CONTENTS
4 Notes from the Chair
4 Industry News
Standards and Regulation Focus
12 European Medical Device Regulation and its Impact on Market Access for Innovative Medical Devices
16 Highlighting the Responsibilities of the NSAI and how to get Involved.
Clinical/Biomedical Engineering
19 Pioneering Excellence in Clinical Engineering and Sustainability
20 Guidewires and Shape Manipulation
25 MRI Installation at Letterkenny University Hospital
Clinical
29 The Role of Clinical Neurophysiology in a Healthcare Setting
30 Sentimag Platform in Breast Cancer Surgery
32 Cardiac Rehabilitation in Hospital and in Outpatient Treatment
36 Continuous Nerve Block Infusions in the Management of Pain
Industry
40 Advancing Ultrasound Transducer High-Level Disinfection
Foreword
Welcome to the Summer 2024 edition of Spectrum Journal. In this issue we include a focus on Standards & Regulation: turn to page 12 to read Suzanne O’Rourke’s review of the limitations start-ups are facing in bringing novel medical technology to market in the context of the European Medical Device Regulation; while on page 16 Jonathan Quigley highlights the importance of the National Standards Authority and how to get involved.
Elsewhere, Colin Hendrick discusses sustainability and excellence at the forefront of clinical engineering and healthcare distribution; Ren Abraham Roy addresses manipulation of guidewires stiffness using shape memory materials as part of his thesis research for MSc in Innovative Technology Engineering SETU; Maighréad Gallagher offers a report on the process of installation of a new MRI Scanner at Letterkenny University Hospital; and Sarah Alas discusses the role of clinical neurophysiology in a healthcare setting. This issue also features a report from Serica Jege on the introduction of The Magseed® and The Magtrace® Lymphatic Tracer to breast cancer surgery; Michelle Barrett discusses cardiac rehab, which starts in hospital and progresses to an outpatient programme; Elaine Clear examines the use of continuous nerve block infusions in the management of acute postoperative and post-trauma pain; and, Tracey Nugent reports on ultrasound transducers, a key component of the ultrasound device used in medical imaging.
It is a jam-packed issue and our thanks, as always, go to Frank Kelly for co-ordinating and to all of those who contributed. If you would like to contribute to a future edition, please email Frank Kelly. We are already gearing up for our next BEAI Annual Scientific Conference, which takes place in Croke Park, Dublin on September 20th. We look forward to seeing you all there.
Eoghan Hayden