Medical e-News Round-Up - Issue 17

This issue covers:

Warnings over latest faulty heart defibrillator report

Warnings over faulty heart defibrillators have again highlighted the urgent need for regular testing of in-service health equipment, says Rigel Medical.

Tens of thousands of Automatic External Defibrillators (AED) in public places like shopping centres and airports may not work because of defective components that could unexpectedly fail warns the FDA (Food and Drug Administration, USA) and MHRA (Department of Medicines and Healthcare Products Regulatory Agency, UK).

The defibrillators are used to provide life-saving treatments to people having a cardiac arrest but both FDA and MHRA warn that unexpected component failure including batteries, make them inoperable at times when you most need them.

Indeed the MHRA recently reported that more than 1,300 emergency AEDs in public places like shopping centres may not work because of battery related problems.

John Backes, associate director at Rigel Medical, stresses the need to ensure AEDs are regularly checked and tested as lives could be placed at risk by faulty or failing equipment.

“Many people are under the (false) impression that these automatic defibrillators have an auto test function that can highlight component failures but both FDA and MHRA reports clearly show that this is not always the case.”

“Testing these AED’s is easy, relatively inexpensive yet vital and 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.”

The UNI-PULSE defibrillator analyser, for instance, 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.

Bluetooth and USB has been incorporated for improved connectivity, enhanced memory capacity for the storage of results, defibrillator waveforms and test programmes and a clear, easy-to-read colour graphics display screen. An optional paddle adaptor box includes a version with variable loads from 25 – 200 Ohms for compliance with IEC 60601-2-4 requirements.

Proposed new European medical device regulations

The European directives on medical devices are being overhauled and the European Commission has published its proposals for regulations on medical devices and in vitro diagnostic medical devices.

The proposed regulation includes important new categories of products that are either currently outside the scope of the existing directives or where there is doubt of coverage. These include devices that have been identified by their manufacturers as single-use products that have been reprocessed with a view to being reused in the context of a clinical procedure and replacement parts that significantly alter the characteristics of devices that would be considered devices in their own right and subject to the full CE marking process.

The proposal calls for the formation of a committee called the Medical Device Coordination Group (MDCG), made up of members appointed by the member states and chaired by the EC.

One of the major, and most controversial, roles of this group would be to subject a number of conformity assessment files for innovative, high-risk devices to an additional central scrutiny procedure. Under this procedure, Notified Bodies would be obligated to notify the Commission of applications for conformity assessments of new Class III devices. The Commission would pass details of the new device to the MDCG, which will have 28 days to decide whether or not to request the Notified Body to submit a summary of the preliminary conformity assessment prior to issuing a certificate.

The regulation is now under review by the European Parliament and European Council and it could be two years before a common position is reached. Once the final wording of the regulation is published in the Official Journal of the European Communities, it will enter into force 20 days from publication and come into full effect three years after entry into force.

This means it could be 2017 before medical device companies are required to comply with the new requirements, although there is a provision in the proposal for manufacturers to be able to conform at any time after entry into force. Any prudent company will keep a very close watch on this process and, if necessary, make their views known through their industry associations if they believe that the proposed revision is likely to be more detrimental than beneficial to European citizens.

1. Communication on safe, effective and innovative medical devices and in vitro diagnostic medical devices for the benefit of patients, consumers and healthcare professionals; http://ec.europa.eu/health/medical-devices/files/revision_docs/com_2012_...

2. Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009; http://ec.europa.eu/health/medical-devices/files/revision_docs/proposal_...

3. Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices; http://ec.europa.eu/health/medical-devices/files/revision_docs/proposal_...

MEDRAD benefits from ‘easy-to-use’ 288

One of the world’s leading suppliers of advanced medical devices is using Rigel Medical 288 electrical safety analysers for improved safety testing of contrast injectors used at sites across the UK and Western Europe.

Nine analysers are in use with the MEDRAD team of UK field service engineers with further units deployed across the rest of Western Europe.

Using the 288s provides MEDRAD with a highly cost effective, versatile and portable testing solution, enabling engineers to quickly and accurately undertake more than 1,500 safety tests a year in the UK alone during the routine service and maintenance of MEDRAD’s installed base of contrast injectors.

Adam Reid, the company’s UK service manager, said: “The 288 is an excellent instrument, providing a cost effective, high end testing solution. The engineers find it easy-to-use and appreciate the fact that it’s compact enough to carry around with them.”

New body to improve lab managers’ skills

The new British Laboratory Managers Association (BLMA), launched by the trade association GAMBICA, will enable managers to improve their skills in laboratory management.

Laboratory managers face a blend of technical and people management challenges. Many have climbed the technical ranks and are well positioned to address the technical challenges but need more formal training in management skills, especially when they start managing a laboratory.

