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The Power of Track and Trace

The Power of Track and Trace

Imagine a world where every item in the healthcare supply chain is uniquely identified so that its lifetime history, from manufacturer to patient, can be recorded with total accuracy ….

Imagine a world where medical products are identified with certainty and their dates and lot numbers of manufacture recorded through every step of the supply chain …….

Imagine a world where the patient can be treated in the sure knowledge that the right treatment has been applied at the right time, with the right frequency, with the right medicine or drug, to the right dosage and with the right route of administration

Imagine a world where customers, suppliers and manufacturers can meet the ever-increasing demands of patients and regulatory bodies for greater patient safety and improved patient care.

This is not a world of tomorrow but is a world of today. It is world enabled by the tracking and tracing of healthcare products, of all kinds and at all points of the supply chain, wherever they are - for better product re-call, inventory management, servicing and asset management and patient safety. This is the power of track and trace.

What is traceability in healthcare?

“….. The capability to follow the path of a specified unit of a healthcare product through the supply chain as it moves between organisations – from manufacturers to distributors to hospitals to patients. Products are tracked routinely for obsolescence, inventory management, potential recall and logistical purposes…”

“... The capability to identify the origin of a particular unit and/or batch of product and its location within the supply chain (including the hospital) by reference to records held upstream in the supply chain. Products are traced for purposes such as product recall, investigating complaints, and product servicing and repair ….”

(Source: GS1 Fresh Produce Traceability Guidelines: 2001)

Whilst the requirement for traceability is currently indicative of supply chain pressure, increasing legislative moves at national, European and global levels will make traceability mandatory within the healthcare sector throughout Europe.

Enabling track and trace

What is required is a method of bringing certainty to the whole process of patient care and its associated supply chain and that means supporting human action with automation through the use of proven, reliable technology.

Traceability requires each organisation within the supply chain to implement compatible and accurate data management systems based on open standards. This means that organisations need reference to common definitions and data structures throughout the whole supply chain, with no interruptions. The GS1 System provides the basis for such systems. Effective traceability systems require the long-term commitment of all organisations involved since traceability breaks down wherever there is a failure to meet the necessary standards. Any re-labelling operation puts traceability in danger, as it introduces a new source of potential errors. We believe that source marking of medical products is the key to accurate traceability

The basic requirement for any traceability system is to uniquely identify the item that is to be traced. This is normally done by an appropriate and neutral data element (the item identification), which is carried in a bar code : this allows for automatic identification which minimises errors and processing time. Item identification is then communicated to other members of the supply chain and entered into a database from which information can be retrieved using this unique item identifier as the key.

The data can be held on a central server or on local databases at various points in the supply chain. In addition, relevant traceability information, together with the item identifier, may be encoded in the bar code printed on the item. This enables a standardised datastructure, allowing any party in the supply chain to process this kind of information about any product from any supplier with the minimum of effort.

Traceability systems may track items at individual product level (the single vial, the single implant) or at the trade item level depending on the supply chain's specific requirements. Further, for medical devices and drugs, it will be necessary to track specific production batches right through to the individual patient. For special products, like customised implants or radio-active products as in vivo diagnostics, the serial number will identify the item itself within its pairs.

The amount of data required to be stored about an item will also vary according to the supply chain characteristics. With drugs for example, it will be necessary to record information about the manufacturing batch number and expiry date, the storage environment and history in the cool chain, and the identity of the previous and next step in the supply chain.

GS1 System supporting track and trace

The mission of GS1 and the Member Organisations, is to take a leading role in establishing a global multi-industry system of identification and communication for products, services and locations based on internationally accepted and business led standards. The objective is to improve the efficiency of integrated logistics while contributing added value to partners involved, as well as to consumers.

GS1 is a global organisation of more than 100 member organisations. They support the needs of over one million member companies who conduct more than 5 billion transactions per day in 23 sectors of industry (including healthcare) using the standards.

The benefits of the GS1 system: