A new approach to medical device testing in hospitals is available following the launch of an advanced interface developed by Rigel Medical and EQ2.

The move sees the Rigel Medical 288 safety analyser integrated with EQ2’s clinical equipment management system HEMS to provide a fully automated, highly accurate and easily portable system for capturing and documenting medical device safety records.

A new module has been incorporated into EQ2’s HEMS Enterprise software to make it fully compatible with the automated Rigel analyser.

This module – the EQ2 Rigel SA Interface – enables the biomed engineer to harness the 288’s full capabilities to capture valuable information at the point of testing in a hospital or healthcare centre before sending the data automatically to the HEMS system to complete safety checks and link to the medical device’s inventory, test library and performance history.

John Backes, Associate Director at Rigel Medical, said the international and domestic hospital markets are key areas of growth and we have partnered with EQ2 to provide an advanced testing solution for this sector.

He added: “EQ2 has simplified the user interface experience while delivering accurate and robust interoperability with the Rigel 288 was a key to our interest in EQ2.

“EQ2 has delivered on their vision with the release of this simple, intuitive interface to our Rigel 288 – a perfect complement to our great safety analysers.”

EQ2 is the first Rigel authorised provider of automated CMMS – Rigel interfaces. Vishal Malhotra, EQ2 Director of Development, said: “With this first release, EQ2 and Rigel prove that complex interoperability can be accomplished through good system design to be stunningly simple for the customer to use.”

The Rigel 288 features a compact Bluetooth barcode scanner, enabling devices and equipment to be quickly and easily identified, while test results can be stored internally and printed wirelessly to a small battery operated printer. Users also have the facility to select from a range of pre-set test programs or develop their own customised routines.

EQ2, based in Burlington, Vermont, U.S. is global supplier of healthcare and clinical equipment management systems.

This issue covers:

• Faulty NHS equipment kills 300 people a year
• Republican knives out for Obama’s medical devices tax
• Video star
• Tap into £1m of R&D funding
• Rigel analyser leads the way in dialysis machine testing in Japan

Faulty NHS equipment kills 300 people a year

More than 300 patients a year are dying due to faulty NHS equipment, according to an article in the Daily Mail about a report from the Institution of Mechanical Engineers.

The report says nearly 5,000 people were left seriously injured last year after using faulty equipment including pacemakers, MRI and CT scanners. In the highest annual total of deaths since records began, 309 patients died last year in ‘adverse incidents’ linked to medical devices.

In total, there were 13,642 incidents relating to faulty equipment reported to health officials. Medics have also been forced to delay life-saving operations because their machines and tools don’t work.

Patients also suffered delays and injuries after issues with incubators, wheelchairs, artificial limbs, syringes and specialist beds.

The report says boosting the number of engineers in hospitals would help cut the number of deaths and injuries, and warns that while technology is leading to huge advances in healthcare, it remains dependent on the work of biomedical engineers to fix and maintain it.

There are concerns that a lack of engineers to maintain equipment might be exacerbating the problem with the report calling for the introduction of a Chief Biomedical Engineer at each NHS trust.

Dr Patrick Finlay, of the Institution of Mechanical Engineers, said: “Government and the NHS need to take urgent action to prioritise the role engineers play in hospitals and trusts.

“Technology is leading to huge advances in healthcare, but this technology is dependent on the work of biomedical engineers who are inadequately recognised and in short supply in most hospitals.

“Clinicians and engineers need to work in partnership to ensure that advances in medical technology are applied in the best interest of patients. The benefits of hospitals having a designated chief biomedical engineer responsible for healthcare technology are clear.”

Read in full at www.dailymail.co.uk

Rigel comments: This and other similar reports once again highlight the urgent need for regular testing of health equipment, says John Backes, associate director – Rigel Medical. “There is always a need to ensure devices 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 medical devices, so it’s vital they are properly checked and maintained. Testing these medical devices and other items including AEDs is easy, relatively inexpensive yet vital. 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.”

This includes the Rigel Medical Uni-Pulse defibrillator analyser, which 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.

Republican knives out for Obama’s medical devices tax

News agency Reuters reports that republicans in the U.S. Congress will move to avoid a medical device tax imposed less than two years ago under President Barack Obama’s healthcare law.

