FDA Looks to Registries and New Adverse Event Reporting Systems to Improve Device Safety

Posted 26 April 2013 | By Alexander Gaffney, RAC 

US medical device regulators may be getting a lot of attention of their new proposals to finalize a unique device identification (UDI) rule, but four other proposals will be critical as well in the US Food and Drug Administration's (FDA) attempts to build a national postmarket surveillance system, says a new agency report.


Numerous issues associated with medical devices in recent years have highlighted the importance of developing new ways to keep track of medical devices once they are approved or cleared by regulators.

Prominent examples of suspected or confirmed device failures include metal-on-metal hip implants, vaginal mesh implants, ICD leads and automatic external defibrillators, to say nothing of hundreds of other prominent recalls.

Those problems have raised several regulatory questions for FDA, including one it is not focusing particularly hard on: How do you detect problems with devices once they are approved or cleared by the agency?

Traditionally, FDA has left most of those activities to the manufacturers, either requiring them to conduct postmarketing Phase IV clinical trials to test whether a device is indeed safe, or simply relying on the submission of adverse event reports to its MedWatch database to identify problems.

However, that strategy isn't without its faults. In the case of the former, many devices never undergo extensive clinical testing to begin with, and FDA doesn't normally subject devices cleared through the 510(k) process to testing. And while medical device reporting to MedWatch may identify reports, it can be difficult to differentiate correlation from causation in the reports, and even more difficult to determine which lot or manufacturing facility a particular device came from.

A New Strategy

That's where a new FDA strategy aims to make improvements. In its new report, "Strengthening our National System for Medical Device Postmarket Surveillance: Update and Next Steps," the agency identifies five main areas in which it wants to build a foundation for the rest of its national surveillance system.

The first of those areas should be familiar to many medical device professionals. The UDI proposal, which has been under development for many years, was released in draft form in 2012 and released for comment. The proposal would seek to develop unique identifiers for most medical devices, and would help regulators to keep track of marketed devices, assist in the recall of defective devices, and otherwise strengthen the supply chain by making it easier for physicians to check if a device is authentic and not subject to any problems. The final rule is due to be released by June 2013, while its various components will be delivered by the end of 2013 if all goes according to plan.

But lesser known are the other four proposals, all of which are touted by FDA in the new report as core components of its emerging national strategy.

Pinnacles of a Surveillance System

The first, the Medical Device Postmarket Surveillance System Planning Board, would act as an advisory committee to the agency tasked with identifying, "the governance structure, practices, policies, procedures, methods and business model(s) necessary to facilitate the creation of a sustainable, integrated medical device postmarket surveillance system that leverages and complements existing and on-going efforts," FDA explained.

Previous FDA reports indicate the agency is moving to get this planning board up and running by the end of September 2013.

The report also mentions that FDA plans to lean heavily on medical device registries, including national and international ones. The agency recently announced plans to create a massive international cardiovascular registry for medical devices, giving industry a first look into the size and scope of some of these potential registries. FDA plans to create a task force to oversee this area known as the Medical Device Registry Task Force by June 2013.

That task force will be tasked with five duties, FDA said:

  • Identify existing registries that may contribute to the system.
  • Leverage on-going registry efforts focused on quality improvement, reimbursement, patient-centered outcomes and other activities to best meet the needs of multiple stakeholders.
  • Identify priority medical device types for which the establishment of a longitudinal registry is of significant public health importance.
  • Define registry governance and data quality practices that promote rigorous design, conduct, analysis, and transparency to meet stakeholder needs.
  • Develop strategies for the use of registries to support premarket approval and clearance.

Adverse Event Overhaul and Tracking Implanted Devices

Adverse event reporting, too, is due to be overhauled. The first deliverable in this set of tasks was unveiled earlier this week when FDA launched its MedWatcher program, an adverse event reporting mobile application meant for use by consumers and healthcare providers (though neither industry nor healthcare facilities are supposed to use it). Other projects in the works include a pilot program to test a modernized database for adverse event reports known as FAERS (FDA Adverse Event Reporting System), the launch of prospective data mining tools to study "at least three major device areas" to identify trends and adverse event clusters, and the issuance of a final report on the ASTER-D (ADE Spontaneous Triggered Electronic Reporting for Devices) reporting system that is supposed to automate much of the adverse event reporting system through the use of electronic health records.

A fifth and final area will look to develop new methods to generate evidence and ways to collect and analyze it. Key among the goals of such a program would be promoting interoperability between systems. FDA explained elsewhere that it will look to collaborate with stakeholders on the use of what it called "structured data"-traditionally based on an extensible markup language (XML) backbone-in the hopes of launching a pilot program.

FDA also said that it wants to target its efforts toward developing methodologies for "two classes of implantable devices to combine diverse data sources and/or combine data from multiple registries to provide more timely and comprehensive assessments of device benefit-risk profiles."

Both projects will be completed by October 2012, FDA said.

FDA: National Medical Device Postmarket Surveillance Plan

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