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By: Bill Meltzer
Published: 10/10/2007
Infection Controversy
Hospital, Sterilizer Manufacturer Debate Responsibility for Deadly Bacteria Outbreak
The Steris System 1 sterilizer is at the center of a public battle between Pittsburgh's Allegheny General Hospital and Steris Corp. Both parties are blaming the other for the deadly bacteria outbreak that infected 16 patients who underwent bronchoscopy at the hospital last year. One person died. (Eight other infected patients also died, but their deaths were not attributed to Pseudomonas aeruginosa, according to numerous published reports.) According to published reports, Allegheny General claims the sterilizing systems were defective. Steris claims the hospital didn't follow proper sterilizing procedures. The FDA says it is investigating.
An Allegheny General spokesperson declined comment, but the hospital blames the Pseudomonas infections on two serious potential equipment defects that prevented the sterilizers from properly sterilizing the bronchoscopes, according to published reports:
Steris, which has made more than 16,000 sterilizers used by 5,000 healthcare facilities across the United States, "categorically rejects" the hospital's findings. In a statement released to Outpatient Surgery, Steris says it is cooperating fully with an FDA investigation and calls the hospital's claims "false, misleading and not reflecting an appropriate investigation."
Regarding the filter, Steris's Kevin Marsh says in an interview that the letter Steris received was a request for information, not a warning letter. He says, "we responded [to the FDA] with technical data supporting the safety and efficacy of the System 1 filtration system, and we answered the agency in full." According to Steris, "technical studies performed by third-party experts have demonstrated ' [the] bacterial retentive filter reliably produces sterile water for processing." Outpatient Surgery could not obtain copies of the data. Mr. Marsh adds that the System 1 has a built-in diagnostic cycle that notifies the user when to change the filter.
Regarding the tube, Mr. Marsh says that the hospital did not purchase the accessory in question.
Steris says the hospital's internal investigation is inconsistent with the preliminary FDA findings. The company says an FDA spokesperson stated, "the proper cleaning and disinfecting procedure may not have been followed. It looks like that may have been the problem, not the unit itself."
ASCs in Britain
UK Looking to Emulate U.S. ASC Model
Britain's National Healthcare Service (NHS) is looking to the U.S. outpatient surgery model to help alleviate some of the strain on the country's backlogged hospitals. In December 2002, delegates from the NHS led by Thomas Mann, MD, visited Nashville, Tenn., in search of healthcare companies interested in building outpatient surgery centers in the UK. According to Dr. Mann, the NHS is looking for U.S. companies to partner with British companies and U.S. companies who want to run facilities themselves. Says Dr. Mann, "We are just looking for good quality businesses at a value."
With Britain's nationalized healthcare system backed up with ailing patients, some patients wait more than a year for treatment, according to Dr. Mann. The NHS would like to see more ASC-like "diagnosis and treatment centers" (DTCs) up and running in the next two years with the hope that patients will only have to wait six months for surgery.
While in Nashville, home to more than 220 healthcare companies, Dr. Mann pitched his ideas to a number of interested healthcare companies at a luncheon forum hosted by the Nashville Health Care Council.
Robotic Surgery As with other laparoscopic surgeries, robotic laparoscopic surgery helps improve patient discharge and recovery times. For example, doing the prostate procedure laparoscopically allows more than half of Dr. McGinnis's patients to go home after only overnight hospital admission, with much less postop pain and faster recovery times. The downside to robotic surgery? The technology is prohibitively expensive for many facilities. The Aesop robot, manufactured by Computer Motion, costs between $40,000 and $60,000. There is no CPT code for doing prostatectomy laparoscopically and no additional reimbursement for using the robotic during the surgery. |
Florida Patient Tragedy
CRNA Pleads Guilty to Negligence in Patient's Death
Admitting she failed to monitor the vital signs of a 75-year-old woman who went into cardiopulmonary arrest three minutes into routine laser retinal surgery and died six days later, Tina Mays, CRNA, pleaded guilty last month to a misdemeanor negligence charge, officials say.
Ms. Mays, who was assisting an anesthesiologist, did not monitor the vital signs of Nealia Cunningham during an April 2001 case at the Northpoint Surgery Laser Center in West Palm Beach, Fla. A blood pressure monitor and heart rate alarm that would have sounded if Ms. Cunningham's vital signs fluctuated were switched off, court documents state. It was not until another nurse attempted to wake Ms. Cunningham after the surgery that resuscitation attempts began.
Ms. Mays, 65, a nurse for more than 40 years, subsequently falsified medical records and repeatedly lied to other medical workers about when Cunningham's heart stopped beating, according to court records. As part of her plea arrangement, Ms. Mays has agreed to serve six months of probation and surrender her nursing license.
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Hospital Reimbursement Cuts
MedPAC Recommends Less-Than-Inflation Updates For Hospitals
The Medicare Payment Advisory Commission (MedPAC) next month will recommend that Congress pass legislation to reduce the annual cost-of-living Medicare adjustment for hospital reimbursements, effective in 2004. Federal law requires a Medicare update equivalent to the Consumer Price Index (CPI). Hospitals received a 3.5% adjustment for outpatient services in 2003.
MedPAC proposes a reduction of hospital outpatient updates to the CPI minus 0.9%. Inpatient rates would be reduced to 0.4% below full inflation. MedPAC estimates that hospitals will receive $1 billion to $5 billion fewer over the next five years if Congress enacts the legislation this year. MedPAC says hospitals already receive reimbursement from Medicare to address rising technology costs, thus offsetting the need for full inflationary increases. MedPAC cites hospital new technology APCs and so-called Medicare "pass-through" payments as two ways rising costs are offset.
Spring is the season for conferences and live events, which can go a very long way toward revitalizing your outlook....
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