FDA Wants Comments on Medical Device Identifier Affect on EHRs, Databases
The Food and Drug Administration will hold a free public workshop in September covering the adoption, implementation and use of a unique device identifier for medical devices, and how the identifier affects other systems, such as registries and databases within electronic health records systems. A proposed rule to establish the device identifiers is under Office of Management and Budget review, which is one of the last steps before publication. Under the rule, the identifier will identify
The Food and Drug Administration will hold a free public workshop in September covering the adoption, implementation and use of a unique device identifier for medical devices, and how the identifier affects other systems, such as registries and databases within electronic health records systems.
A proposed rule to establish the device identifiers is under Office of Management and Budget review, which is one of the last steps before publication. Under the rule, the identifier will identify a device through distribution and use, and may include the lot or serial number. The identifier is mandated under the Food and Drug Administration Amendments Act of 2007.
The FDA workshop, Sept. 12-13 in Bethesda, Md., also will be Web cast via fda.gov/UDI, with the agenda and information on discussion topics posted by Aug. 12. Electronic health records related topics, according to a notice available now and being published July 21 in the Federal Register, include:
* The current state of documentation of device use in heath-related databases including EHRs;
* Barriers to, and various possible incentives for, the development, implementation and use of unique device identifiers in EHRs;
* Possible roles and activities of various government stakeholders necessary to drive adoption and use of device identifiers in EHRs and other health-related databases; and
* Other issues or concerns that could affect the efficient and effective incorporation of the identifiers in EHRs and other health-related data.
The workshop also will cover multiple issues related to the role of unique device identifiers in registries, national and local data standards, hospital information systems, personal health records, and postmarket surveillance and compliance.
A proposed rule to establish the device identifiers is under Office of Management and Budget review, which is one of the last steps before publication. Under the rule, the identifier will identify a device through distribution and use, and may include the lot or serial number. The identifier is mandated under the Food and Drug Administration Amendments Act of 2007.
The FDA workshop, Sept. 12-13 in Bethesda, Md., also will be Web cast via fda.gov/UDI, with the agenda and information on discussion topics posted by Aug. 12. Electronic health records related topics, according to a notice available now and being published July 21 in the Federal Register, include:
* The current state of documentation of device use in heath-related databases including EHRs;
* Barriers to, and various possible incentives for, the development, implementation and use of unique device identifiers in EHRs;
* Possible roles and activities of various government stakeholders necessary to drive adoption and use of device identifiers in EHRs and other health-related databases; and
* Other issues or concerns that could affect the efficient and effective incorporation of the identifiers in EHRs and other health-related data.
The workshop also will cover multiple issues related to the role of unique device identifiers in registries, national and local data standards, hospital information systems, personal health records, and postmarket surveillance and compliance.