US Congress considers new tracking system for medical devices after excessive recalls

BMJ 2012; 344 doi: (Published 23 April 2012) Cite this as: BMJ 2012;344:e2915
  1. Keith Epstein
  1. 1Washington, DC

The recall of thousands of medical devices in the United States, some of which pose grave threats to patients’ health, has prompted Congress and the Food and Drug Administration to call for improved surveillance of all devices and stronger international safety standards.

Congressional committees plan to consider a measure on 25 and 26 April that would require a regulation “as soon as practical” to track devices through a unique device identifier (UDI) system by the end of 2012. Each medical device would be linked by lot or serial number to medical records, enabling the FDA to find faulty devices and notify patients and hospitals about safety problems or recalls.

More than three quarters of all high risk medical devices are now given a “fast track” review by the FDA. Of the devices that are approved, more than 90% pass without requiring any clinical testing and can be approved even if they are “substantially equivalent” to a similar device that has been recalled.

The agency, often regarded as the “gold standard” for regulation worldwide, lacks authority to require post-marketing studies of new devices it approves. It relies on voluntary reporting by some 300 hospitals to provide specific alerts when devices malfunction and on a database of voluntary reports from patients, doctors, and hospitals about adverse events involving drugs or devices.

Between 2005 and 2010 more than 4343 devices were recalled in the US, according to the healthcare intelligence firm GBI Research, including 54 “class I” recalls: devices deemed to pose the highest risk of health problems or mortality.

Cardiovascular devices—mostly automatic external defibrillators—accounted for 16% of the recalls, GBI reports, while radiology devices accounted for 16% and orthopaedic devices 12%. Infusion pumps and implantable programmable pumps were also regularly recalled.

Adding to concern in the US is new evidence linking the Riata and Riata ST defibrillator leads made by St Jude Medical to 20 deaths, reported on 26 March 2012 by the medical journal Heart Rhythm. St Jude stopped selling the Riata leads in December 2010 and recalled them a year later amid reports that they could break through the insulation coating and fail to work properly. Some 79 000 patients in the US are fitted with the devices.

The company, which is urging against having the devices surgically removed, has said that a clinical trial will examine the extent of the malfunction, that it has improved its practices of monitoring patients with new devices, and that performance of its Riata leads is similar to that of other products available to patients. The company has urged Heart Rhythm to publish a retraction, but the journal has declined to do so.

“We are absolutely committed to the highest levels of device performance and public transparency,” Mark Carlson, St Jude Medical’s chief medical officer, said in a statement.

In 2007 Medtronic withdrew from the market a brand of lead that sometimes fractured. The problems have been linked to 13 deaths; 200 000 of the Medtronic devices had been implanted.

Concern about devices is causing some advocates around the world to urge more support for the Global Harmonization Task Force (, which is seeking to align regulatory practices around the world. “The organization may prove vital in the future as dangerous recalls seem set to continue if regulations and testing are not tightened,” GBI Research noted in a 19 April press release.

The push for a post-marketing device tracking system is included in FDA user fee legislation that would expand fees paid by drug and device companies to help pay for the FDA’s review of applications for marketing approval. User fees now pay for 60% of the costs of reviewing applications for brand name drugs and 20% for medical devices.

The Senate Committee on Health, Education, Labor and Pensions and the House Energy and Commerce Committee’s health subcommittee are expected to finish reviewing the legislation by May, and it could face a vote in Congress by early summer. Also included in the current draft is $1.5bn (£0.9bn; €1.1bn) over five years to speed reviews of generic drug applications.

The concern about device safety comes at a time when the medical devices industry is urging Congress to further ease federal oversight to spur new technological innovation and hasten delivery of new devices to patients.

Patient safety advocates, meanwhile, say that the proposed legislation doesn’t go far enough. Lisa McGiffert, director of the “safe patient” project of the Consumers Union, a large policy and advocacy group, said, “Our system for overseeing medical implants and other high risk devices is clearly broken and allows too many dangerous devices on the market. Tens of thousands of patients have been injured or died in recent years because current law fails to ensure medical devices are safe. Unfortunately, these bills don’t fix the most serious flaws in our current system and leave patients at risk.”

Congress has agreed to the UDI device tracking system before. In 2007 it agreed to an FDA blueprint to electronically track and recall any devices that could jeopardise the safety of patients. Five years later the regulatory process drags on, and executive agencies have not published a proposed rule. In February three senators—Charles Grassley, Herb Kohl, and Richard Blumenthal—urged the Office of Management and Budget to release the delayed rule.


Cite this as: BMJ 2012;344:e2915