The Wall Street Journal (WSJ) reports on Friday the House passed a bill that would improve the safety monitoring of medical devices. It was inspired by a gynecological device – the power morcellator.
The morcellator is a tool that is used to grind up growths in the uterus, however a woman has a one in 350 chance that the fibroid is masking a dangerous cancer causing it to spread. See background story here on Mesh News Desk.
The danger came to light over the very public prognosis last year of Dr. Amy Reed, who had the procedure. She and her husband, Dr. Hooman Noorchashm, MD, have taken to social media to call for a ban of the power morcellator.
One manufacturer, Johnson & Johnson has taken its device off the market but the morcellator remains on hospital shelves and it and other versions are still used by some hospitals and doctors despite the risks. The FDA added a black box warning but did not order a recall saying it could be appropriate for some patients.
Dr. Reed continues to speak out about patient safety and the role the FDA fails to play. She and her husband have met with the FBI which is investigating what Johnson & Johnson knew about the risks of its morcellator back in 2006. Meanwhile, insurance giant Aetna has ended coverage for the power morcellator.
Bill Includes Unique Device Identifier (UDI)
The proposed improvement would include a bar code be added to medical devices. Two years ago the FDA proposed requiring the unique device identifier (UDI), not unlike a VIN number on your car. It allows the vehicle or device to be tracked if there’s a recall.
The FDA takes the “least burdensome approach in all areas of medical device regulation” (least burdensome on the manufacturer) and UDIs are not currently included in all electronic health records, making it virtually impossible to track any trends in patient harm can be tracked.
The bill does not appear to address the 510(k) approval process of the FDA which allows about 90 percent of medical devices, including the power morcellator and pelvic and hernia mesh onto the market with very little regulation. Long considered a hole in the patient safety net, the 510(k) allows manufacturers to exchange paperwork with the FDA while giving assurances its medical device is safe, without the burden of clinical trials.
**NEW** According to this Op-Ed in the New York Times, it would essentially weaken the already fast-tracked 510(k) oversight which has led to so many injuries from unregulated medical devices.
21st Century Cures Bill
The amendment passed Friday is part of the so-called 21st Century Cures Bill, sponsored by Rep. Mike Fitzpatrick (R-Pa). It increases funding for patient safety, research and changes drug approvals.
It also uses words such as “streamlining the drug and device development process,” in other words making it easier to put devices on the market. The 510(k) approval process for manufacturers takes under $5,000 and under 90 days to approval with no clinical trials. Considering the harm done to pelvic mesh patients and those injured by the power morcellator, should medical device approvals really be made easier?
Rep Fitzpatrick said it was the power morcellator that moved his action. #
New York Times, Op-Ed, July 15, 2015, FDA’s Medical Device Problem
See WSJ article (subscription required)
Change.org Petition on the Power Morcellator
Mesh News Desk, Report Finds Doctors Still Using Power Morcellator Despite the Risks
MND August 15, 2014 Power Morcellation, the Risk of Uterine Sarcoma Dissemination
What You Can do! 21st Century Cures Bill
Let them know what you think about the 510(k) approval process. Should devices make it to the market faster or safer?
“The committee is seeking input on this bold new initiative from a wide variety of interested stakeholders.
Email the committee using the email address firstname.lastname@example.org
21st Century Cures is a truly collaborative effort. Please be advised that submissions sent to email@example.com will be made publicly available on energycommerce.house.gov/cures as part of the effort to encourage continued discussion about opportunities and ideas to accelerate the pace of cures. We thank you for participating.”
– See more at: http://energycommerce.house.gov/cures#sthash.h20tdYI6.dpuf