Whose responsibility is it to spread the word that a medical device that’s being used in major hospitals everywhere is causing needless injury and death?
Apparently, for the last several years, no one seemed to be particularly sure.
An investigation by the Food and Drug Administration was prompted by reports that two different medical devices were known to have problems that could harm unwitting patients. Power morcellation devices, used in some of the nation’s best hospitals for laparoscopic and other procedures, were actually spreading previously undetected cancer cells throughout patients’ bodies. A design flaw in certain duodenoscopes, a type of scope commonly used in a number of procedures, allowed drug-resistant bacterial infections known as “superbugs” to be spread from patient to patient.
The FDA found that the vast majority of the 17 hospitals it inspected didn’t file timely reports about the injuries and deaths caused by these two devices. While the FDA stated that the “adverse events” associated with the devices appeared to fall under the current reporting guidelines, there’s no record that they were ever reported.
Hospitals and medical centers are required by federal law to report adverse outcomes involving a patient’s injury or death to the FDA within 10 days of the incident. In some cases, the hospitals involved didn’t believe that the incidents met the requirements of the law, so they simply didn’t report them. In other cases, the hospitals didn’t have written reporting procedures or appropriate record-keeping procedures, leaving the information lost in the institution’s internal network.
The FDA believes that the noncompliance probably extends much further than the 17 hospitals investigated, yet it intends to take no further disciplinary action. Essentially, the FDA believes that the violations weren’t willful, just the result of confusion and unclear policies inside the facilities for such actions.
The hospitals, for their part, are willing to address the violations and find more effective ways to collect the data needed. They hope to work with the FDA to improve compliance through awareness and education programs.
Where does this leave patients and the families of deceased patients who were already affected by the defective devices?
Anyone in that position would probably benefit from speaking to a medical malpractice attorney. Not only could the hospital and doctor be potentially responsible for your injuries, so could the manufacturer of the defective devices.
Source: The Cancer Letter, “FDA Finds lapses in Reporting of Patient Harm, Deaths Resulting from Medical Devices in Hospitals Nationwide,” Matthew Bin Han Ong, Dec. 16, 2016