Home E-Weekly May 9, 2017

News & Notes

Published: May 8, 2017

  • Medtronic issues warning related to navigation device Medtronic is updating its labeling to warn users that its NavLock Tracker device should be used only with Medtronic instruments, and that using other companies' instruments with it "may result in inaccuracy, leading to serious injury or death." The FDA identified 196 related medical device reports (MDRs) between January 2013 and March 2017, and says 2 patients died from post-operative hemorrhaging after spinal procedures in which 3rd-party navigation instruments were used with the Medtronic device.
  • Are outcomes better at Bariatric Centers of Excellence? Surgeons at surgical facilities that earn the coveted "Bariatric Center of Excellence" designation don't necessarily perform safer surgeries. Researchers who reviewed the outcomes of 45,000 surgeries performed at 165 bariatric surgery centers of excellence in 12 states from 2010 to 2013 found that rates of serious post-op complications, including heart attack, kidney failure or blood transfusion, ranges from 0.6% to 10.3%. The researchers note that Centers of Excellence must meet minimum standards with respect to case volume and bariatric equipment, but not surgical outcomes.
  • Obesity a relatively minor risk factor for pulmonary complications A new study finds that patients in the class II (BMI between 35.0 and 39.9) and class III (BMI above 40) obesity classifications are more likely than normal-weight patients to develop pulmonary complications in the first 30 days after outpatient surgery, but that the obesity-associated risk is low, compared with the risks associated with advanced age, longer surgeries and other co-morbidities, including congestive heart failure, COPD and renal failure.
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