In a recent report, the United States Food and Drug Administration (FDA) reported that 12 hospitals in the United States failed to comply with their requirement to report device-related patient fatalities to the devices’ manufacturers in a timely manner. Device manufacturers have a 30-day window to report the patient fatalities to the FDA, which may then review the devices for their safety and effectiveness. Some of the hospitals included in the report failed to report the fatalities at all while others simply failed to report them within the required 10 days following the patient’s passing.
In order to create medical devices that are safe and effective, all parties must work together to identify actual and potential issues. Sometimes, doctors are not made aware of the potential issues that can arise with a piece of equipment or hospital staff members are not trained to report accidents properly, both of which can result in substandard reporting due to poor communication. Medical malpractice claims can be expensive and take a significant toll on a doctor’s career. If you are a doctor facing a claim for an issue related to poor communication or reporting in your hospital, work with an experienced health care lawyer to demonstrate that you were not negligent.
Why Did Hospitals Fail to Report Patient Fatalities?
The report found that in many of the hospitals reviewed, their staff members were not trained to comply with FDA standards. In some cases, they were not even aware of the FDA reporting standards for device-related patient deaths.
At one of the hospitals included in the report, a patient passed away due to complications from an infection linked to a contaminated duodenoscope, a device that is placed in the patient’s throat. This device is susceptible to becoming contaminated, and between 2010 and 2015, the FDA found that 350 patients had been exposed to contaminated duodenoscopes, some of whom then suffered infections as a result.
The hospitals chosen for review were facilities that have had safety issues with medical devices in the past. In total 17 hospitals were reviewed, and of that 17, 12 had failed to report device-related patient fatalities. In the report, the FDA also turned its spotlight to itself, finding that it, too, had been lacking when it came to overseeing these hospitals.
Philadelphia Health Care Lawyers at Sidney L. Gold & Associates, P.C. Defends Doctors Accused of Misconduct
If you are a doctor or another health care provider facing a disciplinary action, consider working with the Philadelphia health care lawyers at Sidney L. Gold & Associates, P.C. to defend your case. Complete our online form or call our Philadelphia offices at 215-569-1999 to schedule your initial consultation with us. We proudly serve clients from Pennsylvania, New York, and New Jersey.