FDA Lays out Plan for National Medical Device Surveillance System

Posted 07 September 2012 | By Alexander Gaffney, RAC 

On the eve of several public meetings aimed at reworking the US Food and Drug Administration's (FDA) medical device postmarket surveillance system, the agency has released a new plan it says offers its own roadmap on how to improve safety monitoring of potentially dangerous devices.

The report, entitled, "Strengthening our National System for Medical Device Postmarket Surveillance," proposes four changes to be made to the current system of postmarket surveillance: the establishment of a unique device identification system, the promotion of medical device registries, the modernization  of adverse event reporting and analysis and the development of new ways to generate and evaluate evidence.

A New System of Medical Device Surveillance

All together, these changes would come to constitute a new system FDA is calling the National Medical Device Surveillance System. The agency said it hopes the system will eventually be able to, "Quickly identify poorly performing devices, accurately characterize and disseminate information about real-world device performance … and efficiently generate data to support premarket clearance or approval of new devices and new uses of currently marketed devices."

"We are suggesting smart, tailored modifications to the existing postmarket surveillance program," FDA wrote in its report. The agency called on stakeholders to provide input and participation in the development of the new surveillance system, saying it is unable to implement or achieve its goals on its own.

The system would build to compliment FDA's Sentinel Initiative, formed in 2007 under the FDA Amendments Act (FDAAA) to collect diagnoses, procedures and results from aggregated administrative claims. FDA notes that the current system, "Lacks manufacturer or brand-specific device identifiers and therefore cannot be leveraged to perform meaningful medical device postmarket surveillance."

The new system would not be dissimilar to its current sentinel system, FDA explained. "FDA envisions using similar distributed data sources, which would include electronic health records (EHRs) and registries, for the medical device Sentinel System to help maintain patient privacy, administrative and claims databases, and other external data sources."

A National Unique Device Identification System

The first change to the current system of postmarketing surveillance would involve the creation of a unique device identification (UDI) system-something FDA is already in the process of doing. In a 3 July Federal Register notice, FDA said the UDI system, "Will help reduce medical errors, and will allow FDA, the healthcare community and industry to more rapidly review and assess adverse event reports, identify problems relating to a particular device, and thereby allow for more rapid and effective corrective actions."

The system proposed by FDA would establish a UDI database, known as the Global Unique Device Identification Database (GUDID), which would collect all UDI information. On products, the UDI information would appear as both plain-text and barcode-formatted information, and long-lasting devices would need to be labeled with the UDI directly.

In FDA's 7 September report, it said the system will, "Enhance postmarket surveillance activities by providing a standard and unambiguous way to document device use in EHRs, clinical information systems, and claims data sources.

"As a result, this information would potentially become available for use in assessing the benefits and risks of medical devices."

The system is also likely to help doctors, explained FDA, who would be able to use the system to quickly look up the characteristics of a particular device and the latest safety alerts regarding its use.

National and International Registries for 'Selected Products'

FDA's establishment of registries would also be applied to its second proposed change, which would involve the development of national and international registries for some products.

These registries might be used in the case of a particular problem, such as widespread problems or concerns with a particular device, and would be able to track outcomes and information regarding patients associated with that particular device.

Unlike the first system, over which FDA would maintain significant control, FDA would not seek to develop a, "Centralized repository of registry data," it said. Rather, it wants to help facilitate the development of new registries, such as those already created and maintained by many medical societies.

These systems could be useful in providing control data for clinical studies seeking to show the superiority of a particular product over a control group, identify patient sub-groups who might benefit from a particular therapy, or show the relative safety of a product to support reduced regulatory oversight.

New Data: Real-Time and Going Mobile

But more than just getting new sources of data, FDA said it wants to develop new ways of looking at that data. Current data systems are limited in their inability to conduct real-time analysis of incoming data.  FDA says it hopes to develop such capabilities in the form of automated analysis reports that are able to accurately identify unexpected adverse event signals.

The agency says it is aware of studies that showed when the reports were conducted automatically, adverse event reporting increased as the public and physicians felt their concerns would actually be evaluated appropriately.

Regulators are also looking to develop mobile adverse event reporting applications to allow for faster and easier reporting. FDA said it has partnered with Boston Children's Hospital to develop and implement such a mobile application, and the application is currently at the late stages of development.

FDA also noted that its Manufacturer and User Facility Device Experience (MAUDE) adverse event report database is nearly obsolete, both nearing the limits of its design capacity and limited by its age and inherent capabilities. "The database platform cannot be extended further," remarked FDA. "Therefore, a new adverse event reporting system is needed."

The new reporting system, known as the FDA Adverse Event Reporting System (FAERS), will have an expanded capacity to receive report, modern analytical capabilities, and will be able to present information report in a variety of formats for end users.

Generation and Evaluation of Data

Finally, FDA said it hopes to be able to generate new and innovative methodologies and strategies for evaluating medical devices, saying broader, big-data approaches could eventually help it create better approaches to regulation.

"The development of new tools and methods to generate, synthesize, and interpret postmarket information will improve the efficiency and quality of decision-making by identifying new and better ways to leverage existing data sources by providing more timely information about the benefits and risks of marketed products, and by translating data into knowledge to help better inform regulatory and clinical decisions," explained FDA.

This is also likely to include ways to better assess the benefit:risk paradigm and provides ways to bring in the views and needs of patients into the review process. By quantifying more of the regulatory process, explains FDA, the agency can reduce the amount of regulatory uncertainty in the process for industry.

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