It is important to note that the production identifier instance data will not be submitted to the GUDID but rather the type of production identifiers that are used for a particular medical device and appearing on the corresponding device package label.
Not unlike a national electronic catalogue of medical devices, the GUDID is opened to the general public through the National Library of Medicine where all domestically distributed medical devices will be searchable by the device identifier, manufacturer, device trade name or model, http://accessgudid.nlm.nih.gov/ .
III. Integrating UDI into Patient Care
a. Healthcare Supply Chain
Hospitals are not required to implement UDI as it is expected that healthcare will adopt the new identification standards …show more content…
To enable this premise, UDI(s) will be recorded at the point of patient care in Electronic Health Records, (EHRs). This will significantly enhance the FDA 's ability to effectively manage medical device safety surveillance and execute effective recall …show more content…
Accelerated Adverse Event Reporting
The objective in accelerating adverse event medical device reporting is an ambitious goal in transitioning from the current state of reliance on manual data entry methods to an automated real time event reporting system. Rather than relying on the current system metrics where it can take several weeks in reporting an adverse event to affected patients and the FDA, critical device safety issues can be addressed in terms of scope and overall patient safety risk in a matter of minutes, [8].
d. UDI and Health Insurance Claims
Current claims data may only include a medical device model number or more often an ambiguous codification or description. The standardized UDI system will systematically automate claims reimbursement and simplify rebate processing, [9]. UDI(s) will improve the quality of data being transmitted resulting in fewer errors thus augmenting reliable flow of critical transactional master data information between all stakeholders.
IV. UDI Challenges
a. Manufactures Perspective
Manufactures are facing the challenge in applying device identification, revising existing package labelling, to include AIDC technology and submitting master device data attributes required for GUDID device identification
Not unlike a national electronic catalogue of medical devices, the GUDID is opened to the general public through the National Library of Medicine where all domestically distributed medical devices will be searchable by the device identifier, manufacturer, device trade name or model, http://accessgudid.nlm.nih.gov/ .
III. Integrating UDI into Patient Care
a. Healthcare Supply Chain
Hospitals are not required to implement UDI as it is expected that healthcare will adopt the new identification standards …show more content…
To enable this premise, UDI(s) will be recorded at the point of patient care in Electronic Health Records, (EHRs). This will significantly enhance the FDA 's ability to effectively manage medical device safety surveillance and execute effective recall …show more content…
Accelerated Adverse Event Reporting
The objective in accelerating adverse event medical device reporting is an ambitious goal in transitioning from the current state of reliance on manual data entry methods to an automated real time event reporting system. Rather than relying on the current system metrics where it can take several weeks in reporting an adverse event to affected patients and the FDA, critical device safety issues can be addressed in terms of scope and overall patient safety risk in a matter of minutes, [8].
d. UDI and Health Insurance Claims
Current claims data may only include a medical device model number or more often an ambiguous codification or description. The standardized UDI system will systematically automate claims reimbursement and simplify rebate processing, [9]. UDI(s) will improve the quality of data being transmitted resulting in fewer errors thus augmenting reliable flow of critical transactional master data information between all stakeholders.
IV. UDI Challenges
a. Manufactures Perspective
Manufactures are facing the challenge in applying device identification, revising existing package labelling, to include AIDC technology and submitting master device data attributes required for GUDID device identification