Medical e-News Round-Up – Issue 19

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This issue covers:

Japan’s medical device market improves

Japan’s med-tech market is showing signs of improvement following efforts by the regulatory body to reduce product approval lag times and the government’s targeting of the industry as a key growth sector.

A report in the trade journal European Medical Device Technology claims that Japan’s ageing population could benefit foreign companies, in particular. According to the Ministry of Health, Labour and Welfare, all artificial cardiac valves (worth €141 million), 99.6% of artificial hearts (€256 million), 98.4% of artificial respirators (€376 million) and 81.4% of contact lenses (€1.6 billion) sold in Japan are manufactured abroad.

Overall Japan accounts for 10% of the total global market for medical devices, and ranks as the third largest after the United States and the European Union. It is reported that high-end medical technology from the United States and Europe continues to be in great demand.

Historically, Japan’s rigid regulatory system has been a barrier to entry, but the government now appears to be more receptive to streamlining the product approval process and encouraging innovation. For example, the Ministry of Health, Labour and Welfare has more than doubled the number of reviewers at the Pharmaceuticals and Medical Devices Agency (PMDA) in the past three years. More at www.emdt.co.uk 

Optical company sees the benefits of Uni-Therm

Field engineers at Olympus KeyMed Ltd have turned to Rigel Medical’s Uni-Therm analyser for improved in-service performance testing of its electrosurgical devices. These items of equipment use electricity to produce enough heat to enable surgeons to cut body tissue or seal bleeding vessels during operations.

Twenty Uni-Therm units have been specified to allow automation of the performance testing of Olympus’s electrosurgical equipment, resulting in greater efficiencies. Already, the new testers have enabled engineers working at sites across the UK to accurately measure the performance of each device and complete high frequency leakage, high current, power distribution and patient return plate alarm testing.

Compliant with IEC 60601, the high performance Uni-Therm is capable of verifying and calibrating the electrosurgical equipment while guiding the engineer through all test procedures automatically and most of all safe.

Olympus is a leading manufacturer of advanced optical and digital equipment for the healthcare and consumer electronics sectors, leading the way in designing endoscopy and microscopy products among others.

Martin Wallace, head of field service at the Southend-on-Sea based company, said: “Rigel supplies us with a range of high performance, high quality instruments, which provide the engineers with convenient, easy-to-use and accurate testing solutions.

“The Uni-Therm incorporates an excellent range of features for a tester of its size, while the added value benefits, like improved connectivity and ease-of-use, are particularly impressive.

“The ability to import and export data is also a particularly beneficial feature, enabling us to store test information which can then be easily retrieved and used for quality control purposes at a later date.”

Senators push to repeal U.S. medical device tax

A group of U.S. senators have introduced legislation to try to repeal a tax on medical devices, which is part of President Barack Obama´s controversial new healthcare reforms.

The tax applies to a range of medical products – everything from bedpans and surgical tools to the expensive heart devices produced in the home states of the senators backing the repeal. It is among several new industry levies in Obama´s 2010 healthcare overhaul law, which aims to provide health insurance for the tens of millions of Americans who currently do not have any cover.

The 2.3% has already come into effect and is projected to raise about $30 billion over a decade to fund extended coverage. Senators from Minnesota, Indiana and Pennsylvania, where many big medical technology companies are based, are among those who have been pushing for the tax repeal.

“In order to compete in the global economy our medical device businesses need a level playing field,” said Democratic Senator Amy Klobuchar of Minnesota, home to Medtronic Inc, one of the biggest medical device makers.

Although dozens of industry officials and supportive lawmakers say the tax will hurt innovation and job creation, the law is already being implemented and was declared constitutional by the U.S. Supreme Court last year. That and the cost of repeal – depriving the federal government of billions at a time of dire fiscal straits – suggest the measure to kill the tax is unlikely to win approval.

Russian medical device regulations planned for 2013

Changes to how medical devices are regulated in the Russian Federation are planned for early 2013 but final implementation of the new rules remains tentative, according to medical device consultants Emergo Group.

