Public Health Effectiveness of the FDA 510(k) Clearance Process Measuring Postmarket Performance and Other Select Topics: Workshop Report (2011) / Chapter Skim
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4 Postmarket Surveillance of Medical Devices: Panel Discussion
4 Postmarket Surveillance of Medical Devices: Panel Discussion
Pages 39-46
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From page 39... ...
In the discussion, panelists expanded on the topics of predicates; device development, including the conduct of clinical studies; data collection and data-sharing; unique device identifiers; encouraging broader participation in device surveillance systems; and risk communication. SUSAN ALPERT: INDUSTRY DEVICE SURVEILLANCE As device manufacturers develop technologies and evaluate them, Alpert said, they have expectations for the performance of the devices in the marketplace.
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From page 40... ...
Many active implantable devices have electronic monitoring systems, often bedside monitors, to which the devices automatically send information about the patients and the performance of the devices every night. Through CareLink, this information can be transmitted to the provider for remote monitoring.
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From page 41... ...
predicate approach, Kessler said, and he urged the committee to look at other models, such as the Global Harmonization Task Force guidance Essential Principles of Safety and Performance of Medical Devices, which is used in the European Union and elsewhere (GHTF, 2005)
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From page 42... ...
The primary incentive for any action by a manufacturer is getting a product to market. Peterson said that the reason that drugs companies conduct large randomized trials and device manufacturers do not is that regulations require trials for approval to market a drug.
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Hall responded that a lot of European device indications are more "engineering indications." A particular device is capable of performing a particular task (for example, cut and ablate)
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From page 44... ...
A committee member wondered whether it would be possible to have a core set of data in a precompetitive, publicly accessible space with appendixes of private data for specific studies. UNIQUE DEVICE IDENTIFIERS Developing standardized nomenclature for devices and a unique device identification (UDI)
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From page 45... ...
One of the challenges is to facilitate data collection outside the hospital procedure-based structure. RISK COMMUNICATION A committee member asked, With continuous accrual of information in the postmarket period, at what point do actions need to be taken to communicate the information?
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From page 46... ...
In the conduct of the DELTA studies in collaboration with FDA, Resnic said, results were shared with the FDA postmarket staff, who shared them with the premarket staff who looked at the internal FDA datasets, including engineering data and preapproval and postapproval studies, to see whether there were concordant signals. Such hypothesis-generating signals must be vetted through a relatively rigorous mechanism to avoid undue alarm in patient communities.
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