A comprehensive medical research bill that passed the U.S. House of Representatives on July 10 includes a provision designed to improve the safety monitoring of medical devices.
The amendment, proposed by Rep. Mike Fitzpatrick (R., Pa.), was inspired by the laparoscopic power morcellator, a controversial medical device that has been the subject of numerous lawsuits. The chairman of the Senate health and education committee, Sen. Lamar Alexander (R., Tenn.), has said that he intends 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 in thousands of minimally invasive laparoscopic hysterectomy and myomectomy procedures each year. They allow surgeons to chop up the uterine tissue or fibroids and remove the matter through a small abdominal incision to minimize scarring and reduce recovery time. However, because there is no definitive way to diagnose uterine cancer before using morcellator devices, when the tissue is ground up, undetected leiomyosarcoma, endometrial stromal sarcoma, and other types of cancer cells can be spread throughout the abdomen, leading to rapid upstaging of the disease.
21st Century Cures Act
The amendment is part of the bill known as the 21st Century Cures Act, which aims to increase federal funding for medical research and change the drug approval process, among other things. The provision will require unique device identifiers, such as the make or model number of devices used in treatment, to be included in electronic health records so that patient injury can be more closely monitored.
FDA Recommends Unique Device Identifiers
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, but these identifiers are not currently incorporated into all electronic health records. Supporters of the amendment said the provision would likely help hasten the process.