Medical e-News Round-Up - Issue 11

This issue covers:

Rigel shows new products at AAMI 2012 (June 2 – 4th)

The benefits of the new Rigel Uni-Therm high current electrosurgical analyzer, Uni-Pulse hand-held defibrillator tester and the new Multi-Flo infusion pump analyzer will be the highlights of Rigel Medical’s presence at this year’s AAMI show in Charlotte, North Carolina.

The new high power Rigel Uni-Therm accurately verifies and calibrates the performance of electrosurgical generators.

Measurements include high frequency leakage, high current, power distribution and patient return plate alarm testing. A large color screen, onboard data storage and test automation make the Uni-

Therm ideal for field and workshop based testing.

The Multi-Flo infusion pump analyzer offers accurate and instant high and low flow measurements, occlusion, back pressure and bolus measurement. Available in one, two and four independent channels, tested simultaneously from as low 100 μL (microlitre) with results stored in the instrument’s large internal memory.

The innovative Rigel Uni-Pulse Defibrillator Analyzer is the most compact and versatile instrument on the market, able to accurately verify all mono- and bi-phasic defibrillators and AED’s. Features include: onscreen waveform capture, built-in 12-lead ECG simulator, onboard memory and optional variable load box ensuring the Rigel Uni-Pulse meets all the requirements of IEC 60601-2-4.

Andrew Upton, Vice President of the Seaward Group USA, distributors of the Rigel Medical brand in the United States, said: “Rigel Medical is committed to bringing innovative new products to market to meet customer requirements and we’re sure the many new features and benefits of Uni-pulse and Multi-Flo will attract significant interest.”

Also showing will be the Rigel 288 electrical safety analyzer and the Rigel UNI-SIM, the industry’s first hand-held automated safety analyzer and vital signs simulator. The UNI-SIM is capable of undertaking synchronized vital signs parameter tests simultaneously: NIBP, SpO2, ECG, temperature, IBP and respiration functionality tests.

Make an appointment to find out more from Rigel during the show by emailing or visit us at booth 915.

Strong growth for medical device sector

The medical device manufacturing industry has enjoyed strong growth and is forecast to continue expanding in the years ahead, according to IBIS World industry analyst Nima Samadi.

Since 2007, revenue has increased at an average annual rate of 12.8%, and sales are expected to remain strong, growing 7.4% in 2012 alone to $64.7 billion.

The US economic downturn did little to deter hospitals and other customers from purchasing medical devices. In fact, more industry companies gained sales in 2008 and 2009 than lost them.

The aging US population is a major factor driving demand, as the occurrence of health issues that require medical devices is higher in the elderly population. This demographic is forecast to expand further as a percentage of the total population during the five years to 2017, helping to maintain industry growth.

However Samadi believes revenue in the industry will not grow as quickly over the five years to 2017 because the changing regulatory environment will be a hindrance and cites the Patient Protection and Affordable Care Act of 2010 as an example - this will place an excise tax on medical devices, eating into revenue and reducing profit.

Also, potential reform to the approval process for new devices will likely hamper innovation and encourage more companies to shift functions overseas. Read in full at

Hitachi puts Rigel to the test

Healthcare equipment manufacturer Hitachi Medical Systems UK Ltd has specified Rigel 288 analysers to reduce the time it takes for engineers to test the electrical safety of its ultra sound scanners in service in the UK.

Using the 288s, the engineers can quickly check the safety of approximately 500 scanners at least twice a year while in service to ensure compliance with the recurrent and post repair test requirements of the IEC 62353 standard for medical devices.

UK-based Hitachi Medical Systems is part of the Hitachi Group which designs, manufactures and supplies advanced medical equipment and solutions to healthcare markets worldwide.

Its ultra sound platforms range from state-of-the-art devices used in doctors’ surgeries to the ultimate high-end machines, designed for hospitals.

Roy Cartwright, technical support manager at Hitachi, said: “We have been impressed with what the 288 offers in term of quality, versatility and ease-of-use.

“Robust and fully functional means the 288 meets the demanding requirements of field testing, while its portability, flexibility and added value features are very good. All in all, it’s an impressive and unique product that will make the job of electrical safety testing for our engineers a whole lot easier.”

Ireland backs EU stability treaty

The Irish Medical Devices Association (IMDA) has given its support for the EU stability treaty, saying that it’s necessary to help Ireland’s exporters continue driving economic growth.

The aim of the treaty is to support ‘sustainable growth, employment, competitiveness and social cohesion’ in Europe through budgetary rules. Only countries that have ratified the treaty will be able to receive funds from the new rescue fund, the European Stability Mechanism.

The med-tech sector in Ireland employs 25,000 people and it’s hoped that the move will encourage businesses to continue to invest in Ireland.

About half of the med-tech companies in Ireland are indigenous and the medical technology industry is supporting the treaty believing that the medical technology sector is playing a vital role in Ireland’s export-led recovery and creating jobs in the process.

Value driven engineering

Experts from some of America’s leading biomedical device engineering companies and research institutions have advised the US health care device industry to accelerate innovation by changing their approach to research and development.

That was the key message from delegates attending the inaugural Value-driven Engineering: A National Conference on Medical Innovation for US Global Competitiveness Conference at the Austen Bio-Innovation Institute in Akron (ABIA).

Value-driven engineering focuses on improved clinical utility and reduced complexity to the end user, as well as value and cost efficiency across the entire health care continuum.

Over the past 12 months, members of a national steering committee, led by ABIA, have been promoting value-driven engineering as a strategy for medical device development. This embraces simplicity while advancing quality and improved, patient-centred care to drive innovation, value and efficiency across the entire US health care system.

Details at

China medical device testing: An awakening dragon?

China must gradually establish an international device regulatory philosophy to adapt strategy to the globalisation of trade, according to State Food and Drink Administration (SFDA) commissioner Yin Li.

He was speaking at the medical device testing conference held recently in Zhuhai, where he added that the medical device testing institutions are an important force in the medical device regulatory system, and have played a huge role in the development of China’s device industry.

Those who attended the conference included the State Food and Drug Administration Medical Device Supervision Department, the Food and Drug Verification Research Institute, Guangdong Province Medical Device Quality Supervision and contractors of the Food and Drug Administration.

More about this and other China medical devices news is available on the SDFA website at



















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