Medical Device Daily Washington Editor

Traumatic brain injury has been the focus of federal research dollars for some time, but the National Institutes of Health and the U.S. Department of Defense have decided to combine their resources to build a database on traumatic brain injury (TBI) in hopes of developing comparative effectiveness data that will enhance care. As might be expected, imaging technology will play a vital role in this effort.

According to an Aug. 29 NIH statement, the database will go by the name of the Federal Interagency Traumatic Brain Injury Research (FITBIR) database, and will be financed to the tune of $10 million for four years. Much of the drive toward this is the sheer numbers of TBI incurred by American citizens, but the incidence of TBI among the men and women in U.S. military service is another motive. While NIH states that 1.7 million Americans receive a cranial trauma each year, roughly 200,000 of the nation's uniformed military veterans have sustained TBI due to improvised explosive devices and other implements of war. The NIH statement pegs the annual cost of treating TBI among American citizens, in or out of uniform, at $60 billion.

One of the difficulties of treating TBI is the vast range of functions captured by the human brain, and long-term outcomes have proven resistant to prognostication. Col. Dallas Hack, director of the U.S. Army Combat Casualty Research Program and joint chairperson for the Defense Health Program, said in the NIH statement, “despite the great burden of neurotrauma incidence, developing objective diagnostics and treatments has proven especially challenging for the medical community. Only by combining efforts through initiatives such as the FITBIR database can we hope to make major progress in this field.“

NIH and DoD anticipate that the database will help researchers to build a more exhaustive taxonomy of TBI than currently exists, but the hope is also that a more refined set of diagnostic criteria for “concussion and milder injuries“ will emerge from the effort as well. In an attempt to leverage existing information technology infrastructure, NIH's Center for Information Technology will manage the database using its database on autism research as a structural template for the TBI database rather than designing something from scratch. This, the NIH statement indicates, may save as much as half the cost of the project and “significantly reduce the time to achieve meaningful results.“

NICE says Inditherm blanket cost effective

The UK's National Institutes of Health and Clinical Excellence released an analysis of the patient warming mattress made by Inditherm (Rotherham, UK) and concluded that the argument for use of the mattress “is supported by the evidence.“ Stating that the device's efficacy in maintaining body temperature above 36-degrees Celsius “is similar to that of forced air,“ the memo also states that the Inditherm device “may have practical advantages“ over forced air.

One of the big issues for NICE is cost, and the undated memorandum states that the annual cost savings compared to forced air may be as much as £9,800 “per operating theatre,“ assuming a unit cost of £1,300, including accessories and associated maintenance.

Regarding clinical evidence, NICE states that it had examined five clinical studies for effectiveness, including a published randomized trial for patients undergoing elective abdominal surgery. For 47 patients, the mattress was active two hours prior to surgery until two hours after the procedure while the mattresses were inactive under patients in the control arm. Patients in both arms also received forced air, and mean body temperatures were 36.4-degrees C for the study group and 36-degrees C for controls.

Inditherm announced the results in an Aug. 31 statement in which the company quotes Nick Bettles, CEO as stating that the analysis “will allow all [National Health Service] hospitals to implement Inditherm patient warming with confidence.“ Bettles stated further that the evaluation process “has included in-depth analysis that validates the clinical performance and financial benefits of Inditherm's systems,“ adding that the company “hope[s] this will accelerate uptake in the UK operating theatre market and help the NHS in meeting their cost saving targets at the same time as improving clinical care.“

Saudis restrict new devices to GHTF nations

The government of the Kingdom of Saudi Arabia has issued a series of interim steps on establishment of medical device regulations, and any new entrants into the market will henceforth be restricted to devices that have been approved in the nations that were the founding members of the Global Harmonization Task Force.

According to an undated memo, the Saudi Food and Drug Administration has implemented a number of rules, including those governing conformity assessments, establishment registrations, and medical device listings, but the memo also states that after June 30, only devices that pass muster in one of the founding GHTF member nations will be permitted onto the Saudi market. This list includes the U.S., China, Japan, Australia and the European Union.

Canadian province boosts PET/CT capacity

The government of Canada's province of British Columbia (BC) announced recently that it will install a new PET/CT scanner at the British Columbia Cancer Agency, a move that will double the number of scans that can be performed at the facility in Vancouver.

According to the Aug. 29 statement by the government of BC, the new PET/CT unit will be installed at at the Centre of Excellence for Functional Cancer Imaging at the BC Cancer Agency campus and comes less than a year after the provincial government opened a $15 million radiopharmaceutical production plant, also located in Vancouver. The first PET/CT unit went live in 2005, and thanks to the additional hardware, the provincial government will be able to perform more than 6,000 procedures a year, although the statement does not identify the manufacturer of the PET/CT equipment.

The funding for all this activity is coming from several sources, including the Provincial Health Services Authority, which put together $1.5 million for operational costs for the new PET/CT machine, as well as $3.2 million from the BC Cancer agency for the purchase of the new unit, although the original machine will also get an upgrade.

Margaret MacDiarmid, MD, Parliamentary Secretary for Seniors to the Minister of Health in Canada, said in the statement that the additional PET/CT unit will allow residents in BC to “continue to have some of the best cancer outcomes in the country,“ but she also said that as a former physician and former cancer patient, “I know the importance of an accurate diagnosis.“

AECL reactor back online

The Chalk River reactor operated by Atomic Energy Canada, Ltd. (AECL; Mississauga, Canada) is back online after a maintenance shutdown, giving the pipeline for technetium-99 a much-needed boost.

According to an Aug. 25 statement at the AECL website, the reactor was taken offline Aug. 16 for planned maintenance, the second such episode in the past three months. The reactor was also offline in May when the agency took the reactor out of service for nearly five weeks (Medical Device Daily, May 24, 2011). The reactor has been in operation for more than five decades, however, and maintenance work is routinely taking the unit out of service several times a year.

Mark McCarty, 703-268-5690