Medical e-News Round-Up – Issue 43

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This issue covers:

FDA: 72,000 cases of defib failure

Automated external defibrillators – those installed and ready for use in many public spaces – can save lives when needed, but the U.S. Food and Drug Administration says that since 2005, it has also received 72,000 reports of the devices failing.

The agency said that, based on these incidents, it will strengthen its approval process for external defibrillators and their accessories, including batteries, pad electrodes, adapters and other items.

Automated external defibrillators are portable devices that automatically detect potentially deadly heart rhythm problems in a patient and deliver an electrical shock to restore normal rhythm.

The devices do “save lives,” Dr. William Maisel, deputy director for science, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in an agency news release.

However, the new changes “will allow us to more closely monitor how they are designed and manufactured,” he said. “This will go a long way towards correcting long-standing problems and ultimately improving the reliability of these devices.”

The FDA said it will also carry out inspections of manufacturers’ facilities prior to approving the defibrillators. After approval, manufacturers will have to file annual reports on each device’s performance and inform the agency about any changes made to the defibrillators that affect safety and effectiveness.

The FDA said that devices currently on the market will remain available while manufacturers work to meet the new requirements for the devices, which take effect in mid-2016. New requirements for current, necessary accessories will take effect January 2020.

More at www.webmd.com

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Rigel 62353 analyser powers NHS equipment supplier

Medstrom, a UK medical equipment and service supplier, has improved the electrical testing of thousands of its medical devices using Rigel’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 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.”

European patent applications in medical technology increase

The European Patent Office has published its annual data, which has revealed that medical device innovators remain at the top of the patent protection rankings.

Dr Thomas Prock, a UK, German and European Patent Attorney at Marks & Clerk, says in his article for EMDT that in 2014, more patent applications were filed for medical technology than for any other type of technology, including digital communication, biotechnology and pharmaceuticals.

Figures show an average increase of about 3% per annum in the number of patent filings relating to medical technology over the past ten years while 41% of the European patent applications filed in 2014 in the medical devices field originated from within Europe. Another 39% originated in the USA.

Given that applicants tend to protect their inventions on their “home turf” before seeking patent protection abroad and Europe is a foreign market for US innovators, this data suggests that US research and development activity in medical technology is more intense than in Europe.

Many medical treatment providers are under pressure to reduce invasiveness of treatments and decrease associated recuperation time. While the factors driving the growth in patent filings will be manifold, this pressure appears to be contributing to a healthy culture of innovation among medical technology providers.

He says that we shouldn’t ignore the increasing consumer demand for medical technology – personal healthcare devices are now a source of revenue for many high-tech companies, requiring research and development, leading to patent filings.

As the demands of both consumer and healthcare systems grow, so will the R&D programs developing technology to meet those demands, and the numbers of patent applications flowing from them. Read in full at www.emdt.co.uk

IEC 62353 Guidance Booklet

The new edition of the IEC 62353 standard, which applies to ‘Medical electrical equipment – Recurrent test and test after repair of medical electrical equipment’, 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.

It also provides details of the tests that should be performed under these circumstances and discusses the reporting of the results of your testing 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 organisational equipment users.

To help, Rigel has published an IEC 62353 (2015) Guidance Booklet which is available at www.rigelmedical.com/

UAE medical appliances’ growth

A Dubai Chamber of Commerce and Industry study indicates that expenditure on medical appliances and equipment in the UAE has experienced a strong increase, valuing the market at around AED 2.87 billion in 2014.

It is also forecasted to increase at a Compound Annual Growth Rate (CAGR) of about 9.78% from 2014 to 2020 as, by then, the value of expenditure will increase to around AED 5.03 billion.

This increase, the study adds, has come in light of the growth in income and population, together with increased awareness about the importance of healthy living across the MENA region and South and East Asia.

This has created demand for medical services and generated potentially lucrative opportunities for Dubai to become the hub for medical tourism for these regions.

