Gathering views on implanted medical devices
The Scottish Government's Medical Devices and Legislation Unit asked us to find out about patients' experiences of receiving an implanted medical device, sometimes known as an implant.
The Medical Devices and Legislation Unit (MDLU) within the Scottish Government has developed Scotland’s first Medical Devices Policy Framework and Action Plan. The policy Framework's purpose is to take forward policies that aim to improve patient safety and outcomes in the context of medical device use in Scotland. The Framework also seeks to enhance the availability of medical device information and system-wide data to empower patients in making informed choices about their treatment and care.
The Scottish Government commissioned us to undertake a Gathering Views exercise to support the implementation of the Medical Devices Policy Framework, and to deepen policy insight into people’s experiences of living with an implanted medical device.
The definition of an “implanted medical device” used for this Gathering Views exercise means anything embedded into the body to be used in a patient’s diagnosis, treatment, or care. These may also be known as “implants”, and can include, for example, pacemakers or joint replacements. Devices are also referred to as “implantable” in the Medical Devices Policy Framework and Action Plan, and in some places in this report.
Since the commissioning of this work, the Framework and initial Action Plan have been developed by Scottish Government, and this Gathering Views work, which was already underway, was found to align in particular with Theme 3: Improving the information available to patients about medical devices used in their care.
The Gathering Views exercise was undertaken during July and August 2023 across all NHS board areas in Scotland.
Individual interviews took place via telephone calls, video calls and in face-to-face settings. The work involved gathering people's views on their experience of living with an implanted medical device. This report outlines the feedback from participants as well as the key areas they highlight for improvement. During these interviews, participants were asked to recall details and relied on their memory to answer the interview questions. Therefore, the findings reflect the participants’ perceptions at the time and their narratives at the time of interview.
A total of 65 people from across Scotland took part in this exercise over an 8-week period. Interviews were organised through engagement offices using links through local contacts, NHS services and third sector organisations. A mix of participants from all demographics were sought, collecting views from urban, rural and island communities and a diverse range of individuals. The participants had a range of devices, and many had multiple devices. However the participants’ devices do not reflect the full range of implanted medical devices.
Key findings
- Information before the procedure: For a large proportion of their devices, participants got information from their medical team before the procedure, covering many important elements. However, many didn’t receive all the aspects of information, noticed inconsistencies in the information they received, and had further information needs, for example the device type and longevity, and around the procedure, recovery and potential risks.
- Setting expectations, understanding risks, and providing consent: For many of their devices, participants had enough information to help set their expectations, understand benefits and risks, and provide fully informed consent. However, for some of their devices, this was not the case, and participants discussed inconsistencies and further information needs.
- Information after the procedure: for over half of their devices, participants said they would have wanted to get further information from their medical team after getting the device. For most of their devices, participants did receive post-procedure information from their medical team, for example who to contact if there were issues. For half of their devices, participants said they got information about the actual device type and for over a third of their devices, participants also got an implant card. However, for some of their devices, participants did not get any information after the procedure or there were issues with the information they did receive.
- Feedback processes: For half of their devices, participants said they had not been asked to provide feedback about their experience, and participants had only been asked to provide feedback for around a third of their devices. For just under half of their devices, participants said they did not know how to provide feedback.
- Further information sources: For over half of their devices, participants were not signposted to further information sources by their medical team and did not have a discussion about this. For more than half of their devices, participants did look for further information, from a range of sources and in different ways.
- Multiple devices: People who receive one implanted medical device as part of their care may be more likely to receive further devices, highlighting the need to consider this aspect when planning and delivering care and support for these patients, including when considering their information needs.
- Tracking system: Participants have positive views about a potential implanted medical device tracking system and can see a range of benefits for both staff and patients, including enhanced communication and increased access to information.