The 2.3% excise tax on sales of most medical devices sold in the United States helps fund the law, known as Obamacare, and applies to products ranging from bedpans to heart pacemakers. It took effect in January 2013 and is projected to raise about $30 billion a year in government revenue over 10 years.

Though no full-scale repeal of Obamacare is expected, even with the Senate now under Republican control, the move against the tax is part of efforts to gradually chip away at the law.

The recent mid-term elections will elevate Republican Senator Orrin Hatch, a long-standing opponent of the tax, to the chairmanship of the tax-writing finance committee in the Senate.

“The senator will continue to examine and support every viable opportunity to permanently repeal Obamacare’s onerous tax on medical devices,” said his spokeswoman Julia Lawless.

In 2013, the Senate approved a symbolic resolution calling for repeal of the tax, with more than 30 Democrats joining Republicans in support of the non-binding measure.

Opposition to the tax is also widespread in the House of Representatives, so there is a strong chance it could be repealed. Republicans held the majority there even before the elections and voted on 50 occasions to repeal all or part of Obamacare. More at www.reuters.com

Video star

The Rigel 288 has become one of the most recognised electrical safety analysers on the market today. Its unique, earth bond technology and use of internal memory make it a truly valuable tool for every biomedical test professional.

Now, in a move to boost the support and service Rigel provides to customers, a new online video has been produced explaining more about the benefits of this highly versatile analyser and demonstrates how biomed engineers can take advantage of the product for comprehensive, high performance in-service testing. Watch in full at www.rigelmedical.com/288

Tap into £1m of R&D funding

Companies in Wales with a medical project it feels is risky, can now bid for funding to research and develop the project

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Risky projects may be difficult for companies to take forward and develop – Innovate UK is looking to help these projects, where the majority of the project activities take place in and around the South Wales medical technology cluster.

Up to £1 million is on offer through our new Launchpad competition, along with a programme of business support. We’ll also help applicants raise more external finance to help fund and commercialise the project.

Medical technology is one of Wales’ major industrial strengths. There are around 300 life science businesses in the country, including rapidly growing small businesses. Many of these are in South Wales.

The aim of the Launchpad is to help companies clustered there to go further and faster towards commercial success. We want to draw investment and people into the area and to encourage networking and collaboration.

The competition is now open with the deadline for stage 1 video submissions/applications on midday on 10 December 2014. More at https://ts.catapult.org.uk

Rigel analyser leads the way in dialysis machine testing in Japan

Nikkiso Co Ltd, the leading manufacturer of dialysis machines and related devices in Japan, is using the Rigel Medical 288 automated safety analyser to improve biomed electrical safety testing.

The move has led to improvements in testing procedures as part of an in-service annual safety check programme for its machines installed at hospitals and healthcare facilities throughout the country.

The portability of the 288 is a benefit to Nikkiso’s team of over 100 technicians who are able to take advantage of a single solution to quickly and easily complete both earth bond and leakage testing on the dialysis machines. Rigel’s unique earth bond test circuit ensures accurate measurements at low currents which have resulted in a drastic reduction in size and weight of the Rigel 288.

It remains the industry’s smallest automatic safety analyser, providing fast and accurate testing of patient, enclosure and earth leakage as well earth continuity and insulation resistance. Its compact design and user friendly interface is particularly beneficial for the technicians involved in testing, providing improved portability and ease-of-use during completion of electrical safety checks.

Satoru Kawarabayashi, Marketing Manager at Nikkiso, said: “The 288 is an excellent instrument, providing a fast, cost effective reliable testing solution. The engineers, in particular, find it easy-to-use and appreciate the fact that it’s compact enough to carry around with them.

“It incorporates a good range of features for a tester of its size, while the connectivity benefits are particularly impressive. The user-friendly screen, featuring a simple step-by-step test diagram, is also easy to understand and follow.

“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 audit purposes.”

Do you use Rigel Medical equipment? – If you think you may have a story for future e-news bulletins, please let us know by contacting us here.

