EU Court of Justice rules on definition of a medical device
Life science and IP lawyer Erik Vollebregt, who blogs about medtech matters on medicaldeviceslegal.com, has said that a recent ruling by the EU Court of Justice might make it less clear what the difference is between the definition of medical devices and devices for general health. The case Brain Products GmbH v BioSemi VOF concerns the definition of medical devices in the Medical Device Directive and specifically if Biosemi’s ActiveTwo, a device recording brain activity, is a medical device. The EU court ruled that a device is considered medical if it is 'intended for a medical purpose.' Vollebregt added that the ruling is problematic because it relies on the manufacturer’s intent and definition of a medical purpose, instead of a more objective measure, and it fails to define exactly what medical means. He also said that the ruling will potentially broaden the scope of the Medical Device Directive and could enlarge the scope of the proposed medical device regulations.
medtechinsider, 8 Jan. 2013. http://tinyurl.com/ae7rtp3
WEEE2 Directive puts medical device industry on notice
Medical equipment has been largely exempt from meeting the recovery and recycling targets of the Waste Electrical and Electronic Equipment directive. However the revision of the directive contains a number of aspects that have consequences for the medical device industry, according to Andy Vaughan on the Eucomed blog. He says that the most significant change is a reduction from the current 10 equipment categories to six after the transition period, which ends on 14 August 2018. The abridged set of categories is: temperature exchange equipment; screens, monitors and equipment containing screens having a surface greater than 100 sq cm; lamps; large equipment; small equipment; small IT and telecommunication equipment. Medical equipment will fall within categories 4 (for equipment larger than 50 cm) and 5. Adds Vaughan: an exemption still exists for '...medical devices and in vitro diagnostic medical devices, where such devices are expected to be infective prior to end of life, and active implantable medical devices.'
medtechinsider, 8 Jan. 2013. http://tinyurl.com/bxf4jjf
Game changers: technology trends to watch in 2013
According to a Forsa survey, more than 90% of the population sees developments in preventive medicine, diagnosis and treatment as positive. Details some of the most important of 2013's medical device technology trends including: biochip technology - the use of microelectronic technologies to detect biomarkers; stretchable electronics - flexible medical devices such as such as unobtrusive, wearable health monitors and advanced surgical tools; electronic implants - how devices are becoming smaller, smarter and more technically refined; materials - a new implant coating developed by MIT engineers that promotes bone growth and creates a stronger seal between the device and the patient’s bone than bone cement; and personalised medicine - the application of electronics in homecare technology to help the elderly remain active and independent for as long as possible.
medtechinsider, 8 Jan. 2013. http://tinyurl.com/a9roy48
EU grants CE Mark approval for NeoChord mitral valve repair device
The European Union has granted CE Mark approval for a mitral valve repair system by US company NeoChord. The company claims that the DS1000 Mitral Valve Repair system can be used to implant artificial chordae tendinae. Chordae tendinae are thin, threaded tissues that help anchor leaflets found in the mitral valve to the heart muscle. With the device, surgeons can repair a mitral valve prolapse through an off-pump, transapical operation. The company has also stated that its Transapical Artificial Chordae Tendinae registry had been started with an initial 50 patients. The first commercial procedure with the device is expected in the first quarter of 2013.
Qmed Daily Europe, 8 Jan. 2013. http://tinyurl.com/afqpfm2
Praxair receives Class 1 recall for portable oxygen cylinder
US company Praxair has received Class I status from the United States Food and Drug Administration due to concerns over its Grab ‘n Go Vantage Portable Oxygen Cylinder. According to the FDA notice, the Grab ‘n Go Vantage system can leak oxygen and could be a fire hazard. In November 2012, Praxair recalled the cylinder due to concerns over breakage. Under some conditions, the device may break and leak oxygen into the environment. This can lead to severe health consequences or death. In the notice, the FDA stated that customers should never place the cylinder in an elevated area such as a shelf. The device should be placed in areas where it will not experience bumps or jarring motions. Customers can return the cylinders to Praxair for repair and refill. (Item contains no further information).
Qmed Daily Europe, 9 Jan. 2013. http://tinyurl.com/a9k2oxz
Miniaturised pressure sensors could improve medical implants
As micro-electromechanical system pressure sensors are made smaller, simultaneously achieving high sensor stability and sensitivity becomes increasingly more difficult. However, a research team from Singapore and South Korea has now overcome this technical challenge by producing a miniaturised sensor that couples a key component - a stable diaphragm - with sensitive silicon nanowires. By combining and optimising three forms of silicon, the team was able to develop an MEMS pressure sensor that is operationally robust, and shows promise for use in robotic surgery. The team’s main aim now is to realise an implantable miniaturised medical device.
Qmed Daily Europe, 9 Jan. 2013. http://tinyurl.com/b6l8f5h
Biocompatibility and Performance of Medical Devices Symposium
Details the symposium, which is based on the definitive new publication 'Biocompatibility and Performance of Medical Devices' assembled by registered ANSM expert Dr. Jean-Pierre Boutrand and will be held in London, February 12-14, 2013. The symposium is the medical device manufacturers’ leading event for science and education, specifically designed for professionals in research and development, quality assurance, regulatory affairs, product engineering and other device-related positions.
Qmed Daily Europe, 9 Jan. 2013. http://tinyurl.com/b9bhpes
