World first for Shepton Mallet emphasises patient safety
10 March 2021
Practice Plus Group Hospital, Shepton Mallet is the first in the world to be awarded the United Kingdom Conformity Assessed (UKCA) certificate by the British Standards Institution (BSI) for medical devices, in this case, theatre instrument sets.
They were assessed by BSI on the requirements necessary to achieve the certificate through changes in legislation and Brexit.
The UKCA mark is the new UK product marking that will be required for in vitro diagnostics (IVDs) and medical devices being placed on the market in Great Britain (England, Wales, and Scotland). BSI is a European Notified Body and UK Approved Body, with one of the widest ranges of market access solutions, its team brings years of industry experience and expertise.
As well as protecting patient safety, the UKCA mark also ensures that the UK maintains access to high-quality medical devices post-Brexit.
The UKCA certificate was achieved by the hospital’s Central Sterile Services Department (CSSD), which is responsible for effectively decontaminating equipment used at the hospital. Since the hospital opened in 2005 the CSSD has processed more than six million surgical instruments.
Jim Rawles, CSSD Manager at Practice Plus Group Hospital Shepton Mallet, commented: “My team and I are on a real high – we are truly delighted to have achieved a world first. Patient safety sits at the heart of everything we do and being awarded the first UKCA certificate by BSI for medical devices is proof positive of this.”
Andrew Oakerbee, Hospital Director at the hospital, added: “We are immensely proud of Jim and his team for this outstanding achievement. I know that they have worked hard to facilitate this through a period of operational, legislative, and political change. At a time when independent healthcare providers are stepping up to support the NHS during the COVID-19 pandemic, it is important that we do so while maintaining the highest standards of care and clinical excellence. The UKCA certificate stands testament to our commitment to quality care for our patients.”
Dr Manuela Gazzard, Group Director of Regulatory Services at BSI, said: “We are truly proud to be issuing the world’s first conformity certificate under the new UK legislation for medical devices. We are committed to supporting the UK market and playing our role in ensuring the supply of safe medical devices to patients in the UK.”
Dr Jayanth Katta, Head of the UK Approved Body at BSI, added: “We are delighted to have issued the first UKCA certificate for medical devices under the new UK Regulation. The new requirements have meant additional obligations on manufacturers and conformity assessment bodies; the BSI team has shown extraordinary dedication in preparing and rolling out UKCA certification activities in a short time frame.”