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Bill to Improve Safety Monitoring of Medical Devices Passes House

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A comprehensive medical research bill that passed the U.S. House of Representatives on July 10th includes a provision designed to improve the safety monitoring of medical devices. The amendment, proposed by Rep. Mike Fitzpatrick (R., Pa.), was inspired by a controversial gynecological device – the laparoscopic power morcellator.

The amendment is part of the bill known as the 21st Century Cures Act, which among other things, aims to increase federal funding for medical research and change the drug approval process. The provision will require unique device identifiers, information such as the make or model number of devices used in treatment, to be included in medical records so that patient harm can be more closely monitored.

Currently, these identifiers are not incorporated into all electronic health records, although the Food and Drug Administration (FDA) issued a guidance document in 2014 recommending that labels of medical devices include unique device identifiers and planned to phase the system in over the next several years. Supporters of the amendment said the provision would hopefully speed up the process.

Although there is no parallel bill in the Senate, Senator Lamar Alexander (R., Tenn.), the chairman of the Senate health and education committee, has commented that he hopes to get a measure through his panel by the end of 2015 and onto the Senate floor in 2016.

What are Power Morcellators?

Morcellators are medical devices that are used during minimally invasive laparoscopic hysterectomy and myomectomy procedures. The devices are used in thousands of procedures each year, and allow surgeons to grind up the uterus or uterine fibroids and remove the tissue through a small abdominal incision, with minimal scarring and reduced recovery time.

But because there is no definitive way to diagnose uterine cancer before using morcellator devices, when the tissue is ground up, the undetected cancer cells can be spread, leading to rapid upstaging of the disease. As a result the morcellator lawsuits are starting to increase as more and more women and their families realize the effects of these deadly devices.