What started out as an FDA initiative has become a globally harmonised and consistent approach to unique device identifiers (UDIs). The European Commission and International Medical Device Regulator Forum (IMDRF) have joined with FDA to establish a framework that will optimise patient safety and care by using global standards to synchronise UDI legislation. It is also hoped that this will modernise post-market device surveillance and encourage further innovation.
Unique requirements
On 24 September 2013, FDA established a unique system to identify medical devices through distribution and use in the US. It applies to the majority of medical equipment, including those intended for single, as well multiple, use.
The UDI rule requires that the label on every piece of medical equipment includes a numeric or alphanumeric code, and that a corresponding description of each device is submitted to a global database.
“A UDI comprises a unique code provided by a standards organisation, such as GS1, identifying the manufacturer and product type, and a production identifier, which provides information such as lot, batch, serial number and expiry or manufacturing date,” says Mike Rose, Johnson & Johnson vice-president of supply chain visibility.
FDA created a Global Unique Device Identification Database (GUDID), which contains certain information – supplied by the labeller – about each device. It includes a standard set of basic identifying elements, which the manufacturers are responsible for submitting and maintaining. The device indentifier will appear on the database and act as the key for obtaining any data about that piece of equipment. FDA has provided some exceptions and alternatives to the UDI requirements to ensure costs and burdens are kept to a minimum.
All set for 2020
It is expected that UDI will allow industry and regulatory authorities to identify medical devices that are involved in adverse events more rapidly, providing more targeted safety alerts and field-safety corrective actions. They will also identify counterfeit products, while helping healthcare providers to accurately identify medical devices that they receive and dispense. In the longer term, companies will be able to use the data in procurement systems, inventory management systems, electronic health record systems and implant registries.
Every medical device labeller must comply with the rules following a prescribed schedule. It will take seven years for the framework to be fully instated; it began with initial components of the Class III requirements in 2014, and will conclude with the final compliance components for Class I, and other uncategorised devices, in September 2020. The EU’s pending Medical Device Regulation (MDR) will include UDI requirements, while other countries – China, Saudi Arabia and Brazil, for example – are either developing or considering UDI regulation.
IMDRF has developed a framework guide for those global regulatory authorities that plan to develop UDI systems. Its purpose is to encourage a globally harmonised approach; the US and EU UDI rules are substantively aligned to the IMDRF’s guidance and with each other, but there are some differences. For example, the EU’s MDR may require additional data elements to be submitted to the European database on medical devices (EUDAMED).
The EU published a draft version of MDR in June 2016. Once implemented, it will affect every medical device company trading in the EU. By 2020, they must all demonstrate and maintain compliance in accordance with MDR.
Applicable medical devices/accessories that are sold in the EU must have an assigned UDI from an authorised issuing agency; these must be labelled with the appropriate device UDI in a format that can be read by automatic identification and data-capture machines and the human eye. They must also contain published data about the product in the EUDAMED.
As with FDA’s UDI rule, MDR will further tighten rules for independent, accredited bodies that are responsible for assessing medical devices before they can be placed on the market. Under the rules, they will have the right – and duty – to carry out unannounced factory inspections. It will also strengthen the surveillance of these notified bodies by national authorities.
The draft regulations establish explicit requirements on manufacturers’ responsibilities for monitoring the quality, performance and safety of devices placed on the market. This will enable manufacturers to act quickly when concerns arise, and will help to improve their devices continuously on the basis of actual data. The regulations also improve the availability of clinical data on devices, and strengthen the protection of patients participating in clinical investigations.
Similarly, this framework intends to improve adverse event reporting; facilitate recalls and corrections; assist post-market activity by regulators; enable database queries; and reduce medical errors by ensuring the appropriate device is used in the procedure. Traditional medical devices, active-implantable medical devices and in-vitro diagnostic devices will be covered under the framework.
Make it stick
Regulatory bodies must ensure that the standards set out are adhered to – but how? FDA’s requirements are based on the use of international standards that must be followed by UDI-accredited issuing agencies and UDI labellers, and are included in the 2013 final rule. An organisation must be accredited by FDA to become a UDI-issuing agency. Initially, this will be for three years, with subsequent renewals lasting seven years.
The agency must remain compliant with the eligibility and accreditation criteria set forth by FDA; if any requirements are violated, FDA can terminate its accreditation. Similar stipulations have been incorporated into the upcoming EU MDR.
Johnson & Johnson is focused on ensuring the integrity and safety of its supply chain. It embraces product identification and traceability because of its considerable benefits to the industry, customers and patients. It is complying with the UDI mandate, and has established a UDI programme focused on meeting the UDI milestones set by FDA. It has also selected the GS1 global-trade identification number as its standard device identifier.
It tracks compliance, and also performs internal audits to ensure that every demand of FDA UDI regulation is being met. Plans are being created to ensure compliance with MDR as well as other future global requirements.
In order to ensure the success of UDI, companies must have a thorough understanding of the regulations, using expertise from across the organisation, including regulatory affairs, quality, compliance, supply chain, labelling, document service, IT and many others, says Tom Jones, Johnson & Johnson UDI project director of supply chain visibility.
“A team with this broad level of expertise will enable your company to interpret the regulation appropriately, and to understand the activities you must complete in order to achieve compliance and develop appropriate metrics to measure your progress towards compliance,” he continues. “Once you’ve defined the requirements, your team must focus on execution. Many companies will have hundreds, if not thousands, of devices that are subject to UDI regulation. In these cases, a focused team with full-time dedicated resources should dramatically increase your success.
“Regular progress reviews, using your metrics from the first step, will identify areas where your plan is working well, in addition to opportunities for improvement. Candid conversations regarding risks and headwinds are critical; unlike some other projects, your compliance date cannot slip.”
Jones goes on to say that creating a sustainable, steady environment is critical for long-term success. Initial efforts might focus on collecting and submitting a massive amount of data; updating labels; and direct marking of the current offering of products.
Ensuring UDI compliance should be part of standard operating procedure, with UDI requirements being considered in new product development, acquisitions and changes to existing products. Conforming Amendments, a component of the FDA’s UDI regulation, requires companies to update specific procedures to ensure that UDI becomes part of companies’ quality systems.
Future compliance
Dennis Hahn, director of regulatory policy innovation at Ethicon (a Johnson & Johnson company) believes the future for UDIs will involve expansion and connectivity.
“Many foreign regulators have been carefully studying the US FDA regulation and watching the progress on implementation as they develop their regulation,” he says. “UDI experts in Johnson & Johnson companies have been sharing their US UDI experience with foreign regulators with respect to progress, and what has been learned during the implementation of UDI-compliant barcodes and databases. Regulators are encouraged to harmonise local UDI requirements, consistent with the guidelines developed by the IMDRF.
“A globally harmonised UDI system will streamline data exchange on medical devices used anywhere in the world, with the potential to reduce medical errors from the misidentification of a devices, provide more accurate reporting of adverse events, and allow useful information to take appropriate, better-focused, corrective action, including recalls.”
A worldwide strategy towards UDI, including input from the US, EU and further afield, should lead to the comprehensive labelling of medical equipment, thus enabling the tracking of every device, from manufacturing to point of use.
The initiative will improve patient safety and monitoring, the reporting of adverse events and healthcare records. But implementing a successful UDI strategy requires the expertise of many company departments, and the continued collaboration of all involved, from an individual to a governmental level.
