Medical Device Daily Washington Editor
The June 10 warning to Arjo Med (Gloucester, UK), came as bad news indeed for the maker of patient lifts, given that the letter announced that FDA has put the company's lifts on import detention. The enforcement action was predicated on the company's failure to report several adverse events within prescribed timeframes in connection with roll pins used in the patient lifts, including two events associated with patient deaths.
However, FDA also indicted that this is not the first time the agency has taken this action. The warning letter says that the agency slapped a detention on the firm in 2005 in connection with a warning letter dated Jan. 10 that year, which dealt largely with good manufacturing practices rather than medical device reports. The latest warning letter is the third for the firm since the beginning of the decade, a fact that certainly did not help the firm's position.
FDA says in the latest warning letter that the January 2009 inspection disclosed that the company did not make a determination regarding the reportability of three complaints despite that "two of these events resulted in a patient death." The agency found the firm's Feb. 20 response to this finding inadequate, stating that the offer to revise complaint-handling procedures should have been forwarded to the agency's Chicago district office. This comment in the warning letter deals with "a new field correction with the roll-pin related complaints (since 2000) with the Chicago district office, a procedure which FDA asserts was encoded in the company's standard operating procedures.
Arjo was cited for failing to coordinate complaint handling across multiple plants in a citation stating, "complaints are initiated, investigated and, maintained at three different company locations." FDA said the company's response "appears to be adequate because the designated complaint handling unit" in the UK "will request a written complaint investigation from the sling manufacturer for any alleged deficiencies," although the UK unit "will be responsible for the overall investigation of the complaint as well as making the final decision on reportability."
The agency states that a lack of quality records means that "complaint handling procedures for complaints have not been implemented." This citation deals with the fact that complaint records "were destroyed when your firm moved its manufacturing" to plants in operated in Belgium (Medibo N.V.; Limburg) and Canada (BHM, Quebec). Hence, while FDA acknowledges that the new protocol calls upon the UK unit to "process all complaints for patient lifts," it nonetheless "does not address the protection of complaints for future evaluation or whether the complaints will be destroyed or moved to a new facility" should Arjo shutter the UK plant.
Regarding the three mishaps that were not reported as MDRs, FDA states that an event that took place on Feb. 23, 2007, was followed by the patient's demise the following day. The agency asserts that Arjo was notified of the death four days later, but that FDA did not receive notice until April 27, 2009. The warning letter states, "the hanger bar spring pin" on the lift "failed while the patient was suspended approximately four feet in the air." The patient's fall resulted in injury to the left hip and ankle, and the patient "died approximately six hours later" after administration of "pain medications."
According to FDA, the company's conclusion was "that the anti-crush function failed to work," although the warning letter states that the lift unit "was 13 years old." However, Arjo is said to have been unable to determine whether the roll pin was at fault "because the user facility would not release the parts for testing."
Another event associated with a patient death took place the following year. During a patient transfer on Feb. 9, 2008, "the support/hanger bar fell out of the lift arm (lift pin sheared)," and the patient "dropped to the chair and slid to the floor. FDA states that this patient "passed away a few hours later," although "no injuries were apparent at the time of the incident."
A subsequent inspection of the lift in this incident disclosed that it was "in poor condition, with evidence of corrosion and damage to the paint work" and that "the roll pin that held the hanger bar in place had broken and was corroded." FDA does not mention the age of this unit but states that the company received word of this event on Feb. 21 and that the agency heard nothing until May 9, 2008.
FDA cited Arjo for failure to investigate each of the three events (the third of which was not associated with a fatality), stating that the company had "concluded that the user facilities failed to maintain the lifts," but that Arjo "did not evaluate the complaints to determine if the pin had been replaced as required by the recall or if the recall was effective." This citation also suggests – but does not explicitly state – that records for these units were among those that "were moved or thrown away since they stopped operations in June 2006."
The company did not respond to contacts for comment.
FDA still after workplace drug tests
When is a test only a test and not a diagnostic in regulatory terms? When it is used to test employees for illicit drug use and nothing more.
This fact seemed no deterrent at all to FDA in its July 30 warning letter to American Bio Medica (Kinderhook, New Jersey), which cited the company for promotion of its OralStat system, promoted on the firm's web site for "forensic use only" as an on-site drug test. According to the warning letter, FDA took up the issue with ABM in a letter dated Sept. 20, 2008, but the company had argued that the "forensic use only" claim meant that the device was outside the agency's purview.
The agency rebutted that the company's web site, which mentioned use of the test by a major retail chain and a city fire department, "indicate that you are marketing this test to the public for use in workplace settings."
Melissa Waterhouse, VP/chief compliance officer at ABM told Medical Device Daily "we have some questions about FDA's jurisdiction over workplace drug testing ... given that it's not a diagnostic or for treatment," a factor that is "the core of the issue at hand."
"We're one of many companies that are selling these products to the workplace, none of which by the way have clearance from FDA," Waterhouse noted.
Mark McCarty, 703-268-5690;