The study, which is based on a BMI Espicom Business Intelligence report titled ‘UAE Medical devices report Q4 2014’, discusses opportunities and ways for UAE businesses to benefit from growing demand for medical devices in the UAE and in foreign markets.

It also states that traders in this area can expect potentially robust growth in a range of products within the UAE and across the surrounding regions. More at www.dubaichamber.com/

See us during 2015…

A reminder that you can meet us at several events this year. On April 30th we’ll be at the EBME 2015 Seminar in Milton Keynes, UK. Summer will see us at June’s AAMI Conference & Expo 2015 in the USA, and then in the autumn at the MD Expo, Las Vegas (21 – 23 October). The last event of the year will be MEDICA, the world leading medical trade fair, from the 16 – 19 November. Full details at https://www.rigelmedical.com/events

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.

Medical e-News Round-Up – Issue 42

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This issue covers:

India’s new medical device regulations

A proposed draft of new legislation for medical devices has been released by India’s Health Ministry, according to the website, India Briefing.

The Drugs and Cosmetics (Amendment) Bill is expected to be submitted to the country’s parliament later this year, and would make India’s regulations the same as the European Medical Device Directives.

According to the article…”the new legislation would simplify import procedures and affect change across many areas including: manufacturing, sales, distribution and clinical trial of medical devices.”

It will also establish a Medical Devices Technical Advisory Board. Full details here.

288 success at Hitachi

Leading healthcare equipment manufacturer Hitachi Medical Systems UK Ltd uses 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.

The Rigel 288 enables engineers to quickly check the safety of around 500 scanners while they are in use to ensure compliance with the recurrent and post repair test requirements of the new IEC 62353 standard for medical devices.

Bluetooth technology enables Hitachi’s engineers to carry out cable-free data transfer and safety labelling, without the cumbersome plugging and unplugging of leads and cords.

Wellingborough-based Hitachi Medical Systems is part of the Hitachi Group that designs, manufactures and supplies advanced medical equipment and solutions to healthcare markets worldwide. Roy Cartwright, Hitachi’s technical support manager, 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 makes the job of electrical safety testing a whole lot easier.”

Global refurbished medical equipment market to hit more than $9 billion by 2019

The global refurbished medical equipment market is expected to grow at a compound annual growth rate (CAGR) of 12.5 percent and reach $9.37 billion by 2019, according to a new MarketsandMarkets report.

The market includes operating room, medical imaging, cardiology, intravenous therapy systems, endoscopy equipment, patient monitors, defibrillators, intravenous therapy systems, intensive care and neonatal intensive care units, blanket warmers, autoclaves, suction pumps, sequential compressor devices, stretchers, cath labs, stress test systems, heaters/coolers, dry imagers and beds.

Financial challenges are increasing the global interest in low-cost refurbished medical equipment and growing privatization in the health care sector is also driving the market. But at the same time, the market is restricted by the lack of standard policies for the sale and use of refurbished medical equipment and a public institutional stance against purchasing the equipment.

In 2014, North America made up most of the global market, followed by Europe, but the Asia-Pacific region is projected to gain momentum and grow at a CAGR of 13.7 percent from 2014 to 2019. That is being driven by privatization, reduced reimbursement rates, a growing population base and an increase in low budget hospitals and clinics.

The emerging markets, including India, Brazil, and Mexico hold great potential for refurbished medical equipment companies. Medical tourism is growing in those regions and there is also an increase in the population bases and privatization.

As of 2014, the global refurbished medical equipment market was dominated by GE Healthcare (UK), Philips Healthcare (Netherlands), and Siemens Healthcare (Germany), which together accounted for about 41% of the market. www.dotmed.com/

Total capability at EBME

Rigel Medical will be showcasing its advanced range of electrical safety analysers and vital signs simulators, which provide accurate solutions for testing medical devices and equipment, at EBME (30th April 2015) in Milton Keynes.

Event details at www.rigelmedical.com/events

New technologies will cut healthcare costs

In a report issued by market research firm IBISWorld, industry analyst Sarah Turk predicts that burgeoning digital technologies will pay substantial dividends for healthcare by 2020, both reducing healthcare costs and improving access to care.

