As part of the UDI system, the FDA is also creating the Global Unique Device Identification Database (GUDID) which will include basic identifying elements for each device with a UDI. Most of this information will be made available to the public so that users of a medical device can easily look up information about the device. The UDI does not indicate, and the database will not contain, any information about who uses a device, including personal privacy information. (From FDA website)
Healthcare providers have the ability to store the UDI of a medical device used on a patient in the patient’s medical record. In the event of a problem or recall of a device, healthcare providers could search their records for patients that were treated with the problem device. But, patient information is never submitted to the GUDID. The privacy of patient records is protected by the HIPAA privacy law.
Medical device companies will have to include a UDI on some of their products and submit identifying information about those products to the GUDID starting on September 24, 2014.
USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet the new regulations. Our team of experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID database. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.
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