From Scan4Safety to UDI: Unique identifiers for the UK

Peter Rose, managing director of Maetrics, discusses plans by NHS England to roll out a trial scheme involving barcoding for medical implants and how this is placing them as pioneers in the movement towards being UDI compliant

As the implementation of a new NHS scheme called Scan4Safety rolls out, six NHS trusts throughout the UK are embarking on a journey to increase patient safety and save the NHS up to £1billion over the next seven years.

NHS sites in Derby, Leeds, North Tees and Hartlepool, Plymouth, Cornwall, and Salisbury are currently putting a new barcoding system into place that will ultimately allow more-efficient identification and location of patients, drugs and devices.

The initiative will lead to savings at the NHS and make it possible to locate equipment in hospitals faster, which can make all the difference when trying to save a patient’s life

The barcoding system follows the standards set by GS1, a not-for-profit organisation dedicated to unifying barcoding standards worldwide.

For this trial phase in the UK, breast and hip implants will receive unique barcodes, making it easier to track and identify the materials used, time and place of the procedure, and the name of the medical staff involved.

This will prove advantageous in the case of product recalls, streamlining the process of identifying who has been implanted with a particular device.

Furthermore, the initiative will lead to savings at the NHS and make it possible to locate equipment in hospitals faster, which can make all the difference when trying to save a patient’s life.

European regulation is coming

However, Scan4Safety will certainly not be the final system of unique identifiers introduced in the UK and Europe.

Later this year the new Medical Device Regulation will roll out, initiating a three-year implementation phase before the changes are mandatory throughout Europe.

As part of the Medical Device Regulation, Unique Device Identification (UDI) will become a requirement for manufacturers of medical devices.

It can only be helpful for manufacturers of medical devices in Europe to start preparing for UDI now

Originally introduced by the American drug regulations agency, the FDA, UDI are the key element of a barcoding system designed to improve patient safety, modernise device post market surveillance, and facilitate medical device innovation.

In the US, the implementation of UDI is still ongoing and will not be finished before 2020.

Currently, Class III devices need to follow UDI regulations, with Class II devices following in 2018 and Class I devices in 2020.

However, manufacturers of medical devices that intend to have their products authorised by the FDA need to be aware of the upcoming changes in legislation – and with the Medical Device Regulation bringing UDI to Europe, the issue is of great importance to healthcare institutions in the UK as well.

Preparing for UDI

It can only be helpful for manufacturers of medical devices in Europe to start preparing for UDI now. However, making this start can be difficult.

Fortunately, following certain steps can ensure success when embarking on the UDI journey.

First, it is important for manufacturers of medical devices to calculate the cost of implementing UDI for their business.

The next step is to set up a team that solely focuses on the realisation of UDI implementation.

In order to guarantee a smooth and fully-compliant implementation of UDI, it is essential for manufacturers to set a manageable and realistic time frame for the process

It is highly important that this task is not just added on top of the existing tasks of any team within the business, as this could lead to conflicting priorities in day-to-day tasks and ultimately cause delays in implementation.

Once the designated UDI team of resources is set up, a UDI strategy can be outlined.

This is a particularly-tricky step in the implementation process as several factors need to be considered.

On the one hand, the resources available need to be taken into account. While, on the other hand, potential obstacles need to be planned for right from the onset to avoid financial pitfalls and unnecessary slow-downs.

This requires an experienced project manager, which some businesses might find themselves lacking. In this case, it can be cost-effective and more efficient to outsource the process.

Finally, in order to guarantee a smooth and fully-compliant implementation of UDI, it is essential for manufacturers to set a manageable and realistic time frame for the process.

Peter Rose

Only when expectations for the different stages of implementation are managed from the beginning can delays and unnecessary additional costs be avoided.

Even though the investments and efforts required to stay compliant with the Unique Device Identification do not seem lucrative at first, they do come with significant benefits and long-term savings.

Becoming compliant to UDI as soon as possible presents a significant advantage on the market.

Early adaption of the new regulation makes it possible for businesses to trial the system and ultimately outpace less-ready competitors. Furthermore, businesses profit from improved inventory control, reduced fraud, and improved billing accuracy.

Only when expectations for the different stages of implementation are managed from the beginning can delays and unnecessary additional costs be avoided

It can only be profitable for UK manufacturers to begin the process of UDI compliance as soon as the Medical Device Regulation is confirmed.

The risk of financial pitfalls and delays are not worth postponing the compliance journey.

The healthcare system is going to benefit greatly from unified identification on medical devices by a reduction in adverse events and fraud that UDI can bring.

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