Posted: 02 Mar 2015 07:34 PM PST
ByAllyson B. Mullen –
In 2012, CDRH initiated an action plan to strengthen the medical device surveillance system (we previously reported on this planhere). As part of this initiative, a multi-stakeholder Planning Board was created with the purpose of “envisioning an MDS with the capability of accurately and systematically evaluating potential medical device safety signals in near real-time, measuring the benefit-risk profile of devices throughout their life cycle, and developing meaningful information to support pre-and postmarket regulatory decision making.”
The Engelberg Center for Health Care Reform at the Brookings Institution (Brookings) brought this board together in 2014. On February 24, 2015, Brookings issues a report documenting the board’s recommendations for a National Medical Device Postmarket Surveillance System (MDS) (the report can be found here). The report sets forth the board’s recommendations on the “mission, principles, and key functions for the MDS.”
The MDS is intended to aggregate significant amounts of both pre-and postmarket information into a single system, including information from claims and administrative systems, patient-generated data, EHRs, and device-specific and clinical care registries. This information is intended to be useful to a wide variety of stakeholders, including CDRH. According to the report, the information in the new MDS should have a focus on patients and clinicians. The information should also be collected with minimal burdens being placed on those required to submit and collect the information. The report indicates that information should be collected once, but for multiple purposes. While achieving these lofty goals, the MDS should be adaptable to the future and continuously evolving.
While this report is lengthy (75 pages), it contains very few specifics, including, who will be responsible for/required to submit data to the MDS, what specific information will be submitted, where/how the information will be stored, how FDA will use the data to assess marketed devices. The report recommends that the MDS be developed, implemented and managed by a joint public-private partnership, not solely by CDRH like current systems. The report lays out the high-level organizational and governing principles for the partnership. As one of the overriding goals, the report indicates that the public-private partnership should collaborate with those individuals who will be submitting data to the MDS to develop an effective infrastructure and policies. Specifically, the board believes that the new MDS should promote use of UDIs and common data standards in all data sources, including those that protect patient privacy.
Perhaps most interesting, the report acknowledges that government funding alone may be insufficient to develop such a new and novel system. The report suggests charging membership fees for those entities participating in the system, including, “manufacturers, nonprofits, CROs, academic institutions, and others who support MDS’s objectives.” Although it is not addressed in the report, our view is that manufacturers who would be asked to pay a membership fee would be those wishing to access and utilize the data for its own purposes, and manufacturers would not be charged a “membership fee” in order to submit adverse event information.
Finally, the report sets out a timeline for implementation. In years 1 and 2, the board proposes that FDA perform fact-finding activities and pilot programs to develop and 5-year implementation plan for MDS. Then in years 3 through 7, the public-private partnership should be created and it should implement the MDS that is developed through the pilot program. As we noted in our earlier post on this topic, the information provided on the new MDS has left several key questions unanswered, such as how FDA will use the information in the new MDS, how it will affect premarket requirements, and how would it be used in regulating products that are on the market. Unfortunately, this new report continues to leave these important questions unanswered.
In 2012, CDRH initiated an action plan to strengthen the medical device surveillance system (we previously reported on this planhere). As part of this initiative, a multi-stakeholder Planning Board was created with the purpose of “envisioning an MDS with the capability of accurately and systematically evaluating potential medical device safety signals in near real-time, measuring the benefit-risk profile of devices throughout their life cycle, and developing meaningful information to support pre-and postmarket regulatory decision making.”
The Engelberg Center for Health Care Reform at the Brookings Institution (Brookings) brought this board together in 2014. On February 24, 2015, Brookings issues a report documenting the board’s recommendations for a National Medical Device Postmarket Surveillance System (MDS) (the report can be found here). The report sets forth the board’s recommendations on the “mission, principles, and key functions for the MDS.”
The MDS is intended to aggregate significant amounts of both pre-and postmarket information into a single system, including information from claims and administrative systems, patient-generated data, EHRs, and device-specific and clinical care registries. This information is intended to be useful to a wide variety of stakeholders, including CDRH. According to the report, the information in the new MDS should have a focus on patients and clinicians. The information should also be collected with minimal burdens being placed on those required to submit and collect the information. The report indicates that information should be collected once, but for multiple purposes. While achieving these lofty goals, the MDS should be adaptable to the future and continuously evolving.
While this report is lengthy (75 pages), it contains very few specifics, including, who will be responsible for/required to submit data to the MDS, what specific information will be submitted, where/how the information will be stored, how FDA will use the data to assess marketed devices. The report recommends that the MDS be developed, implemented and managed by a joint public-private partnership, not solely by CDRH like current systems. The report lays out the high-level organizational and governing principles for the partnership. As one of the overriding goals, the report indicates that the public-private partnership should collaborate with those individuals who will be submitting data to the MDS to develop an effective infrastructure and policies. Specifically, the board believes that the new MDS should promote use of UDIs and common data standards in all data sources, including those that protect patient privacy.
Perhaps most interesting, the report acknowledges that government funding alone may be insufficient to develop such a new and novel system. The report suggests charging membership fees for those entities participating in the system, including, “manufacturers, nonprofits, CROs, academic institutions, and others who support MDS’s objectives.” Although it is not addressed in the report, our view is that manufacturers who would be asked to pay a membership fee would be those wishing to access and utilize the data for its own purposes, and manufacturers would not be charged a “membership fee” in order to submit adverse event information.
Finally, the report sets out a timeline for implementation. In years 1 and 2, the board proposes that FDA perform fact-finding activities and pilot programs to develop and 5-year implementation plan for MDS. Then in years 3 through 7, the public-private partnership should be created and it should implement the MDS that is developed through the pilot program. As we noted in our earlier post on this topic, the information provided on the new MDS has left several key questions unanswered, such as how FDA will use the information in the new MDS, how it will affect premarket requirements, and how would it be used in regulating products that are on the market. Unfortunately, this new report continues to leave these important questions unanswered.
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