News: Medical e-News Round-Up - Issue 20

This issue covers:

Leading medical equipment supplier powers ahead with Rigel 62353 analyser

Equipment and service supplier to the NHS, Medstrom, has improved the electrical testing of thousands of its medical devices using Rigel Medical’s 62353 safety analyser.

The company supplies and maintains electrically operated paediatric cots, bed movers, reactive therapy systems, patient beds, trolleys and carts among other items to hundreds of hospitals and healthcare facilities across the UK. These have to be regularly tested to ensure compliance with IEC 62353, the standard for in-service and after repair testing of medical electronic devices.

The testing work is undertaken by Medstrom’s field service engineers using Rigel 62353 analysers, enabling them to check the electrical safety of equipment to ensure it is safe for use by both patients and staff.

The ability to be able to do this quickly and efficiently means that critical safety tests are completed successfully as an integral part of Medstrom’s after sales support, and dedicated service team, saving time and boosting customer service levels.

Darren Hunt, Medstrom’s technical training manager, said the Rigel 62353 was an excellent instrument which, in addition to enabling the company to comply with the requirements of IEC 62353 was easy-to-use and offered many beneficial features.

He said: “The Rigel 62353 is a superb high performance instrument that works extremely well and delivers consistent results. It’s very intuitive, offering a single-button test solution which engineers, who have busy service schedules to complete, really appreciate.

“Test results are easily downloaded to our asset database while the memory and operating instructions are clear, straightforward and easy to navigate."

Expert says medical technology is a neglected part of India´s healthcare

“Medical technology is critical to improving health outcomes but it is an often neglected component of healthcare in India,” says Sanjay Banerjee, managing director of medical products company Zimmer India.

Speaking in an interview published by MEDTEC Connection he said medical devices, in particular, need to be considered in a wider context of a complete healthcare package targeting the public health needs of India.

In the wide-ranging interview, Banerjee discusses the many challenges facing India’s healthcare ecosystem - a small indigenous manufacturing base, regulatory delays and the burden of healthcare costs on individuals - as well as the opportunities, which are legion.

“Medical technology is one of the fastest growing sectors of Indian industry,” says Banerjee, noting that its growth has been driven by a healthcare sector that has been expanding at 15 to 20% per year.

Read the full interview at http://medtec-connection.emdt.co.uk

Free guide to electrosurgical testing

Rigel Medical has produced a free new guide to electrosurgical testing which will be available in April 2013.

The guide explains the issues involved and offers expert advice about using the latest test instruments such as the Uni-Therm to ensure devices are safe to operate. Compliant with IEC 60601-2-2 and fully compatible with products from the leading electrosurgical device manufacturers such as Olympus KeyMed, Erbe, Bowa, Eschmann and Covidien, the analyser verifies and calibrates all major electrosurgical generators while guiding the user through all test procedures quickly, automatically and most of all safe.

The instrument measures high frequency leakage, (high) current, power distribution and patient return plate alarm testing. A high power load bank enables performance testing up to 8A RMS to allow testing and calibration of high current vessel sealing technologies and with a duty cycle of up to 100% making the analyser an extremely versatile test instrument for calibrating and performance testing of conventional and high power electrosurgical generators.

The large array of internal resistors, ranging from 0-5115Ω in 5Ω steps provide not only the most accurate and detailed power curves, the Uni-Therm also advocates safe working practise by providing all necessary resistors within a single enclosure.

Public-private partnership speeds patient access to medical device technologies

The U.S. Food and Drug Administration is part of the first public-private partnership to promote medical device regulatory science with a focus on speeding the development, assessment and review of new medical devices.

The Medical Device Innovation Consortium (MDIC) is an independent, non-profit corporation, which receives input from industry, government, and other organisations. MDIC will prioritise the regulatory science needs of the medical device community and fund projects to help simplify the process of medical device design and pathways to market for these innovations.

Regulatory science – the science of developing new tools, standards and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products – is critical to the medical device industry and to public health. Advancements in regulatory science not only aim to improve how products are developed and evaluated, but also could reduce the cost and time it takes for a promising device to come to market.

The MDIC will bolster the country’s investment in regulatory science research by pooling people, funding, resources, and ideas to develop new tools, models, and methods that may be utilised to better and more efficiently evaluate new devices. FDA staff may collaborate with the MDIC on MDIC-supported research and other projects.

“By sharing and leveraging resources, MDIC may help the industry to be better equipped to bring safe and effective medical devices to market more quickly and at a lower cost,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

Russia Makes Medtech Power Play

If Russia is not currently on your radar as a medtech market, it will be soon. That was the message delivered by Alexandra Tretiakova, executive director of Russia’s International Medical Device Manufacturers Association, speaking at MEDTEC to European Medical Device Technology.

Currently valued at $6.4 billion, the medtech market is projected to grow 13.5% annually to become the world’s sixth largest by 2020, said Tretiakova. “It is a sophisticated, premium-price market with enormous potential for medical device manufacturers,” she added, noting that she has witnessed the sector’s evolution from the trenches.

The healthcare sector languished for many years, and is the last major public sector to undergo reform in Russia, said Tretiakova. The government’s ‘Strategy 2020’ aims to make up for lost time by pouring significant resources into the device and pharmaceutical sectors. Elements of the programme include modernising the infrastructure and growing the indigenous medical device industry.

“By 2020, the [Russian] government wants to increase the market share of national medical device manufacturing from the current 18% to 40%,” said Tretiakova.

There is no denying that Russia has ambitions for its healthcare industry and is not shy about providing the necessary resources. The government is laying the foundations for future growth through new regulatory measures, increased privitisation of clinical facilities and infrastructure renewal.

The focus on healthcare is not surprising in some respects, given that as much as “70% of hospital equipment is outdated, by some accounts,” said Tretiakova.

Join the 62353 LinkedIn discussion group

Catch all the latest news about IEC 62353 and join John Backes, associate director – Rigel Medical – and others at the LinkedIn debate, believing that many people do not understand what installation they are measuring on and how this impacts on electrical safety testing.

John says that critical issues such as test setup and incoming mains for IT supply and direct method measurements must be highlighted and understood by test engineers. He wants to encourage ongoing debate and, after five years since the publication of 62353, is keen to hear the views of others as work gets underway on a second edition with a release date at the end of the year.

You can join him and others by visiting the 62353 group on LinkedIn.