Manufacturers – it's time to prepare for Unique Device Identification (UDI)

Steve Cottrell, president of Maetrics; and Madris Tomes, chief executive of Device Events, highlight the importance of unique device identification in the healthcare sector and the key lessons the UK can learn from the US FDA

Steve Cottrell

Unique Device Identification (UDI) is a system used to identify medical devices through distribution and use.

The NHS in the UK came up with its own version of UDI through the Department of Health e-Procurement Strategy, which was published in 2014.

While there are significant challenges that come with implementing UDI; manufacturers do stand to gain significant long-term benefits, particularly if they ensure they are meeting compliance standards early on in the implementation process

The reason why the NHS introduced UDI was not only to improve patient safety and healthcare business processes, but to enable transparency and efficiency in NHS procurement to help support patient safety.

With the draft version of the new Medical Device Regulations (MDR) having already been published in Europe – it is clear that UDI is well on its way to becoming a prerequisite for all medical device manufacturers.

While there are significant challenges that come with implementing UDI; manufacturers do stand to gain significant long-term benefits, particularly if they ensure they are meeting compliance standards early on in the implementation process.

Manufacturers should be looking to implement UDI into their systems to restructure their operations in order to adopt more-thorough tracking and inventory systems – positive results from this could be significant cost savings from improved inventory control and other business measures.

Having access to an updated platform for tracking, cataloguing and entering information for UDI compliance can generate significant benefits - it will make it far easier for manufacturers to see a reduction in counterfeit products and they will be able to better manage consignment products as a result of a more-efficient tracking process. Not to be forgotten, UDI positions manufacturers to closely evaluate their product portfolios.

UDI does not just help towards benefitting patient safety; it can strongly help business practices too and work towards growing the business’ bottom line

Implementing UDI means that manufacturers can set up a complete database of manufactured products, facilitating the process of highlighting out-dated products which need to be removed from its catalogue. Patient safety is continuously being improved – for example, if there are any instances in a hospital where contaminated devices have been used, then the hospital can easily track those specific devices that have been used on patients based solely on the UDI information.

UDI does not just help towards benefitting patient safety; it can strongly help business practices too and work towards growing the business’ bottom line. Not only this, but it can have a significant impact on performing due diligence when firms embark on a merger and acquisition route. Using all the available information obtained from UDI can, in fact, significantly help towards a seamless business transition.

It could not be more critical than it is now for medical device manufacturers in the UK to ensure they are meeting all necessary compliance standards – particularly when looking to export devices in Europe and in the US. If a manufacturer does not comply with the federal regulations, they do, in fact, risk facing severe legal consequences as well as simultaneously putting their business under excess strain. The US FDA, in particular, takes non-compliance very seriously and will prohibit non-compliant manufacturers from importing devices into the US. It is important for manufacturers to know that in some very extreme cases, if products don’t include UDI, the only outcome might be for the manufacturer to abandon the product.

This is not to scare manufacturers off – the benefits from early compliance are indeed worth the time, money and resources which manufacturers will need to invest to prepare the company for meeting UDI compliance regulations. It is very important that manufacturers conduct a proper readiness assessment to determine whether all products are compliant or will be compliant by the next approaching deadlines.

To help manufacturers avoid big problems, it is crucial to dedicate a full team to UDI compliance as well as ensure that there is an appointed project manager – this does not have to be someone in-house. In fact bringing in an external consultant who will be objective and has the extensive knowledge about the ins and outs of UDI could be invaluable. Taking this type of approach to UDI compliance will help manufacturers to avoid fines, recalls, rejections and any other unnecessary delays. It is important that manufacturers do not isolate the process when implementing a UDI strategy into a company; it is important to integrate across the organisation.

The risk of losing sales or damaging a good reputation is not worth delaying compliance - medical device manufacturers that launch an all-encompassing UDI implementation plan as soon as possible will start reaping the rewards straight away

Despite the initial upfront costs which are required to implement UDI there are significant benefits that come with it. Manufacturers in the UK should continue to take full advantage of becoming UDI compliant as quickly as possible – particularly now, as a draft version of the new MDR has been published, which means UDI will be mandatory for all medical devices. The risk of losing sales or damaging a good reputation is not worth delaying compliance - medical device manufacturers that launch an all-encompassing UDI implementation plan as soon as possible will start reaping the rewards straight away.

Madris Tomes

Companies