2017年 10月 3日
EMERGO SUMMARY OF KEY POINTS:
The International Medical Device Regulators Forum (IMDRF) continues advocating for greater use of registries for regulatory oversight of medical devices, recently issuing recommendations for how to assess and use device registry information for premarket reviews and related decisions.
The latest IMDRF proposal, the third in a series on device registries by the organization’s Patient Registries Working Group, provides recommendations to regulators on how to effectively utilize registry data to support oversight activities such as premarket registration and approval, changing or expanding device indications for use, post-market surveillance and device tracking. Previous IMDRF proposals defined and qualified device registries, and identified methodologies for registry data analysis.
First, it’s important to note what the IMDRF means by the term “medical device registry.” The organization defines a device registry as any organized system that collects data on routine clinical care and assesses meaningful outcomes while comprehensively covering a device’s target patient population.
The latest IMDRF proposal identifies six major regulatory applications for medical device registry data:
Although each of these applications require their own degrees of “robustness” from registry processes, IMDRF cites four key attributes regulators should require from a registry in order to determine usability for their decision-making: device information, quality and methodological processes leading to actionable data, transparency and governance, and linkability to other data sources.
Any usable medical device registry should provide “unambiguous” identification of devices associated with its records, ideally through Unique Device Identification (UDI), a concept long advocated by IMDRF.
In cases where a device registry has not yet implemented UDI, the registry should at least be able to provide identifiers such as manufacturer and device name, model name, catalogue or reference code and serial number.
Second, IMDRF argues that linking device registries to related data sources covering issues such as short-term health complications and long-term treatment outcomes ultimately provides more comprehensive and useful information for agencies to make regulatory decisions. Appropriate linkable data sources include other device registries, electronic medical records and death records.
Third, IMDRF emphasizes the need for registry transparency in order for regulatory agencies to find these data sources useful for their device-related deliberations and actions. Transparency may be achieved via a publically accessible website that clearly lays out a registry’s aim and mission, and that clearly explains the registry’s governance process, participation requirements and funding mechanisms.
Since some registries have been established for non-regulatory purposes, regulators must carefully assess whether data available in such registries is relevant enough to be useful for their purposes.
When assessing usability of registry data, regulatory agencies should consider whether a particular registry incorporates nationally and internationally recognized standards for harmonization of Common Data Models, as well as how clearly defined a registry’s data collection procedures are, and whether a standard operating procedure is followed.