FDA Seeks Improved Reporting on Medical Device Injuries DeathsNov 9, 2016
The U.S. Food and Drug Administration (FDA) is seeking to improve hospital reporting of deaths and injuries after inspections last year at 17 hospitals exposed numerous device safety issues. During last December's FDA inspections, it was revealed there was a limited or no reporting of injuries or deaths originating with the use of medical devices at these hospitals. This led the FDA to ramp up the way it interacts with hospitals regarding medical device data collection and reporting, Fierce Biotech wrote.
FDA Findings During Hospital Inspections
The 17 hospitals inspected by the FDA were chosen due to reports of unintentional spread of uterine cancer when power morcellators were used, as well as infections that were spread from one patient to another due to contaminated endoscopes, as reported in a recent FDA blog post by the director of the FDA's Center for Devices and Radiological Health, Dr. Jeffrey Shuren.
The inspections revealed that hospital staff were frequently not aware of or not trained to comply with FDA medical device reporting requirements. The FDA also discovered that some hospitals did not file the obligatory reports for device-related deaths or injuries that occurred at their sites. Some hospitals were found to not have the necessary infrastructure available for reporting adverse events to the FDA or manufacturers, according to Dr. Shuren.
"Based on the number of user facilities in the United States and the number of reports we receive, we believe that these hospitals are not unique in that there is a limited to no reporting to FDA or to the manufacturers at some hospitals," said Dr. Shuren.
Shuren's blog post stated that the agency will work with hospitals on various ways to help promote the safe use of medical devices. The FDA will examine whether the current reporting requirements should stay in place, or be amended to use new software tools as well as using information available from the National Evaluation System for Health Technology.
The FDA is planning to hold a public workshop on December 5, 2016 on the role of hospitals in data generation in post-market surveillance and hospital-based surveillance, along with integration of unique device identifiers into electronic hospital records. Dr. Shuren remarks that "Once a device is on the market, for example, doctors may use it beyond the FDA cleared intended use. In addition, subsequent modifications to the device or changes in how the device is used in practice can result in new safety risks or greater frequency of known risks."
Previous FDA Warnings of Reporting Issues
The FDA cited three device manufacturers, Olympus, Pentax, and Fujifilm, with warning letters concerning their duodenoscopes. The letters criticized the companies for neglecting to report contamination problems with the endoscopes and, at times, for not verifying that the devices had been sufficiently cleaned, Bloomberg reports.
Olympus, the largest United States manufacturer of duodenoscopes, did not report cases for three years of 16 patients contracting Pseudomonas aeruginosa infections following a procedure with its scope, the FDA said in its letter to the company. Pentax did not report cases of patients developing CRE infections after being treated with their devise within the designated 30-day reporting period, said the FDA in a separate latter. CRE (carbapenem-resistant Enterobacteriaceae) is a bacteria that have become resistant to most available antibiotics, according the Centers for Disease Control (CDC).
In 2014, the FDA increased its oversight for power morcellators and recommended that they not be used for hysterectomy or uterine fibroid removal procedures as it was found device could spread hidden cancer in some patients. This was greeted with resistance from physicians who maintained that the FDA used flawed data in their evaluation of the morcellator's safety, and that restriction of power morcellator use would limit choices for women who need to have fibroid removal.
Steps Taken to Improve Medical Device Oversight
According to Fierce Biotech, the FDA after reviewing medical literature in 2015, found that women having minimally invasive surgeries to remove uterine fibroids had a 1 in 350 risk of having uterine sarcoma and that the power morcellator could spread cancerous tissue. The FDA then required manufacturers to add boxed warnings and two contraindications for the power morcellator in their product labels that educate patients and providers about potential morcellator dangers. The agency also noted that power morcellators are not recommended for use in older women or patients who could have tissue removed intact through the vagina or a mini-laparotomy incision.
Do You Seek Legal Advice Concerning a Medical Device Injury?
If you or someone you know has been injured or died due to a medical device, you may have valuable legal rights. Parker Waichman LLP is a national personal injury law firm that has years of successful experience handling medical device injury cases. If you have any questions or believe you or someone you know has a claim, we urge you to contact the Parker Waichman medical device injury lawyers at 1-800-YOURLAWYER (1-800-968-7529).