A Medical Device Daily

Medicare’s approach to clinical trial reimbursement has garnered a lot of attention of late, but participants in those trials may have difficulty understanding what they have to gain and what they could conceivably lose by taking part in those trials.

In response, two divisions of the National Institutes of Health have cobbled together a web page that gives seniors a closer look at clinical trials. The Jan. 4 statement at the NIH web site reported the publication of the page, titled Participating in Clinical Trials, which apparently went live the previous day.

The information is posed at the site, titled NIH Senior Health (http://nihseniorhealth.gov), which is sponsored by the National Library of Medicine and the National Institute on Aging (NIA). The trials page gives details on trial participation in clear language, albeit from the perspective of a patient with cancer.

The content is available both in text format on a web page and as an audiovisual presentation with subtitles that parallel the audio portion of the presentation. Among the comments is a recommendation that prospective study participants check with their insurance about reimbursement for study treatment. The video also informs viewers that most trials involve randomization.

According to an NIH statement, seniors are “[o]ne of the fastest growing age groups using the Internet,” and they “increasingly turn to the Internet for health information.

“In fact, 68% of ‘wired’ seniors surf for health and medical information when they go online,” NIH asserts.

Richard Hodes, MD, director of NIA, said in the statement, “[t]he risk of many diseases and conditions increases with age, and it is important that clinical trials include older participants, who can help researchers find out if a drug, therapy, lifestyle change, device or medical test is safe and effective in the older population.”

The NIH said that other topics coming soon to NIH Senior Health will include Parkinson’s disease, nutrition and cholesterol.

Contracting SOPs a hazard for device makers

Contract manufacturing requires strict adherence to standard operating procedures and is rather tricky, as demonstrated by the Nov. 30 warning letter to Avicenna Laser Technology (West Palm Beach, Florida), maker of laser devices designed to exert an analgesic effect.

The agency cited the firm for “failure to establish procedures to control the design process.” This citation was inked in connection with the outsourcing for the manufacture of one of the firm’s units, the AVI HP-75.

Avicenna’s documents did not include design inputs, outputs, reviews, transfers and management approvals before handing off the task of manufacturing the unit to the contractor, according to the letter.

The letter also states that Avicenna had no procedures for employee training in reference to those employees tasked with “conducting receiving inspections, collecting information for and preparing the device history reports (DHR), final releasing, and shipping finished devices to customers.” It added that Avicenna “uses several contractors and suppliers and none have been evaluated.”

Another passage demonstrated yet another tripwire for firms contracting out manufacturing.

The warning letter states that during the inspection, it was found that Avicenna “discontinued purchasing your Class II medical laser, model VTR-75 manufactured by one OEM manufacturer, and replaced it with model AVI-HP 7.5, manufactured by another OEM, without submitting a new 510(k) notice or filing a supplement to the existing cleared 510(k) notice.” Thus, the device was deemed misbranded. FDA also cited the company for failure to file an annual report for its therapeutic laser systems.

The Dec. 13 warning letter to the G. Dundas Company (Black Diamond, Washington) was one of those that suggested a lack of familiarity with 21 CFR 820, as FDA cited the maker of anesthesiology equipment for a quality audit system that “only covers tools and test equipment and inspection requirements.” FDA said that Dundas “could not provide design control change procedures during the inspection even though you have made changes to two of your devices.”

The letter states that Dundas modified the Active Gas Scavenger model 1925, a 510(k) device, but that “test data collected during the inspection do not match the data collected from an unmodified device,” which “indicates that the new [redacted] affects device functionality.”

FDA cited the company for failure to file a new 510(k) stating this change. The letter also says that the Passive Gas Scavenger model 39951 was also tweaked enough to require a new 510(k).

Polychrome Medical (Brooklyn Center, Minnesota), maker of a diagnostic for cystic fibrosis (CF) that employs perspiration as the medium of detection, received a Dec. 7 warning letter citing it for device master record problems. According to FDA, device master records were not maintained for the past two years of production for the CF system, and “[I]t was unclear how much of each raw material was added, what specifications were followed, and identity of the individual conducting the manufacturing.”

The firm also lacked procedures for corrective and preventive action, and FDA said that several of the inspectional findings were repeats of findings from an inspection conducted in 2003.