The Health Sciences Authority (HSA), Singapore’s regulating authority in the sphere of medical devices, has announced the Unique Device Identification (UDI) system for medical devices to be introduced in the country.
Regulatory Background and Current Situation
HSA describes the reasons and preconditions for the UDI system implementation. According to the official presentation published by the authority, there are a lot of medical devices with moderate or high associated risks that are being used in the country nowadays. In order to ensure the correct performance of medical devices placed on the market, and also the safety of patients, the following types of tracking of medical devices have been already implemented:
- Investigation of adverse events, conducting recalls, implementation of corrective actions and clinical follow-up,
- Tracking utilization of medical devices for Health Technology assessments,
- Tracking procurement and distribution of medical devices,
- Inventory management, operation records, billing, and registries.
The HSA also states that the absence of the standardized identification codes used in the country results in the following consequences:
- inefficient information exchange among all existing databases,
- mismatch in fields and attributes collected manually.
At the moment, some of the medical device users (for example, healthcare facilities) still record the information about impacted medical devices manually, which makes the whole information flow unreliable and inefficient since it results in significant inaccuracy in data capture. Moreover, manual recording requires additional resources to be dedicated, which increases the workload for healthcare institutions.
The authority emphasizes the most important effects caused by inaccurate and unreliable record-keeping, namely:
- Potential delays in the actual implementation of follow-up actions initiated in case of recalls or adverse events associated with medical devices,
- Human-related errors occurring in the course of manual data entry,
- Inadequate information about the use of medical devices in general.
The first point from above creates the most concerns since it could directly affect the safety of the patients.
On the basis of all the issues highlighted hereabove, the HSA finds it necessary to develop and introduce a harmonized identification system in order to resolve the abovementioned matters and ensure the record-keeping performed in an accurate and timely manner.
Singapore’s Unique Device Identification System
As it is stated in the presentation published by the HSA, a Unique Device Identifier could be used as some sort of standardized identification code for all medical devices registered with the HSA and allowed for importation, marketing, and use in Singapore. It is expected that the implementation of the UDI system would improve significantly the traceability of medical devices, as well as the identification of patients for whom the particular medical devices were applied, which becomes vitally important in case of severe adverse events or recalls. Unique Device Identifiers could be used by all the parties involved in operations with medical devices, including medical devices manufacturers, regulating authorities, distributors, and healthcare facilities.
The UDI system is also expected to improve the overall effectiveness of the data capture processes and reduce the number of errors.
The main element of the UDI system is a numeric or alphanumeric code which includes two components:
- UDI-Device Identifier (UDI-DI), and
- UDI-Production Identifier (UDI-PI).
Device Identifier (UDI-DI) constitutes a unique numeric or alphanumeric code specific to a model of the medical device. This part identifies the specific product and package configuration and could be used to access the information about the device included in the appropriate database (UDID).
Product Identifier (UDI-PI) constitutes a numeric or alphanumeric code that identifies the unit of device production. It includes special elements used to identify the particular device (item), e.g. serial number, batch or lot number, version of the software, manufacturing, and/or expiration date.
The Human Readable Information of the Unique Device Identifier also contains Data Delimiters used to improve the interpretation of the information provided in the coded format. It is important to mention that different agencies use different Data Delimiters.
Thus, the UDI system to be introduced in Singapore includes both barcode that could be scanned and additional part providing the most important information in human-readable interpretation (HRI) format. This approach simplifies and collection of the information by regulating authorities, and also by healthcare facilities.
The HSA also additionally emphasizes that the Unique Device Identification system described hereabove actually constitutes an international system initially developed by the International Medical Device Regulators Forum (IMDRF), a voluntary association of the national regulating authorities of different countries collaborating for the further improvement of the existing regulatory framework. The suggested utilization of the harmonized approach in the context of the Unique Device Identification is important for ensuring effective information exchange on the international level.
Additionally, the HSA presentation also provides a general overview of the process of implementation of the Unique Device Identification systems in other countries. For instance, according to the information contained in the presentation:
- the US has already implemented the UDI system for all medical devices, except certain devices with the lowest associated risk,
- the EU intense to commence the UDI implementation process later in 2021, at the first stage it would cover only high-risk medical devices,
- Australia is still in the process of the UDI framework development,
- South Korea and PRC have already commenced the UDI system implementation process.
UDI System: Key Elements and Components
The document published by the HSA also describes the Unique Device Identification system to be implemented in the country in detail. For instance, the presentation describes the two-step implementation process consisting of the following steps:
- Initial implementation of the Unique Device Identifiers. At this step, the medical device manufacturers intended to market their devices in Singapore would provide the UDI information to the online database maintained by the HSA, concurrently placing the Unique Device Identifiers on the labeling of medical devices.
- Expanded use of the UDI system by other parties, inching healthcare institutions, and other stakeholders.
As it was already mentioned before, the new regulatory framework for Unique Medical Device Identification is actually based on the approach to the UDI developed by the IMDRF. In particular, the HSA states that Singapore’s UDI system employs the principles established by the following IMDRF guidelines:
- UDI guidance in 2013 (IMDRF/UDI WG/N7FINAL:2013), and
- UDI Application Guide (IMDRF/UDI WG?N48 FINAL:2019).
The whole UDI system implementation process is based on a risk-calibrated approach, under which the implementation of the Unique Device Identifiers depends on the risk associated with the medical device.
The Unique Device Identification system requires the participation of special organizations responsible for assigning the UDIs. According to the presentation, the HSA recognizes the following organizations:
- GS1,
- Health Industry Business Communications Council (HIBCC),
- International Council for Commonality in Blood Banking Automation (ICCBB).
Thus, upon implementation of the UDI system in Singapore, the Unique Device Identifiers assigned to the medical devices in other countries would be also admissible in Singapore since the new system does not prescribe any country-specific requirements. All information contained in the UDIs would be uploaded to the Singapore Medical Device Register (SMDR), the country’s national register of medical devices allowed to be placed on the market.
Summarizing the information provided here above, the presentation on the implementation of the Unique Device Identification system published by the HSA describes the core components of the new system, as well as the main implementation steps.
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