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Medical e-News Round-Up - Issue 52


This issue covers:

India looks to reduce dependency on imported medical devices

In India, the Andhra Pradesh government has announced proposals for a dedicated industrial park for the manufacture of medical devices in the state.

The decision to set up a medical devices park in a 200 acre area was taken jointly by state and central government officials with the Association of Indian Medical Device Manufacturers (AIMED).

The park will have a common manufacturing centre acting as a hub for SMEs and will create an ecosystem for high-end medical device manufacturing aimed at import substitution as well as export opportunities, according to the industry body.

It is estimated that the value of medical device imports into India is around $4 billion and the country has an 80% dependency on imported high-end medical devices.

The centre was working towards addressing the issue of inverted duty structure, which is stunting the growth of the medical devices industry and also provide preferential market access to boost domestic manufacturing, according to the industry body. Full story here

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Ventilator product recall

Reports in the USA say eVent Medical is recalling the LS, 5i and 7i Inspiration Ventilators because of a faulty switch on the ventilator's power board that may fail, causing the device to shut down without sounding an alarm, according to the FDA's latest safety alert.

The recalled devices are all models of the ventilators manufactured prior to Jan. 21, 2015 equalling to 6,441 units around the world, including 251 distributed in the U.S.

"If the ventilator shuts down, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death," the FDA said in the alert.

The agency said CA's eVent Medical received one report of the issue occurring, though there were no deaths or injuries. Details of the recall notice are here

Specialist electro medical equipment services from Calibrationhouse

The expanded Calibrationhouse now has the capability to provide full calibration, repair and service for all types of electro medical test equipment including oscilloscopes, diathermy testers, defibrillator testers, infusion device analysers, occlusion testers, NIBP and other types of patient simulators.

In addition, in compliance with IEC 60318 and BS EN 60645, Calibrationhouse has the ability to undertake the specialist calibration and servicing of dedicated audiology equipment including audiometers, sound calibrators and acoustic ear instrumentation.

Calibrationhouse is accredited to ISO9001:2008 and ISO17025:2005 with service, calibration and repairs of all types of electronic equipment being undertaken with assured traceability to national UKAS standards.

This service is provided both at the company’s advanced technology workshops and also via a specialist on-site calibration service enabling work to be carried out on customer premises to minimise downtime for vital equipment.

Specialist calibration, service and repair expertise is provided by Calibrationhouse to a range of NHS trusts and private healthcare providers for medical test equipment brands such as; Rigel, Fluke Biomedical, Bio Tek, DNI Nevada, Datrend, Metron and others.

Further details on Calibrationhouse on 0191 587 8736, via or at www.calibrationhouse.com

Infusion pump analyser

Market predictions for European MedTech sector

An interesting article on the online news site EMDT (www.emdt.co.uk) includes a number of market predictions for the European MedTech sector.

Overall the report forecasts that the medical device market in Western Europe will remain constrained by weakness in the Eurozone, which is struggling to recover momentum. It follows, therefore, that non Eurozone markets will record higher 2014-2019 CAGRs, led by the UK.

The analysis also says that Western European markets will remain highly import dependent, in spite of increasing exports, but will lose market share in global trade, reflecting a shift in manufacturing to lower cost production bases in Eastern Europe and Asia.

Overall the report anticipates that Western Europe will continue to account for around 40% of global medical device imports over the next five years, which is a market share similar to that recorded in 2014, but is lower that 45% registered in 2009. Germany, the Netherlands, Belgium, France and the UK will continue to be the leading importers. The full article is available here

Rigel at Arab Health show

Don’t forget you can see the latest biomedical test products from Rigel at the Arab Health show (stand MD33) on January 25-28th. On display will be new safety testing technology for both general purpose medical equipment and specialist medical devices.

Rigel’s latest new product is the SafeTest 60, an entry level safety analyser which has been purposefully designed for more basic and general purpose medical equipment testing where simplicity of testing is of the essence.

vThe new SafeTest 60 tests in accordance with IEC 60601, 62353 and 61010 including equipment, earth and touch leakage as well as insulation and earth bond testing and is suitable for the safety testing of a wide range of equipment used in hospitals and healthcare facilities such as, electronic beds and hoists, as well as infusion pumps, CPAPs and centrifuges.

Also on display for the first time will be Rigel’s new ‘Plus’ range of testers. This new introduction sees the well-established Rigel 288 and 62353 safety testers being relaunched as the 288+ and 62353+ models, incorporating special battery-powered leakage tests to enable testing to the full range of international standards to be carried out without compromise on portability or speed of testing.

John Backes of Rigel said: “Arab Health is a key show and this year we look forward to using it as the perfect platform to launch our world leading, all-in-one vital signs simulator solution to the important Middle East market.”


Christmas opening times

We would like to make you aware as early as possible about our reduced working hours over December and January.

Seaward Group’s Christmas party is taking place today, 18th of December. Staff will only be available until approximately 12pm. Seaward officially break up for Christmas at 12:30pm on Thursday, 24th of December, and do not return until Monday, 4th of January at 8:30am.

Season's Greetings to everyone.

Vital Signs Booklet


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