Medical Device Daily Washington Editor

WASHINGTON — The devil in the details is not always terribly obvious to the casual observer in most parts of life, but just invite an FDA investigator to your plant if you want to find those devils in short order.

That was part of the underlying message embedded in a Nov. 1 warning letter addressed to Troy Innovative Instruments (Middlefield, Ohio), which included a laundry list of deviations from good manufacturing practices (GMPs) that ran long enough to suggest a lack of familiarity with regulations.

The September inspection generated nine findings on the warning letter, but the company had not replied to the inspectional form 483 in time to make the publication date of the warning letter. However, a company spokesperson said that Troy had recently responded to the inspectional findings, although it does not have all the devils completely corralled.

FDA cited Troy, which makes a variety of accessory devices and surgical instruments such as lumbar bone screws and trocars, for failure to validate an ultrasonic cleaning process or an "electropolishing" process. This citation also listed a failure to validate passivation of unspecified containers and/or instruments (passivation is the processing of surfaces to prevent corrosion or other chemical interaction).

Several of the validation issues also populated a citation dealing with device history records. According to the warning letter, "all 17 of the device history records reviewed by the FDA investigator were incomplete," including lack of exposure times for sonic cleaning and passivation.

Another pair of citations made clear that FDA takes seriously a manufacturer's responsibilities for purchased components. The agency cited Troy for failure to "adequately inspect or test incoming product to verify conformance to specifications" in the case of three of eleven records that the warning letter said were incomplete without giving specifics, but FDA also cited the company for "failure to evaluate potential suppliers and contractors," citing lack of documentation to this end for three of the four contractors with which Troy was doing business.

Tracy Stone, the company's treasurer, told Medical Device Daily that "we responded to the letter" in the week prior to its publication on the FDA web site. She said the company has dealt with all the issues with the exception of the validation citations, which will be completed by 1Q08.

An Oct. 31 warning letter addressed to ProBed Medical Technologies (Abbotsford, British Columbia), maker of "powered patient rotation beds," hinted that post-inspectional negotiations between the agency and manufacturers sometimes drag on for months. The four-citation warning was issued in connection with an inspection that took place in late May and cited responses to the inspectional findings in a letter from ProBed dated June 25.

FDA cited the company for lack of complaint-handling procedures in connection with the Freedom Bed, designed to reduce the incidence of bedsores, in connection with a premature battery failure.

According to the warning letter, an unspecified number of units experienced power failures in connection with the two 6-volt batteries attached to manipulate the bed. FDA stated that the investigation undertaken by the company in response to the failures "did not scientifically determine the cause of the failure... but simply proposed a fix" by replacing the two batteries with a single 12-volt battery. FDA deemed the company's proposed correction inadequate because "your firm did not provide documentation showing that personnel had been adequately trained on the complaint procedures to include thorough investigations."

This incident also served as the driver for a citation regarding corrective and preventive action (CAPA) procedures. The warning letter stated that ProBed's response lacked documentation to the effect that personnel had been trained on appropriate CAPA procedures and because the documentation did not include data that would support the conclusion that the change to the 12-volt battery "does not adversely affect the finished device."

FDA also cited ProBed for lack of design control procedures that mandate a description of design outputs "that allow an adequate evaluation of conformance to design input requirements" in connection with components of a device that was purged from the warning letter. Again, the company's June 25 response to the 483 fell short, this time because "your firm has not provided your revised design control procedures." At press time, ProBed had not responded to calls for comment.

PCMA says 'hurry' to HIT

The Pharmaceutical Care Management Association (PCMA; Washington) has weighed in on the question of e-prescribing for Medicare, declaring that the Centers for Medicare & Medicaid Services should require it for all providers. The association of pharmacy benefits managers stated last week that e-prescribing's benefits are fully detailed after four years of review by a host of stakeholders and include fewer adverse drug events, administrative savings and greater use of generic drugs. The organization's president/CEO, Mark Merritt, said in a statement, "CMS estimates even modest adoption of e-prescribing could save billions and greatly reduce adverse drug events."

PCMA is putting its money where its mouth is with a "Before More People Die" campaign that features spokesman Lyle Bootman, PhD, a panelist on the report published last year by the Institute of Medicine (Washington) that urged mandatory Medicare e-prescribing, a move that would likely simplify the lives of both pharmacists and PBMs considerably.

According to the PCMA web site, the IOM report regarding medication errors from 2000 concluded that at least 7,000 Medicare beneficiaries die each year from medication errors. However, IOM's calculations have been the subject of some controversy due in part to methodological issues and excessively wide margins of error.