Regulators, Lawmakers Want Better Reporting for Medical Device InjuriesNov 1, 2016
In light of medical devices that have raised concerns in recent years, regulators and lawmakers are both looking to improve the way medical device injuries and deaths are reported. Specifically, there has been criticism over the delayed awareness of power morcellators, devices that can inadvertently spread hidden uterine cancers during minimally invasive gynecologic procedures. Additionally, contaminated specialized endoscopes were linked to an outbreak of antibiotic-resistant bacteria.
The U.S. Food and Drug Administration (FDA) requires hospitals and manufacturers to report injuries and deaths associated with the use of a medical device. To address whether this reporting system has been adequate, last December the agency investigated 17 hospitals where issues with power morcellators or contaminated duodenoscopes were reported. Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a blog post that the investigation turned up “little to no reporting” of medical device injuries and deaths at these hospitals. Following these findings, the FDA is looking to improve the way medical device adverse events are reported at hospitals.
The investigations found hospitals may be under-reporting medical device injuries due to various reasons. Dr. Shuren writes that oftentimes, hospital staff did not know adverse events need to be reported or were not trained in how to comply with FDA requirements. In some hospitals, the infrastructure was not even set up for this type of reporting. Shuren writes that this finding is likely not limited to the hospitals in the investigation, stating, “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 limited to no reporting to FDA or to the manufacturers at some hospitals,”
The FDA will team up with hospitals in various ways to improve reporting. The conversation will involve whether reporting requirements need to be updated and what actions should be implemented to make use of new software tools. The agency will also consider how the National Evaluation System for Health Technology can be used to more easily identify medical device issues.
On December 5th, the FDA is holding a public workshop to discuss ways to improve hospital reporting of medical device injuries. The session will discuss post-market surveillance and hospital-based surveillance as well as the integration of unique device identifiers in electronic hospital records.
Power morcellators cut up tissue into small pieces for easy removal through small incisions. They are sometimes used to remove uterine fibroids. The issue is that in some cases, the presumed fibroid is actually an undetected uterine cancer, which is greatly worsened through morcellation. Previously, it was thought that the risk of this hidden cancer was extremely rare; a physician couple, however, shed light on the issue in 2013. The FDA warned in 2014 that 1 in 350 women undergoing a hysterectomy or myomectomy (fibroid removal) have a hidden uterine sarcoma.
Duodenoscopes manufactured by Olympus, Pentax and Fujifilm, came under fire after being implicated in an outbreak of infections with multi-drug resistant bacteria. The FDA warned that the complex design of the device makes it difficult to clean thoroughly.
Power morcellator concerns prompted lawmakers to propose the “Medical Device Guardian’s Act”, which would require physicians to report medical device injuries and deaths to the FDA. The goal is to identify medical device problems as early as possible.