Medical Device Tracking: How UDI Can Strengthen India’s Healthcare Supply Chain

With the integration of digitalization aspects in the healthcare industry, ensuring patient safety along with regulatory compliance has become a priority. In this regard, the Unique Device Identification System could support transparency, security, and compliance in the healthcare sector. The Unique Device Identifier (UDI) is an identifier that helps track a medical device during its distribution and use, meeting the requirements of 21 CFR 830.20, which states that the UDI must be issued under a system operated by an FDA-accredited issuing agency and compliant with international standards. Recognizing the importance of traceability and integrity in the healthcare supply chain, regulatory bodies such as the US Food and Drug Administration (FDA) and the European Commission have developed regulations for the Unique Device Identification (UDI). The Unique Device Identifier is mandatory in the US, requiring global suppliers of medical devices to the US market to adopt the system. However, the implementation of Unique Device Identifier for approved medical devices has been delayed in India due to regulatory challenges but is expected to be announced soon, giving the healthcare system time to better understand its use.

A Brief Description of UDI in Medical Devices

According to the International Medical Device Regulators Forum (IMDRF), the Unique Device Identification (UDI) system was designed to provide a single, globally accepted system for accurate identification of medical devices in the supply chain. The Unique Device Identifier has a unique code consisting of two components – Device Identifier and Production Identifier. Device Identifier (DI) is a static part of the UDI that represents the medical device and helps identify the device model and manufacturing details, making it easier to store inventory. On the other hand, Production Identifier (PI) is a dynamic part such as serial number, batch number, production date, and expiration date.

Interestingly, the Unique Device Identification Rule mandates that medical device labels must include a unique identifier on the data carrier (AIDC). If required, the label or device will also include a human-readable interpretation (HRI). Both must be compliant with the standards of accredited issuing agencies such as GS1 to ensure effective and efficient implementation of UDI by all healthcare entities worldwide. In this regard, GS1 would act as the UDI issuing agency, and GS1 standards would provide a global framework to facilitate the identification, recording, and efficient sharing of details of medical device products.

Regulatory Landscape for UDI for Medical Devices in India

Rule 46 of the Medical Devices Rules was to be replaced by Unique device identification of medical devices. As per this amendment, every medical device approved for manufacture for sale, distribution or import was to have UDI as per UDI requirements by January 2022. However, in 2021, the Ministry of Health and Family Welfare of India and the Department of Health and Family Welfare issued a notification regarding Rule 46 of the Medical Device Rule 2017 amendment, delaying the expected implementation of UDI standards until further notice. In particular, the Ministry of Health and Family Welfare is expected to provide guidance on how to display the unique device identification number and the information it will contain. The new requirements may be based on the IMDRF UDI guidelines, which mandate that device labels and/or packaging should include a human-readable form and AIDC carrier. Once implemented, the UDI regulations will impact all medical devices, even those registered under an import license.

Role of UDI in Improving Patient Traceability and Safety in India

The Unique Device Identifier (UDI) system can benefit the Indian healthcare sector in many ways. For example, the Unique Device Identifier can help increase transparency in the healthcare supply chain by allowing users to trace the original Unique Device Identifier (UDI) of a device to its product line and manufacturer. It can help increase patient safety by allowing them to identify counterfeit medical products.

Such a feature could help device manufacturers quickly identify affected device batches and notify registered owners of problems. It could help with easy product recalls and increase manufacturer accountability.

Unique Device Identifier can play a key role in helping healthcare providers and hospitals identify device usage and shelf life. This knowledge can improve inventory management and help identify and move products approaching expiration to the use list or discard them, avoiding patient safety risks.

With a Unique Device Identifier (UDI), manufacturers can receive feedback and safety concerns directly from end users, such as patients or hospitals, allowing for quick troubleshooting and product quality improvement.

In addition, UDI data can be integrated with billing systems, allowing healthcare providers to bill for all devices used during a procedure. Such a move could help increase the accuracy and transparency of device claims or reimbursements while reducing the overall administrative burden.

The Unique Device Identification system is designed to enhance the traceability of medical products. By helping to promote traceability and accountability in the medical device industry, the Unique Device Identification system can increase transparency and compliance at every level. This will not only help simplify healthcare management processes and operations, but also ensure patient safety, significantly improving patient outcomes over time. Therefore, it is important to implement the system as soon as possible.