April 17, 2016 |
The number of potentially deadly infections from contaminated medical scopes is far higher than what federal officials previously estimated, a new congressional investigation shows. As many as 350 patients at 41 medical facilities in the U.S. and worldwide were infected or exposed to tainted gastrointestinal scopes from Jan. 1, 2010, to Oct. 31, 2015, according to the Food and Drug Administration. A separate Senate investigation released in January found 250 scope-related infections at 25 hospitals and clinics in the U.S. and Europe.
February 27, 2016 |
For much of his congressional career, U.S. Rep. Mike Fitzpatrick focused on policy issues from national security, to taxes, to health care. Medical device safety wasn't high on the list. But that changed in 2014 when Fitzpatrick had a chance meeting with cardiac surgeon Hooman Noorchashm and his wife, Amy Reed, an anesthesiologist, during a Christmas parade in Yardley. Noorchashm and Reed approached Fitzpatrick and in an hour-long talk in the chilly rain told him the disturbing story of how a widely used device called a power morcellator had spread an aggressive uterine cancer through Reed's abdomen during a hysterectomy.
January 21, 2016 |
Johnson & Johnson plans to cut about 3,000 employees, or 1 in 20, from its global medical-device workforce in hopes of saving up to $1 billion in yearly costs. The drug and medical-supply company will use that money to invest in "new growth opportunities," J&J said Tuesday. In a statement to employees, J&J said the cuts would "accelerate its pace of innovation. " The company expects a pretax restructuring charge of up to $2.4 billion by 2018, including $600 million later this year.
November 15, 2015 |
The U.S. Food and Drug Administration ordered a Bucks County manufacturer Friday to recall all 2,800 of its automated washing machines that are used to clean and disinfect endoscopes in hospitals and outpatient clinics. The FDA said its action against Custom Ultrasonics, of Ivyland, was prompted by continued violations of federal law and of a consent degree that the company entered into in 2007. Citing reports of serious bacterial infections at hospitals that use the company's machines, formally called reprocessors, the agency said in a news release that technicians should use alternate cleaning methods such as manual disinfection.
November 6, 2015 |
A renowned Boston medical center was ordered by a judge Tuesday to stop imposing extraordinary security measures on a Bucks County cancer patient and her husband, who have been sharply critical of Brigham and Women's Hospital. The Massachusetts judge agreed with the couple, Amy Reed and Hooman Noorchashm, that the security was intended to intimidate them, and violated their right to free speech as well as the hospital's own policies. Hospital officials declined to comment. Reed, 42, an anesthesiologist at the University of Pennsylvania, and Noorchashm, 43, a cardiac surgeon at Thomas Jefferson University Hospital, have led a highly effective national campaign to ban a gynecological surgical device that Brigham doctors used to perform her hysterectomy two years ago. The tissue-slicing device, an electric morcellator, spread her hidden uterine cancer - a danger that they have since publicized.
October 28, 2015 |
A medical device used for decades has emerged as a worrisome source of infections, apparently sickening eight patients at a central Pennsylvania hospital - four of whom died. The device is a heater-cooler unit, widely used during heart bypass surgery to control a patient's blood temperature. The infections at WellSpan York Hospital and elsewhere are attributed to bacteria in water that circulates within the devices. European researchers and the U.S. Food and Drug Administration both say patients can be exposed to bacteria that are aerosolized through the device's exhaust vent.
September 7, 2015 |
The U.S. Government Accountability Office has agreed to investigate why an electric device used in gynecological surgery was marketed for two decades before safety warnings were issued by the Food and Drug Administration. The GAO, which investigates how the government spends tax dollars, sent a confirmatory letter to U.S. Rep. Mike Fitzpatrick (R., Pa.). He and 11 other members of Congress requested the probe last month. The tissue-slicing device, called a power morcellator, enables hysterectomies to be done through small abdominal incisions, but it can also spread and worsen undetected uterine cancer.
September 7, 2015 |
Four years ago, Wendy Schnaars had a medical device implanted in her head so she could receive cancer treatment. Today the South Philadelphia resident is healthy. The device is still in her head, and has done something else for her she never could have imagined: Got her a ticket for the ride of a lifetime. She flew last month on the NASA plane that simulates the weightlessness of being in space. Scientists had searched the nation for people, like Schnaars, who have an implant that would let them measure pressure inside the brain.
May 29, 2015 |
After a surgical device spread an aggressive but undetected uterine cancer inside anesthesiologist Amy Reed in late 2013, she and her husband launched a campaign to ban electric morcellators. Now, the Federal Bureau of Investigation has gotten involved, according to Reed's husband, Philadelphia heart surgeon Hooman Noorchashm, and Sarah Robinson, a California woman whose cancer was also worsened by the device. Both said Wednesday that they have been interviewed by FBI agents, and believe the FBI is looking into whether manufacturers failed to report deaths and serious injuries to the Food and Drug Administration, as required by federal law. "I had been trying to get the FBI's attention for a very long time," said Noorchashm, a heart surgeon at Thomas Jefferson University Hospital.