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Medical e-News Round-Up - Issue 27

This issue covers:

New EU medical device approval move

The European Parliament approved the control on medical devices via strengthened traceability rules and transparency of information for patients and medical staff, but without creating additional burdens for small manufacturers.

MEPs proposed to give patients and health professionals improved access to clinical data and that only a permanent team of in-house experts can give 'CE' proof of conformity marks to medical devices and that the traceability of reprocessed devices should be improved.

The strengthening of the EU rules on medical devices follows a series of health scandals, including the fraudulent use of silicone in breast implants; the so-called PIP scandal. The industry has said for a long time that changing the approval system would create unnecessary burdens and potentially kill off many European small and medium-sized enterprises (SMEs).

Holger Krahmer, a German MEP from the Alliance of Liberals and Democrats for Europe (ALDE), said that his party had improved the committee text for an efficient authorisation system which ensures the highest patient safety and at the same time strengthens the capacity for innovation of the European medical technology sector.

Serge Bernasconi, chief executive of the European medical device industry association, said that the industry had witnessed "positive developments" in the Parliament between the committee phase and the plenary vote.

"We congratulate the Parliament in finding more clarity and positive approaches in important areas supporting safety of patients and innovation for patients in what has been a very complex and highly technical dossier. We are looking forward to seeing continued evolution on a future strengthened EU framework for medical devices,” Bernasconi added.

In a separate legislation on in-vitro medical devices, such as diabetes self-tests, HIV and DNA tests, the Parliament called for an ethics committee to be set up and introduced provisions for the informed consent of patients and genetic counselling. Read in full at http://www.euractiv.com/

Arabian nights

As the Middle East biomed market continues to prosper you can see the latest in advanced performance analysers, electrical safety analysers and vital signs simulators on the Rigel Medical stand Z1G12 at the popular Arab Health Exhibition & Congress (Jan 27 – 30).

The infusion pump analyser MULTI-FLO will headline Rigel’s show at the Dubai Trade Center event. Meeting all the requirements of IEC 60601-2-24, the analyser leads the way in high and low flow, occlusion, back pressure and bolus measurement and features variants of one, two and four independent channels.

Also on display will be UNI-THERM, the easiest way to test all leading electrosurgical devices, providing accurate results as it quickly and automatically guides the user through test procedures. A key feature is the automated activation of the ESU pedal or hand switch from coag to cut, without the need to manually change resistors to simulate different tissue types, while contact quality monitoring (CQM) analysis, high current power measurement and HF leakage are also beneficial.

Associate director John Backes said: “We are committed to investing in high performance products to provide customers with what they want. I’m sure the many features and benefits of all our products will generate significant interest among visitors to the show.”

Make an appointment with the Rigel team at http://www.rigelmedical.com/events/.

Under the microscope

Global market leader in precision optics and engineering technology Carl Zeiss Ltd is using the Rigel Medical 62353 medical safety analyser to comply with IEC 62353, the standard for in-service and after repair testing of medical electronic devices.

Improvements in the testing of hundreds of electrically powered operating microscopes and ophthalmic diagnostic devices have followed Carl Zeiss’ decision to go with Rigel Medical testers.

The company, which supplies and supports technology throughout the UK to the NHS trusts, private hospitals and high street optometrists, uses the 62353 as a cost effective, versatile and highly portable testing solution. This enables service engineers to quickly and accurately check the safety of upwards of 300 different Zeiss products per week at dozens of locations throughout the UK.

Roy Scales, service manager at Carl Zeiss, said: “The Rigel Medical 62353 is a good, reliable instrument which not only enables us to comply with the European standard but ensures our products are safe to use.

“It’s intuitive, easy-to-use and compactness is appreciated by our engineers. It also incorporates a good range of features for a tester of its size, while the connectivity benefits are particularly impressive.”

App for Africa

An interesting new telemedical app has been launched in Africa, allowing patient details to be captured accurately, medical equipment to be correctly set-up and standard medical tests to be undertaken.

The new app allows patient records to be created and personal and medical history captured or edited before medical examination begins for vital signs monitoring and ECG among other tests.

Qualified nurses are being equipped with Samsung GALAXY Tablets pre-loaded with the app which has been developed to guide the user through the necessary processes to ensure that all the relevant information is systematically captured, reducing the chances of human error.

Mike van Lier at Samsung Electronics South Africa said: “It’s all about providing the correct diagnosis as quickly as possible – early detection or treatment could mean the difference between life and death.

“The app prompts the nurse to undertake the correct tests in a standardised manner and through technology; healthcare can now become more accessible and really make a difference to people living in rural areas.”

The availability marks phase I of the app which will be developed and refined further in the coming months - as requests are received for additional services or tests, not to mention the information provided in numerous languages, the app will be customised accordingly.

Full details about this technology at http://www.samsung.com/za/news

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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