The healthcare sector is a complex and global industry sector, with various stakeholders across the supply chain, from pharmaceutical to medical device suppliers, manufacturers, wholesalers, distributors, group purchasing organizations and healthcare service providers. Though there are transformative changes occurring in healthcare, one thing remains the same – the need for consistent, high quality patient care.
GS1 Hong Kong works closely, both locally and globally with the healthcare industry to develop and support the implementation of global standards and solutions, to create a more efficient supply chain, achieve regulatory compliance and increase operational efficiency.
The use of GS1 Standards in healthcare increases patient safety, drives supply chain efficiencies and improves the traceability of medicines.
GS1 Keys (GTIN, GLN and SSCC) – Optimise Supply Chain Management
The use of GS1 Keys can enhance logistics, procurement, stock and asset management processes in healthcare industry.
GTIN (Global Trade Identification Number): provides a unique identification solution for Healthcare Items. When linked with the item’s batch number and expiration date, it can help provide traceability from production to patient delivery. View the GS1 Healthcare GTIN Allocation Rules here.
GLN (Global Location Number): enables the unique and unambiguous identification of any type of location used in business processes, and improves the efficiency of communication between trading partners.
SSCC (Serial Shipping Container Code): provides a key to identify individual logistics units, i.e. pallets, trucks, parcels etc.
GS1 DataMatrix – Improve Patient Safety through Supply Chain Visibility
GS1 Healthcare advocates for ONE barcode symbol to be placed on product packaging, as having more than one symbol on a product creates challenges in the care-giving environment, for example: the time taken to identify which symbol to scan, the impact of the wrong symbol being scanned etc., which impact patient safety.
GS1 DataMatrix is a two-dimensional (2D) matrix bar code, consisting of black and white “cells” or modules, that can be arranged in a square or rectangular matrix.
It can efficiently help to meet the needs of pharmaceutical and medical device industry, by:
- Allowing the encoding and marking of a greater amount of data within a smaller space: GS1 DataMatrix can contain attributes like manufacturer product code(GTIN), expiry date, batch/IoT number, Unique Serial Number etc
- Enabling direct part marking of trade items where labels may not be practical (small medical / surgical instruments)
- Allowing the printing of variable information in a bar code data carrier, at high production rates
- Providing error detection and correction capabilities to improve the readability of bar code symbols despite irregular packaging or physical damage to a label
GS1 Hong Kong has drafted the DataMatrix implementation guideline for Hong Kong healthcare industry and is working closely with industry stakeholders to advocate the adaptation of GS1 DataMatrix, improving the quality of patient care.
Besides, the regulatory landscape continues to evolve and new regulations make further impacts on the healthcare supply chain, e.g. requiring operators to implement automatic identification technologies, electronic catalogues, serialization (a unique number on each package or product, where appropriate) and/or traceability systems.
The US Food and Drug Administration (FDA) released in September 2013 a UDI rule which establishes a UDI system applying to all medical devices placed in the US market, and GS1 has been accredited by the US FDA as issuing agency for unique device identifiers (UDIs). GS1 Hong Kong helps healthcare manufacturers in Hong Kong to meet the requirements of US FDA UDI regulation to support patient safety.
Ensuring patient safety
The healthcare sector has already started to adopt GS1 barcodes to identify, capture and share information on medicine, surgical equipment and patient records, aiming to reduce errors and ensure patient safety.
Applying these standards, from manufacturers and distribution centres to hospital wards, can help safeguard and optimise the management of the whole healthcare supply chain, ultimately bringing improved safety to patients.
*GS1 Healthcare GTIN Allocation Rules updated!
To accommodate global new requirements, new regulations and new business processes that have come up in the last decade since the original Healthcare Global Trade Item Number (GTIN) Allocation Rules were developed, the GS1 Healthcare GTIN Allocation Rules were updated and ratified and Release 10.0 of these rules was published in June 2020 and in effect immediately. The rules are designed to help the industry make consistent decisions about how to manage the unique identification of trade items, thus enhancing efficiencies and patient safety when all partners in the supply chain adhere to the Healthcare GTIN Allocation Rules.
Impact to stakeholders:
- Procurement and Distributors: Some existing products may be updated with new GTIN's due to the new allocation rules
- Manufacturers and Suppliers: Required to review if the updated rules have any impact to the GTIN allocation of the products, and communicate with affected parties.
You are strongly recommended to review your healthcare products if their GTIN are required to be revised based on the updated rules.
