Jeff Jones, coding and tracking business manager at Sewtec Automation, explains the historic use of Unique Device Identifiers (UDIs) and what changes set to come into effect next year are likely to mean for the production and packaging of the industry’s products.
The serialisation of medical devices will be a familiar concept to any manufacturer, but proposed changes to mandatory regulations look set to further increase the traceability of its products.
For a number of years now, Unique Device Identifiers (UDIs) have been closely associated with the production and distribution of medtech products in Europe and the US. Since 2013, the Food and Drug Administration (FDA) has mandated the inclusion of UDIs on products marketed in the US, and with many suppliers of products into North America also distributing to the UK and Ireland, coded identifiers are also a common sight this side of the Atlantic.
Historic use of UDIs
UDI regulations essentially require the primary packaging for every medical device to carry a code displaying the product’s serial number and information relating to the manufacture of the device. Under the current regulations, serial numbers are applied in a generic manner, meaning the serial number will be the same for every unit of a specific manufactured product. With all of this data stored in a centralised government database, this system enables the end user – whether a pharmacist or a consumer – to access key information about a product should they need to.
The second major benefit of the UDI regulations is that they provide authentication that a product is legitimate, rather than counterfeit. Back in 2010, the World Health Organisation (WHO) reported that 8% of all medical devices were known to be fake, with many suspecting that the actual numbers are likely to be much higher. While regulators and manufacturers have been striving to drive that percentage down over the last decade, the industry is conscious of the room for improvement that remains.
The main drawback of the FDA’s UDI regulation is that the system does not enable a product to be tracked through the whole supply chain. However, thanks to a new set of proposals put forward by the European Union (EU), that is about to change, bringing with it a much more comprehensive set of track and trace requirements for manufacturers.
Introducing the new European Medical Device Regulations 2017/745
First proposed in 2017, the new EU Medical Device Regulations (MDR) 2017/745 proposes a new type of serialisation comprising of a UDI for every product pack, which is then aggregated at every stage of the supply chain. Under these new requirements, all UDIs will be stored on a centralised European database, which is set to be created and controlled by the European Database on Medical Devices (EUDAMED).
The key difference here is the aggregation. For the first time, it is made possible for a product to be tracked at every step of its journey from manufacture to consumer transaction. For example, it may be that a primary pack is placed within a shelf display carton before being packed within a case and then onto a pallet. Under previous regulations, it would have been impossible to check how far along the supply chain the product was unless you had the identification of the pallet or case. Under the new proposals, however, it is possible to track any product to its most recent process.
The proposals may initially appear to add complexity to the supply chain and demand greater sophistication from packaging lines, However, these complexities also bring with them a number of benefits.
Firstly, the drive to suppress counterfeit products remains high on the industry’s agenda and this will be bolstered by greater traceability. Secondly – and arguably of greater direct benefit to a manufacturer’s bottom line – the new regulations aim to simplify the product recall process. Should there ever be an issue with a specific batch of medical devices, for example, the new system will make it easier to pinpoint the specific batch affected rather than requiring the manufacturer to recall all stock. Naturally, recalling a batch of a given product is much more cost-effective for a manufacturer than having to recall every product unit known to be in circulation.
Opportunity to upgrade
Such a significant change to legislation presents an opportunity for manufacturers to review their existing processes and consider how they may be able to enhance existing manufacturing and packaging lines to aid their compliance. Not only that, but an audit of existing lines may also present an opening to improve operational efficiency at the same time.
For track and trace within the medical device industry, opting for a bespoke system which has been invented and manufactured to meet the requirements of a manufacturer’s specific production line can bring with it a host of major advantages. As well as ensuring product aggregation is made more effective and reliable, a purpose-built packaging line also has the potential to enhance the efficiency levels of the entire system and improve its overall equipment effectiveness (OEE).
MDR 2017/745 was originally set to come into force on 26 May 2020 but has been delayed until May 2021 in light of the Coronavirus pandemic. As the industry readies itself for the introduction of the new regulations, it is certain that manufacturers need to prepare to offer a greater level of serialisation and aggregation than they may have done previously. Conducting an in-depth review of any existing packaging and labelling lines to establish their level of compliance with the new requirements is certainly a worthwhile first step to take for those manufacturers yet to have their processes reviewed.