A Medical Device Daily

Filling the executive branch's cabinet and agency posts is a chore for every new occupant of the White House, and the Obama administration finally announced its pick for the director of the Patent and Trademark Office.

In a June 18 announcement, the White House reported that it had selected David Kappos as the director of PTO, announcing at the same time the appointment of Warren "Pete" Miller to the post of director of the Office of Civilian Radioactive Waste Management at the Department of Energy. President Barack Obama said in the statement, "the talent, commitment and expertise these two fine individuals possess make them valued additions to our team as we work to keep our nation safe and put us on a path to prosperity."

Kappos currently holds the position of VP and assistant general counsel for intellectual property law at IBM (Armonk, New York), a firm that is generally seen as a patent colossus. The technology giant announced in January that it had obtained more than 4,100 patents in 2008, and in a Jan. 14 statement that its 2008 total was "nearly triple Hewlett-Packard's and exceed the [combined] issuances of Microsoft (Redmond, Washington), Hewlett-Packard (Palo Alto, California), Oracle (Redwood Shores, California) Apple Computer (Cupertino, California), Google (Mountain View, California)" and two other IT firms.

Kappos was charged with managing IBM's patent and trademark portfolios and was involved in making intellectual property policy as well as in IP-related litigation undertaken by the firm. According to the White House announcement, Kappos serves on the board of directors of several IP associations, including the American Intellectual Property Law Association (Arlington, Virginia).

Also in a June 18 statement, Sen. Orrin Hatch (R-Utah), said he is "impressed with Mr. Kappos' seemingly vast patent and trademark experience." Hatch, who serves on the Senate Judiciary Committee and has feuded with the committee over patent reform legislation (Medical Device Daily, April 3, 2009), also remarked that "whoever takes the helm at the USPTO is going to need to hit the ground running, especially in light of how the current economic downturn has negatively affected the agency." Hatch's objections regarding provisions for inequitable conduct in the Patent Reform Act of 2009 bubbled to the surface as the committee was marking up the bill earlier this year.

The move was not utterly unanticipated. In a June 5 blog entry for the web site for Intellectual Asset Management, an IP magazine, Joff Wild wrote that he had received an e-mail the previous night "from someone who is usually well-informed about these things," naming Kappos as the administration's favored candidate. Wild said that while "it would not be earth-shattering news," the move would raise questions about his objectivity, given his deep experience in industry.

GAO files follow-up to FDA report

The appearance of Marcia Crosse of the Government Accountability Office at Thursday's hearing in the House Energy and Commerce health subcommittee (Medical Device Daily, June 19, 2009) came on the day that GAO filed a report to follow up on its January report on FDA's medical device approval process, and the current report does not give FDA much higher marks than the January report (Medical Device Daily, Jan. 21, 2009).

According to the summary of the latest report, FDA responded to the controversy over the lack of classification of high-risk, pre-amendment devices by calling on manufacturers in April to "submit information on the safety and effectiveness of these types of devices," but the GAO report pointed out that FDA did not lay down a time-line for completing the reclassification effort. In an interview published in the May 26 edition of Medical Device Daily, Donna-Bea Tillman, PhD, director of the Office of Device Evaluation, said that the Center for Devices and Radiological Health has "competing priority issues" and that of the original 100-plus class III devices that were already on the market before the 1976 Medical Device Amendments, the first ones to be reclassified "were the ones with the biggest public health impact and the ones there were the most concerns about."

GAO's report also commented on FDA's well-known backlog of site inspections, observing that the agency's investigators had inspected facilities making class III devices only once every three years on average rather than the statutorily-mandated two-year schedule. GAO also observed that there is "no comparable requirement to inspect foreign establishments" and that FDA typically inspects overseas plants making class III devices only every six years.

VA drawing fire over infectious disease

Device reprocessing has always raised hackles even as providers struggle to contain costs, and the use of reprocessed endoscopic instruments at Veterans Administration hospitals has drawn fire from Congress.

In a June 16 statement, the Office of Inspector General at the Department of Veterans Affairs blasted what it described as a "pattern of failure to adhere to cleaning and sterilization procedures involving endoscopic equipment, despite an earlier campaign to rectify the problem." OIG states in its report, which was aired at a recent congressional hearing, that the problem persists despite earlier action on the issue.

According to wire service reports, problems had been reported earlier this year with inappropriately reprocessed endoscopic equipment at VA medical centers in Murfreesboro, Tennessee and Augusta, Georgia, because of which roughly 10,000 patients were said to have been exposed to pathogens. A subsequent report on conditions at a VA center in Miami suggested that patients there had been exposed to the human immunodeficiency virus.

David Rehbein, national commander of the American Legion (Indianapolis), described the latest report as "very disturbing," adding that the report "demonstrates a pattern of failure among medical personnel . . . to acquire simple knowledge and follow uncomplicated procedures, thus possibly exposing vulnerable veterans to serious health risks." The House has directed OIG to conduct a fresh round of inspections of VA health facilities in 90 days.