Amendment to Legislation Would Add Medical Device Tracking Numbers To Patient Records

In an attempt to further improve the monitoring and evaluation of medical devices, an amendment to a controversial new bill would require increased use of unique device identifiers to help track which medical devices were used on which patients. 

House Representative Mike Fitzpatrick, a Pennsylvania Republican, added an amendment to the 21 Century Cures bill, which would require unique device identifier numbers of devices used on patients be included in their electronic health records.

The identifiers, which are being implemented through recent FDA regulations, are designed to help track medical devices and identify potential problems with approved products earlier, allowing federal regulators to issue recalls or require safety improvements. The amendment seeks to also make it easier for healthcare professionals to identify which medical devices were used on patients in the past.

According to a Wall Street Journal report on the amendment, it was inspired by problems with power morcellators, which have been linked to an increased risk of spreading undiagnosed uterine cancer in women undergoing laparoscopic hysterectomy for uterine fibroid removal. However, the devices were on the market for nearly a quarter century before the risk was recognized by the FDA last year.

Fitzpatrick, a cancer survivor, said he hopes his amendment and the legislation prevents a similar incident from occurring with medical devices in the future. However, the legislation as a whole has been widely criticized, as it attempts to reduce the FDA’s ability to ensure that new medical devices and drugs are safe by lowering the standards needed to approve them.

Last week, the consumer watchdog group Public Citizen issued a press release warning about severe consequences linked to the bill. Public Citizen and other critics say the legislation lowers the clinical trial standards needed to approve drugs and medical devices, would increase overuse of antibiotics and the spread of drug-resistant pathogens, and would increase the ability of drug companies and medical device companies to discreetly pay doctors and medical professionals to promote their products without acknowledging the financial connection.

The bill comes amid a push for drug companies to release clinical trial data following incidents of ghost-writing and study-tampering that has involved powerful drugs that were later approved by the FDA. Independent researchers warn that in some cases it appears the agency was outright lied to about adverse events and effectiveness of drugs in company-sponsored clinical trials.

In February, a study found that the FDA was finding evidence of clinical trial fraud, but not reporting it in most cases.

Supporters of the proposed legislation say more flexibility in the FDA approval requirements is necessary to speed up the process of getting vital drugs to patients in a timely manner. The bill has already been approved unanimously by the House Energy and Commerce Committee, and House Republicans have established an ambitious timeline that may result in it being enacted by the end of the year if it is not stopped.