Example business scenarios that require a new GTIN:
- Single language products with different target market/country >>> new GTIN
- When a language is removed from a multilingual package >>> new GTIN
- Change in declared net content >>> new GTIN
- Inclusion of a Certification Mark >>> new GTIN
GS1 HK enables healthcare companies to drive supply chain efficiency, improve traceability of medicines and increase patient safety.
a) Cold Chain Management Solution – Real-time temperature monitoring
Empowered by the global traceability platform ezTRACK™ with RFID sensor tags embedded in logistics units, full traceability information, temperature and humidity condition can be monitored during the whole logistics process to assure quality and safety of pharmaceutical products
b) REAL Visibility – Prevent Counterfeits
Empower healthcare stakeholders and consumers with instant product authentication and traceability to ensure products are genuine and prevent counterfeit healthcare products and fake medicines
c) ezTRADE – Facilitate Pharmaceutical Procurement Process
Facilitates paperless trading and automates pharmaceutical procurement processes among trading partners.
• Hospital Authority(HA) started using GS1 Hong Kong’s ezTRADE to facilitate paperless trading with vendors for enhanced efficiency in 1996. 88% of HA’s pharmaceutical orders are automated, with higher efficiency and consistency in supply-chain operations, from product orders to physical receipt of the items procured.
“The Hospital Authority has successfully implemented a modernized supply chain model over the recent years through adopting the GS1 standards, introducing barcode technology applications and establishing its own Electronic Data Interchange network. These initiatives have not only improved its operational efficiency and product traceability from its pharmaceutical supplies, but have also reduced service risks and enhanced patient safety in the public hospitals,”
Dr. W L CHEUNG, Director (Cluster Services) of the Hospital Authority
Business case sharing
Hospital Authority - Supply chain modernisation aimed at improving medication safety
Even in the early 1990s, the Hospital Authority (HA) had foreseen the growing importance of medication safety, supply chain efficiency and traceability in its routine operations. To prepare itself for these challenges, HA started using GS1 Hong Kong’s ezTRADE, a standard-based e-commerce platform that facilitates paperless trading with its vendors for enhanced efficiency, in 1996. Under this platform, the organization has been able to transmit pharmaceutical orders to its suppliers through a standardized purchase order (PO) form online. This is part of HA’s Supply Chain Modernization (SCM) project, which was further rolled out in 2010 to facilitate automation of the pharmaceutical procurement process and provide accurate tracking of pharmaceutical products from one location to another along the organization’s supply chain.
The entire implementation, which encompasses seven clusters of 42 public hospitals and clinics under HA, has been completed in 2014. With 88% of its pharmaceutical orders automated, HA has experienced higher efficiency and consistency in its supply-chain operations, from product orders to physical receipt of the items procured. HA’s financial settlements with its trading partners have also seen significant improvements. The project has also bolstered the track and trace capability of HA stores on the movements of pharmaceutical supplies, leading to better inventory planning and stock allocation.
“The Hospital Authority has successfully implemented a modernized supply chain model over the recent years through adopting the GS1 standards, introducing barcode technology applications and establishing its own Electronic Data Interchange network. These initiatives have not only improved its operational efficiency and product traceability from its pharmaceutical supplies, but have also reduced service risks and enhanced patient safety in the public hospitals,” said Dr. W L CHEUNG, Director (Cluster Services) of the Hospital Authority.
Nex Medical Limited - Taking patient safety to the next horizon via medical device tracking
Patients today face significant risks that a recalled medical device could be used in their treatment if there is no way for quick and reliable identification of a recalled device. Without an appropriate identification and tracking system, a defective device could remain undiscovered for a longer time, which is a significant patient safety concern. Having a wider connection in the global distribution chain and increasing alerts in patient safety, Nex Medical face the challenges of effective identification of individual medical devices produced, inefficient and ineffective product recalls, incomplete adverse event reporting, counterfeit products and inefficient healthcare supply chain processes.
A strong need for Nex Medical was developed to implement an effective product identification mechanism to automatically document and track the disposable laparoscopic devices it distributes, in order to enhance the traceability of these products.
Under GS1 Hong Kong’s consultancy and assistance, the device manufacturer decided to implement the new unique device identification (UDI) codes recommended by the U.S. Food and Drug Administration (FDA). As such, the company is required to assign a UDI number to each version and model of its devices. With the unique device identification system, the company can adequately identify each medical device.
The UDI is required on the label in a human readable format, as well as in a manner that can be read by automatic identification and data capture (AIDC) technology, such as a linear or 2D DataMatrix barcode. A unique UDI must be applied to the “base package” and higher levels of packaging.
Given the need for Nex Medical to assign UDI numbers to its products, a database with identifier numbers, corresponding products, respective manufactures and other distributes has to be maintained.
The GS1 solution for creating the device identifier of a UDI is the Global Trade Item Number (GTIN). The “dynamic” portion of a UDI is a production identifier generated in manufacturing and includes expiry data, lot number or serial number (depending on how the device is controlled) and is printed on the product label.
In the course of its consultancy work, GS1 Hong Kong provided training to key operational staff from Nex Medical in order to educate the FDA standards and UDI guidelines and the various operational practices, including database setup and maintenance, to ensure their smooth implementation.
By embracing GS1 solutions, Nex Medical has been able to meet globally recognized identification standard for medical services, by which it can track and trace its device distribution efficiently, while being able to develop a database for system integration of information if necessary.
