- Clarity for EU medical device regulations moves closer
- Check out the new Rigel Uni-Therm
- New US guidance on home-use medical devices
- Under the microscope
- China´s medical sector on the march
- AED safety and performance critical over next five years, says Rigel
- Join us at Arab Health
An update on the anticipated timetable for the parliamentary vote on the European Commission’s proposal for a revision of the Medical Devices Directive (MDD), submitted last September, has been published by MedTech Europe.
The European Parliament’s Committee for Environment, Public Health and Safety (the ENVI Committee) is charged with considering the revision of the Medical Devices Directive, and its anticipated timeline has become clear over the past month, says MedTech Europe, an alliance of European medical technology industry associations founded by EDMA and Eucomed.
The first exchange of views will take place on February 18 followed by an ENVI workshop on medical devices (February 26). The draft report will then be considered by ENVI on April 24 before members table amendments (May 3) and final voting on the report in July.
The report is slated to be voted on by the full Parliament in a plenary session in September 2013. Details at www.europarl.europa.eu
Advanced verification and calibration of electrosurgical generators is provided by Uni-Therm, the IEC 60601 compliant instrument that accurately measures performance levels including high frequency leakage, high current, power distribution and patient return plate alarm testing.
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.
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.The large array of internal resistors, ranging from 0-5115Ω 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.
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.
Home-use medical device manufacturers should now have a clearer idea of which issues the Food and Drink Administration (FDA) staff will focus on most keenly during registration reviews and audits, says the Emergo Group in its latest regulatory update.
The latest FDA guidance for medical devices highlights risk management processes as particularly important, notably important environmental issues that manufacturers should bear in mind, including:
• Location - do different physical structures affect the device’s intended use?
• Temperature – can the device function during temperature fluctuations?
• Dampness/humidity – how do variable humidity levels impact the device’s functionality?
• Contaminants – how would non-sterile settings impact the device’s functionality?
• Water supply – tap versus distilled • Child proofing - whether or not the device is designed for use by children?
• Travel/international use – how would air travel, security screening technology and voltage rates affect the device?
For devices that use electricity, FDA advises manufacturers to consult ANSI/AAMI/ES 60601-1:2005 on medical electrical equipment safety and performance. Read the full report and find links at www.emergogroup.com
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.
This has improved the testing of hundreds of electrically powered operating microscopes and ophthalmic diagnostic devices which Carl Zeiss supplies and supports throughout the UK to the NHS trusts, private hospitals and high street optometrists.
Using the Rigel 62353 provides a cost effective, versatile and highly portable testing solution, enabling Carl Zeiss 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 62353 is a very good, highly reliable instrument which not only enables us to comply with the European standard but has definitely helped us ensure 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.”
China’s healthcare and medical equipment market is on a growth spurt that has Western OEMs salivating over sales potential and priming the supply chain for profit opportunities in the world´s most populous nation, reports Anna Young writing for EBN (www.ebnonline.com)
However, she cautions that danger looms in the $357 billion market and failure to understand the challenges of China´s evolving healthcare industry could lead to missed opportunities and losses for medical equipment vendors, citing researcher and market consultancy McKinsey.
The firm projects the Chinese healthcare sector will nearly triple in value to $1 trillion by 2020 (from $357 billion in 2011) following demographic changes, increased investment as part of the country´s five year growth plan and the growing impact of the private sector in healthcare delivery.
The prospect of such growth has attracted Western multinationals in droves, but according to McKinsey, an inevitable shakeout in the industry could leave many late starters disappointed.
It is possible many could fail in China reports Young, but the handful that succeed in getting a slice of the market will benefit from a large and fast-growing industry segment.
She sees opportunities for medical equipment manufacturers and concludes that if China delivers on the promise everyone expects in healthcare services and medical equipment, local and Western companies will benefit from the continued opening of its economy.
Safety and performance will remain an important issue for AEDs in the coming years, according to John Backes, associate director – Rigel Medical.
Commenting in US biomed magazine ‘TechNation’, he believes manufacturers have increasingly made AEDs successful and safer to use by people but the challenge going forward will be to make them even more widely available, which will occur when they become more cost effective.
He says: “Although manufacturers provide built-in check procedures, these are not always sufficient to warn the user in advance. Problems with equipment more often than not will only surface when cardio version is required – of course, this is far too late and patients’ lives will be placed at even more risk if equipment doesn’t work.
“No doubt manufacturers will be able to address some of these concerns and perhaps even consider letting their users have remote (wireless) access using public (wifi) hotspots to monitor AED status.
” However, the necessity for testing defibrillators will remain no matter what level of self-testing is incorporated into future defibrillator technology says John, adding that taht the automotive industry is a good analogy because innovation has increased dramatically the reliability of cars.
“Most modern cars are fitted with several self-test and alarm features but this hasn’t eliminated the need for regular check-ups in the garage or by the owners. Wear and tear is difficult to monitor and visual damage always requires human interpretation. It’s the same for AEDs.”
Read John Backes’s interview with the editor at www.1technation.com
Don’t forget to catch Rigel at Arab Health, Dubai, the largest healthcare exhibition and medical congress in the Middle East.
Visit us on stand PZJ23, where our range of advanced medical device performance analysers, electrical safety analysers and vital signs simulators will be on display and where will be providing advice and support for the industry.
Venue: Dubai International Convention & Exhibition Centre, UAE
Date: 28th – 31st January 2013
Stand Number: PZJ23