This issue covers:
- New FDA test to standardise medical device labels
- Smallest all-in-one vital signs solution leads for Rigel at MEDICA
- China calls for greater use of home grown medical devices
- At the heart of cardiac surgery robot testing
- EU move on medical devices’ Directives
- Check for your Pulse
New FDA test to standardise medical device labels
The US Food and Drug Administration (FDA) plans to study whether it could standardise device labelling with the use of new content and format standards now under development.
At present, there are no regulations defining a standardized approach for how content should be structured or formatted for medical devices. This is considerably different than the requirements for other FDA-regulated products, such as food or pharmaceutical products, which must adhere to strict requirements regarding everything from the font size and required information to layout and required statements.
Now the agency says it wants to move forward with an additional study on standardized device labelling. It plans to compare labelling from six different types of medical devices using two different "standard content and format" labels being developed by FDA researchers.
As with the agency's first study, the new one is to be quite small, with just 38 respondents - all healthcare providers. Of the 38, eight will be hospital-based healthcare providers, while the remaining 30 will be healthcare providers "participating at FDA."
"We will conduct the studies at three different sites including two area hospitals using their devices, existing labelling, and HCPs," the FDA explained in the notice.
"Given a sample of 6 devices with 2 different labelling types, there will be 12 different labelling types to be tested. We plan to have eight people test each type of the labelling. We will also conduct the studies on FDA's campus using medical devices received from medical device industry representatives through a material transfer agreement."
The study is yet another indication that FDA is seriously considering how to standardize device labels, and its second study could mean new standards could be arriving within a few years. More at www.raps.org/
Smallest all-in-one vital signs solution leads for Rigel at MEDICA
The world’s smallest all-in-one vital signs solution will be the highlight of the Rigel Medical display of advanced medical device analysers, electrical safety testers and simulators at this year’s MEDICA (Hall 11 / H11).
Rigel’s hand held vital signs simulator UNISIM - capable of undertaking six synchronised vital signs parameter tests simultaneously - has been linked with the new PULS-R SpO2 simulation finger to provide improved vital signs simulation and measurement.
UNISIM can check NIBP, SpO2, ECG, temperature, IBP and respiration functionality in a single test, while the compact Rigel PULS-R universal SpO2 simulation finger can produce accurate SpO2 simulations in 1% resolution from as low as 30% using the pre-programmed manufacturer specific R-curves. It can also be configured to meet customer specific R-curves via a simple-to-use configuration tool.
Also showing will be the Multi-Flo infusion pump analyser, which leads the way in high and low flow, occlusion, back pressure and bolus measurement and meets the requirements of IEC 60601-2-24.
Featuring variants of one, two and four independent channels, each MULTI-FLO channel can be tested simultaneously across a range of 100 μL (microlitre) to 1,500 mL per hour with results stored in the instrument’s large internal memory. With a sampling rate of 1Hz, the analyser accurately details changes in flow and pressure rates, providing a real-time picture of the quality of infusion.
Associate director John Backes said: "MEDICA is a key show for us and this year we look forward to revealing our world leading, all-in-one vital signs simulator solution, which will undoubtedly draw significant interest because of the rapid and accurate testing it provides."
China calls for greater use of home grown medical devices
Reuters reports that China may use incentives to encourage domestic hospitals to use Chinese-made medical devices as it looks to stimulate the local market and reduce soaring healthcare costs, a potential threat to the global firms who currently dominate the sector.
This will speed up the development of China’s medical device industry and promote wider use of local products to "effectively control unreasonable increases in the cost of medical care and reduce the burden on patients," the country's health ministry said in a statement posted on its website.
The overt backing by Beijing for home grown medical devices will raise protectionism concerns and is a headache for the global firms attracted to China by annual growth rates, which McKinsey & Co expect at around 20 percent over the next few years.
Global medical device makers, especially from the United States, Europe and Japan dominate around three-quarters of China's medical device market, which was worth 212 billion yuan ($34.51 billion) in 2013, according to figures from the Hong Kong Trade and Development Council (HKTDC).
"We want to strongly advocate health ministry organisations to use domestically-made medical devices, especially pushing top level class III hospitals to use domestically-made products," the statement said, citing Li Bin, the head of China's National Health and Family Planning Commission.
Li was speaking at a medical device conference in Beijing to promote the domestic sector, the statement said.
The fast growth of China's medical devices market has drawn in firms including Siemens AG, General Electric Co, Koninklijke Philips NV, Johnson & Johnson and Medtronic Inc who compete with local companies such as Mindray Medical International Ltd and China Resources Wandong Medical Equipment Co Ltd.
Hospitals are the biggest distribution channel for medical devices, accounting for almost 80 percent of the market, according to HKTDC figures. There were around 13,400 public hospitals in China last year, and a further 11,300 private hospitals, according to a June report from Deutsche Bank.
Read in full at www.reuters.com
At the heart of cardiac surgery robot testing
Robin Heart, a ground breaking project in Poland to create a new generation of advanced cardiac surgery robots, uses a 288 electrical safety analyser to improve electrical safety testing during product development.
Instigated by the Professor's Zbigniew Religa Foundation of Cardiac Surgery Development, the project is Europe's first medical robot for cardiac surgery with semi-automatic movements, an advanced human-machine interface and a 3D virtual training system.
Ensuring that all the vital electrical components of the robot system function properly and safely during the various stages of product development is a critical part of this research project that could radically alter the future shape of medical surgery. Testing has to be undertaken in accordance with IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. The components also have to be regularly inspected and tested to make sure they comply with IEC 62353, the standard for in-service and after repair testing of medical electronic devices.
The 288 analyser supplied by Rigel’s distributor in Poland, SAMSO, features multi-lingual menu driven instructions, with download report, for simple operation and test control of all electrical safety tests in manual, semi-automatic or fully automatic test modes. The compact design is beneficial for the technicians involved in the Robin Heart project, providing improved portability and ease-of-use during completion of electrical safety checks.
Kamil Rohr, engineer at the Foundation of Cardiac Surgery Development, has been impressed by the reliability and accuracy of the tester. He said: “It provides a higher degree of measurement accuracy than other testers, while the advanced software is impressive, allowing us in particular to plot trends in measurement values.
“It incorporates a good range of features for a tester of its size, while the connectivity benefits are particularly impressive. The ability to create our own test sequences is particularly useful while we find it easy-to-use and appreciate the fact that it’s compact enough to carry around our research facility.
“The multi-lingual functions are also a beneficial feature, while importing and exporting data capabilities is particularly helpful, enabling us to store test information which can then be easily retrieved and used for audit purposes.”
Read the full case study here.
EU move on medical devices’ Directives
The European Parliament has voted on new legislation to replace the current Directives on medical devices and in vitro diagnostic medical devices. The draft text reflects many of the concerns put forward by the European Office on behalf of the NHS and will include the following changes:
- Wider, clearer scope for EU legislation on medical devices – extended to include, for example, implants for aesthetic purposes, and clarified as regards genetic tests
- Stronger supervision of independent assessment bodies by national authorities
- More powers for assessment bodies to ensure thorough testing and regular checks on manufacturers, including unannounced factory inspections
- Clearer rights & responsibilities for manufacturers, importers and distributors, which would also apply to diagnostic services and internet sales
- Extended European database on medical devices - Eudamed will provide comprehensive information on products available on the EU market. Non-confidential data will also be publicly available
- Better traceability of medical devices throughout the supply chain – enabling a swift and effective response to safety problems (e.g. recalls)
- Stricter requirements for clinical evidence to support assessments of medical devices
- Updated classification rules dividing medical devices into four different risk categories and health & safety requirements, including labelling rules – to keep pace with technological and scientific progress
- Better coordination between national surveillance authorities, with the Commission providing scientific, technical and logistic support
- Existing international guidelines to be incorporated into EU law.
The proposals will now have to pass through the EU legislative procedure, with agreement needed between the European Parliament and the Council of Ministers. Once adopted, the new Regulations on medical devices and in vitro diagnostic medical devices will replace the existing medical devices and in vitro diagnostic medical devices Directives. Visit www.nhsconfed.org
Check for your Pulse
Make sure you have your copy of The Pulse, Rigel Medical’s medical industry publication covering infusion device testing and the advantages of using automatic flow analysers. Look out also for the regular section inside where John Backes, associate director, replies to readers’ questions on medical device testing. Download a PDF copy at www.rigelmedical.com/pulse
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