This issue covers:

• New IEC 62353 edition
• Join the 62353 LinkedIn discussion group
• India considers relaxing FDI medical devices policy
• New PULS-R simulation finger
• Medtech market outlook: Europe struggles to recover momentum
• MOD plugs into the benefits of 288 field service kit
• Catch us at MEDICA

New IEC 62353 edition

A new edition of IEC 62353, which applies to ‘Medical electrical equipment – Recurrent test and test after repair of medical electrical equipment’, has been published.

The IEC 62353 covers the general requirements for testing equipment prior to it going into service, after modifications, after repair, and as part of a recurrent testing protocol, and provides details of the tests that should be performed under these circumstances. It also discusses the reporting of test results and how to evaluate your findings.

The standard is intended for use by equipment manufacturers, testing equipment manufacturers, regulatory authorities, equipment suppliers, service personnel and organizational equipment users. As a technical revision, the important changes are:

• Clarification of clause 5.3.4.1 on the measurement of leakage currents (plus more information in Annex A)
• Revision of the protective earth resistance requirements
• The addition of expected minimum insulation resistance values in Table 2
• The reordering of the testing sequence found in Annex B

More at http://webstore.iec.ch/

Join the 62353 LinkedIn discussion group

Catch all the latest news and thinking about IEC 62353 with John Backes, Associate Director – Rigel Medical and others at the LinkedIn debate. He wants to encourage ongoing debate and is keen to hear the views of others as the second edition comes into force. You can join him and others at www.linkedin.com

India considers relaxing FDI medical devices policy

India’s Government is looking at relaxing the foreign direct investment (FDI) policy for the cash-starved medical devices sector to attract more investments and boost domestic manufacturing.

Inter-ministerial consultations are on to liberalise the foreign direct investment policy for the sector “which badly needs foreign investment”, sources said.

Besides the Commerce and Industry Ministry, the Finance Ministry, the Health and Family Welfare Ministry and the Department of Pharmaceuticals are involved in the consultations.

FDI in the medical devices sector is permitted through the government-approval route and the industry has been demanding that it be put under the automatic route, they said.

“India badly needs FDI in the medical devices and equipment sector. The industry is not modern and there is no threat of mergers and acquisitions from multi-national firms as domestic companies are not big unlike drug firms. So it should not be subjected to FDI limits and other restrictions,” said a source.

Industry officials have maintained for long that in the current “restrictive regime”, no foreign investor would invest in the sector and to make the segment modern and self-dependent, the government should relax the FDI policy.

The sector currently falls under the pharmaceutical category and is accordingly subjected to FDI limits and other conditions, such as the mandatory government approvals.

Read in full at www.dnaindia.com

New PULS-R simulation finger

A new simulation finger which combined with its advanced hand-held UNISIM simulator, provides the world’s smallest, high performance all-in-one vital signs solution. The compact Rigel PULS-R universal SpO2 simulation finger can produce accurate SpO2 simulations in 1% resolution from as low as 30% using the pre-programmed manufacturer specific R-curves. It can also be configured to meet customer specific R-curves via a simple-to-use configuration tool. This improves the detection of degrading and inaccurate SpO2 probes, reducing incidences of failure and providing the user with peace of mind. When linked with the UNISIM vital signs simulator – capable of undertaking NIBP, SpO2, ECG, temperature, IBP and respiration functionality tests simultaneously – it provides improved and customised vital signs simulation and measurement. Administration time is also reduced as the data recording and storage is undertaken directly and automatically.

Medtech market outlook: Europe struggles to recover momentum

The operating environment for medical device companies is primed to become more challenging – but transparent – as a result of new legislation that will overhaul the EU medical device directives, according to an article published in the ‘European Medical Device Technology’ magazine.

In response to increasing safety concerns, the legislative changes envisage stricter and more detailed monitoring and enforcement requirements for both Notified Bodies and national Competent Authorities. More stringent approval procedures with additional clinical evidence requirements for high-risk devices will also increase the regulatory burden on manufacturers.

Longer and more costly approval procedures threaten to undermine the competitiveness of the European medical device industry, which comprises largely of small and medium-sized companies.

The EU Parliamentary elections in May 2014 interrupted negotiations. But the legislative process is expected to gain momentum over the coming months, although the German industry association Spectaris does not expect the new law to go into effect prior to 2018.

