A Medical Device Daily

The cost of care for diseases of the heart has risen over the past decade or so, to no one's surprise, but the degree of increase might set some observers back.

According to numbers released recently by the Agency for Healthcare Research and Quality (AHRQ), the cost of dealing with cardiovascular disease jumped by 40% between 1997 and 2006 to about $57.9 billion. Reversing the raw numbers back to baseline suggests that the absolute dollar amount in 1997 was about $41 billion, but the agency notes that its numbers adjust for inflation.

On the other side of the coin is the fact that AHRQ's numbers, drawn from the Hospital Cost Utilization Project (HCUP), indicate that the pace of increase has slowed to about 2% per year. According to the AHRQ statement, this is "attributable to a slight decline in the number of heart disease cases and slower increases in the cost per case."

Leading the inflation of cardiac care was treatment for chest pain "with no determined cause," which rose at a 10%-a-year clip, from $1.6 billion to $3.9 billion. Electrophysiology disease came in second in the race, almost doubling from $3.5 billion to $6.8 billion for an average increase of 7.7%.

In terms of absolute cost, coronary artery disease is tops, from $14.5 billion to $17.5 billion, but the rate of increase was the lowest at 2.1% a year. Congestive heart failure took a $6.6 billion bite out of the nation's healthcare budget in 1997, but flirted with a doubling to $11.6 billion in 2006 for an annual jump of 6.1%, placing it third in absolute terms.

Myocardial infarction, or heart attack, accounted for a 3% increase each of the 10 years, rising from $9 billion to $11.8 billion for second place in absolute numbers. Heart attacks, which typically are caused by blocked coronary arteries, still are the source of the greatest number of fatalities by some accounts.

According to AHRQ, treatment for these conditions aggregately "accounted for 17.6% of the $329 billion hospitals spent on patient care in 2006 slightly lower than in 1997 when these conditions accounted for 18.7% of the $216 billion spent."

FDA inks guidance on sterilization

FDA's guidance machine churns on with a new guidance on sterilization methods via a Dec. 12 document prompted by "an increased number of 510(k)s for devices labeled as sterile that use non-traditional sterilization methods in their manufacture."

The agency notes that the guidance does not deal with sterilizers "that are themselves medical devices subject to 510(k)" rules or to reusable devices sterilized in healthcare settings. The agency also notes in the document that "there may be novel non-traditional sterilization technologies used in the manufacture of class I and class II devices," although FDA doesn't state whether it intends to deal with this issue for PMA devices.

Other exclusions are "processes that rely on microbial exclusion," such as heparin and saline lock flush solutions, and any process "that incorporates materials of animal origins," which will be addressed in a separate guidance.

Among the non-traditional methods of interest to the agency are chlorine oxide and "ethylene dioxide (EtO) in a bag," which is often delivered via diffusion or injection. According to FDA, the in-the-bag mode "specifies a volume of EtO instead of a concentration" and delivers the agent via a cartridge, capsule or humidichips. This guidance also addresses "long gas dwell times" for EtO. Other methods include microwave radiation, various light sources and sound waves.

The guidance notes that the Office of Device Evaluation should refer these new sterilization methods to the infection control devices branch at the Center for Devices and Radiological Health for "sterility consultation review."

The agency confirms that because a sterility failure carries a great risk to patients "we intend to inspect the manufacturing facility before clearing a 510(k) for a device that is sterilized by a novel non-traditional" process.

FTC hits cosmetic lens makers

The holidays are supposed to give us a new look at things, something the contact lens industry has wanted to aid us with for years. However, FDA has cracked down on the marketing of such lenses along with the help of the Federal Trade Commission.

FTC announced Dec. 11 that it was fining two web-based manufacturers of cosmetic contacts for selling their products minus prescriptions.

According to FTC, See Right Vision (Wellesley Hill, Massachusetts) is under order to pay a civil penalty of $27,000, while Contact Lens Heaven (Plantation, Florida) was penalized $233,498. The latter firm is apparently able to pay only $15,000, as suggested by the FTC statement that "because of the company's inability to pay, all but $15,000 has been suspended."

FTC notes that the court order obtained for the action "also prohibit the defendants from selling contact lenses without obtaining or verifying prescriptions directly from the prescribers," and also "contain various record keeping provisions to assist the FTC in monitoring the defendants' compliance."