A Medical Device Daily

As scrutiny by FDA and Congress increases, the device industry may be inclined to think that its fortunes on Wall Street and among private investors may be weakened, and a recent report from Moody's Investor Service (New York) hints at precisely such a scenario.

The July report by Moody's notes that "increased scrutiny could lead to greater volatility in sales and profitability, or even a prolonged downturn in credit fundamentals for some device companies." This pertains especially to "more technologically advanced companies," the report states, but "even commodity-type products can be subject to scrutiny," as was recently the case for contact lenses (Medical Device Daily, June 11, 2008).

A greater emphasis on both pre-market and post-market studies is part of the increasing cost picture for device makers, and the Moody report says that Medtronic (Minneapolis) "said that clinical expenses have risen to about 17% of its total R&D expenses this year," up from 10% in 2003. Medtronic apparently reported that it anticipates that figure to hit 20% next year.

How the agency handles the information will prove pivotal. The report notes "publicity about safety concerns ... could create 'headline risk' and have a disruptive effect on sales," but the agency's use of the Sentinel initiative may help boost consumer confidence over the long term. Nonetheless, Moody's says device makers "face more downside risk than upside over the next few years."

In a table that rates drug and device companies for their exposure, Medtronic was rated as a stable risk whereas Boston Scientific (Natick, Massachusetts) was deemed a negative risk. The only firm listed that drew a positive rating was Talecris Biotherapeutics (Research Triangle Park, North Carolina), which specializes in protein therapies.

Recalls dot FDA chart

Two device makers initiated recalls in the past few days, including orthopedic device maker Zimmer (Warsaw, Indiana).

The company notified FDA at the beginning of the month that it had recalled the tibial broach impactor, used in minimally invasive knee surgeries. Zimmer indicated that surgeons have alternate instruments for the impactor, which is used to fix an artificial knee component to the tibia, the larger of the two major bones of the lower leg. At press time yesterday, Zimmer had not responded to a call for comment.

AngioDynamics (Queensbury, New York) also fell into the recall bin with a July 10 announcement of a recall for its Centros catheter, a "self-centering central venous catheter for dialysis."

AngioDynamics says that it "became aware that the catheter cuff, a component intended to anchor the catheter in subcutaneous tissue, was inadequately attached to the catheter in a few instances, allowing movement of the catheter within the insertion site, leakage around the site, or the retention of the cuff in the tissue when the catheter is removed." The company is contacting hospitals to return all 1,500 catheters made since the beginning of the year. The problem is said to affect less than 1% of those shipped and is preliminarily attributed to the operations of a contract manufacturer. At press time, the company had not returned a call for comment.

CT energy may interact with devices

FDA published a public safety statement yesterday that some pacemakers, defibrillators, neurostimulators and infusion pumps may present a hazard when exposed to X-rays during computed tomography (CT) imaging sessions in a small percentage of cases.

The July 14 statement indicated that the problem has been discussed in the medical literature and in the MedSun reporting system. According to FDA, "it is possible that this interference is being reported more frequently now because of the increased utilization of CT, the higher dose-rate capability of newer CT machines, an increase in the number of patients with implanted and externally worn electronic medical devices, and better reporting systems."

Among the potential hazards are "generation of spurious signals, including cardiac defibrillation pulses," and resets or reprogramming of device settings. However the interaction can work both ways, possibly causing the CT procedure to miss signals or otherwise cause misinterpretation of those signals.

GHTF publishes diagnostics guidance

The Global Harmonization Task Force (GHTF) has published a guidance for classification of in-vitro diagnostics (IVD) for those who want to market internationally.

The guidance describes four categories of classification, from A to D, and states that when an IVD that falls into more than one group, the manufacturer should allocate the diagnostic to the higher-risk classification. The guidance also states that if the regulations of a particular nation indicate a lower classification than is suggested by the new guidance, "this may be unacceptable to other jurisdictions."

Among the diagnostics that would fall into the highest risk group of D are those that detect the human immunodeficiency virus and the human T-cell lymphotrophic virus, which can cause leukemia and lymphoma. IVDs that test for sexually transmitted diseases other than acquired immune deficiency syndrome, such as chlamydia, would fall into the second highest risk category, C, while hormone assays qualify for the next lower group.