September 08, 2021 Industry news
Background
Following the recommendations outline in Baroness Cumberlege’s Independent Medicines and Medical Device Safety Review – IMMDS Review (also known as the Cumberlege Review), The Centre have begun to implement measures to ensure the appropriate traceability of medical devices used at the point of use or care.
“Recommendation 7: A central patient-identifiable database should be created by collecting key details of the implantation of all devices at the time of the operation. This can then be linked to specifically created registers to research and audit the outcomes both in terms of the device safety and patient reported outcomes measures.”
In response, NHS Digital are in the process of developing a Medical Device Information System (MDIS) designed to act as a centralised national registry to meet this requirement.
What is the MDIS?
The MDIS will serve as a patient-identifiable database designed to capture key procedural-related information gathered from healthcare provider organisations across the UK.
This will include accurate details of:
- Medical device – the device used in the procedure (including batch, manufacturer, expiry)
- Patient – accurate, unique, positive patient ID
- Clinician – the clinician that performed the procedure
- Location – details of where the procedure took place
N.B. Reference data to be captured by trusts include GS1 standards: Global Trade Item Number – GTIN, for device information, and Global Location Number – GLN, for manufacturer information.
Public consultation
As a starting point, NHS Digital are implementing a “Pelvic Floor Registry and associated information system” to “support the future development of a UK-wide Medical Devices Information System – dependent on regulations being introduced under the Medicines and Medical Devices Act.”
Open to trusts, suppliers and solution providers for completion, NHS Digital have since released a public consultation requesting feedback on the proposal. The deadline for submissions is Sunday 12 September 2021.
Supporting information to help complete the survey can be found below – “Key considerations for the consultation”.
We know exactly what implants we have used on which patients and we can tell you pretty quickly. If you take the surgical mesh issue, we can tell you exactly which women have had which mesh implanted and which batch number…"
Gavin Boyle
Chief executive, University Hospitals Derby and Burton NHS Foundation Trust
Key considerations for the consulation
The IMMDS Review notes: “2.89…The data fields we propose feature routinely in the treating surgeon’s operation note so should pose no new data collection burden. The scan4safety programme has shown that the technology exists to create a medical devices database that records the UDI [Unique Device Identifier] for each device. To move towards one hundred percent compliance across the NHS and private sector requires the collection of this data to be mandated by the Secretary of State for Health and Social Care…”
The Scan4Safety report highlights: “Since Scan4Safety involves scanning a product to a patient – or into stock until it’s used – complete traceability is available at the click of a mouse. This means not only significant patient safety improvement but also that, in the event of a recall, staff spend much less time identifying products and patients.
- To capture the data (about who, what, when) in a standardised data format would be more efficient
- Global unique identifiers should be used for every person, every product and every place
- Person – using the NHS Digital standard DCB1077 and the automatic data capture for patient identification using the GSRN (Global Service Relation Number)
- Product – GTINs provide unique identifiers for products/devices (UDI) to enable product traceability, and GIAIs (Global Individual Asset Identifiers), to capture asset/medical equipment details
- Place – GLNs enable the unique identification of organisations and locations
- Trusts are embarking on, or are already capturing this data from implementing Scan4Safety principles and using GS1 standards across systems
- Improves patient safety – facilitates product recalls and monitoring of patient outcomes
- More efficient to capture this information electronically at the point of care – reduces manual errors and improves the quality of the data
- Promotes interoperability by allowing this information to be shared between systems and organisations
- Complies with the technology specifications, for ICSs and their associated healthcare organisations, for digital tools and systems that support safer patient care outlined in the NHSX What Good Looks Like Framework
- Data must be captured and shared electronically to reduce transcription errors
- Along with the Scan4Safety programme, the NHS eProcurement Strategy promotes the adoption of GTINs for products and GLNs for manufacturers and trusts
- GS1 standards are already used for UDI to meet international medical device regulations
- Promotes medical device traceability throughout the supply chain
- Better post-market surveillance of medical device performance once on the market