July 15, 2016
By Michael T. Hamilton Pennsylvania, one of the first colonies-turned-states to declare unalienable a person's right to life, must act soon to avoid becoming one of the last states to secure for terminally ill patients the right to try to save their own lives. It is natural for people to try to extend their lives and improve their quality of life, and it is fitting for people whose lives are at risk to do all they can to save themselves. Most will agree people have a fundamental right to do so, provided they exercise this right without encroaching on the rights of others.
June 10, 2016 |
WASHINGTON - The medical procedure was supposed to help Amy Reed. Instead, it spread cancer through the Bucks County woman's body, and helped spark a national fight that arrived at the Capitol on Wednesday. With Reed and her family looking on, two lawmakers rolled out bills to increase oversight of medical devices like the one that harmed her. Reed, an anesthesiologist from Yardley, had a hysterectomy in 2013 to address what doctors thought were benign growths in her uterus. Her doctors used a power morcellator to chop up her uterus.
May 27, 2016 |
Over the last 15 years, the Food and Drug Administration has approved numerous high-risk women's health devices based on weak clinical studies, including some that showed no effectiveness, according to an analysis by Northwestern University researchers. Using the FDA's database, the researchers looked at all 18 high-risk devices approved between 2000 and 2015, including products for fetal monitoring, contraception, and reducing abnormal uterine bleeding. Of the 18, four devices did not demonstrate effectiveness, six were not required to conduct postmarketing safety studies, and three have been withdrawn from the market by makers because of safety or other problems.
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.
February 20, 2016 |
As superbug outbreaks raised alarm across the country last year, a prominent doctor at Fox Chase Cancer Center wrote in a leading medical journal about how to reduce the risk of these often-deadly patient infections. Jeffrey Tokar, director of gastrointestinal endoscopy, pointed to recent outbreaks from contaminated medical scopes, and discussed steps doctors and hospitals could take to ensure patient safety, in his Sept. 22 article in the Annals of Internal Medicine. "Health-care facilities and providers should strive to establish an environment of open information exchange with patients about what is being done to maximize their safety," Tokar and his two coauthors wrote.
February 4, 2016 |
Jay Timmons was preaching to the choir in GlaxoSmithKline's sun-drenched lobby at its Navy Yard offices. Timmons, who heads the National Association of Manufacturers, emphasized the value of manufacturing, expressed concerns about what he described as business-stifling regulation and overtaxation, and stressed the importance of introducing young people to careers in manufacturing. His audience of about 60 manufacturers, business association officials, and consultants didn't sing out any amens - it wasn't that kind of crowd that gathered Tuesday to hear Timmons' talk as part of his nationwide 2016 State of Manufacturing tour.
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.
January 13, 2016 |
Thousands of women around the country who claim harm from Essure sterilization coils hope a federal judge in Philadelphia will allow five lawsuits to proceed against manufacturer Bayer Healthcare despite the device's protected status. But at a hearing on Monday, U.S. District Judge John R. Padova sounded unimpressed with some of the legal arguments submitted by lawyers for the five women. Padova directed lead attorney Marcus Susen of Fort Lauderdale, Fla., to resubmit part of the case with more specifics by Friday.
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.