She focuses on three key modalities in her report: telehealth, mobile health (mHealth), and interoperability.

Telehealth technology may help “mitigate the burden of the projected shortage of 20,400 primary care physicians by 2020,” Turk says. She notes that while many healthcare providers already engage in telehealth, the technology’s potential “has yet to be fully harnessed”.

Similarly, she says, mHealth—the “use of mobile applications and devices to exchange medical information, data or to provide clinical services”—will also transform healthcare information technology. Combined with the rise of telehealth, mHealth will move healthcare away “from relying on inpatient care and … toward outpatient, namely in-home, patient-monitoring services.”

However, for these advances to occur, the healthcare industry must overcome the challenge of interoperability. Due to the lack of “interoperability standards for medical equipment and related software,” Turk says, “the implementation of new technology may pose … an arduous task for healthcare providers.”

More at www.ibisworld.com

Check your Pulse

Finally, make sure you collect your copy of the latest edition of The Pulse, Rigel Medical’s medical industry publication. We look at the new edition of IEC 62353 which applies to ‘Medical electrical equipment – recurrent test and test after repair of medical electrical equipment’ and answer some of your questions in our regular ‘Question Time’ slot.

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.

Medical e-News Round-Up – Issue 41

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This issue covers:

Medical Device Tax facing the axe

The U.S. medical device tax is the issue that won’t go away. Elected officials and medical device companies began railing against Obamacare’s medical device tax before it even became law and have complained about it ever since it did.

Now with a Republican majority in Congress and bipartisan support from legislators in states that host major medtech firms, it appears the 2.3% tax may be axed from the Affordable Care Act by the end of March, according to a report in the political news website thehill.com.

Paulsen and Rep. Ron Kind (D-WI) said they expected lawmakers to replace the money lost in a repeal, the Hill report said.

Senator Orrin Hatch (R-UT), who last April called the levy a “stupid, dumbass tax,” does not believe a “pay-for” will be necessary to get Paulsen’s bill passed. The incoming chair of the Senate Finance Committee, Hatch proposed his own repeal bill last year.

Sens. Al Franken and Amy Klobuchar (D-MN.) have also long opposed the tax, and medtech companies have paid lobbyists significant sums of cash to pressure Congress to repeal it.

More at www.qmed.com/news

Passing the test in Tel Aviv

One of the largest hospitals in Israel uses Rigel Medical’s range of testers and analysers to improve the testing and calibration of biomedical devices.

The move allows The Herzliya Medical Center (HMC) to simplify testing procedures as part of an in-service planned preventative maintenance programme overseen by its Biomedical Department.

This has seen improvements in the speed and ease by which electrosurgical units (ESU), vital signs monitors, infusion devices and defibrillators among other items of medical equipment are maintained and checked for electrical safety and performance accuracy.

The Rigel 288 automated safety analyser, Uni-Therm electrosurgical generator calibrator, Uni-Pulse defibrillator analyser, Multi-Flo infusion pump analyser and Uni-Sim combination vital sign simulator are among the Rigel Medical products the hospital’s uses for compliance with standards including IEC 62353 IEC/EN60601-1, VDE 0751-1, AS/NZS 3551, AAMI, NFPA-99, MDA DB 9801-2006.

Director of the Biomedical Department and engineer Tamim Jaber said that turning to Rigel Medical met the HMC’s ‘real life biomedical’ requirements, providing the first opportunity to bring all aspects of biomedical testing within a single software solution (Rigel’s Med-eBase) and to generate reports and certificates for all devices under test.

France medical devices market worth over $20 billion by 2020, says report

A new report estimates that the size of France’s medical devices market is expected to reach approximately $20.8 billion by 2020.

The ‘CountryFocus: Healthcare, Regulatory and Reimbursement Landscape – France’ report identifies the trends in the healthcare market and provides insights among other matters on the demographic and regulatory landscape, and healthcare infrastructure of France.

