With the amendment from Rep. Mike Fitzpatrick, (R., Pa.), lawmakers would express “a sense of Congress” that “unique device identifiers” should be included in electronic health records.
Supporters 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,” Mr. Fitzpatrick’s office said in a statement.
The amendment is part of the so-called 21st Century Cures bill, which would boost federal funding for medical research and changes drug approvals.
There is no parallel bill in the Senate, but Sen. Lamar Alexander (R., Tenn.), chairman of the Senate health and education 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 Food and Drug Administration 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. Mr. Fitzpatrick’s office said his action “adds pressure.” The FDA declined to comment on the amendment.
It is unclear what practical impact the amendment will have, but Mr. Fitzpatrick used it as an opportunity to open a larger debate about how devices are regulated and tracked. He said he had been moved to action by devices called laparoscopic power morcellators.
The tools were previously used in tens of thousands of minimally invasive procedures a year, mostly in hysterectomies, to cut up benign uterine growths known as fibroids so the bulky tissue could be removed through tiny incisions. 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.
The agency called for a black-box warning—its strongest caution—on the tool. Johnson & Johnson, which was the largest manufacturer of the device, pulled its version off the market last July, while many hospitals have halted or limited use of morcellators. Morcellators made by other companies remain on the market.
The FDA has cleared at least 10 power morcellators for sale since the first one hit the market 24 years ago. Though records from device applications and reviews show the FDA knew in the early days that morcellators could spread dangerous cells, the agency said the magnitude of the risk wasn’t realized until the issue gained prominence in late 2013.
The system under which morcellators and nearly all other devices were authorized has long drawn criticism for being too lax. The FDA has defended it as a good way to balance innovation and safety.
“What happened with the power morcellator should never be allowed to happen again,” Mr. Fitzpatrick, who is a cancer survivor, said at a hearing of the House Rules Committee last week before the Friday vote on the bill.
Several other amendments, offered by Mr. 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.”
Speaking in opposition was Rules Committee member Rep. Michael Burgess, a Texas Republican and a doctor who formerly practiced obstetrics and gynecology. Mr. 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. “In this instance, I think that it was clinical judgment that was at fault, not the FDA approval process,” he said.
Mr. Fitzpatrick’s constituents include Amy Reed, a Philadelphia-area anesthesiologist whose cancer was worsened by a morcellation procedure in 2013.
July 12, 2015 5:23 p.m. ET
Write to Jennifer Levitz at [email protected]
Source: Wall Street Journal Health