FDA: Some hospitals not following reporting rules on medical devices

How hospitals act when it comes to medical devices matters greatly. This includes what a hospital does after injuries or deaths occur in relation to such a device at the hospital.

The U.S. Food and Drug Administration puts reporting requirements on hospitals when it comes to such incidents. Among these rules are ones requiring hospitals to report such incidents within a certain amount of time of them occurring. Prompt reporting of such occurrences can shine a light on whether there are any ongoing safety issues/problems with a given medical device. This, in turn, can give the government and manufacturers the opportunity to promptly address such problems/issues.

So, one would hope hospitals would closely follow such rules. Unfortunately, FDA investigations have revealed that hospitals sometimes fall short when it comes to meeting these requirements. Among the things the investigations found was that 12 hospitals failed to engage in prompt reporting after medical-device-related injuries or deaths occurred. These hospitals were from all across the country, including here in New York.

FDA officials believe problems with following the reporting rules are something that might be present in many hospitals in the country.

What do you think should be done at hospitals to help ensure better compliance with these rules?

Another thing it can be vital for hospitals to do when it comes to medical devices is to exercise care when performing procedures on patients related to medical devices. Errors made during such procedures could pose major health risks to patients. Individuals harmed during a medical-device-related procedure at a hospital may want to have an attorney look into whether the hospital, or any other party, engaged in carelessness that contributed to the harm.

Source: NPR, “FDA Faults Hospitals For Failing To Report Safety Problems With Medical Devices,” Chad Terhune, Oct. 28, 2016