Medical Device Safety Part of 21st Century Cures Act Passed by House of Representatives

As part of the 21st Century Cures bill that passed the U.S. House of Representatives on July 10, the legislation included a provision to improve the safety monitoring of medical devices. The house passed the act by a 344-77 vote.

The 21st Century Cures Act contained multiple health IT-related provisions, particularly in the areas of U.S. Food and Drug Administration (FDA) regulation, telehealth, and interoperability. It also would boost federal funding for medical research and changes drug approvals.

The medical device amendment from Rep. Mike Fitzpatrick, (R-Pa.) was inspired by controversial gynecological devices called power morcellators, which were used in thousands of minimally invasive procedures a year—mostly hysterectomies—to cut up benign uterine fibroids. Last year, however, the FDA warned that women undergoing the procedure have an estimated 1 in 350 chance of harboring a dangerous hidden cancer that power morcellators can spread and worsen. Johnson & Johnson, which was the largest manufacturer of the device, pulled its device off the market a year ago. Most hospitals have halted or limited use of morcellators. Morcellators made by other companies remain on the market.

Fitzpatrick’s amendment calls for unique device identifiers to be included in electronic health records.

“Unfortunately, it is becoming clear that the reporting system for faulty and deadly devices is broken,” Fitzpatrick said in the Congressional Record. “What happened with the power morcellator should never be allowed to happen again.”

Supporters of the bill say information such as the make or model number of devices used in treatment should be included in medical records so patient harm can be closely tracked. Currently, the identifiers are not incorporated into all electronic health records, “which makes it difficult to fully achieve the benefits to patient safety,” Fitzpatrick’s office said in a statement.

There is no parallel bill in the Senate, but Sen. Lamar Alexander (R-Tenn.), chairman of the Senate’s health, education and labor committee, has said he hopes to get a measure through his panel by year-end and bring it to the Senate floor next year. It is uncertain whether it would contain similar language.

The FDA issued a rule in 2013 requiring labels of medical devices to include unique device identifiers and said it would phase in the system over several years, focusing first on high-risk devices. Fitzpatrick’s office said his action “adds pressure.”

Fitzpatrick has used the morcellator issue to open a larger debate about how devices are regulated and tracked. Several other amendments, offered by Fitzpatrick and prompted by the morcellator issue, didn’t make it through the rules committee. One amendment would have directed the Government Accountability Office to investigate FDA medical device safety reporting regulations, “focusing on reporting problems involving power morcellators.”

A voice of opposition was rules committee member Rep. Michael Burgess, a Texas Republican and a doctor who formerly practiced obstetrics and gynecology. Burgess, who said he left active practice more than 10 years ago and didn’t use power morcellators, argued that doctors, rather than regulations, were to blame for problems resulting from the device, according to The Wall Street Journal.

“In this instance, I think that it was clinical judgment that was at fault, not the FDA approval process,” he said.