As the number of cancer spread by morcellator reports continue to rise, the FDA announces it will step up its data collection methods.

To properly address and evaluate the risk of cancer spread by morcellator, the agency is exploring different methods in obtaining data and is encouraging reporting of complications.

The agency had recently increased the amount injury reports that could be submitted in regards these power morcellator complications, after kicking off inspections at 17 hospitals in December 2015.

These same 17 hospitals will also by subject to the agency’s new data collection and injury reporting methods.

These particular hospitals were chosen due to reports of alleged unintentional cancer spread by morcellator.

According to FDA Center for Devices and Radiological Health Dr. Jeffery Shuren, power morcellator infections were also reported.

Even worse, these infections had allegedly spread from patient to patient due to contaminated endoscopes.

Overview of Cancer Spread by Morcellator

The issue of cancer spread by morcellator came to the public’s attention in April 2014, when the FDA warned the public against power morcellator cancer.

The agency went on to say that these devices unintentionally spread cancerous tissue throughout the abdominal cavity during gynecological surgery procedures.

While the chances for cancer spread by morcellator are lowered by using surgical bags, the agency still warns women against using power morcellators.

There is currently no way to diagnose women with benign uterine cancer, before undergoing surgery.

Furthermore, the FDA estimates that is one in 350 women with undiagnosed uterine cancer may be negatively affected by power morcellator use.

So far, FDA inspections discovered the majority of the hospitals’ staff were not properly educated in “FDA medical device reporting requirements.”

The agency had also found that some of the hospitals did not file required device related deaths, complications, or injuries.

In the worst cases, the FDA found that some hospitals did not even had a system in place for reporting these complications either the FDA or the device’s manufacturer.

“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,” Dr. Shuren said.

The agency stated it will continue to work with hospitals in a various ways to determine the best methods for injury reporting and other pieces of data collection.

The FDA is also hoping this effort will help promote safe use of power morecellators and other medical devices.

Among the possible new reporting methods include software tools, and encouraging hospitals to use the National Evaluations System for Health Technology.

The FDA will hold a public workshop regarding this issue on Dec. 05, 2016, focusing on “data generation in post market surveillance and hospital based surveillance.”

The agency may also discuss different device identifiers, which may help organize electronic hospital records.