Raising the standard of patient safety

Andy Crosbie, MHRA Devices Division, explains how Unique Device Identification and GS1 standards can help to improve patient safety while increasing efficiency.

Patient safety is at the forefront of all that we do at the Medicines and Healthcare products Regulatory Agency (MHRA) and we’re always working to see what more we can do, and how we can improve, to ensure medical devices and medicines are as safe as possible.

In 2015 we received and investigated nearly 17,400 adverse incident reports related to medical devices. This represents an increase of 22 per cent over the last three years.

As a result of this we issued 41 Medical Device Alerts (MDAs) and oversaw 810 Field Safety Corrective Actions (FSCAs) undertaken by manufacturers.

Whilst it is important to note that a report of an incident does not necessarily mean that the device was at fault it is still important they are reported and investigated. It is also important that when action is needed the device in question can be easily and properly identified in the supply chain in order for the correct action to be taken. To assist with this we have, for a number of years, been helping the NHS to adopt GS1 standards for medical devices.

GS1 Standards
These standards are one of the main systems being adopted in Europe and worldwide for Unique Device Identification (UDI).

Barcodes based on GS1 standards can be read at any point in the healthcare supply chain so a device that is subject to a safety alert can be easily identified and appropriate action taken quickly and easily.

Once it is decided that corrective action is required these new identifiers mean that not only the device but, importantly, patients with the device can be identified so that appropriate advice and treatment can be given.

In mid-2015 MHRA informed the medical professionals about a medical product recall using UDIs based on GS1 standards for the first time. This was a significant milestone for the healthcare industry and set the scene for how important patient safety information about actions such as recalls will be communicated to patients and healthcare professionals alike in the future.

Real benefits
Using a UDI system based on GS1 standards significantly enhances the post-market safety of medical devices by: improving reporting and monitoring; targeting recalls; reducing medical errors; and fighting counterfeit devices.

Sharing information about medical devices across the supply chain using a single entry point allows manufacturers, suppliers and healthcare providers to exchange information seamlessly; this is especially useful for implant registries and for product safety recalls.

Identifying patients
Once you have identified the device you then need to identify the patient. Since October 2013 all patient wristbands used in the NHS have had to include a GS1 barcode containing at least the following patient information: NHS number; first name and last mame; or date of birth.

When combining this unique identification of patients with the unique identification of healthcare products, it means that every procedure, product, or implant for every patient can be directly attributed to them and recorded on their electronic record, giving complete end-to-end traceability all the way from manufacturers to patients.

Patients can have peace of mind knowing their implants are immediately identifiable and connected to their personal records. Additionally, healthcare professionals can identify quickly which patients are affected, should a safety concern arise with a particular device.

When recalls take place, hospitals can now easily identify all of the affected products that they hold, preventing their use. They can identify all patients that may have been affected by the product – including patients with implants who are now at home – making it quicker and easier for any required actions to take place. By 2020 providers of NHS‑funded healthcare, including the independent sector, must be able to electronically track and trace individual medicines and medical devices to a specific patient.

GS1 standards are also being adopted across hospitals to improve purchasing efficiency and control of supply chains with the ultimate aim of improving and protecting patient safetyThe NHS eProcurement strategy – which was launched in May 2014 – includes a mandate from the Department of Health, that means any service or product procured by an NHS Acute Trust in England must be compliant with GS1 standards. Currently every one of the 154 NHS Acute Trusts in England is a GS1 UK member as every Trust has so far achieved at least some degree of ‘readiness’.

Compliance with these standards will enable Trusts to manage their non-pay spending through the adoption of master procurement data, automating the exchange of procurement data, and benchmarking procurement expenditure against other Trusts and healthcare providers.

While UDIs present a major opportunity to improve healthcare recalls, they will also help to reduce counterfeit products within the healthcare system, by making it easier to identify products which have not been supplied via the legitimate supply chain. This is a hugely important step in protecting patients in ensuring that only high quality products from approved suppliers are being used in their treatment.

New regulations
New regulations for medical devices are currently under negotiation in Europe and are likely to be introduced in 2016. These will supersede existing medical device directives and will require UDIs for all devices sold in Europe with phased implementation – according to device risk – beginning in the next few years. With early implementation of GS1 standards, the NHS in England will be ahead of the curve.

All can benefit
Strong links, even between a few of a hospital’s operational areas, enhances the patient experience, makes for quicker, safer and more effective treatment and reduces processing time, cost and administration errors. It gives Trusts and healthcare professionals complete visibility. GS1 unique identifiers can be applied to patients, medicines, surgical instruments and more. Put simply, using GS1 standards to uniquely identify every patient, product and place, enable increased patient safety, regulatory compliance and operational efficiency. 

The use of Unique Device Identifiers presents a major opportunity to speedily identify exactly where products are in case of any safety recalls, as well as reduce any counterfeit products within the healthcare supply chain.

They provide a common foundation that, in turn, improves confidence in the delivery of care.

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