The industry may have been heartened by a recent statement from EU Commission President-Elect Jean-Claude Juncker that cautioned against hindering the ability of companies to innovate by overregulation. Nevertheless, companies are already facing a draft of regulatory measures to improve patient safety, including the new patient implant card, which will be mandatory in Germany by October 2015.

While Western Europe will continue to see steady demand for medical devices, healthcare providers will be forced to seek better value for their money, thereby creating a more challenging operating environment and further squeezing profit margins.

In response to these challenges, the industry is experiencing a period of consolidation to provide economy of scale to healthcare providers or pay lower corporate taxes. Recent mergers among major players include deals between Baxter and Gambro, Zimmer and Biomet, and Medtronic and Covidien. Other notable developments include Danaher’s acquisition of Nobel Biocare and Smith & Nephew’s acquisition of Arthocare.

The above is an extract from an article published in EMDT. You can read in full at www.emdt.co.uk.

MOD plugs into the benefits of 288 field service kit

Rigel Medical’s 288 field service kit is used to test dozens of devises at Ministry of Defence medical, veterinary and dental servicing centres around the world.

Using the new testers, military technicians can significantly reduce the time involved in undertaking electrical safety checks on devices and equipment used at the military healthcare facilities, using the barcode functionality that is available with the tester. Also, the 288’s ability to use barcodes and recall the test history of a device is invaluable.

The Medical and General Supplies Team (M&GS) specified the 288 kit after assessments by technicians at RAF Henlow in Bedfordshire.

One of the key advantages of the 288 is a light, portable and integrated barcode reader and printer which means equipment can be identified and records recalled quickly, meeting the needs of technicians operating across the MOD in a more demanding mobile environment.

The field service kit reduces the time taken to test the electrical safety and operation of a wide range of medical devices and equipment used in hospitals, operating theatres and other facilities.

It offers a flexible, easy-to-use and accurate solution for testing devices for electrical safety to appropriate standards and guidelines including IEC 62353 IEC/EN60601-1, VDE 0751-1, AS/NZS 3551, AAMI, NFPA-99, MDA DB 9801-2006.

A state-of-the-art bluetooth barcode scanner enables devices and equipment to be quickly and easily identified, while test results can be stored within the Rigel 288 safety analyser and printed wirelessly to the rugged battery operated Elite Test n Tag printer.

Traceability is improved as information can be downloaded into Med-eBase – the easy-to-use test solution software. This enables the user to store and manage test results, email html test certificates to clients and schedule new work orders, which can then be fully uploaded into the large on-board memory.

The kit comes in a hard wearing, impact and water resistant Pelican carry case featuring dedicated foam inserts to safely hold the instrumentation in place and provide optimum protection during transportation.

Catch us at MEDICA

And finally, don’t forget to visit us at MEDICA (Hall 11 / H11), where the PULS-R will be the highlight of our display of advanced medical device analysers, electrical safety testers and simulators.

Alongside the world’s smallest all-in-one vital signs solution will be the MULTI-FLO infusion pump analyser, which leads the way in high and low flow, occlusion, back pressure and bolus measurement and meets the requirements of IEC 60601-2-24.

Featuring variants of one, two and four independent channels, each MULTI-FLO channel can be tested simultaneously across a range of 100 μL (microlitre) to 1,500 mL per hour with results stored in the instrument’s large internal memory. With a sampling rate of 1Hz, the analyser accurately details changes in flow and pressure rates, providing a real-time picture of the quality of infusion.

The UNI-SIM Vital Signs Simulator will complete Rigel Medical’s display for MEDICA which, says associate director John Backes, continues to be a key show for the company, adding: “This year, we look forward to revealing our world leading, all-in-one vital signs simulator solution, which will undoubtedly draw significant interest because of the rapid and accurate testing it provides.”

Do you use Rigel Medical equipment? – If you think you may have a story for future e-news bulletins, please let us know by contacting us here.

This issue covers:

• New FDA test to standardise medical device labels
• Smallest all-in-one vital signs solution leads for Rigel at MEDICA
• China calls for greater use of home grown medical devices
• At the heart of cardiac surgery robot testing
• EU move on medical devices’ Directives
• Check for your Pulse

New FDA test to standardise medical device labels

The US Food and Drug Administration (FDA) plans to study whether it could standardise device labelling with the use of new content and format standards now under development.