The Russian Ministry of Health has already approved new orders regarding medical device classification, importation and adverse event handling but now under consideration are medical device vigilance processes, conformity assessments as well as quality and safety issues.

All orders under consideration must be approved before authorities begin implementing actual regulations. Some of the most important changes that may occur include a less direct regulatory role for public healthcare watchdog Roszdravnadsor – final approval will be made by ‘expert reviewers’ rather than the regulator itself. The move may also see a lack of timelines for medical testing, meaning the whole process could last for years, and inclusion of medical device registration fees written into law.

However, exact implementation timeframes for the new regulations are not yet clear according to the Emergo Group, which is providing regular updates about the regulatory developments as they come into force across Russia. Find out more at www.emergogroup.com

Make a date with Rigel

Rigel Medical will be exhibiting at a number of events and shows in 2013 including MD Expo (2-4 April 2013, Washington DC, USA); EBME Associates 2013 Seminar (1st May 2013, Milton Keynes, UK); Wümek – Euritim (May 13-14, 2013, Würzburg, Germany); AAMI (June 1-3, 2013, Long Beach, CA, USA); and MEDICA (November 20 – 23, 2013, Dusseldorf, Germany).

We look forward to seeing you at these and other events throughout the year where you can see all our products and talk to the experts; so make sure you have all the details and keep abreast of the latest news by visiting our website www.rigelmedical.com/events

Medical e-News Round-Up – Issue 18

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This issue covers:

Clarity for EU medical device regulations moves closer

An update on the anticipated timetable for the parliamentary vote on the European Commission’s proposal for a revision of the Medical Devices Directive (MDD), submitted last September, has been published by MedTech Europe.

The European Parliament’s Committee for Environment, Public Health and Safety (the ENVI Committee) is charged with considering the revision of the Medical Devices Directive, and its anticipated timeline has become clear over the past month, says MedTech Europe, an alliance of European medical technology industry associations founded by EDMA and Eucomed.

The first exchange of views will take place on February 18 followed by an ENVI workshop on medical devices (February 26). The draft report will then be considered by ENVI on April 24 before members table amendments (May 3) and final voting on the report in July.

The report is slated to be voted on by the full Parliament in a plenary session in September 2013. Details at www.europarl.europa.eu

Check out the new Rigel Uni-Therm

Advanced verification and calibration of electrosurgical generators is provided by Uni-Therm, the IEC 60601 compliant instrument that accurately measures performance levels including high frequency leakage, high current, power distribution and patient return plate alarm testing.

A high power load bank enables performance testing up to 6A RMS 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.

Remote electrode monitoring capability is carried out using a rotary encoder, which also controls the potentiometer, scaling up and down in manual or automatic mode to capture the alarm using the on-screen dedicated fast key. Data can be stored onboard for future traceability.The large array of internal resistors, ranging from 0-5115Ω in 5Ω steps provide not only the most accurate and detailed power curves, the Rigel Uni-Therm also advocates safe working practise by providing all necessary resistors within a single enclosure.

Bluetooth-enabled technology allows wireless connectivity to PCs and other equipment for the fast and convenient downloading of test data and the uploading of the electrosurgical device’s power curves and the manufacturer’s test specific programmes. Output waveforms can be examined through a built-in scope output which allows for easy confirmation of the desired waveform shape.

New US guidance on home-use medical devices

Home-use medical device manufacturers should now have a clearer idea of which issues the Food and Drink Administration (FDA) staff will focus on most keenly during registration reviews and audits, says the Emergo Group in its latest regulatory update.

The latest FDA guidance for medical devices highlights risk management processes as particularly important, notably important environmental issues that manufacturers should bear in mind, including:

• Location – do different physical structures affect the device’s intended use?
• Temperature – can the device function during temperature fluctuations?
• Dampness/humidity – how do variable humidity levels impact the device’s functionality?
• Contaminants – how would non-sterile settings impact the device’s functionality?
• Water supply – tap versus distilled • Child proofing – whether or not the device is designed for use by children?
• Travel/international use – how would air travel, security screening technology and voltage rates affect the device?

For devices that use electricity, FDA advises manufacturers to consult ANSI/AAMI/ES 60601-1:2005 on medical electrical equipment safety and performance. Read the full report and find links at www.emergogroup.com

Under the microscope

Global market leader in precision optics and engineering technology Carl Zeiss Ltd is using the Rigel Medical 62353 medical safety analyser to comply with IEC 62353, the standard for in-service and after repair testing of medical electronic devices.

This has improved the testing of hundreds of electrically powered operating microscopes and ophthalmic diagnostic devices which Carl Zeiss supplies and supports throughout the UK to the NHS trusts, private hospitals and high street optometrists.

Using the Rigel 62353 provides a cost effective, versatile and highly portable testing solution, enabling Carl Zeiss service engineers to quickly and accurately check the safety of upwards of 300 different Zeiss products per week at dozens of locations throughout the UK.

Roy Scales, service manager at Carl Zeiss, said: “The 62353 is a very good, highly reliable instrument which not only enables us to comply with the European standard but has definitely helped us ensure our products are safe to use.

“It’s intuitive, easy-to-use and compactness is appreciated by our engineers. It also incorporates a good range of features for a tester of its size, while the connectivity benefits are particularly impressive.”

China´s medical sector on the march

China’s healthcare and medical equipment market is on a growth spurt that has Western OEMs salivating over sales potential and priming the supply chain for profit opportunities in the world´s most populous nation, reports Anna Young writing for EBN (www.ebnonline.com)

However, she cautions that danger looms in the $357 billion market and failure to understand the challenges of China´s evolving healthcare industry could lead to missed opportunities and losses for medical equipment vendors, citing researcher and market consultancy McKinsey.

The firm projects the Chinese healthcare sector will nearly triple in value to $1 trillion by 2020 (from $357 billion in 2011) following demographic changes, increased investment as part of the country´s five year growth plan and the growing impact of the private sector in healthcare delivery.

The prospect of such growth has attracted Western multinationals in droves, but according to McKinsey, an inevitable shakeout in the industry could leave many late starters disappointed.

It is possible many could fail in China reports Young, but the handful that succeed in getting a slice of the market will benefit from a large and fast-growing industry segment.

She sees opportunities for medical equipment manufacturers and concludes that if China delivers on the promise everyone expects in healthcare services and medical equipment, local and Western companies will benefit from the continued opening of its economy.

AED safety and performance critical over next five years, says Rigel

Safety and performance will remain an important issue for AEDs in the coming years, according to John Backes, associate director – Rigel Medical.

Commenting in US biomed magazine ‘TechNation’, he believes manufacturers have increasingly made AEDs successful and safer to use by people but the challenge going forward will be to make them even more widely available, which will occur when they become more cost effective.

He says: “Although manufacturers provide built-in check procedures, these are not always sufficient to warn the user in advance. Problems with equipment more often than not will only surface when cardio version is required – of course, this is far too late and patients’ lives will be placed at even more risk if equipment doesn’t work.

“No doubt manufacturers will be able to address some of these concerns and perhaps even consider letting their users have remote (wireless) access using public (wifi) hotspots to monitor AED status.

” However, the necessity for testing defibrillators will remain no matter what level of self-testing is incorporated into future defibrillator technology says John, adding that taht the automotive industry is a good analogy because innovation has increased dramatically the reliability of cars.

“Most modern cars are fitted with several self-test and alarm features but this hasn’t eliminated the need for regular check-ups in the garage or by the owners. Wear and tear is difficult to monitor and visual damage always requires human interpretation. It’s the same for AEDs.”

Read John Backes’s interview with the editor at www.1technation.com

Join us at Arab Health

Don’t forget to catch Rigel at Arab Health, Dubai, the largest healthcare exhibition and medical congress in the Middle East.

Visit us on stand PZJ23, where our range of advanced medical device performance analysers, electrical safety analysers and vital signs simulators will be on display and where will be providing advice and support for the industry.

Venue: Dubai International Convention & Exhibition Centre, UAE
Date: 28th – 31st January 2013
Stand Number: PZJ23

High Performance Analysers Headline For Rigel Medical At Arab Health 2013

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Arab Health 2013 will see Rigel Medical (Booth PZJ23) showcasing its advanced medical device performance analysers, electrical safety analysers and vital signs simulators.

Leading the way will be the Multi-Flo infusion pump analyser, which meets all the IEC 60601-2-24 requirements and can be used for high and low flow, occlusion, back pressure and bolus measurement and features variants of one, two and four independent channels.

Also showing will be the new Rigel Uni-Therm high current electrosurgical analyser which is able to test accurately all modern low, medium and high current electrosurgical generators. With a new ultra-low inductance, high resolution load bank, the Uni-Therm can accurately detail the power in response to varying loads. Automatic control of the CUT/COAG allows automatic testing and improves safety whilst reducing test times.

The compact Uni-Pulse defibrillator analyser will be showcasing advanced measurement technology to verify the correct operation and functionality of all defibrillators. The battery powered analyser offers both manual and automatic test programs for testing of all mono-phasic, bi-phasic and pulsed waveform defibrillators.

Rigel performance analysers incorporate the latest state-of-the-art electronics and developments in electrosurgical device testing while the range of electrical safety analysers feature the first dedicated IEC 62353 safety analyser – the Rigel 62353 – offering automatic sequencing, onboard data storage and data entry in a lightweight, easy-to-carry enclosure.

The simulator range includes the Uni-Sim, which is capable of undertaking six synchronised vital signs parameter tests simultaneously: NIBP, SpO2, ECG, temperature, IBP and respiration functionality tests.

Rigel Medical’s presence at Arab Health comes as it continues to benefit from strong growth in the important Middle East market, where demand for high performance biomed device testers, featuring advanced added value capabilities remains strong.

Associate director John Backes said the event is one of the most important platforms for showcasing the benefits of the company’s product range.

“We are committed to investing in high performance products to provide customers with what they want,” said John Backes. “I’m sure the many features and benefits of all our products will generate significant interest among visitors to the show.”

Medical e-News Round-Up – Issue 17

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This issue covers:

Warnings over latest faulty heart defibrillator report

Warnings over faulty heart defibrillators have again highlighted the urgent need for regular testing of in-service health equipment, says Rigel Medical.

Tens of thousands of Automatic External Defibrillators (AED) in public places like shopping centres and airports may not work because of defective components that could unexpectedly fail warns the FDA (Food and Drug Administration, USA) and MHRA (Department of Medicines and Healthcare Products Regulatory Agency, UK).

The defibrillators are used to provide life-saving treatments to people having a cardiac arrest but both FDA and MHRA warn that unexpected component failure including batteries, make them inoperable at times when you most need them.

Indeed the MHRA recently reported that more than 1,300 emergency AEDs in public places like shopping centres may not work because of battery related problems.

John Backes, associate director at Rigel Medical, stresses the need to ensure AEDs are regularly checked and tested as lives could be placed at risk by faulty or failing equipment.

“Many people are under the (false) impression that these automatic defibrillators have an auto test function that can highlight component failures but both FDA and MHRA reports clearly show that this is not always the case.”

“Testing these AED’s is easy, relatively inexpensive yet vital and owners and operators could benefit by using the latest generation of easy to use, portable and lightweight analysers to quickly and easily verify the safe operation and functionality of equipment.”

The UNI-PULSE defibrillator analyser, for instance, features advanced measurement technology, the battery powered analyser offers both manual and automatic test programs for the safe testing of all mono-phasic, bi-phasic and pulsed waveform defibrillators and AEDs.

Bluetooth and USB has been incorporated for improved connectivity, enhanced memory capacity for the storage of results, defibrillator waveforms and test programmes and a clear, easy-to-read colour graphics display screen. An optional paddle adaptor box includes a version with variable loads from 25 – 200 Ohms for compliance with IEC 60601-2-4 requirements.

Proposed new European medical device regulations

The European directives on medical devices are being overhauled and the European Commission has published its proposals for regulations on medical devices and in vitro diagnostic medical devices.

The proposed regulation includes important new categories of products that are either currently outside the scope of the existing directives or where there is doubt of coverage. These include devices that have been identified by their manufacturers as single-use products that have been reprocessed with a view to being reused in the context of a clinical procedure and replacement parts that significantly alter the characteristics of devices that would be considered devices in their own right and subject to the full CE marking process.

The proposal calls for the formation of a committee called the Medical Device Coordination Group (MDCG), made up of members appointed by the member states and chaired by the EC.

One of the major, and most controversial, roles of this group would be to subject a number of conformity assessment files for innovative, high-risk devices to an additional central scrutiny procedure. Under this procedure, Notified Bodies would be obligated to notify the Commission of applications for conformity assessments of new Class III devices. The Commission would pass details of the new device to the MDCG, which will have 28 days to decide whether or not to request the Notified Body to submit a summary of the preliminary conformity assessment prior to issuing a certificate.

The regulation is now under review by the European Parliament and European Council and it could be two years before a common position is reached. Once the final wording of the regulation is published in the Official Journal of the European Communities, it will enter into force 20 days from publication and come into full effect three years after entry into force.

This means it could be 2017 before medical device companies are required to comply with the new requirements, although there is a provision in the proposal for manufacturers to be able to conform at any time after entry into force. Any prudent company will keep a very close watch on this process and, if necessary, make their views known through their industry associations if they believe that the proposed revision is likely to be more detrimental than beneficial to European citizens.

1. Communication on safe, effective and innovative medical devices and in vitro diagnostic medical devices for the benefit of patients, consumers and healthcare professionals; http://ec.europa.eu/health/medical-devices/files/revision_docs/com_2012_…

2. Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009; http://ec.europa.eu/health/medical-devices/files/revision_docs/proposal_…

3. Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices; http://ec.europa.eu/health/medical-devices/files/revision_docs/proposal_…

MEDRAD benefits from ‘easy-to-use’ 288

One of the world’s leading suppliers of advanced medical devices is using Rigel Medical 288 electrical safety analysers for improved safety testing of contrast injectors used at sites across the UK and Western Europe.

Nine analysers are in use with the MEDRAD team of UK field service engineers with further units deployed across the rest of Western Europe.

Using the 288s provides MEDRAD with a highly cost effective, versatile and portable testing solution, enabling engineers to quickly and accurately undertake more than 1,500 safety tests a year in the UK alone during the routine service and maintenance of MEDRAD’s installed base of contrast injectors.

Adam Reid, the company’s UK service manager, said: “The 288 is an excellent instrument, providing a cost effective, high end testing solution. The engineers find it easy-to-use and appreciate the fact that it’s compact enough to carry around with them.”

New body to improve lab managers’ skills

The new British Laboratory Managers Association (BLMA), launched by the trade association GAMBICA, will enable managers to improve their skills in laboratory management.

Laboratory managers face a blend of technical and people management challenges. Many have climbed the technical ranks and are well positioned to address the technical challenges but need more formal training in management skills, especially when they start managing a laboratory.

The BLMA’s move will not only help to improve managerial skills but will also provide opportunities for managers to share best practice, exchange ideas and build on the experience of others to improve laboratory management skills.

The BLMA is being setup as a separate association within GAMBICA and will be run by and for the people in this industry. Tim Collins, Director – lab technology, GAMBICA Association Ltd said: “An initial launch via a selected number of GAMBICA member clients resulted in an extremely positive response with an inaugural management committee meeting set to formulate the issues and activities the BLMA will look at.”

One of these will be an inaugural annual meeting, expected to be in May/June 2013. Other activities could include special interest group meetings as well as a website with a member´s area that would include forums, newsletters and a document depository. Topics covered may include managing laboratories, green laboratories, regulations such as REACH, WEEE and managing waste, HR, health and safety, electronic note books, tendering and purchasing.

If you would like to know more contact Tim Collins at blma@gambica.org.uk

Uni-Therm: The measure of success

Compliant with IEC 60601-2-2*, the Uni-Therm accurately measures the performance of electrosurgical generators including high frequency leakage, high current, power distribution and patient return plate alarm testing.

It’s capable of verifying and calibrating all major electrosurgical generators whilst guiding the user through all test procedures automatically and most of all safe. A high power load bank enables performance testing up to 6A RMS 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 0-5100Ω in 5Ω steps provide not only the most accurate and detailed power curves, the Rigel Uni-Therm also advocates safe working practise by providing all necessary resistors within a single enclosure.

Remote electrode monitoring capability is carried out using a rotary encoder, which also controls the potentiometer, scaling up and down in manual or automatic mode to capture the alarm using the on-screen dedicated fast key. Data can be stored onboard for future traceability.

Bluetooth-enabled technology allows wireless connectivity to PCs and other equipment for the fast and convenient downloading of test data and the uploading of the electrosurgical device’s power curves and the manufacturer’s test specific programmes. Output waveforms can be examined through a built-in scope output which allows for easy confirmation of the desired waveform shape.

* IEC 60601-2-2 specifies the requirements for the safety of high frequency surgical equipment and HF surgical accessories used in medical practice.

Take heed: New China circular on foreign medical devices

China’s State Food and Drug Administration (SFDA) has released a new circular to strengthen the supervision and administration of medical devices.

The ‘Circular on Standardising the Labels and Packaging Marks of Foreign Medical Devices’ (guoshiyaojianxie [2012] No.280), is set to regulate the issues concerning the labelling and packaging marks on foreign medical devices, notably technology sold and used within the territory of China.

These will require attached labels and packaging marks featuring text in Chinese – other languages may be added. Any foreign medical devices not featuring attached Chinese labels or packaging marks will be, according to the new regulations, prohibited from being sold or used.

Manufacturers of foreign medical devices must also establish control procedures in their quality control systems to ensure any medical devices sold and used within the territory of China comply with the regulations. They must also formulate relevant documents and effectively implement such documents to ensure the safety and effectiveness of the medical devices sold and used in within the territory of China.

The Circular is scheduled to take effect from April 1, 2013 and more at www.china-briefing.com

Medica 2012

Earlier this month we visited the Medica Tradefair, a leading medical equipment exhibition located in Dusseldorf, Germany. We showcased some of our market defining new products including the MULTI-FLO infusion pump analyser, the UNI-THERM high current electrosurgical analyser and the UNI-PULSE defibrillator analyser.

We would like to make a personal thank you to everyone that attended our stand at Medica 2012, making the exhibition a great success. It was very nice to meet you all and we hope you found out everything that you needed.

If you missed the chance to grab a copy of our FREE Pulse magazine, packed with expert news and advice for the medical industry, whilst you were at Medica don’t worry you can download a pdf version here.

For more information or to request a demonstration/quote on any of our products please visit www.rigelmedical.com/products.

And finally…see you at Arab Health

Arab Health (January 28 -31, 2013, Dubai International Convention & Exhibition Centre, UAE) is the largest healthcare exhibition and medical congress in the Middle East with trade fairs for surgical and hospital equipment – and Rigel Medical will there again, providing advice and support for the industry.

John Backes, associate director – Rigel Medical, says the event is a great opportunity for customers and specifiers to see the company’s products including the new Uni-Therm and Multi-Flo and how these are used as well as meeting the Rigel team. He’s also looking forward to seeing you next year at Wümek – Euritim (May 13-14 Würzburg, Germany) and AAMI (June 1-3, Long Beach, CA, USA).

Rigel Medical Warns Over Latest Faulty Heart Defibrillator Report

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Recent warnings over faulty heart defibrillators have again highlighted the urgent need for regular testing of in-service health equipment, says a leading supplier of medical device testers and analysers.

Tens of thousands of Automatic External Defibrillators (AED) in public places like shopping centres and airports may not work because of defective components that could unexpectedly fail warns the FDA (Food and Drug Administration, USA) and MHRA (Department of Medicines and Healthcare Products Regulatory Agency, UK).

The defibrillators are used to provide life-saving treatments to people having a cardiac arrest but both FDA and MHRA warn that unexpected component failure including batteries, make them inoperable at times when you most need them.

Indeed the MHRA warned only last week over faulty heart defibrillators, reporting that more than 1,300 emergency AEDs in public places like shopping centres may not work because of battery related problems.

