The U.S. Food and Drug Administration ’s Medical Device Unique Identification System (UDI) has been steadily developed since it became law in 2007, and if it does not stop abruptly on November 7, the interval between quiescent periods should be able to be shortened. That ’s right, November 7 is the day when the results of the US election are announced. More importantly, for those who are concerned about the unique identification of medical devices, as time goes by, stakeholders are more looking forward to joining the US Food and Drug Administration Of the trial regulations to manage the system.
Jay Crowley, M.D., a senior consultant on patient safety at the Center for Devices and Radiation Health of the US Food and Drug Administration, told the Clinical Innovation and Technology website (Clinical InnovaTIon + Technology) that after the identification procedure for the unique identification of medical devices is determined, equipment manufacturers will The standardized bar code label attached to the supervised equipment may one day produce an unimaginable scene-home care patients choose self-service equipment recall and security alarm.
After obtaining the consent of the family care doctor and the patient, the device manufacturer "should be able to communicate directly with the patient," Crowley said. "They will know everyone who owns this special device and the serial number of the related device." The patient can also Check the US Food and Drug Administration's website to clearly see if their equipment is on the recall or warning list.
Crowley pointed out that the most difficult part of the medical device's unique identification system operation was successfully carried out, not related to barcodes, but related to information management. For example, the project requires the definition of standards and the data required by different users. In a recent meeting describing a cardiac stent attribute demonstration project, he pointed out that the team "hasn't spent a whole day solving the attributes of the cardiac stent that users should need to know and what doctors and researchers want to do next. "
During the drafting of the proposal, the US Food and Drug Administration solicited the opinions of consumers. They were all very positive about the advantages of medical device unique label tracking and believed that it played an important role in the life cycle of the device.
The field of equipment industry is the industry most directly affected by the action. The US Food and Drug Administration has always maintained a high degree of vigilance in this industry. Crowley said: "Companies that implement this plan will find that this will bring tremendous added value to themselves and their customers." Agents strive to achieve flexibility on time, for example, manufacturers do not need to discard all label materials that are not suitable for the plan . "We don't want the equipment industry to bear unnecessary expenses."
Some medical professionals have expressed the same concerns. Hospital technical management staff will be troubled by the unique identification of medical devices that will interfere with the hospital's identification system. They have customized inventory management. "This is one of the problems we have to solve," Crowley said. "Medical service providers, distributors, GPOs and other organizations have also established their own numbering systems. The intersection of different numbering systems has caused confusion."
Ultimately, controlling medical decisions vigorously is "the patient's most desired need," Crowley said. As a consumer in the medical industry, he added: "I want to learn about myself, my children, my parents, and others I care about, which I could not have known."
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