Medical Device Daily Washington Editor
There's a saying that one thing leads to another, but sometimes bad things that are connected seem to run in parallel. Just ask the two entities that received warning letters earlier this year, both dealing with medical device reports (MDRs) and both addressing the same medical device.
FDA dropped a Jan. 11 warning letter on Munroe Regional Medical Center (Ocala, Florida), for failure to file a medical device report (MDR) in connection with a July 2009 procedure during which a patient's esophagus was torn while undergoing treatment with the EsophyX, a device made by Endogastric Solutions (Seattle, Washington). For its part, EndoGastric also received a warning letter, this one dated March 12, for problems with its MDR systems in connection with the incident at Munroe.
Despite the two months separating the two warning letters, the audit at Munroe took place in mid-September 2009 while the inspection of EndoGastric took a scant two weeks later, at the end of the month. The Office of Compliance at the Center for Devices and Radiological Health penned the warning to Munroe while the agency's office in Seattle authored the letter to EndoGastric.
According to FDA, Munroe could not document "the decision-making process and final justification" for not filing an MDR on the surgical event. FDA did not describe the hospital's proposed fix to its procedures to deal with this finding, but stated that the hospital's procedures did not include a requirement to provide "timely transmission of event" to the manufacturer and to FDA.
Perhaps as least as problematic is the statement in the warning letter that an employee at Munroe had contacted the agency regarding MDR procedures, but failed to respond to "multiple returned calls, voice-mail messages and a call-back phone number." The agency observed, "it remains unclear if the facility understands its reporting obligations." FDA stated further that the failure to contact EndoGastric precluded any chance the company might have had to conduct an investigation into the matter, "as they are required to do."
The warning letter to EndoGastric asserts that the firm did receive information from Munroe on July 29 regarding the incident with the Esophyx, which is designed to repair structural problems associated with gastric reflux, although FDA states that the company did not file an MDR within 30 days. This incident was said to have been precipitated by a pin that exited "the posterior side of the tissue mold between the junction of the elbow and the first link." This patient is said to have been taken by ambulance to another facility, where the removal was effected.
The audit disclosed also that the company did not report an event dated Aug. 12, 2009, which is said to have involved "the service loop disconnecting from the tissue mold at the distal end of the device, allowing the metal helical retractor to dangle." The retractor is said to have "caught" the esophageal wall a third of the way out, which required the use of forceps for removal.
FDA also cited EndoGastric for failure to fully document MDRs and for posting a video of a device, apparently the EsophyX, that depicted the device's use in patients under the age of 18. This, FDA states, is not covered by the clinical study for the 510(k) device.
Paul Clark, chief operating officer at Munroe, told Medical Device Daily "we have responded to all the questions FDA has asked us, and we have got no response" from the agency on those responses to the warning letter. He declined to go into further detail. An e-mail and a phone call to EndoGastric were not returned.
Medicare fraudster on the lam
The Department of Justice said last Thursday that a Los Angeles man who fled after his conviction for Medicare fraud was sentenced in absentia to pay more than $1 million in fines and restitution. According to DoJ's March 25 statement, Leonard Nwafor, 44, was convicted for his role in filing more than $1.1 million in false claims for high-end powered wheelchairs and accessories and evidently skipped bail sometime after his conviction in September 2008.
A number of elderly and disabled senior citizens testified at Nwafor's trial that he and at least one accomplice approached the beneficiaries, offering free wheelchairs in exchange for Medicare numbers and other personal information. According to DoJ, the scam billed for more than 170 such wheelchairs, some costing as much as $7,000. Several physicians came forward to testify that their signatures were forged on prescriptions.
DoJ states that Nwafor could receive as much as nine years in prison time for the conviction, although the statement says nothing about additional time for skipping bail.
FDA, SOCRA, hold workshop in LA
FDA has reported that it and the Society of Clinical Research Associates (SOCRA; Chalfont, Pennsylvania) will hold a public workshop on clinical trial compliance in the Los Angeles area in May.
The workshop will take place on May 5-6 at the Hyatt Regency Newport Beach in Newport Beach, California. Sessions will cover topics such as informed consent and relations between FDA reviewers and clinical trial staff. The speakers will cover all topics pertaining to drugs, biologics and devices. Interested parties are urged to register at the website http://www.socra.org/html/FDA_Conference.htm.
Mark McCarty, 703-268-5690