A Medical Device Daily

Six manufacturers of respirators – representing, they said, about half the respirator production capacity of the U.S. – have urged President George Bush to back legislation ensuring the supply and availability of disposable respirator masks (N-95 respirators) for healthcare workers and other first responders.

A letter from the manufacturers, they said, essentially “echoes” a letter sent to the administration in May by 86 members of Congress calling for the National Strategy for Pandemic Flu Influenza to stockpile N-95 respirator masks instead of surgical masks.

The manufacturers that sent the letter – Aearo (Indianapolis), Bacou-Dalloz (Smithfield, Rhode Island), Inovel (Culver City, California), Moldex (Culver City, California), MSA (Pittsburgh) and North Safety (Cranston, Rhode Island) – are members of the Coalition for Breathing Safety, formed in 2004 to promote respiratory safety products.

“Unfettered liability costs will dramatically affect our nation's ability to respond to an avian flu pandemic,” wrote the company executives. “Costs of defending litigation, aside from settlements or verdicts, amount to hundreds of millions of dollars. In fact, currently, 90[%] to 94% of profits are being consumed to maintain litigation efforts.”

The letter terms disposable respirators “inexpensive,” hence adding no “unfair liability costs” to the price of the respirator devices. “Thus, we are compelled to withhold further investment in production capacity, exit the marketplace or manufacture abroad for foreign buyers where no litigation crisis exists.

“This is not in the public interest. Respirator manufacturers are not, and have never been, part of the problem underlying end-user illnesses, but we can be part of the solution to minimize the spread of avian flu in the U.S. if a pandemic occurs.

“Without legislation, the ability for American manufacturers to address emergency preparedness or have surge production capacity is and will be severely constrained.”

The companies said that one respirator manufacturer has stopped making the respirators for the industrial market and that another “is seriously considering” such a move.

The result, it said, has been difficulty in convincing shareholders “to invest in new capacity” in the U.S.

The coalition urged Bush to support bi-partisan legislation introduced in the House (H.R. 2357) that would preempt lawsuits claiming defective design or insufficient warning if a respirator is NIOSH-approved.

Union: no discrimination vs. diabetic drivers

In response to a Department of Transportation request for public comment, Edward Wytkind, president of the Transportation Trades Department, AFL-CIO (TTD; Washington), has sent a letter to the DoT regarding the medical qualification standards that would allow diabetic drivers to operate motor vehicles in interstate commerce.

Wytkind's letter says that “Qualified drivers who treat their diabetes with insulin deserve the opportunity to operate commercial motor vehicles in interstate commerce. It is unfair to discriminate against diabetic drivers by placing unwarranted and unjust obstacles in the way of many qualified drivers when diabetes is such a treatable disease.

The letter also notes the “advancement” in the treatment of diabetes and that motor carrier regulations should reflect this. “Thankfully, Congress eliminated the requirement that individuals with diabetes have three years experience operating a commercial motor vehicle while using insulin in last year's surface transportation reauthorization bill. We now call on the DOT to implement this change and to certify qualified diabetic drivers as quickly as possible.”

The letter argues that drivers who are examined and given a positive assessment of their treatable diabetes should receive a license and the approval to operate “without restriction.”

TTD says that its members work in aviation, bus, mass transit, rail, trucking, highway, longshore, maritime and related industries.

House vote backs Health Centers

The House of Representatives on Wednesday approved legislation to reauthorize the federal Health Centers program, H.R. 5573, by a vote of 424-3, sending the bill on to the Senate.

The bipartisan “Health Centers Renewal Act,” introduced by Nathan Deal (R-Georgia) and Gene Green (D-Texas), preserves various elements of the program, including the 51% patient majority governing board, considered the cornerstone of the program's success in keeping communities healthy. The legislators praised the accomplishments of health centers, citing their ability to narrow health disparities among vulnerable populations, keeping down costs, and reducing unnecessary visits to hospital emergency rooms.

“Community Health Centers are the best thing that has happened to ambulatory medical care since Medicaid and Medicare,” said U.S. Representative Danny Davis (D-Illinois). “I have been to health centers across the country and they do an outstanding job.”

Hospital deeming authority to be reviewed

TÜV Healthcare Specialists (TÜVHS; Cincinnati, Ohio) reported that it has been notified by the Centers for Medicare and Medicaid Services (CMS; Baltimore) that it must submit for a second review cycle before its application for hospital deeming authority can be granted.

TÜVHS said it is pushing a new approach – “significantly new,” it said – to hospital accreditation, called National Integrated Accreditation for Healthcare Organizations (NIAHO), combining ISO 9001 quality management with the conditions of Medicare participation that allow hospitals to receive Medicare and Medicaid reimbursement.

“We are very close, and are grateful for the guidance CMS has provided to make sure our new accreditation process is precisely aligned with their highest expectations,” said Rebecca Wise, CEO of TÜVHS. “Much of our fine-tuning will address the unique way that ISO surveys integrate with traditional Medicare audits. The process needs to be extremely consistent, repeatable and ready to meet the demand nationwide.”

The formal announcement of the CMS decision will be published in today's issue of the Federal Register.

“Given the magnitude of what we're doing, I would have been surprised if CMS didn't want some changes,” said Stefan Butz, president and CEO of TÜV America, parent company and majority shareholder in TÜVHS. “CMS has given us the data we need, and we're well on our way to delivering a new proposal that will meet or exceed every requirement. We also look forward to the continued support of our hospital client base in charting new territory to introduce an innovative alternative to current accreditation alternatives.”

TÜVHS said that with approval of the deeming status it will become the first new hospital accreditation program in more than 40 years and the only program to integrate ISO 9001 quality management with Medicare accreditation.

The company said it expects its revised application the deeming authority to be submitted by the end of July.

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