A Medical Device Daily

The FDA this week issued a proposed rule designed to make the contents of medical gas containers more readily identifiable, in order to prevent deaths and injuries from inadvertent use of incorrect medical gas or from use of contaminated medical gas.

Medical gases such as oxygen, nitrous oxide and nitrogen, are administered to patients in healthcare facilities and the home to treat, for instance, emphysema.

The agency said that in some cases, injury or death has resulted from a medical gas mix-up caused by one of several factors, including mistaken administration of industrial gas to patients, improper connection of industrial gases to medical oxygen supply systems, and contamination of medical gas cylinders with residues of industrial cleaning solvents.

The agency said that it has received reports of at least eight deaths and 18 serious injuries as a result of medical gas mix-ups between 1996 and 2006.

“By issuing this proposal, FDA is heightening consumer and industry awareness about this specialty area of regulated products. Greater understanding of the possible problems associated with the use of medical gases and the steps we can take to eliminate them will only lead to safer use of these products,“ said Steven Galson, MD, director of the Center for Drug Evaluation and Research.

This regulation would apply to medical gas manufacturers and distributors and will require that certain portable medical gas containers comply with the following requirements:

  • outlet connections (used to connect these containers to gas supply systems) that cannot be readily removed;
  • identification by labels that wrap all the way around the tops of the containers;
  • painting of high-pressure medical gas cylinders according to a standard color-coding system that corresponds to the gases stored in them;
  • and dedication to medical use and not converted to industrial use.

The FDA said that besides a “careful evaluation“ of the operations and processes required to produce suitable medical gases, the agency has conducted several public meetings to gather comments from the medical gas industry, patients, professional associations and manufacturers.

Additionally, it said that the Joint Commission on Accreditation of Healthcare Organizations and the National Fire Protection Association have taken steps to help prevent medical gas mix-ups and ensure the safe use of medical gases.

The proposed rule is intended to supplement existing FDA regulations and guidance regarding the safe use of medical gases by adding requirements – based largely on current, recommended, industry practice – to minimize the incidence of medical gas mix-ups and contamination. It is intended to ensure that health care facilities and patients receive only appropriate, safe, effective and high-quality medical gases.

There is a 90-day public comment period on the proposed regulation before FDA develops the final rule.

White House blocks Medicare data release

In President George Bush's State of the Union address this year, he stressed the need to give consumers more information concerning the delivery and outcomes of the healthcare service and procedures received, and he has followed that with frequent calls for more of this type of information to empower consumers.

But the New York Times reported Tuesday that the administration is blocking the release of patient claims data held by Medicare to the Business Roundtable (Washington), which is seeking the information, it said, to assist employers in cost-comparison studies. The Business Roundtable represents chief executives from as many as 160 large U.S. companies.

Maria Ghazal, director of public policy at the Business Roundtable, told the Times that the data is “a gold mine of information,“ but the government has cited large difficulties in supplying all of the data and it questioned the validity of the proposed uses.

Specifically, representatives of Medicare have said that the data cannot be used to supply information concerning individual physician performance. They support the position with reference to issues of physician privacy a 1979 ruling prohibiting such disclosure.

Yesterday, a Times editorial criticized the government's position, citing the value of the data, when “properly scrubbed,“ for assessment of healthcare delivery and the need for Congress to change the law so as to allow the disclosure.

Cardiogenesis misses filing deadline

Cardiogenesis (Foothill Ranch, California), a developer of surgical products and accessories used for angina-relief, reported that it filed with the SEC indicating its delay in filing Form 10-K for the year ended Dec. 31.

One reason the company gave for the delays is its work to resolve an issue raised in a letter from the SEC's Division of Corporate Finance, inquiring into the company's accounting policies relating to revenue recognition for its loaned laser program and, in particular, whether lease accounting should apply to such program. The company said that, in its view, the main issue is the treatment of premiums charged on the handpieces sold under the program. It said total premiums associated with the loaned laser program represent 5% to 8% of annual revenues for each of the years ended Dec. 31, 2004, 2003, and 2002.

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