The BLMA’s move will not only help to improve managerial skills but will also provide opportunities for managers to share best practice, exchange ideas and build on the experience of others to improve laboratory management skills.

The BLMA is being setup as a separate association within GAMBICA and will be run by and for the people in this industry. Tim Collins, Director - lab technology, GAMBICA Association Ltd said: “An initial launch via a selected number of GAMBICA member clients resulted in an extremely positive response with an inaugural management committee meeting set to formulate the issues and activities the BLMA will look at."

One of these will be an inaugural annual meeting, expected to be in May/June 2013. Other activities could include special interest group meetings as well as a website with a member´s area that would include forums, newsletters and a document depository. Topics covered may include managing laboratories, green laboratories, regulations such as REACH, WEEE and managing waste, HR, health and safety, electronic note books, tendering and purchasing.

If you would like to know more contact Tim Collins at blma@gambica.org.uk

Uni-Therm: The measure of success

Compliant with IEC 60601-2-2*, the Uni-Therm accurately measures the performance of electrosurgical generators including high frequency leakage, high current, power distribution and patient return plate alarm testing.

It’s capable of verifying and calibrating all major electrosurgical generators whilst guiding the user through all test procedures automatically and most of all safe. A high power load bank enables performance testing up to 6A RMS with a duty cycle of up to 100% making the analyser an extremely versatile test instrument for calibrating and performance testing of conventional and high power electrosurgical generators.

The large array of internal resistors, ranging from 0-5100Ω in 5Ω steps provide not only the most accurate and detailed power curves, the Rigel Uni-Therm also advocates safe working practise by providing all necessary resistors within a single enclosure.

Remote electrode monitoring capability is carried out using a rotary encoder, which also controls the potentiometer, scaling up and down in manual or automatic mode to capture the alarm using the on-screen dedicated fast key. Data can be stored onboard for future traceability.

Bluetooth-enabled technology allows wireless connectivity to PCs and other equipment for the fast and convenient downloading of test data and the uploading of the electrosurgical device’s power curves and the manufacturer’s test specific programmes. Output waveforms can be examined through a built-in scope output which allows for easy confirmation of the desired waveform shape.

* IEC 60601-2-2 specifies the requirements for the safety of high frequency surgical equipment and HF surgical accessories used in medical practice.

Take heed: New China circular on foreign medical devices

China’s State Food and Drug Administration (SFDA) has released a new circular to strengthen the supervision and administration of medical devices.

The ‘Circular on Standardising the Labels and Packaging Marks of Foreign Medical Devices’ (guoshiyaojianxie [2012] No.280), is set to regulate the issues concerning the labelling and packaging marks on foreign medical devices, notably technology sold and used within the territory of China.

These will require attached labels and packaging marks featuring text in Chinese - other languages may be added. Any foreign medical devices not featuring attached Chinese labels or packaging marks will be, according to the new regulations, prohibited from being sold or used.

Manufacturers of foreign medical devices must also establish control procedures in their quality control systems to ensure any medical devices sold and used within the territory of China comply with the regulations. They must also formulate relevant documents and effectively implement such documents to ensure the safety and effectiveness of the medical devices sold and used in within the territory of China.

The Circular is scheduled to take effect from April 1, 2013 and more at www.china-briefing.com

Medica 2012

Earlier this month we visited the Medica Tradefair, a leading medical equipment exhibition located in Dusseldorf, Germany. We showcased some of our market defining new products including the MULTI-FLO infusion pump analyser, the UNI-THERM high current electrosurgical analyser and the UNI-PULSE defibrillator analyser.

We would like to make a personal thank you to everyone that attended our stand at Medica 2012, making the exhibition a great success. It was very nice to meet you all and we hope you found out everything that you needed.

If you missed the chance to grab a copy of our FREE Pulse magazine, packed with expert news and advice for the medical industry, whilst you were at Medica don’t worry you can download a pdf version here.

For more information or to request a demonstration/quote on any of our products please visit www.rigelmedical.com/products.

And finally...see you at Arab Health

Arab Health (January 28 -31, 2013, Dubai International Convention & Exhibition Centre, UAE) is the largest healthcare exhibition and medical congress in the Middle East with trade fairs for surgical and hospital equipment - and Rigel Medical will there again, providing advice and support for the industry.

John Backes, associate director – Rigel Medical, says the event is a great opportunity for customers and specifiers to see the company’s products including the new Uni-Therm and Multi-Flo and how these are used as well as meeting the Rigel team. He’s also looking forward to seeing you next year at Wümek – Euritim (May 13-14 Würzburg, Germany) and AAMI (June 1-3, Long Beach, CA, USA).

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