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.

Figure 2: UDI Code.

The code (can be numeric or alphanumeric) shown above for the UDI is composed of two parts: UDI Device Identifier (UDI – DI), and UDI Production Identifiers (UDI – PI). The UDI – DI is a code unique to a specific MD model. This is used as an “access key” to the information stored in the UDI database (UDID). The UDI – PI identifies the unit of device production. It includes serial number, batch/lot number, software version, and manufacturing and/or expiration date. The Data Delimiters (included in the UDI – PI) allows legible interpretation of the coded information and are used by different issuing agencies.

UDI System

The UDI system is an internationally – recognized system for MD identification. It enables capture of standard information related to the MD by automation using a single barcode scan. The critical information can also be shown in human readable interpretation (HRI) as shown below. 

Figure 3: Automatic Capture of MD Information under the UDI System.

This system is adopted by the International Medical Device Regulators Forum (IMDRF) and has provided a harmonized approach for the global implementation of UDI. Different countries also have different types of implementation plans for the UDI:

• USA: Implemented on all MDs (except some of the lowest risk devices).
• EU: To be implemented to high – risk MDs in 2021.
• Australia: Requirements under consultation (published last 2018 and 2019).
• China and Korea: Started the implementation process.

Key Parts of UDI Implementation in Healthcare System

The schematic diagram for the implementation of UDI has 2 key parts as shown below.

Figure 4: Key Parts of UDI Implementation in Health Care System (first part boxed in red).

The first part entails making the UDI available on the MDs labels in Singapore. This aims to align with the internationally harmonized principles outline in the UDI guidance as published by the IMDRF: the 2013 UDI Guidance (IMDRF/UDI WG/N7FINAL:2013), and UDI Application Guide (IMDRF/UDI WG/N48 FINAL:2019). This will also adopt a risk – calibrated approach and will recognize the following organizations to operate the system of UDI:

• GS1
• Health Industry Business Communications council (HIBCC)
• International Council for Commonality in Blood Banking Automation (ICCBB)

The HSA will accept UDI for manufacturers whose MDs have labels contain UDI barcodes for USA and EU and thus will not require specific UDI for Singapore. This will in turn be captured and be recorded on the Singapore Medical Device Register (SMDR) and will be made available to the public. Essential data such as intended use, product owner, etc will be captured as the SMDR is fit to contain such information. However, additional fields will be added to the register as needed.

As mentioned before, the implementation plan will come in phases. Phase 1 will begin on 2022 to give enough time for the stakeholders to prepare. Only three types of high – risk implantable MDs are required to be labelled with UDI during this phase: coronary stents, orthopaedic joint replacement implants, and intraocular lens. The succeeding phases will start 2 years after each phase. This will cover the requirement of medium to other high – risk MDs requiring the UDI label. For low – risk MDs, UDI will not be mandatory. However, this can be implemented on a voluntary basis (e.g., the MD is already UDI – labelled in the country of origin).

Below is a summary of the phased implementation timeline of the UDI System in Singapore.

Figure 5: Phased Implementation Timeline of UDI System in Singapore

Information for the MD must be uploaded to the SMDR before 2022. At the start of 2022, all respective MD categories must bear UDI on labels.

Figure 6: Key Parts of UDI Implementation in Health Care System (second part boxed in blue).

The second part is the implementation in Singapore’s healthcare system as shown in the figure above. This implementation will result in the consistent and efficient recording of MD information in hospitals. It will also result in a better information flow among hospital systems and faster tracing of MDs used on patients with recalls, defects, or serious adverse events. The MOH, IHiS, ALPS, and HCIs are the key organization for the implementation of the second part.

To ensure the smooth implementation of the UDI in Singapore, guidance on UDI requirements and steps in SMDR submission will be developed. Furthermore, consultation with stakeholders will be done and the contents will be updated as needed. Local/regional manufacturers who do not supply their MDs overseas (USA or EU) will also be provided with assistance to facilitate implementation. A dedicated online feedback process has also been set – up.

References:

Industry Briefing (October 2020)

Medical Device Unique Device Identification (UDI) system in Singapore