MEDICAL DEVICES
on IRIC’s database, peer-to-peer sharing of local safety alerts, and a new national training framework. It was recognised that delivering these improvements would require significant change. Innes Connor finished by saying that significant progress had already been made through collaboration with stakeholders such as Scottish Government and Healthcare Improvement Scotland, but particularly through IRIC’s liaison officer network of Equipment Co-ordinators.
Under-reporting of adverse incidents Calum Campbell, IRIC coordinator at HFS, shared his experience working more closely with stakeholders through a Specialist Advisory Group. He set the scene by illustrating the potential extent of under-reporting of adverse incidents involving equipment in Scotland. IRIC receives approximately 300 reports per year, but Northern Ireland receives around 600 reports annually. To increase reporting rates of incidents involving wheelchairs, IRIC created a Specialist Advisory Group (SAG) consisting of senior managers, bioengineers, and clinical scientists from the five Scottish wheelchair centres, procurement colleagues from National Procurement (since wheelchairs are on National Contract), and the IRIC team. Calum Campbell highlighted that improved communication between these bodies has resulted in a six-fold increase in the number of adverse incident reports involving wheelchairs. If a similar increase could be applied across all of IRIC’s equipment categories, then the Centre could envisage receiving the 1,800 (6 x 300) reports per year it should be expecting. This model of engagement with SAGs complements other forms of stakeholder engagement, and allows IRIC to work more closely, efficiently, and effectively, with stakeholders, resulting in more incident reporting. IRIC will now apply this successful model of engagement across other technical specialities.
MHRA speakers’ varied topics Sarah Tang, Mark Grumbridge, and David Grainger, from the Medicines and Healthcare products Regulatory Agency (MHRA), each delivered presentations on different topics.
David Grainger, senior Medical Device specialist, discussed the regulatory aspects of software and cyber security, while Sarah Tang, Medical Device Regulatory & Policy advisor, gave an overview of the changes introduced by the new EU Regulations on medical devices. Significant changes are expected, which will affect many aspects of the device industry, including clinical research, in-house manufacture, and re-processing of single-use devices. MHRA’s guidance
56 Health Estate Journal October 2018
A multidisciplinary audience attended the Glasgow event.
and consultations relating to the new regulations can be found at
www.tinyurl.com/y8kgw9nr Mark Grumbridge, senior Clinical advisor, MHRA, explained the role of the Medicines and Healthcare products Regulatory Agency (MHRA) as the UK competent authority, and the reporting of incidents related to medical devices to MHRA. The Agency, which administers and ensures compliance with medical device legislation in England, Northern Ireland, Scotland, and Wales, receives thousands of incident reports per annum relating to medical devices; over 19,000 were received in 2017. Mark Grumbridge said the increase in reporting can be attributed, at least in part, to increased awareness of reporting, the promotion of the ‘Yellow Card’ reporting scheme, and the ‘ever-increasing numbers’ of medical devices on the market.
Reporting encouraged The MHRA encourages reporting of suspected adverse incidents, and anyone can make multiple reports at any time. Mark Grumbridge emphasised that incident reports on devices do not
necessarily indicate a fault with any particular device. Common causes of adverse events, he explained, included incorrect device choice, incorrect use, instructions not being followed, inadequate training, local modification(s), devices being ‘too complex’, and failure to monitor. Training and education are paramount in ensuring the safe use of medical devices. The NHS, patients, members of the public, and manufacturers of medical devices, are often the first to identify a significant device problem of national significance. The reporting incident is a part of duty of care to prevent serious harm to others. The speaker encouraged reporting via Yellow Card –
https://yellowcard.mhra.gov.uk/, in addition to local reporting arrangements. Peter Mackie, head of Health & Safety at NHS Forth Valley, outlined a pilot involving central monitoring of safety alerts within Boards and local authorities. The pilot involved Equipment Co- ordinators in recognition of the existing systems they have in place. In addition to managing the cascade of alerts within their remit, they will also monitor cascade of other alert formats such as Drug Alerts and Public Health Alerts. The aims of establishing a central point of safety alert monitoring and management – reporting at corporate level – are to improve local governance of all safety alerts, and to achieve a consistent approach across Scotland’s health and social care providers.
Mesh oversight group
Mike Winter, Medical director at Health Facilities Scotland, chaired the afternoon session.
Fiona Wardell, Standards and Indicators Team lead, Healthcare Improvement Scotland, provided an overview of the Transvaginal Mesh Oversight (TVMO) group. In 2017, she explained, the Scottish
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