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| Feds to Investigate Reprocessing, Reuse of SUDs
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If you employ a third party to reprocess some of your single-use surgical devices, your supply budget could get a little tighter, depending on the outcome of a Government Accountability Office investigation.
The GAO has accepted a request from the House Government Reform Committee to update its June 2000 report on the reuse of single-use devices, focusing on government oversight of reprocessing, says Paul Anderson, a spokesman for the federal oversight committee.
In a letter to Comptroller General David W. Walker, reform committee chair Rep. Tom Davis (R-Va.) and ranking minority member Rep. Henry A. Waxman (D-Calif.) write that they are "alarmed" by "many instances of patient injuries associated with the use of defective or unsterile reprocessed single-use medical devices" and "the lack of independent information available about the safety of the reprocessing of single-use medical devices."
Further, in a letter to Andrew C. von Eschenbach, MD, acting commissioner of the FDA, the congressmen request that the agency reveal
the steps it has taken to ensure SUDs are safe and efficacious;
information regarding any SUD-related complaints received through the MedWatch adverse-event reporting system;
any enforcement action it has taken against third-party reprocessors since the enactment of the Medical Device User Fee and Modernization Act in 2002; and
the current good manufacturing process for reprocessing SUDs and the limits on the number of times a device may be reprocessed.
The FDA did not return requests for comment, but a spokeswoman said in published reports that the agency is engaged in strict oversight of the SUD-reprocessing industry. David Sheon, a spokesman for the Association of Medical Device Reprocessors, says the organization is "confident that the GAO will again take a thorough look at reprocessing and issue a report confirming that the industry is stringently regulated and reprocessed devices are safe."
The GAO will be consulting with the reform committee to determine the scope of work and timing of the investigation, says Mr. Anderson.
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| Iowa Hospital Resuming Bariatric Surgery Following Patient Deaths
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An Iowa hospital that stopped performing bariatric surgery 17 months ago following a rash of patient deaths and negative publicity is set to restart its gastric bypass program next month. Iowa Methodist Medical Center suspended its program in 2004 when seven patients died after undergoing the surgery at the hospital.
The Des Moines hospital has recruited a surgeon who says he has performed 340 of the operations without a single patient death, and he is hiring a bariatric surgery team that will include a full-time dietitian, psychiatric counselor, nurse coordinator, physician assistant and surgeon.
"The only pressure I feel is to do the same good job that we always do," says the new physician, Todd Eibes, MD, FACS. "We'll be going a little slow to educate the people at Iowa Methodist."
Dr. Eibes says he prefers open to laparoscopic gastric bypass, which means his patients generally spend three or more days recovering in the hospital. "My bias is that open's a little safer," he says. "The tradeoff is a higher rate of hernia and wound problems, but I tell patients that I can easily fix those and that they're less likely to suffer intestinal leaks."
Between 2001 and September 2004, Methodist hosted 326 gastric bypass surgeries. The news that surgeons had decided to stop performing them because their malpractice insurance rates had spiked came after disclosures that seven patients had died.
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| Pa. Lawmaker Seeks CON's Return
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Could certificate of need regulations be returning to Pennsylvania for the first time since 1996? Under legislation that Pennsylvania state Rep. Phyllis Mundy plans to introduce, local hearings and permission from the Pennsylvania Department of Health would be required before any hospital or freestanding healthcare facility, including surgery centers, is built. Existing healthcare facilities are expected to be grandfathered, she says.
Ms. Mundy says that her bill is a response to escalating healthcare costs. She contends that an overbuilding of healthcare facilities has led to fewer procedures performed in existing enterprises. Ms. Mundy plans to introduce the legislation later this month. The bill doesn't yet have a corresponding sponsor in the state senate.
Pennsylvania is one of 14 states without CON regulations. While surgery center owners have generally opposed CON regulations, Pennsylvania surgeons don't need to panic yet, observers say. "There have been numerous bills introduced but it hasn't progressed very far," says Anita Fuhrman, CASC, president of the Pennsylvania Ambulatory Surgery Association. "I suspect that it would be a hard sell at the state level."
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| News and Notes
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ANESTHESIOLOGY PRACTICES REPORT that, on average, their profit margins grew faster than their total medical revenue in 2004, according to a recently published industry survey. While median total medical revenue rose only 2.6 percent between 2003 and 2004, from $509,141 to $522,575, the average profit margin — calculated as revenue minus operating costs — jumped 10.5 percent during that time, from $403,029 to $445,339, says the Medical Group Management Association. The Englewood, Colo.-based association, which compiled its annual "Cost Survey for Anesthesia Practices" in collaboration with the American Society of Anesthesiologists, attributed the difference to budget cuts in the interest of staffing. "Anesthesiology has a shortage of physicians, so we pay a premium not only to recruit associate-level physicians but also established physicians and certified registered nurse anesthetists," says Asa Lockhart, MD, a survey advisor to MGMA, in a statement.
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