New Recommendations for Effective Medical Device Registries
A new report from industry stakeholders follows up the Food and Drug Administrations 2012 report on creating a national surveillance system to identify poorly performing medical devices.
A new report from industry stakeholders follows up the Food and Drug Administrations 2012 report on creating a national surveillance system to identify poorly performing medical devices.
The FDA recommended unique device identifiers, development of national registries for different types of devices, streamlining adverse event reporting and analysis, and new methods for evidence generation and assessment.
Now, the Pew Charitable Trusts, Blue Cross and Blue Shield Association, and the Medical Device Epidemiological Network at Weill Cornell Medical College offer a series of recommendations to improve postmarket surveillance of devices.
Registries can support patient care decisions and improve outcomes by providing healthcare professionals with reliable information on the performance of a technology, and can highlight factors that affect the data collected, such as patient selection or operator experience, according to report authors. Registries can also go further than the premarket trials necessary for FDA approval by allowing for the evaluation of devices in wider populations and practice settings.
The report opens with a reminder of the failure of metal-on-metal hip implants after they were FDA-approved, and the lack of a system to monitor approved devices so the implants remained in the market despite an emerging pattern of failure. One manufacturer, for example, used registry data from Australia and the United Kingdom as the basis for recalling its metal-on-metal implant.
The report lays out a series of objectives and supporting recommendations to implement an effective surveillance system:
Establish criteria for determining if a registry is the appropriate tool for postmarket surveillance. Recommendations include weighing criteria such as a device using new technology whose safety and effectiveness is not understood, a device--such as implants--that has substantial design variation, and outcomes that are highly dependent on operator performance.
Deliver timely, actionable information from registries to all stakeholders including the public. Recommendations include have registries regularly release findings for use in making treatment decisions, require transparency of registry operations including influences such as members of the governance structure, and make data available to outside researchers.
Streamline registry data collection through efficiencies that reduce the time and cost of reporting. Recommendations include ways to ensure an appropriate statistical sample size of patients treated with a device are included in research on the device, require registry data fields to use standardized definitions, coordinate registries with national efforts to improve quality measure reporting and use unique device identifiers.
Gain additional value from device registries by using them to accelerate device innovation and to fulfill other regulatory responsibilities. Recommendations include stakeholder-developed guidance regarding use of registries in clinical trials for new products or expanding uses for existing products, and FDA issuance of guidance on how manufacturers can use registry participation to fulfill regulatory responsibilities other than postmarket surveillance.
Provide clarity for stakeholders by resolving varying interpretations of the HIPAA privacy rule and the federal Common Rule for protecting human subjects, as they apply to registries. Recommendations include stakeholder cooperation to better understand and reduce unnecessary barriers to registry data collection and use.
The 44-page report, with detailed explanations of each objective and the complete list of recommendations, is available here.
The FDA recommended unique device identifiers, development of national registries for different types of devices, streamlining adverse event reporting and analysis, and new methods for evidence generation and assessment.
Now, the Pew Charitable Trusts, Blue Cross and Blue Shield Association, and the Medical Device Epidemiological Network at Weill Cornell Medical College offer a series of recommendations to improve postmarket surveillance of devices.
Registries can support patient care decisions and improve outcomes by providing healthcare professionals with reliable information on the performance of a technology, and can highlight factors that affect the data collected, such as patient selection or operator experience, according to report authors. Registries can also go further than the premarket trials necessary for FDA approval by allowing for the evaluation of devices in wider populations and practice settings.
The report opens with a reminder of the failure of metal-on-metal hip implants after they were FDA-approved, and the lack of a system to monitor approved devices so the implants remained in the market despite an emerging pattern of failure. One manufacturer, for example, used registry data from Australia and the United Kingdom as the basis for recalling its metal-on-metal implant.
The report lays out a series of objectives and supporting recommendations to implement an effective surveillance system:
Establish criteria for determining if a registry is the appropriate tool for postmarket surveillance. Recommendations include weighing criteria such as a device using new technology whose safety and effectiveness is not understood, a device--such as implants--that has substantial design variation, and outcomes that are highly dependent on operator performance.
Deliver timely, actionable information from registries to all stakeholders including the public. Recommendations include have registries regularly release findings for use in making treatment decisions, require transparency of registry operations including influences such as members of the governance structure, and make data available to outside researchers.
Streamline registry data collection through efficiencies that reduce the time and cost of reporting. Recommendations include ways to ensure an appropriate statistical sample size of patients treated with a device are included in research on the device, require registry data fields to use standardized definitions, coordinate registries with national efforts to improve quality measure reporting and use unique device identifiers.
Gain additional value from device registries by using them to accelerate device innovation and to fulfill other regulatory responsibilities. Recommendations include stakeholder-developed guidance regarding use of registries in clinical trials for new products or expanding uses for existing products, and FDA issuance of guidance on how manufacturers can use registry participation to fulfill regulatory responsibilities other than postmarket surveillance.
Provide clarity for stakeholders by resolving varying interpretations of the HIPAA privacy rule and the federal Common Rule for protecting human subjects, as they apply to registries. Recommendations include stakeholder cooperation to better understand and reduce unnecessary barriers to registry data collection and use.
The 44-page report, with detailed explanations of each objective and the complete list of recommendations, is available here.