Medical Device Daily Washington Editor

Unique device identifiers (UDIs) are a hot topic for FDA, but the issue has also spurred activity by Eucomed (Brussels), which recently published a set of proposed guidelines for a UDI system. Not surprisingly, the major features of Eucomed's proposal align fairly neatly with the emphasis at FDA.

Dan Schultz, MD, director of the Center for Devices and Radiological Health at FDA, told a recent gathering, "a single, global system for unique device identification is our mission" (Medical Device Daily, June 18, 2009). Schultz also lamented the fact "that it has taken us this long to get here" in reference to an impending guidance from FDA on UDI standards.

The June 2009 document from Eucomed states that the guidance is intended only as a basic guide "on how UDI can be implemented practically by using a risk-based system." The document also notes that the sense of urgency on the eastern side of the Atlantic Ocean is somewhat amplified by an EU legislative proposal described as a "counterfeiting directive," which the Eucomed document says includes "a legal basis for serialization of pharmaceuticals, potentially setting a precedent for medical devices."

Developed by Eucomed's e-Business and Supply Chain Task Force, the guideline's key elements include a global standard for UDI and "a risk-based approach for traceability requirements." That risk-based approach would cover several factors, including the risk of medical errors and the degree of invasiveness of the device. The ease with which a device might be counterfeited is another factor to be used in a risk calculation, as is the incentive derived from the price the product typically commands.

In terms of technology, Eucomed indicates, "its members are increasingly using and moving toward the use of linear and/or two dimensional ... bar-code symbologies." While the document acknowledges the potential role of radio frequency ID tags, the document's authors assert that the technology carries "issues [that] remain to be solved for the medical device industry," although the document does not discuss those issues.

Legislation for medical isotope in play

Congress has acted to address the recent string of reactor failures leading to a global crunch of supplies for technetium-99 (Tc-99) in the form of H.R. 3276, the American Medical Isotopes Production Act of 2009. Sponsored by Rep. Edward Markey (D-Massachusetts), the bill has been introduced to the House Energy and Commerce Committee but has not seen the light of day yet, thanks to healthcare reform legislation.

The bill calls for $163 million to be put toward the development of domestic supplies of the Tc-99 precursor, molybdenum-99, over five years starting in fiscal year 2010, and requires the use of a reactor not using highly enriched uranium to produce the molybdenum unless a low-enriched source is not available.

In a July 28 statement, the Society of Nuclear Medicine (SNM; Reston, Virginia) states that it and eight other organizations have issued a white paper on the matter and lend their support to the Markey bill. Michael Graham, PhD, SNM's president, said in the statement that Congress "should take steps to boost production domestically and to ensure that the transition away from using highly enriched uranium in medical isotope production does not further strain supplies." Graham also said that SNM "applaud[s] Congress for taking up this issue and urge[s] the government to act without delay."

The coalition, which also includes the American College of Radiology (Reston, Virginia) and the American Society of Nuclear Cardiology (Bethesda, Maryland), notes that the situation is exacerbated by "recent recommendations to curtail the use of [high-enriched uranium] in radionuclide production because of potential security concerns," but that "the conversion to the alternative low-enriched uranium ... is still years away." The statement argues that "large-scale commercial facilities must be planned, converted and demonstrate efficacy" before a transition to low-enriched sources can take place.

The statement also suggests "a public-private partnership to speed the availability" of the required materials, identifying the University of Missouri Research Reactor Center (Columbia, Missouri) as one promising supply. The statement identifies "the collaborative effort between the companies Babcock & Wilcox (Lynchburg, Virginia) and Covidien (Mansfield, Massachusetts) to build a reactor running strictly on" low-enriched uranium as the other. "Together, these two sources could eventually meet 100% of the U.S. demand for Mo-99," the paper states.

Obesity said to drive healthcare costs

The nation's expanding waistline is expanding the nation's healthcare tab right along with it, according to a recent report published in the healthcare policy journal Health Affairs, which made the case that spending on weight-related health issues made up 9.1% of all medical spending.

The study, conducted in part by the Centers for Disease Control and Prevention and the Agency for Healthcare Research and Quality, concluded that obesity rates "grew by 37% between 1998 and 2006," according to a July 27 statement, an increase that is blamed for adding $40 billion to the U.S. healthcare tab. The statement also noted that the study saw obesity's share of healthcare spending as rising to the 9.1% figure from 6.5% in 1998.

Lead author Eric Finkelstein, PhD, director the public health economics program at RTI International, the third party involved in the study, said in the statement that obesity "will continue to impose a significant burden on the health care system as long as ... prevalence remains high." The report also concluded that per capita healthcare spending for obese people was 42% higher – or $1,429 more per year – than for their more svelte neighbors. The greatest part of this increase for Medicare beneficiaries was for prescription drugs, pegged at $600 a year more for the obese.