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Medical e-News Round-Up - Issue 36

This issue covers:


Innovation centre to test new medical devices

An innovation centre to test out new medical devices has been set up at the Golden Jubilee National Hospital in Scotland.

Individuals and organisations will be able to submit healthcare devices for review by experts, who will test their potential for use within the NHS. It is hoped the scheme will mean patients can have earlier access to the latest medical technology.

Health Secretary Alex Neil visited the centre at the Clydebank hospital near Glasgow to meet its staff.

The facility will bring together health professionals and clinical experts, who will be responsible for turning new ideas into better treatment for patients. They will be joined by Scottish Health Innovations Ltd, which will be relocating its base to join the innovation team in Clydebank.

Mr Neil said: "Scotland is already a world-leader in developing new treatments within a variety of different specialisms. The Golden Jubilee National Hospital continues to be at the centre of this innovation.

"The testing and early implementation of new medical devices is crucial to this work and the new testing process at the Golden Jubilee could see earlier roll-outs of new hi-tech and potentially life-saving medical technology across Scotland's NHS."

He said the Government had recently announced an £100,000 national health and social care innovation fund, which aims to develop pioneering treatments, and added: "The Golden Jubilee National Hospital will also work on behalf of NHS Scotland to raise funds for new initiatives from a variety of sources".


Infusion pump testing covered in new free booklet

A new booklet from Rigel Medical provides guidance for people involved in testing medical infusion devices and highlights the benefits of the Multi-Flo analyser used to verify the performance of infusion devices.

The illustrative 'An Introduction to Infusion Pump Testing' booklet covers the history of infusion and features an easy-to-follow explanation of the different types of devices available to deliver an accurate, predetermined rate over a set period of time.

The main section provides advice and guidance on the various methods for testing infusion devices and a clear definition of the common flow measuring principles: volumetric, mass, bubble tracking, pressured based and displacement of syringe plunger.

Details are included about the Multi-Flo high performance analyser, which doubles infusion pump test capacity, saving time and delivering productivity improvements through instantaneous high accuracy flow measurements.

A copy of the full version of the guidance booklet is available to download here


New Chinese medical device regulations

China's medical device market regulators have published updates covering IVD products and labelling requirements which come into force this October, according to global medical device regulatory affairs firm Emergo Group.

First, China Food and Drug Administration (CFDA) Administrative Order No. 4 encompasses multiple areas of medical device registration, in-country representation, clinical trial requirements and related submission procedures.

Regulators have also issued Administrative Order No. 5 regarding registration and approval of IVD products in China. The order will implement a three-tier, risk-based classification system (Class I, II and III), as well as authorised representation, clinical trial and other requirements similar to those in Order No. 4 for medical devices.

Finally, Administrative Order No. 6 covers medical device indications for use (IFUs) and labelling requirements.

Emergo's Beijing office is conducting a thorough analysis of the new CFDA regulations to determine their impact for medical device and IVD manufacturers selling in China; additional details are forthcoming. More at www.emergogroup.com


Passing the test at Siemens

Healthcare equipment manufacturer Siemens is using Rigel 288 electrical safety analysers to reduce the time taken for engineers to complete electrical safety checks on MR, CT, nuclear, PET, ultrasound and radiotherapy equipment at UK hospitals and other medical centres.

The lightweight portability and versatility of the Rigel 288 enables the engineers to move swiftly from job to job, completing electrical safety testing and repairs quickly and in compliance with the IEC 62353 standard for medical devices.

Bluetooth technology for the wireless connection of bar code scanners, label printers and other accessories enables cable-free data transfer and safety labelling, without the cumbersome plugging and unplugging of leads and cords.

As well as storing the results of electrical tests, the instrument also has the ability to record user defined inspections and measurements from specialist electro medical equipment such as SpO2, NIBP, ECG and other patient devices.

Michael Bernard, who helped to deliver Siemens's engineer training programme for electrical safety testing utilising the Rigel 288, said: "The 288 can perform any test required on portable medical equipment to any standard currently in operation throughout the world. It is the smallest and lightest unit on the market and very reasonably priced."


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