Medical e-News Round-Up - Issue 12

This issue covers:

New in service defibrillator tester

The compact, lightweight and portable Rigel Medical Uni-Pulse defibrillator analyser enables biomed technicians and engineers to quickly verify the safe operation and functionality of defibrillators and AEDs (automated external defibrillator).

Featuring 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.

The colour LCD provides easy navigation around the functions and simulations including defibrillator waveform capture, accurate energy measurements, cardio synch times, peak voltage and current.

A 12-lead ECG simulation with substantial variation of atrial and ventricular arrhythmias and performance wave forms provides faster, easier and more accurate testing of defibrillators with built-in monitoring functions. Automatic test programs for AEDs leads to fast and effective testing of AED response, interpretation and performance.

Uni-Pulse can also be used with Rigel Medical’s Med-eBase PC software to provide enhanced electronic recording and management of medical device safety testing programmes. More at www.rigelmedical.com

Asia healthcare moves

India’s Working Group on Health Research (WGHR), appointed by the country’s Planning Commission, is proposing a Medical Technology Development Board to promote the activities of local medical device manufacturers.

According to some experts, 85% of medical devices used in India are imported so the working group has proposed establishing initiatives to promote the development of indigenous products, mirroring outreach efforts implemented by the Department of Science and Technology and the Council of Scientific and Industrial Research.

The move comes at a time when patents for billions of dollars worth of drugs and medical equipment and devices are expected to expire during the next five years, giving the domestic industry a good opportunity for growth. More at http://www.india.medtechinsider.com

China: The Jiangsu Province Medical Device Testing Center has been certified for five years to conduct conformity testing on electrical equipment and more than 150 other medical device products while the Anhui Medical Device Testing Center has also been approved to undertake conformity testing on over 140 pieces of healthcare equipment. To read RegLink Associates’ latest ‘Global Medical device Update’ click here.

IEC 62304: medical device standard?

Properly applying the IEC 62304 standard to medical development and integrating third-party software will pay long term dividends, according to Anil Kumar and Mark Pitchford writing in ‘Medical Electronics Design’ on easing the certification for medical devices.

They report that for many years, the medical device industry has operated without a consistent and internationally recognised regulatory process. In the U.S., companies have needed compliance to FDA guidelines, which some have lambasted for unnecessary delay while others complain about its lack of rigor.

Others heartily approve of the FDA, but argue for government legislation that gives the FDA more power to hold company executives responsible when they don’t follow the FDA guidelines with due diligence.

In Europe, government approval of a medical device is through its corresponding Competent Authority (CA). Although this process is said to be more rigorous than the U.S. guidelines, companies can typically get their products to market faster in Europe - something Kumar and Pitchford claim galls American-based businesses.

With the ratification and update of IEC 62304, a standard for design of medical products recently endorsed by both the European Union and the U.S., medical developers throughout the world are asking if this could form the foundations of a medical device standard which enables all countries to follow good practice and to produce high-quality software for the medical community. To find out more click here.

Rigel at leading primary care supplier 

Williams Medical Supplies (WMS), the UK’s leading provider of medical supplies and services to primary care, has drastically cut the time taken to test the safety of hundreds of ECG machines by using Rigel Medical 288 electrical safety analysers.

Using the Rigel 288 has enabled the 18-strong team of technicians to save, on average, 25 minutes when testing the electrical safety of ECG machines. Using the previous testers, it used to take 30 minutes to complete a test but this can now be achieved in five minutes – an 80% time saving.

Technicians undertake test and calibration services in over 2,500 GP premises in the UK and use the Rigel 288 at many of these sites. Hugh Hamer, head of medical services at WMS, estimates that they are operating 15% more efficiently when it comes to testing all types of medical equipment thanks to the portability and time saving benefits of the 288.

He added: “The 288 is an excellent test instrument. The technicians find them easy-to-use and appreciate the fact that they’re compact enough to carry around with them.

“Rigel provides excellent after sales support, which is another important reason why we use their products. Product training has been very good while they have been very responsive to our needs over the past few years.”

The Rigel 288 incorporates easy-to-follow menu driven instructions for simple operation and test control of all IEC 62353 required electrical safety tests in manual, semi automatic or fully automatic test modes.

Five years of IEC 62353

Over the decades, improvements in occupational health and safety have come on in leaps and bounds as the level of injury, or even death, caused by hazards in our community or workplace have fallen in most developed countries to record low levels.

However, better safety has come at a price. For instance, fallout from previous incidents and increasing moves toward a litigation culture have added to both the personal and financial costs associated with progress, while safety and well-being are often taken for granted.

On the health care front, things have also progressed, with medical procedures more successful, effective, safer, and predictable than ever before. In the future, matters will continue to improve as we look forward to even better and more efficient health care systems.

Telemedicine and home treatment are becoming increasingly common in today's health care landscape as we see medical procedures simplified, reducing recovery times and ultimately benefiting the patient and society in return.

And so it goes for medical devices - to make medical diagnoses and treatment more effective, manufacturers are continually developing more sophisticated and sensitive medical devices. To find out more by reading ‘24x7’ magazine’s informative article on IEC 62353 click here, this looks at the standard for assessing the electrical safety of medical devices five years after its introduction.

Pulse reading

Make sure you catch our brand new newsletter ‘Pulse’ at www.rigelmedical.com where you’ll find plenty to interest including the latest industry and product news. In the first issue we answer some of your questions in our ‘Questions Time’ section and explain how customers benefit from our products. There’s also a chance to win an Amazon Kindle Touch if you send in your questions by the end of July.

Another addition to our expanding literature portfolio is the new vital signs booklet, an ‘Introduction to measuring and simulating vital signs’. Easy to read and fully illustrative, this helps people understand more about what’s involved and covers the performance tests that are typically executed using calibrated simulators across a number of applications and are all part of an acceptance test, preventative maintenance cycle or repair.

For a pdf or hard copy of the booklet, register online by clicking here. You can also telephone +44 (0)191 587 8730 for a free copy.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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