At present, there are no regulations defining a standardized approach for how content should be structured or formatted for medical devices. This is considerably different than the requirements for other FDA-regulated products, such as food or pharmaceutical products, which must adhere to strict requirements regarding everything from the font size and required information to layout and required statements.

Now the agency says it wants to move forward with an additional study on standardized device labelling. It plans to compare labelling from six different types of medical devices using two different “standard content and format” labels being developed by FDA researchers.

As with the agency’s first study, the new one is to be quite small, with just 38 respondents – all healthcare providers. Of the 38, eight will be hospital-based healthcare providers, while the remaining 30 will be healthcare providers “participating at FDA.”

“We will conduct the studies at three different sites including two area hospitals using their devices, existing labelling, and HCPs,” the FDA explained in the notice.

“Given a sample of 6 devices with 2 different labelling types, there will be 12 different labelling types to be tested. We plan to have eight people test each type of the labelling. We will also conduct the studies on FDA’s campus using medical devices received from medical device industry representatives through a material transfer agreement.”

The study is yet another indication that FDA is seriously considering how to standardize device labels, and its second study could mean new standards could be arriving within a few years. More at www.raps.org/

Smallest all-in-one vital signs solution leads for Rigel at MEDICA

The world’s smallest all-in-one vital signs solution will be the highlight of the Rigel Medical display of advanced medical device analysers, electrical safety testers and simulators at this year’s MEDICA (Hall 11 / H11).

Rigel’s hand held vital signs simulator UNISIM – capable of undertaking six synchronised vital signs parameter tests simultaneously – has been linked with the new PULS-R SpO2 simulation finger to provide improved vital signs simulation and measurement.

UNISIM can check NIBP, SpO2, ECG, temperature, IBP and respiration functionality in a single test, while the compact Rigel PULS-R universal SpO2 simulation finger can produce accurate SpO2 simulations in 1% resolution from as low as 30% using the pre-programmed manufacturer specific R-curves. It can also be configured to meet customer specific R-curves via a simple-to-use configuration tool.

Also showing will be the Multi-Flo infusion pump analyser, which leads the way in high and low flow, occlusion, back pressure and bolus measurement and meets the requirements of IEC 60601-2-24.

Featuring variants of one, two and four independent channels, each MULTI-FLO channel can be tested simultaneously across a range of 100 μL (microlitre) to 1,500 mL per hour with results stored in the instrument’s large internal memory. With a sampling rate of 1Hz, the analyser accurately details changes in flow and pressure rates, providing a real-time picture of the quality of infusion.

Associate director John Backes said: “MEDICA is a key show for us and this year we look forward to revealing our world leading, all-in-one vital signs simulator solution, which will undoubtedly draw significant interest because of the rapid and accurate testing it provides.”

China calls for greater use of home grown medical devices

Reuters reports that China may use incentives to encourage domestic hospitals to use Chinese-made medical devices as it looks to stimulate the local market and reduce soaring healthcare costs, a potential threat to the global firms who currently dominate the sector.

This will speed up the development of China’s medical device industry and promote wider use of local products to “effectively control unreasonable increases in the cost of medical care and reduce the burden on patients,” the country’s health ministry said in a statement posted on its website.

The overt backing by Beijing for home grown medical devices will raise protectionism concerns and is a headache for the global firms attracted to China by annual growth rates, which McKinsey & Co expect at around 20 percent over the next few years.

Global medical device makers, especially from the United States, Europe and Japan dominate around three-quarters of China’s medical device market, which was worth 212 billion yuan ($34.51 billion) in 2013, according to figures from the Hong Kong Trade and Development Council (HKTDC).

“We want to strongly advocate health ministry organisations to use domestically-made medical devices, especially pushing top level class III hospitals to use domestically-made products,” the statement said, citing Li Bin, the head of China’s National Health and Family Planning Commission.

Li was speaking at a medical device conference in Beijing to promote the domestic sector, the statement said.

