NHS Scotland is developing a policy aiming to improve patient safety with regards to medical devices in Scotland, by improving available information and system-wide data.
The policy is being developed by the SG Medical Devices and Legislation Unit (MDLU). It seeks to improve traceability of medical devices and equipment through manufacture to implantation and in the longer term aims to improve linkage of medical devices to patient outcomes.
The NHS Scotland Scan for Safety Programme has been established to take a “Once for Scotland approach” to electronic point of care data capture using worldwide data standards. The programme will aim to enable rapid electronic traceability, improve ability to use data to expand knowledge of medical device outcomes, and improve information available to patients on their medical device.
As part of the work, an equality impact assessment (EQIA) has been carried out to analyse the impacts to the people in Scotland, with a view to eliminate discrimination; remove or minimise barriers; assist equality; encourage participation; and foster good relations.
The evidence reviewed suggests that a system-wide approach to capturing medical device data electronically should have a “significant positive impact on al patients, their families, and carers”.
The implementation of Scan for Safety methodology “has the potential to improve the evidence base relating to the use of implantable devices in people with various protected characteristics”, including pregnancy, sexual orientation or transgender people.
The EQIA has also identified some considerations which should be taken into account, with key themes identified as accessibility and inclusivity of public communications; digital exclusion; lower income barriers; trust regarding the gathering and storage of medical data; and accessibility and inclusivity of any future public engagement.
The EQIA concludes with an expectation that the policy will have a “positive impact on all patients by improving patient safety and improving data collection, which has the potential to enable the addressing of data gaps and improve research”.
It adds that the potential for unintended discrimination, particularly around accessibility requirements and digital exclusion, will be kept under review as the policy progresses.
To read the assessment in full, click here.