A Medical Device Daily

The House of Representatives passed H.R. 3276 last Thursday by a landslide vote of 400-17, putting a resounding stamp of approval to legislation that will authorize $163 million for a new program at the Department of Energy intended to encourage domestic production of a medical isotope that has been in short supply throughout much of the past year.

The bill, dubbed the American Medical Isotopes Production Act of 2009, was introduced to a subcommittee this summer (Medical Device Daily, July 30, 2009), and serves the dual purpose of encouraging domestic development of radioisotopes for medical use and discouraging the use of high-enriched uranium (HEU) for energy production. Congress favors the use of low-enriched uranium (LEU) for energy production purposes as part of an overall strategy for reducing nuclear weapons proliferation.

H.R. 3276 passed through the Energy and Commerce Committee last month (MDD, Oct. 23, 2009) and authorizes the funding between fiscal years 2011 and 2014, but it appears that the Senate has yet to craft a companion bill, so the Senate will likely take up the House bill as is.

The House is reacting to a persistent shortage of technetium-99, which is processed from molybdenum-99. Molybdenum is in turn a byproduct of uranium, which is widely used in energy production across the globe. However, several plant shutdowns in production facilities in Canada and the Netherlands have crimped supplies sharply of technetium of late, leading hospitals and radiology clinics to suspend needed radio-imaging procedures.

The Society for Nuclear Medicine (Reston, Virginia) has been a steady supporter of H.R. 3276, and the association's president, Michael Graham, MD, said in a Nov. 6 statement, "the worldwide isotope shortage has long been adversely affecting patients in the U.S." He noted that the legislation "will bring us one step closer to solving this chronic problem."

Graham also noted that the shutdowns of overseas processing facilities has resisted correction and presents a grim outlook for patients. "To date, it has not been a pretty picture," he said, which is "why SNM is so supportive of the House's approval of this bill."

FDA eyes energy levels in defibrillators

FDA has received a trickle of reports over the past three years of external defibrillators that failed to defibrillate or cardiovert patients after providing a jolt of 200 joules, and is asking healthcare providers to file reports with the agency on similar situations.

According to a Nov. 5 statement, the agency has data suggesting that when a 200-joule shock failed to defibrillate or cardiovert the patient, "a subsequent shock from a different 360 J biphasic defibrillator resulted in immediate" restoration of normal rhythm. FDA states further that the majority of these events "occurred during attempts at cardioversion of atrial fibrillation, but there was at least one instance with defibrillation of a ventricular arrhythmia as well." The agency is trying to establish "whether FDA activities are advised."

To date, FDA's analysis of the 14 cases "does NOT (emphasis theirs) suggest the need for any change to current clinical practice," but the agency is aware of only one randomized trial "comparing effects of different energy levels focused on patients with cardiac arrest." The statements indicates that the trial suggested that higher energy levels "resulted in a greater proportion of successful cardioversion/defibrillation," but "there were no detectable differences in clinical outcomes" in terms of 24-hour survival and survival to discharge.

The reference is to an article appearing in the March 12, 2007, edition of Circulation, penned by a group including Ian Stiell, MD, of the Ontario Hospital Research Institute (Ottawa, Canada). This article details a study of biphasic shock in roughly 220 patients randomized to 150 joules or higher levels, including 200, 300 and 360 joules. The patients in the 150-joule arm were more likely to need a second shock, the authors note. However, while "patients in ventricular fibrillation benefit from higher biphasic energy levels if multiple defibrillation shocks are required," the authors state that there are, as FDA noted, "no distinguishable differences" in survival.

AdvaMed places rep in China

The growing relative importance of Asian markets is hardly lost on the device industry, and the recent promise on the part of Beijing to lower its barriers to imported devices is just a part of industry's efforts to pry open this Oriental pearl (Medical Device Daily, Nov. 5, 2009). In an effort to ensure the sustenance of that momentum, the Advanced Medical Technology Association (AdvaMed; Washington) has undertaken a shared position with the American Chamber of Commerce in China (AmCham-China; Beijing) to foster greater access.

According to a Nov. 6 AdvaMed statement, the association's representative will share "a position dedicated to medical devices" with AmCham-China in the latter organization's building in downtown Beijing. AdvaMed states that the move "reflects the association's commitment to addressing the challenging regulatory and reimbursement processes there and the overall importance of the Chinese marketplace to American medical device manufacturers."

Steve Ubl, President/CEO of AdvaMed, said in the statement that device firms in the U.S. "currently export $1.1 billion worth of products to China, but there remain significant market access challenges as China reforms its healthcare system." Ubl said that the presence of an association representative in China "allows us to address these issues more directly and efficiently with the Chinese government."

Ubl also said that AdvaMed "welcomes this collaboration ... which will give us a stronger presence in Beijing, the heart of Asia's second largest medical device market."

The first occupant of this position will be Victoria Qu, who AdvaMed says recently held the position of senior regulatory specialist for Johnson & Johnson Medical China (Shanghai). Ralph Ives, executive VP for global strategy & analysis, said in the statement that Qu is "highly regarded for her in-depth knowledge of the regulatory system in China." Ives states further that the association is "excited to have her on board and believe she will be a tremendous asset as we work to resolve the regulatory and reimbursement challenges facing our members."

AdvaMed also noted that this appointment is "AdvaMed's second overseas representative; the other is in Tokyo, Japan."