John Backes, associate director at Rigel Medical, which manufactures and supplies equipment used to test the safety of electrically operated medical devices, says the news highlights a problem facing potentially thousands of automatic defibrillators installed across UK and an even greater number globally.

He’s stressing the need to ensure AEDs are regularly checked and tested as people’s lives could be placed at risk by faulty or failing equipment.

“This is the latest report of problems associated with this type of medical device used in public places, so it’s vital they are properly checked and maintained.”

“Many people are under the (false) impression that these automatic defibrillators have an auto test function that can highlight component failures but both FDA and MHRA reports clearly show that this is not always the case.”

“Testing these AED’s is easy, relatively inexpensive yet vital and owners and operators could benefit by using the latest generation of easy to use, portable and lightweight analysers to quickly and easily verify the safe operation and functionality of equipment.”

The Rigel Medical Uni-Pulse defibrillator analyser, for instance, features advanced measurement technology, the battery powered analyser offers both manual and automatic test programs for the safe testing of all mono-phasic, bi-phasic and pulsed waveform defibrillators and AEDs.

Bluetooth and USB has been incorporated for improved connectivity, enhanced memory capacity for the storage of results, defibrillator waveforms and test programmes and a clear, easy-to-read colour graphics display screen. An optional paddle adaptor box includes a version with variable loads from 25 – 200 Ohms for compliance with IEC 60601-2-4 requirements.

The colour LCD provides easy navigation around the functions and simulations including defibrillator waveform capture, accurate energy measurements, cardio synch times, peak voltage and current.

A 12-lead ECG simulation with substantial variation of atrial and ventricular arrhythmias and performance wave forms provides faster, easier and more accurate testing of defibrillators with built-in monitoring functions.

Automatic test programs for AEDs leads to fast and effective testing of AED response, interpretation and performance.

Medical e-News Round-Up – Issue 16

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Issue 16 of our Medical News Round-Up – A bulletin that contains the latest Medical Testing news has now been published.

New EU standards list for in vitro medical device

An updated list of standards to demonstrate compliance with the essential requirements of its Directive 98/79/EC, dealing with in-vitro diagnostic medical devices, has been published by the Commission of the European Union (EU)…
Read More

EU conformity move

The Commission of the European Union (EU) latest updated list of standards can be used to demonstrate conformity with the essential requirements of its Directive 90/385/EEC, relating to active implantable medical devices…
Read More

Check out those vital signs

Medical devices and equipment used to check for and monitor people’s vital signs – blood pressure (invasive or non-invasive methods), temperature, electro cardiogram (ECG), respiration and blood oxygen saturation (SpO2)…
Read More

TRaC first

UK-based test house TRaC Global claims to be the first in the country approved to certify remote medical monitoring devices for the Continua Health Alliance. The approval also makes TRaC the only test house in the world approved to test devices by the health alliance…
Read More

And finally…

Don’t forget to catch Rigel at MEDICA 2012 where its range of advanced medical device performance analysers, electrical safety analysers and vital signs simulators will be on display. Visit us on stand C12, hall 11…
Read More

Medical e-News Round-Up – Issue 15

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Issue 15 of our Medical News Round-Up – A bulletin that contains the latest Medical Testing news has now been published.

On show at MEDICA

Plans have been finalised for MEDICA 2012 where Rigel will be showcasing its range of advanced medical device performance analysers, electrical safety analysers and vital signs simulators…
Read More

Medical device testing lab awarded major contract

A Bridgend NHS laboratory is celebrating after winning a contract worth thousands of pounds to test medical devices. The Surgical Materials Testing Laboratory, hosted by ABMU Health Board and based at the Princess of Wales Hospital…
Read More

Table top success

The Rigel 62353 is an excellent product which has been easy to integrate into the engineering maintenance schedule.” That is the view of Alasdair Owen, Service Manager for TRUMPF Medical Systems Ltd…
Read More

China moves

The Chinese State Food and Drug Administration (SFDA) has published the revised Medical Device Good Clinical Practice (GCP), a compilation of high-level principles for the conduct of clinical studies – the revised one has significantly…
Read More

Go with the Flo

The Multi-Flo infusion pump analyser, on show at MEDICA, features variants of one, two and four independent channels – each channel can be tested simultaneously across a range of 100 μL (microlitre) to 1,000…
Read More

New guidance from Canada

Health Canada has announced the release of the final version of the‘Guidance on supporting evidence to be provided for new and amended license applications for Class III and Class IV medical devices, not including In Vitro Diagnostic Devices (IVDDs)’…
Read More

Medical e-News Round-Up – Issue 14

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Issue 14 of our Medical News Round-Up – A bulletin that contains the latest Medical Testing news has now been published.

