- Balancing medical devices’ innovation and safety
- Improved testing at medical devices company
- Opportunities abound in Brazil’s medical device market - but expect delays
- What’s On?
- Double your infusion pump test capacity - watch the video now
Revised legislation which creates the right conditions for safe and innovative medical devices is essential says Neven Mimica, EU Commissioner for Consumer Policy, who spoke recently in Brussels about the Commission's proposed revisions to legislation on medical devices and in-vitro diagnostic medical devices.
According to the Commissioner, the proposed revisions succeed in striking the delicate balance between encouraging innovation and protecting patient safety. He noted: “Our ambition is to establish a framework... that is flexible enough to reap the benefits that innovation can bring to patients and for the competiveness of the industry.”
Europe will face major challenges to its healthcare systems in coming years. Across the EU, the population is ageing - it is estimated that, in 2060, there will be twice as many Europeans aged 65 or over as there are now. This demographic change increases the prevalence of chronic disease and puts intense pressure on healthcare budgets.
On the other hand, innovation in medical devices has gained pace in recent years. The move towards remote diagnoses is just one example of the tech revolution sweeping our healthcare services.
Although increasingly innovative medical devices have the potential to allow for early disease diagnosis and treatment, keep us healthier for longer and shift care from hospital to home, they bring with them concerns for patient safety. Such anxieties are particularly felt in light of scandals in recent years regarding defective medical products.
In April 2014, the European Parliament confirmed its proposed amendments to the Commission's proposed text. However, Member States continue to consider their position on the proposals despite many days of meetings.
The Commissioner underlined how eager he is to see movement on the issue - the proposals are now almost two-years old: “Further delays would be prejudicial not only to patient safety but also to innovation. Swift access to innovative and life-saving technology is an important aspect of public health...An uncertain and unpredictable framework does not create a favourable environment for the businesses and the investors.”
More at http://ec.europa.eu/health
BCAS Bio-medical Services Ltd (BCAS Biomed), one of the UK’s leading independent medical device sales and service companies, has specified Rigel Medical’s range of advanced testers for improved compliance testing.
The move by the High Wycombe-based firm has simplified testing procedures as part of its in-service preventative maintenance programme for NHS, emergency and rescue and private healthcare sector customers in the UK and Middle East.
This has seen improvements in the speed and ease by which electrosurgical units (ESU), vital signs monitors, infusion devices and defibrillators, among other items of medical equipment are maintained and checked for electrical safety and performance accuracy.
The 288 automated safety analyser, Uni-Therm electrosurgical performance analyser, Uni-Pulse defibrillator analyser, Multi-Flo infusion pump analyser and combination Uni-Sim vital sign simulator are used by BCAS to ensure compliance with manufacturer's recommendations to the appropriate standards including IEC/EN 62353 and IEC/EN 60601.
Managing director of BCAS Biomed Ian Roberts said: “Our engineers appreciate the fact that they are compact enough to carry from site-to-site, offering full automation of test procedures and leading to more efficient testing schedules and, ultimately, better standards of customer service and care.
“The fact that they are supplied by a British company is also important. It means that quality is assured and good after sales maintenance and support is always available.”
Demand for improved healthcare and changing demographics make Brazil’s medtech market ripe for targeting but registration and admittance procedures pose distinct barriers to market entry.
Stephanie von Meien, a senior manager at Germany Trade and Invest in Berlin, writing in European Medical Device Technology reports that as one of the high-profile BRIC countries, Brazil boasts an increasingly alluring medical technology market that has captured the attention of foreign medical device manufacturers.
In fact, the Latin-American giant currently imports 60% of its medical equipment - amounting to US$1.9 billion - while the first half of 2013 experienced a sizable increase of almost 20% compared with the same period of the previous year. Further boosting Brazil’s appeal is the mounting investment by public and private facilities to meet the demand for improved healthcare for the country’s 200-million inhabitants.
But despite the region’s notable growth, experience has shown that the difficult registration and admittance procedures can make it difficult to exploit the market’s full potential, especially for small and medium- sized companies.
Regardless, accelerating market entry for foreign medical technology and addressing major barriers is critical to the future of the market. Doing so means quicker and easier access to life- saving innovation and, in turn, access to the better standard of care demanded by the Brazilian people. Read Stephanie von Meien’s article in full at www.emdt.co.uk
Make sure you catch Rigel at the 18th National Biomedical and Clinical Engineering Conference (Oct 23 2014, Silverstone Circuit, Northamptonshire) - the annual conference that brings together the entire bio-med community. Also make a date to visit the Rigel stand at MEDICA (Nov 12-15 2014, Düsseldorf, Germany) and Arab Health (26 - 29 Jan 2015, Dubai International Convention & Exhibition Centre, Dubai, UAE) to find out more about our products and solutions for the international medical device market. More at www.rigelmedical.com/events
Take a look at the latest video from Rigel Medical, outlining the many benefits of the new Multi-Flo Infusion Pump Analyzer and how it could improve your testing capacity and productivity. View it here
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