Priorities and key considerations discussed by participants included:
- the importance of addressing information needs in shaping the overall patient experience, with participants often linking their overall positive experience with having satisfactory information
- getting the right information, the right way, and adopting a person-centred approach so information suits people’s needs and preferences
- ensuring information is provided and available through a range of methods and avenues
- considering the role of people’s “independent research” and patient initiative
- existing differences and inconsistencies in information provided between different procedures, which have significant impact on the participant experience and could lead to unequal outcomes for patients, for example between different devices, between initial and replacement procedures, or between less and more high-risk procedures
- the perceived impact of the COVID-19 pandemic
Recommendations
For Scottish Government
Recommendation 1: Consider the findings in this report to guide the implementation of Scotland’s first Medical Devices Policy Framework, and work towards addressing health inequalities and barriers which may be more prominent among certain groups of the population.
Recommendation 2: Continue to work on the development and implementation of an electronic implanted medical device tracking system through the NHS Scotland Scan for Safety Programme.
Recommendation 3: Consider how to support NHS boards on a national ‘Once for Scotland’ basis to provide all patients receiving an implantable medical device with the right information, at the right time, in the right way, both before and after receiving their implant, based on their needs and preferences. Work towards improving consistency in the information provided to patients around their implanted medical devices and related procedures and processes.
For wider consideration
Recommendation 4: Consider how NHS boards and local organisations can best address patient information needs and ensure that information processes around implanted medical devices are person-centred.
Recommendation 5: Consider how feedback processes can be improved within the patient journey of people with implanted medical devices, and how routine feedback may help ensure a person-centred approach in addressing patients’ information needs.
Recommendation 6: Consider further exploring the barriers to patients fulfilling their information needs around implanted medical devices.
Impact
This report has been shared with the Scottish Government and has informed the Medical Device Policy Framework’s initial Action Plan. This work was mentioned in the Framework under Theme 3: Improving the information available to patients about medical devices used.
Six months following its publication, this report and recommendations have had a significant impact on medical device policy development at both a Scotland and UK level. The work was very well received, as it evidences what was understood anecdotally, providing insights and evidence for future policy development.
This work has had input in ongoing discussions between Scottish Government and the Medicines and Healthcare products Regulatory Agency (MHRA), which is the UK regulator for medical devices, and the Department of Health and Social Care, focusing on the information that patients and public require around medical devices and related procedures.
In Scotland, this work is ensuring patient input across national medical device policy development. It has been shared in regular meetings with NHS board Chairs of Medical Device Committee’s and in national briefings provided to boards, with the NHS Scotland Scan for Safety Programme, and with wider key stakeholders in Scottish Government and NHS Scotland.
This work has influenced all policies and work progressed by the Scottish Government Medical Devices and Legislation Unit (MDLU). For example, the information provided in the report on patient information preferences is being used in the development of an NHS Inform patient resource.
This work is also being used:
- by the Scottish Government MDLU, to shape a national guide to be developed for boards and local authorities on best practice in providing information to patients about medical devices, as outlined in the CMO Letter 2024.
- by Scottish Government Medical Devices Policy teams, to inform policy development on an ongoing basis, including the development of patient information resources
- by NHS boards, to inform Equality Impact Assessments for their board Medical Device Policies,
- by Scottish Government and the NHS Medical Devices Committee, to inform the development of national policy around patient focus in medical device policy and medical device safety, particularly looking at the use of the Yellow Card scheme for patients, and
- by the national Medical Devices Committee, to consider what can be done by boards, the MDLU, and the MHRA to address the lack of information and resources available to patients and the public around medical devices, as highlighted by this work.
The NHS Scotland Scan for Safety Programme is using this work to:
- help health boards provide consistent, timely, and appropriate information to patients receiving implantable medical devices. This includes a patient information leaflet that is part of a wider Health Board Implementation pack used across NHS Scotland. There is also a dedicated page for patients on the Scan for Safety website and information on the NHS Inform website,
- ensure feedback options for patients, with both the Scan for Safety and NHS Inform websites giving patients the opportunity to provide feedback or comments, and
- support a person-centred approach, including information after procedures and the consideration of multiple devices. Once the Medical Device Data Hub is live across health boards, clinicians will be able to access information about each patient, enhancing communication and supporting a person-centred approach. While currently not readily available, it is an ambition for patients to also have access to their information in future. As Scan for Safety rolls out to more specialities, more information will be captured and available.
In the longer term, this work and recommendations are being embedded in the approach followed for all relevant policy developments. It is also likely to be of interest for the Scottish Patient Safety Commissioner, once appointed.