Funding boost

The UK medical device market can benefit significantly from over £200 million funds of grants that are available to UK businesses, according to the independent research organisation TBAT Innovation…
Read More

Med-eBase – meeting your needs

The latest Med-eBase incorporates all the features customers require to provide enhanced electronic recording and management of medical device safety testing programmes using…
Read More

Japan eyes new medical device future

The Japanese government has announced a strategy to support the creation of new medical-related markets by 2020, which will pave the way for new medical device developments…
Read More

The (MOD)ern way to test

The Ministry of Defence is using dozens of Rigel Medical 288 field service kits to test the electrical safety of devices at its medical, veterinary and dental servicing centres around the world…
Read More

Expert calls for more local manufacturing for India

India’s medical device manufacturing sector is not achieving its potential because of government policies and practical difficulties that discourage companies from venturing into the sector…
Read More

And finally…see you at National Biomed and Clinical Engineering Conference

The National Biomedical and Clinical Engineering Conference and Exhibition is the only annual conference that brings together the entire bio-med community…
Read More

Medical e-News Round-Up – Issue 13

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Issue 13 of our Medical News Round-Up – A bulletin that contains the latest Medical Testing news has now been published.

FDA move boosts safety

The U.S. Food and Drug Administration is proposing that most medical devices distributed in the United States carry a unique device identifier (UDI) in a move…
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Rigel 288 on test at Siemens

Engineers at healthcare equipment manufacturer Siemens Healthcare are using Rigel 288 electrical safety analysers to undertake rapid electrical safety checks…
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Uni-Therm: The measurement of success

The new Uni-Therm measures the performance of electrosurgical generators including high frequency leakage, high current, power distribution and patient return plate alarm testing…
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Anticipating future design

The EU directive on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS) is a fine example of why device manufacturers…
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India moves to fill skills gap

The Federation of Indian Chambers of Commerce and Industry (FICCI) has joined forces with the All India Council for Technical Education (AICTE) – the advisory body for all matters relating to technical education – to develop vocational courses in the healthcare sector to improve medical device skills…
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IEC 62353…the debate goes on

Should medical equipment manufacturers consider their end of production line testing based on IEC 62353 routine procedures instead of IEC 60601 type tests? That’s the question Rigel Medical associate director John Backes poses in his latest Linked In debate…
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Medical e-News Round-Up – Issue 12

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Issue 12 of our Medical News Round-Up – A bulletin that contains the latest Medical Testing news has now been published.

New in service defibrillator tester

The compact, lightweight and portable Rigel Medical Uni-Pulse defibrillator analyser enables biomed technicians and engineers to quickly verify the safe operation…
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Asia healthcare moves

India’s Working Group on Health Research (WGHR), appointed by the country’s Planning Commission, is proposing a Medical Technology Development Board to promote…
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IEC 62304: medical device standard?

Properly applying the IEC 62304 standard to medical development and integrating third-party software will pay long term dividends…
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Rigel at leading primary care supplier

Williams Medical Supplies (WMS), the UK’s leading provider of medical supplies and services to primary care, has drastically cut the time taken to test…
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Five years of IEC 62353

Over the decades, improvements in occupational health and safety have come on in leaps and bounds as the level of injury, or even death, caused by hazards in our community or workplace have fallen in most developed countries to record low levels…
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Pulse reading

Make sure you catch our brand new newsletter ‘Pulse’ at www.rigelmedical.com where you’ll find plenty to interest including the latest industry and product news. In the first issue we answer some of your questions in our ‘Questions Time’ section…
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