Medical e-News Round-Up - Issue 7

This issue covers:

Arab Health success 

Rigel Medical has had a successful Arab Health 2012 Show as it continues to build market share across the Middle East - the new UNI-PULSE defibrillator analyser launched at the show in particular caught the eye of stand visitors.

The compact, lightweight and portable Rigel UNI-PULSE is able to test the correct performance of all mono and biphasic defibrillators and boasts a large colour display able to show all measured values as well as a real time energy discharge curve.

The new MULTI-FLO infusion pump analyser, available next year and meeting the need for high and low flow, occlusion, back pressure and bolus measurement, also garnered considerable interest from stand visitors.

Divisional manager John Backes explained to stand visitors that the new brand positioning, built around customer input in the development of test equipment, will continue to underpin Rigel’s marketing push throughout all the territories in which it operates.

European e-labelling 

Manufacturers will have the option to implement e-labelling for medical devices in the near future once the final wording of draft regulations gets the stamp of approval.

This March will see the publication of the EU Council and European Parliament regulation on the use of e-labelling - or electronic instructions for use (IFU) as it is sometimes called.

The scope of the regulation means that only devices for professional users will be able to use e-labelling and is applicable to Medical Devices Directive 93/42/EEC (as amended by 207/47/EC) and Active Implantable Medical Devices Directive 90/385/EEC.

This will include standalone software, devices and accessories with a built-in system displaying IFUs, fixed installed medical devices and accessories and active implantable devices. The use and provision of e-labelling will remain at the discretion of the manufacturer and will not be mandatory for all medical devices.

Full details at www.standards.org

EU advises over medical device vigilance 

The vigilance system for medical devices must be further developed in order to allow a coordinated analysis and a coherent EU-wide response to safety issues.

That’s one of the findings noted in the Council of the European Union conclusion on innovation in the medical device sector.

The Council also says it is desirable to consider a European coordination mechanism founded on a clear legal basis and mandate in order to ensure efficient and effective coordination between national authorities while creating a level playing field.

Synergies with existing bodies with relevant expertise should also be explored when deciding on the mechanisms for such coordination. Consideration should also be given to which activities are best carried out in cooperation between member states. Read the full conclusion at www.eur-lex.europa.eu

Rigel 288 passes hospital safety test

Glan Clwyd Hospital, in North Wales, has cut the time taken to test the electrical safety of thousands of medical devices using Rigel Medical 288 electrical safety analysers.

Using the testers has enabled the 14-strong team of service engineers to reduce the time taken to check medical devices in use at Glan Clwyd and other sites the hospital supports are working correctly.

This has led to an improvement in the use of resources as the engineers can complete more tests in less time, delivering cost saving benefits for the local NHS Trust.

Additional time saving benefits are provided because the information captured by the 288 can be quickly and easily downloaded via Bluetooth technology to a central computer database, which stores the test history of every medical device in use.

Head of Electro Biomedical Engineering at Glan Clwyd Hospital is Alun Griffiths, who said: “The 288 is a very good instrument and has been a huge improvement on the previous testers.

“The engineers, who are very happy with the 288s, find them extremely easy to use and really appreciate the fact that they’re compact enough to carry around with them.

“Another great advantage we’ve found is that we can pick and choose the test for each device. This has speeded up procedures and contributed to the increased number of tests now be completed daily.”

The Rigel 288 incorporates easy-to-follow menu driven instructions for simple operation and test control of all IEC62353 required electrical safety tests in manual, semi automatic or fully automatic test modes.

Growth ‘threatened’?

It says biomedical CEOs in California continue to see a burdensome FDA regulatory environment as a major hindrance to the industry's growth, according to preliminary results of a survey conducted by the California Healthcare Institute, BayBio and PwC.

In a preview of a broader survey to be released in February, 8 in 10 CEOs said that the current FDA regulatory approval process "has slowed the growth of their organization" and is among one of the biggest threats to the growth of the med-tech sector in the U.S. The preliminary results were released at the JP Morgan Healthcare conference in San Francisco.

US leadership in the biomedical world was in jeopardy due to the cumbersome FDA process and that within five years, felt the CEOs, and "another country could conceivably recreate the ecosystem that has made the U.S. the leading biomedical region in the world," a prepared release described.

Further US moves

Keeping up with the trends - from design to testing - is important to all those involved in the electrical medical devices industry. So find out what’s new by visiting the Medical Design & Manufacturing West conference taking place later this month in Anaheim, California.

The annual event (February 14-16, 2012) brings professionals from all areas of the medical device development industry together to share knowledge concerning new industry developments, and provide access to the tools necessary to bring new medical devices to market. More at www.canontradeshows.com

And finally...EN 60601

On June 1 all applicable devices placed on the EU market must comply with the 3rd edition series of EN 60601, which is used to demonstrate basic safety and essential performance of medical electrical equipment. This applies to all devices that use EN 60601 and not just devices that are new to market after June 1. For example, the same device sold in the EU before June 1 in compliance with the older EN 60601 2nd edition series will need to conform on June 1 to the 3rd edition series. More detail in the next e-news and also at www.standards.org

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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