It has been prepared using data and information sourced from proprietary databases, secondary research and an in-house analysis by GlobalData.

The positive trends in the country’s healthcare market can be attributed primarily to an increasingly elderly population, universal healthcare insurance, and a high degree of access to healthcare facilities.

In 2012, France’s population was approximately 65 million, but the growth rate is decreasing steadily – possibly due to a negative balance between the mortality and birth rates, and a low net rate of immigration. Domestic policymakers are also wrestling with the problems of a Eurozone crisis, a declining working population and an increasing elderly population.

The scope of the report includes an overview of France’s medical devices market, including the market size, market segmentation, key drivers and barriers. Analysis includes details of the regulatory agencies and the approval processes for new medical devices while there’s an overview of the opportunities and challenges for growth that exist in the healthcare market. More at www.cnbc.com

Search for pioneering healthcare innovators

Sir Bruce Keogh, NHS England’s Medical Director, has launched the NHS Innovation Accelerator programme.

Together with hosts UCLPartners and The Health Foundation, NHS England is inviting healthcare pioneers from around the world to apply to develop their tried and tested innovations across parts of the NHS.

The programme will focus on the conditions and cultural change needed to enable the NHS to adopt innovations at scale and pace, aiming to improve outcomes and give patients more equitable access to the latest products, services and technology.

Applicants should be experienced innovators in healthcare who are currently leading or working on new technologies, services and processes that have the potential to make a real difference to patient outcomes.

The programme will offer successful candidates a range of support to develop and spread their innovations across parts of the NHS, such as access to international leaders in healthcare development and established networks through high calibre mentors including Lord Ajay Kakkar, Lord Ara Darzi, Sir John Tooke and Sir Sam Everington.

Sir Bruce Keogh, NHS England’s Medical Director, said: “Britain has made a significant contribution to medical science and humankind.

“The Innovation Accelerator will build on our enviable history of discovery and innovation by embracing cutting-edge healthcare innovators from around the world to improve patient care while reducing costs and providing better value for the taxpayer.”

Details at www.england.nhs.uk

Improved safety analyser makes for faster testing

The improved battery powered 288 analyser from Rigel Medical delivers faster and safer testing of medical devices and installed equipment.

The 288 is one of the most recognised electrical safety analysers on the market today, renowned as the smallest, most compact tester of its type in the world. It incorporates unique technologies and features to provide enhanced performance and improved electrical safety testing of equipment to the appropriate standards including IEC/EN 62353 and IEC/EN 60601.

While most conventional testers rely on mains power, the improved battery powered 288 retains operational integrity, even without mains connection, due to standard AA battery power compatibility. This provides greater user flexibility and makes it quicker to complete in-service testing of point-to-point leakage as well as earth continuity and insulation resistance.

And because the 288 does not require a lengthy power cord to operate, there are no trailing cables to cause potential trip hazards, making it even safer and more convenient to set-up and use on-site. Further time saving benefits are achieved because the analyser’s battery power back-up avoids the need for lengthy boot-up times between tests.

Up to 10 individual patient leakage circuits can be checked in a single test routine, while a further benefit is the ability to automatically warn users of incorrect test set-ups, helping to avoid incorrect readings – it is the only tester of its type providing automated verification of secondary earth paths and incoming mains configuration.

The 288 forms part of a comprehensive range of high performance biomedical test equipment supplied by Rigel Medical. You can find out more at www.rigelmedical.com/288

Watch out for us in 2015

Don’t forget you can catch Rigel at several events this year. March (29 – 31) will see us at MD Expo Nashville before returning to Europe for the EBME seminar (30 April 2015) in Milton Keynes, UK.

Summer will see us at June’s AAMI Conference & Expo (5 – 8 June 2015) in the USA, and then in the autumn at the MD Expo, Las Vegas (21 – 23 October).

The last event of the year will be MEDICA, the world leading medical trade fair, from the 16 – 19 November. Full details at www.rigelmedical.com/events

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.