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| Jury Awards $4.75M in Pain Pump Suit |
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An Oregon jury has ordered medical manufacturer I-Flow Corp. to pay $4.75 million in damages to a Portland man who suffered severe cartilage damage after physicians used the company's pain pump to deliver anesthetics into his shoulder joint after surgery.
The lawsuit, which alleged that I-Flow encouraged the off-label use of its pumps for shoulder-joint surgery patients, is one of more than 100 similar suits filed against pain pump manufacturers nationwide. Studies shown that administering local anesthetics directly into the joint to treat post-op pain can result in chondrolysis.
Since evidence of this potential risk surfaced in 2006, I-Flow has packaged its pumps with instructions not to place catheters in joints and has posted a warning on its Web site, reports the New York Times. But patients and doctors are accusing manufacturers of failing to warn them of the chondrolysis risk, and manufacturers and medical experts say that existing research does not conclusively prove a link.
In a recent warning, the FDA notes that it "has not cleared any infusion devices with an indication for use in intra-articular infusion of local anesthetics," and it now requires the manufacturers of local anesthetics and pain pumps to include chondrolysis warnings on their product labels.
"Local pumps should absolutely not be used in the joint at all," says Arizona-based orthopedic surgeon David S. Bailie, MD, who published a case series on this subject last year. Instead of pain pumps, he says, physicians should use traditional pain medications and/or scalene blocks to treat joint pain after shoulder surgery.
Irene Tsikitas |
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| Haiti Efforts Lead Florida to Ease Nursing Regulations |
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An executive order easing Florida's nurse licensing regulations seeks to fill staffing shortages caused when Haitian nurses left the state to join disaster relief efforts in their homeland.
Nursing union leaders and hospital administrators in South Florida lobbied Gov. Charlie Crist to enact the temporary measure, which he signed last week. It permits the Florida Department of Health to expedite the licensing of nurses from other states to work in Florida facilities for up to 3 months.
Pascal J. Goldschmidt, MD, dean of the University of Miami's Miller School of Medicine, thanked the governor for enabling many more of the state's nurses to travel to Haiti. "It is amazing the amount of work that is going on there," he says.
The Miller School and Jackson Memorial Hospital in Miami have set up a 240-bed field hospital near the Port-au-Prince airport. The makeshift hospital, which can perform approximately 50 procedures a day, has 2 ORs outfitted with anesthesia machines, surgical lights and air conditioning, equipment considered luxuries where many surgeons operate under tents using the most basic of surgical instrumentation. The compound also contains 2 large tents for supply storage and staff housing, and will soon have a pathology lab and imaging center up and running.
"Now we're going to be able to use more modern medicine," says Eduardo de Marchena, MD, the Miller School's associate dean for international medicine. "This is the most inspiring effort I've ever participated in."
Daniel Cook |
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| Insurer Drops ENT Who Gave Genital Exams |
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A postscript to last month's story on the ENT surgeon who allegedly gave unconscious male patients genital exams without their consent: United Health Care has dropped her as an in-network provider.
As a result, patients of Twana Sparks, MD, at the Gila Regional Medical Center in Silver City, N.M., must either pay more to continue to see her or drive hours to the next nearest ear, nose and throat specialist.
The state medical board had placed restrictions on Dr. Sparks's license after investigating allegations that she had unnecessarily examined the genitals of some of her male patients while they were under anesthesia in the OR.
In a letter to her patients dated Dec. 3, 2009, Sparks wrote, "Any visit to me will be more expensive to you. My restrictions have nothing to do with my skills as a physician or surgeon."
Dan O'Connor |
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| InstaPoll: Sexual Harassment in the Healthcare Workplace |
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Have you ever been a victim of sexual harassment on the job? Tell us in this week's InstaPoll. We'll report the results in this space next week.
The 2 procedures that 46 respondents to last week's poll question are most interested in adding are pain management (33%) and spine (30%). Receiving less interest: retina (15%), bariatrics (13%) and endoscopic sinus (9%).
Dan O'Connor |
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| News & Notes |
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Tip of the week "When nurses from several different facilities work together, they all know how to do everything, but they all do it differently," writes Debbie Comerford, BSN, CNOR. Conducting occasional mandatory training meetings for your nursing as well as your reprocessing and housekeeping staffs, during which you quiz them on proper practices, stress the importance of consistency and review compliance with written policies, can get them all on the same page on important subjects such as clinical practices or infection prevention.
Injections may improve knee surgery For arthritic patients recovering from arthroscopic knee surgery, sodium hyaluronate injections can reduce pain while improving mobility and post-op quality of life, according to a study published in the December 2009 issue of the American Journal of Orthopedics. Researchers randomly assigned 46 patients with early-stage osteoarthritis undergoing repairs of meniscus tears into injection and control groups, which were compared at 3 and 6 months post-op. They discovered that patients who received injections enjoyed greater pain relief at 3 months and knee flexion at 6 months than patients who underwent surgery alone. The injection group was also less likely to experience knee tenderness, pain during motion or crepitus at both 3 and 6 months.
Post-op precaution studied The use of pulse oximetry and a monitor that alerts providers when the oxygen saturation level in a patient's blood drops can reduce the incidence of post-operative emergency rescue calls and intensive care transfers, say researchers at Dartmouth-Hitchcock Medical Center in Lebanon, N.H. Their 2-year study, which appears in the February issue of the journal Anesthesiology, found that intervening as soon as O2 saturation levels and heart rates dropped often forestalled the need for rescue procedures.
Universal protocol clarification The Joint Commission is revising its Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery to clarify a site marking rule. While the protocol has previously stated that site marking alternatives are necessary in "interventional procedure cases for which the catheter/instrument insertion site is not predetermined (for example, cardiac catheterization, pace-maker insertion)," the commission's Web site has noted that they are not necessary in such cases. The revision, which will appear in the July 2010 electronic and print manual updates, will conform with the Web site's statement.
New disinfectant developed Researchers at the Robert Koch Institute in Berlin, Germany, report that they have created a new, fast-acting disinfectant that won't harm surgical instruments. The compound, which includes 20% alcohol and an alkaline detergent, was found to eradicate the bacteria, viruses, fungi and prions in coagulated blood without corroding metal, note the researchers in the Journal of General Virology. |
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