The Medical Devices Branch of HSA has organized a webinar to provide a brief introduction of the adoption of the Unique Device Identification (UDI) System last October 19, 2020. The contents of the presentation slides used in the webinar will be discussed in the subsequent paragraphs.
Current System of Tracking MDs and its Limitations and Consequences
Currently, there are 17,500 moderate and high – risk MDs that are registered in Singapore. These MDs are tracked for various purposes as shown below:
Figure 1: MD Tracking in HSA’s Current System.
The limitations of the system shown above includes lack of standardized identification code. This resulted in the lack of synergy of information that was captured among multiple databases, causing poor flow of information. Inconsistency of data fields and attributes can also be due to this lack of identification system when they are obtained from different sources. MDs that are used on hospitals are still being manually recorded, which is an inefficient and error – prone way of data entry. This will also result in inaccurate data capture for certain complex implant system, such as orthopedic implants. In addition, valuable healthcare resources are spent manual tasks instead on high value care delivery work.
The limitations mentioned previously could give rise to a number of consequences. Inefficient and inaccurate identification of MDs used on patients may result in the delay of follow – up actions (e.g., stop the use of MDs in the event of device recall or failure). Inaccurate billing in the hospital will also be the result of such. MDs may also show inaccurate or inadequate information that are utilized locally.
Unique Device Identifier (UDI)
The UDI could serve as a standardized identification code for MDs in Singapore. This can potentially improve the traceability and identification of MDs used on patients that are affected by recalls, failures, or serious adverse events. This could also be improved for various stakeholders (e.g., hospitals, regulators, manufacturers, and distributors). Adoption of this system can also improve efficiency and minimize data capture errors.