A Medical Device Daily

Medical isotopes such as technetium-99, used to treat a range of cancers, are not the stuff of cartels, but recent events have made it clear that the supply of such materials should not be taken for granted.

The news last November that one of the principal suppliers had to shut down a reactor sent a few burps through the supply chain, but Atomic Energy of Canada Ltd. (AECL; Mississauga, Ontario), managed to restart the unit by the following month (Medical Device Daily, Dec. 20, 2007). AECL had commenced work on another reactor to produce the precursor of technetium-99, molybdenum-99, but announced in May that it had terminated the effort due to "the costs of further development, as well as the timeframe and risks involved with continuing the project," according to a May 16 announcement.

The latest body blow to supplies of technetium-99, which has a shelf life of six hours, arrived in the form of an announcement by the Nuclear Research and Consultancy Group (NRG; Petten, the Netherlands), which said it had to shut down a reactor temporarily to deal with the appearance of bubbles that defied explanation.

In an Aug. 26 statement, NRG stated that an inspection conducted last month disclosed the periodic presence of "a very small trace of gas bubbles (as thin as a needle)" migrating into the primary cooling system of the company's High Flux Reactor.

The company said that "source and composition of the gas are currently under investigation," but that "the safety relevance of this anomaly is as yet unknown and as a consequence we have decided that we will not start up the planned irradiation cycle." No public health threat is expected because "the primary system is a closed system," and NRG expected to announce "which measures are needed in order to enable the safe re-start of the reactor" within a week of the shutdown. However, NRC indicated in a Sept. 3 statement that production will not commence until Oct. 25.

In an Aug. 27 statement, Robert Atcher, PhD, president-elect of the Society for Nuclear Medicine (SNM, Reston, Virginia) said the shutdown at Petten "threatens the ability of countries across the globe to access and obtain radioactive isotopes." He said the Petten shutdown, when combined with the situation in Canada, "is simply devastating."

Atcher described the situation as "a perfect storm in isotope availability," adding that the predicament "highlights the vulnerability of having no domestic source of clinically used isotopes in the United States."

In an Aug. 28 statement, MDS Nordion (Ottawa, Ontario), which serves as a wholesaler for medical isotopes, stated that the company is "aware of the shutdown of a nuclear reactor in the Netherlands and of its impact on medical isotope supply."

Company gets warning, drags out fixes

FDA does not frequently lower the boom right away on device makers whose adherence to the quality systems regulations falls short of the mark, but an Aug. 27 warning letter to Fall Prevention Technologies (FPT; Kettering, Ohio) suggested the agency is lenient to makers of non-critical devices. The letter asked about a corrective action that the firm apparently indicated it will need until January to implement.

The warning letter stated that the maker of the Balanceback iVNG, a diagnostic for assessing balance disorders which is sold by Balanceback (Boca Raton, Florida), had not established an exhaustive quality system, noting the absence of procedures for complaints, design controls and corrective and preventive actions. FDA indicated that the firm's response to the inspectional findings was that corrections for this series of citations would not be fully implemented until Sept. 30.

The warning letter said that FPT could not explain "why an investigation was not conducted" on all but one of 128 complaints reviewed by the FDA investigator. FDA asked that the company "provide our office with additional information concerning the new tool you will use to manage and organize your complaints."

The company's records also indicated that five out of 11 device history records "revealed that the devices had been released prior to written approval." The agency acknowledged "that you have fired one employee over this incident and hired and trained a new employee," and noted that documentation offered to clear up the finding "contains spaces for training procedures," but that "none of these spaces are completed."

The warning letter also noted that FPT had no device master record for the iVNG and that "this item is not scheduled for completion until Jan. 15, 2009." The letter requested "an explanation for the delay in completing corrective action for this item."

Attempts to contact the company for comment were unsuccessful.

OIG says Medicare contractor overpaid

Medicare cost control requires a lot of work on a lot of fronts, and a recent analysis of claims paid by Medicare contractor Palmetto GBA (Columbia, South Carolina), suggested that tighter scrutiny of high-dollar payments is needed.

The Sept. 4 report by the Office of Inspector General (OIG) at the Department of Health and Human Services stated that between Jan. 1, 2004, and Dec. 31, 2006, Palmetto overpaid 16 Medicare Part B providers more than $33,000 in claims. OIG recommended that Palmetto undertake the task of getting the money back from the providers.

OIG stated that for the period under review, Palmetto had processed more than 370 claims of $10,000 or better and that 355 of those claims looked appropriate. The providers in question "attributed the incorrect claims to clerical errors" and Palmetto indicated that the claims processing system in place at the time "did not have sufficient edits in place to detect and prevent payments for these types of erroneous claims." Starting in January of last year, however, Palmetto started checking claims for "medically unlikely" claims to weed out the bad claim filings.

In a July 18 response to a draft of the report, Bruce Hughes, President/COO of Palmetto, indicated that he agreed with the OIG findings and that Palmetto "will follow through [with recovery activities] until all overpayments are recovered."

Palmetto had not responded to a call for comment by press time.