Nex Medical’s successful implementation of the UDI on its products means that the healthcare devices it manufactures and distributes will be authorized for use anywhere in the world, especially countries that mandate UDI requirements to be attained. Apart from maintaining its global market presence and fulfilling the regulations, the company also leverages UDI to optimize its manufacturing and supply chain business processes.
This model will allow Nex Medical and other data providers to load their master data once for all geographies. Data recipients, such as its customers from Hong Kong’s healthcare industry and beyond, will also have access to the data through one source.
Zuellig Group - Joining the largest EDI alliance to boost order-to-cash processes
With the mission to enhance the traceability of pharmaceutical products from external vendors into its pharmacy stores in a more accurate and efficient way, HA pharmacies, starting from June 2012, have launched its pharmaceutical supply chain modernization project. In the project, an electronic data exchange platform ezTRADE developed by GS1 Hong Kong, was chosen to facilitate accurate and efficient data exchange between the HA and its suppliers, including purchase orders, purchase order responses, dispatch advice and invoices, etc.
Zuellig Pharma’s was invited to join this project to renovate its supply chain process. Although the company has had streamlined its supply chain with its business partners for years, including an Electronic Data Interchanges (EDI) platform arrangements with HA which was established over more than a decade, the company still took this opportunity to further enhance its supply chain processes to perfection and tied in with the government’s 75 improvement initiatives under a preventive approach to public healthcare in Hong Kong.
As a supply chain consultant to Zuellig Pharma, GS1 Hong Kong assisted the pharmaceutical supplier to adapt to the supply chain process requirements specified by the HA. One of the key recommendations is the adoption of barcode applications for product identification at carton level. The barcodes affixed to each carton can automatically identify their physical content, including pharmaceutical items, assets, logistic units, shipments and physical locations, etc., at any point in the supply chain. This has eliminated the need of physical stock counting, while providing for real-time visibility into its inventory status and ensuring that the shipments do not end up at the wrong delivery addresses.
In addition, Zuellig Pharma embraced a number of other GS1 standards, including Electronic Data Interchanges (EDI) documents such as Purchase Order Response (POR), Advance Shipping Notices (ASN) and invoices.
Upon receipt of purchase orders from the HA, Zuellig Pharma will pack the products with a GS1 Serial Shipping Container Code (SSCC) label attached. At the same time, an electronic dispatch advice will be sent to the HA for advance validation by the purchasing unit. Upon delivery to the HA’s warehouses, the SSCC will be scanned by the pharmacy staff to cross check all product data and physical goods delivered with the purchase information source.Once correctly verified, electronic invoices will be sent to the HA through the ezTRADE platform.
Application of GS1 Standards to the client’s communication protocols and process has significantly enhanced the accuracy of its data exchange with HA and other healthcare customers, ensuring the elimination of processing and other blunders.Ultimately, patient safety has been improved with the implementation of product identification through barcode technology. This has enabled hospital, pharmacy or clinic staff to avoid medication errors by automatically matching product data with patient data.
This exercise has also enabled efficient traceability of pharmaceutical products, all the way from warehouse to patients. This helps the company facilitate prompt identification and removal of infected items in the event of a product recall. Patient safety is also better assured with the reduction of handling and delivery errors arising from manual input.
Zuellig Pharma has improved the accuracy of information captured in its trading documents during the procurement, pre-delivery and actual delivery cycles. The validation of the goods delivery also makes its operations faster and more accurate. The availability of real-time supply chain data, including the product needs of its customers, has enabled more real-time demand planning decision. With the simple standards and appropriate technology and systems in place, Zuellig Pharma is able to improve the better efficiency and higher safety of the pharmaceutical distribution services it provides and cope with fast-changing customer demands, while maintaining a high level of operational service excellence.
With GS1 Global Standards and EDI platform, Zuellig Pharma has streamlined the pharmaceutical procurement processes and facilitated the exchange of data and documents such as purchase order, purchase order response, advanced shipping notices as well as invoices. Over 80% orders were automated effectively whichresults in operation efficiency, accuracy and patient saving.
Advocacy and Events
GS1 Hong Kong is committed to enabling the local healthcare sector to implement global standards to create a more efficient and cohesive supply chain.
Participated at the Gerontech and Innovation Expo cum Summit
GS1 Hong Kong participates at the The Gerontech and Innovation Expo cum Summit (GIES), showcasing solutions empowered by cloud-based IoT platform ezTRACK™ to enhance the life of elderly and support patient care with innovative technology.
Offered Healthcare Training to Leading Healthcare Service Providers
GS1 Hong Kong offers healthcare training to various healthcare services providers, topics covering healthcare standards applications, Electronic Data Interchange (EDI) messaging and technologies implementation etc.
Advocacy on Smart Healthcare
GS1 Hong Kong called for expanding application of global identification standards for traceability of drugs and medical devices in various responses to the Government. View our advocacy here. (link to GS1 HK advocacy)
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