The fast growth of China’s medical devices market has drawn in firms including Siemens AG, General Electric Co, Koninklijke Philips NV, Johnson & Johnson and Medtronic Inc who compete with local companies such as Mindray Medical International Ltd and China Resources Wandong Medical Equipment Co Ltd.

Hospitals are the biggest distribution channel for medical devices, accounting for almost 80 percent of the market, according to HKTDC figures. There were around 13,400 public hospitals in China last year, and a further 11,300 private hospitals, according to a June report from Deutsche Bank.

Read in full at www.reuters.com

At the heart of cardiac surgery robot testing

Robin Heart, a ground breaking project in Poland to create a new generation of advanced cardiac surgery robots, uses a 288 electrical safety analyser to improve electrical safety testing during product development.

Instigated by the Professor’s Zbigniew Religa Foundation of Cardiac Surgery Development, the project is Europe’s first medical robot for cardiac surgery with semi-automatic movements, an advanced human-machine interface and a 3D virtual training system.

Ensuring that all the vital electrical components of the robot system function properly and safely during the various stages of product development is a critical part of this research project that could radically alter the future shape of medical surgery. Testing has to be undertaken in accordance with IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. The components also have to be regularly inspected and tested to make sure they comply with IEC 62353, the standard for in-service and after repair testing of medical electronic devices.

The 288 analyser supplied by Rigel’s distributor in Poland, SAMSO, features multi-lingual menu driven instructions, with download report, for simple operation and test control of all electrical safety tests in manual, semi-automatic or fully automatic test modes. The compact design is beneficial for the technicians involved in the Robin Heart project, providing improved portability and ease-of-use during completion of electrical safety checks.

Kamil Rohr, engineer at the Foundation of Cardiac Surgery Development, has been impressed by the reliability and accuracy of the tester. He said: “It provides a higher degree of measurement accuracy than other testers, while the advanced software is impressive, allowing us in particular to plot trends in measurement values.

“It incorporates a good range of features for a tester of its size, while the connectivity benefits are particularly impressive. The ability to create our own test sequences is particularly useful while we find it easy-to-use and appreciate the fact that it’s compact enough to carry around our research facility.

“The multi-lingual functions are also a beneficial feature, while importing and exporting data capabilities is particularly helpful, enabling us to store test information which can then be easily retrieved and used for audit purposes.”

Read the full case study here.

EU move on medical devices’ Directives

The European Parliament has voted on new legislation to replace the current Directives on medical devices and in vitro diagnostic medical devices. The draft text reflects many of the concerns put forward by the European Office on behalf of the NHS and will include the following changes:

• Wider, clearer scope for EU legislation on medical devices – extended to include, for example, implants for aesthetic purposes, and clarified as regards genetic tests
• Stronger supervision of independent assessment bodies by national authorities
• More powers for assessment bodies to ensure thorough testing and regular checks on manufacturers, including unannounced factory inspections
• Clearer rights & responsibilities for manufacturers, importers and distributors, which would also apply to diagnostic services and internet sales
• Extended European database on medical devices – Eudamed will provide comprehensive information on products available on the EU market. Non-confidential data will also be publicly available
• Better traceability of medical devices throughout the supply chain – enabling a swift and effective response to safety problems (e.g. recalls)
• Stricter requirements for clinical evidence to support assessments of medical devices
• Updated classification rules dividing medical devices into four different risk categories and health & safety requirements, including labelling rules – to keep pace with technological and scientific progress
• Better coordination between national surveillance authorities, with the Commission providing scientific, technical and logistic support
• Existing international guidelines to be incorporated into EU law.

The proposals will now have to pass through the EU legislative procedure, with agreement needed between the European Parliament and the Council of Ministers. Once adopted, the new Regulations on medical devices and in vitro diagnostic medical devices will replace the existing medical devices and in vitro diagnostic medical devices Directives. Visit www.nhsconfed.org

Check for your Pulse

Make sure you have your copy of The Pulse, Rigel Medical’s medical industry publication covering infusion device testing and the advantages of using automatic flow analysers. Look out also for the regular section inside where John Backes, associate director, replies to readers’ questions on medical device testing. Download a PDF copy at www.rigelmedical.com/pulse

Do you use Rigel Medical equipment? – If you think you may have a story for future e-news bulletins, please let us know by contacting us here.