack of data on device reworks and re-evaluations in the device history record. FDA stated that the company's September 2007 response to this finding was adequate thanks to an updated procedure the agency said it would check on the next inspection.

FDA said the company failed to come up with acceptance criteria for device design "prior to the performance of [design] verification activities" in connection with the Baha Intenso model. The firm's updated procedure apparently did the trick, as FDA indicated only that it would check the updated procedure on the next inspection.

The firm's complaint-handling procedures were cited as lacking instructions for establishing whether a complaint qualifies as a medical device report (MDR). The firm's proposed solution failed to mollify the agency because "your firm's procedure . . . fails to discuss how MDR-reportable events will be investigated and submitted to FDA within the 30-day timeframe as required."

FDA also cited the company for failure to report an incident of "loss of osseointegration/loss of implanted fixture" as an MDR. The company's correspondence dated June 8 and Sept. 12, 2007, indicated that Cochlear disagreed with FDA "as to the appropriate level of adverse event reporting" and that the company hoped "to reach consensus with FDA on the issue." All the same, the warning letter insisted that the events were reportable because such events "would likely cause or contribute to serious injury as defined" in the Code of Federal Regulations. "As a result, FDA has issued an import alert . . . whereby FDA may refuse admission of the products . . . until these violations are corrected."

The agency said the detention could be pulled upon receipt of a satisfactory amendment to procedures, but also informed the company "we may need to re-inspect your facility to verify that the appropriate corrections have been made."

CMS provides guide for new tech payments

Pass-through payments for new technology are sometimes described as almost as much of a challenge as developing the new technology itself, but the Centers for Medicare & Medicaid Services (CMS) has issued a guide to make the process of obtaining such payments a less strenuous process.

According to the agency's Aug. 21 announcement, the new guide compiles a number of previous documents and was assembled by the agency's Council for Technology and Innovation, which the statement described as "a CMS-wide working group charged with streamlining and creating a more transparent process to get new technologies to patients more quickly." CTI was mandated by the Medicare Modernization Act of 2003.

The agency's acting administrator, Kerry Weems, said the Innovator's Guide to Navigating CMS "will help [makers of devices and diagnostics] better navigate Medicare requirements by explaining how to make their products available to Medicare beneficiaries." The statement acknowledged the possibility that groundbreaking technology can force "explicit coverage, coding or payment changes to ensure the coverage of reasonable and necessary new treatment options and the availability of medically appropriate technologies to its beneficiaries."

Weems also said the agency's aim "is to provide the highest-quality healthcare to people with Medicare and the tools to help them get that care."