A Welsh based company, KeepMeWell Ltd., has developed a bespoke holistic software solution, Device-Link for managing medical devices and drug products.
Device-Link keeps patients safe and informed of updates, alerts and recalls. In addition to supporting manufacturers with their regulatory requirements as part of their post market surveillance responsibilities for both medical devices and drug products.
Currently, Device-Link is being used in the NHS by the All Wales Immunodeficiency Service. Traditionally, patients would be issued with a paper-based record sheet to record their infusion plasma drug details and subsequently submitted via the postal system to the clinical team for monitoring and retrospective record-keeping. Furthermore, there are statutory legal requirements in place for the traceability and monitoring of blood and drug products issued to patients. However, the current method of retrieval and search of paper-based patient records was impractical, labour intensive and unsustainable for safe and effective ongoing monitoring by the clinical team. Furthermore, each individual patient would have to be contacted notification of any for alerts.
Critical events, such as Creutzfeldt-Jakob and the national Infected Blood Enquiry imposed serious implications for patients receiving infusion plasma-derived drug products, potentially causing irreversible harm. The impact of these events required a ‘look-back’ mechanism to be in place, which was almost impossible to achieve in reality.
The increase in self-administration and hospital at home initiatives has resulted in a rise in medication and medical devices being used at home. This has placed the onus on clinical teams to have greater oversight and surveillance of both medical device and drug products.
KeepMeWell Ltd collaborated with the All Wales Immunodeficiency Service to pilot the use of their software, Device-Link, in order to improve the overall safety and monitoring of patients receiving immunotherapy drug products.
Functionality and features of Device-Link are:
- Highly scalable and sustainable platform capable of managing multiple device types
- Compliance with mandatory In Vitro Diagnostics (IVD)/MDR Regulations
- Improved time efficiency and resource for post-market vigilance procedures
- Facilitate proactive improvements for end users at the point of testing
- Gathering user-reported data via questionnaires/market surveys
- Real-time feedback in the app and linked dashboard
- Instant data sharing with stakeholders
- Facilitation of notifications/Field Safety Notices/device updates to end-users
- Monitoring of warranty dates/drug expiries for devices
- Compliant with data privacy & data security legislations/GDPR compliant
Device-Link has transformed clinical practice by improving the oversight and safety of medication monitoring of rare disease patients, managed by the clinical team. It offers a more effective mode of monitoring patients in real-time, creating a sustainable solution.
The clinical team also plan to use Device-Link to monitor patients with a rare, inherited genetic disorder, Hereditary Angiodema. This can be potentially life-threatening if left untreated. Thus, patient compliance and timely clinical management is critical to monitoring these patients.