U.S. House passes provision to keep tabs on medical devices used on patients

The U.S. House of Representatives passed a far-reaching medical research bill in July 2015 that includes an amendment to better monitor the use of medical devices for patient safety.  The provision in the bill was a result of the controversy over use of laparoscopic power morcellators.

The Wall Street Journal reported that the amendment calls for the make or model number of a device used to treat patients to be included in medical records so they can be tracked.  That kind of information isn’t currently “incorporated into all electronic health records, which makes it difficult to fully achieve the benefits to patient safety,” according to a statement from Rep. Mike Fitzpatrick (R-PA), who sponsored the provision.

The amendment is part of what is being touted as the 21st Century Cures bill aimed at increasing federal funding for medical research and the way drugs are approved.

Fitzpatrick, who is also a cancer survivor, said he was moved to offer the amendment to the bill in the wake of the controversy surrounding the use of power morcellators, and he hopes it creates a larger debate about how medical devices are regulated and tracked.

“What happened with the power morcellator should never be allowed to happen again,” he said.

According to a study conducted by researchers at the University of Michigan’s health system and published earlier this year in the journal Obstetrics & Gynecology, 1 in 368 women who underwent hysterectomies for uterine fibroids had an undetected sarcoma that could be spread by a morcellator.  Those numbers were almost identical to those from a study cited by the FDA last year that said women undergoing minimally invasive procedures with morcellators to remove uterine fibroids carried a 1-in-350 risk of uterine sarcoma.

Last fall, the FDA recommended against using the devices for most women undergoing a hysterectomy or the removal of uterine fibroids, advising that manufacturers should add boxed warnings and two contraindications on product labels.  However, the agency has stopped short of banning morcellators altogether, saying the devices’ benefits may outweigh the risks in some women.

REFERENCE:  Fierce Medical Devices; 13 JUL 2015; Joseph Keenan

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