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Medical e-News Round-Up - Issue 43

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

Defib analyser

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

electrosurgical analyser

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/

IEC 62353 guide


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 http://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.


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