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intensive care, implants, sterili- sation to bandages, adjuvants or surgery materials. “According to the German medical products law (MPG), lab diagnostics are also viewed as medical technology equipment,” adds the BVMed.
Valves as life-savers
Valves are a common compo- nent of life-saving and therapeu- tic devices. They are of decisive importance in surgical equipment, dental stations or ventilators. Essential components, “for which costs and effort to meet relevant regulations and entry require- ments are, however, constantly rising for product development and production,” emphasises Michael Mack, global product manager Piezo, HOERBIGER Com- pression Technology. Reasons are stricter and changing regulations. Furthermore, national and inter- national regulatory requirements need to be observed, as a conse- quence of globalisation.
There is no standstill in medical technology: changes in regula- tions and the development of new, innovative methods in areas such as diagnostics and therapy mean new products and product mod- i cations, underscores Michael Mack, global product manager Piezo, HOERBIGER. Needless to say, investments are a matter of course for HOERBIGER.
Higher requirements
Higher requirements apply for devices or systems covered by Germany’s medical product law (MPG). “Here, the intended purpose of a valve in an applica- tion and inside of a medical tech- nology device plays an important role,” explains Peter Jaschke, head of business development MedLab, Festo. Materials compati- bility needs to meet requirements
– this concerns wetted compo- nents, as well as parts directly in contact with the human body. „Traceability and change manage- ment are topics that in parts need to be considered for risk-relevant components”. However, there also are entirely non-critical areas in medical technology where standard industrial products and components can be used, adds Jaschke.
Additional efforts
This forms a further reason why requirements keep growing for valve manufacturers. “Require- ments for producers and distribu- tors for quality management (QM) and QM systems stemming from the international norm ISO 13485 are increasingly being passed on down to suppliers, such as valve manufacturers. As a consequence, the additional personal and nan- cial expenditure required is con- siderable“, explains Jaschke. Festo was early to notice this and had its research and development and production certi ed for ISO 13485.
Expectations for components in medical technology also are high, reports Michael Mack, HOERBIGER. “Energy ef ciency and weight reduction play a central role for battery-operated and mobile devices – while, at the same time, reliability, operational dependa- bility, a long product lifecycle and product availability over a long period without technical changes aredemanded.
Reduced operating noise
Requirements are especially high for respirators for prematurely born babies, where, in extreme cases, respiration is entirely taken over by the machine. In order to be up to par, HOERBIGER offers a pressure regulating valve from its
piezo valve product portfolio. “Our piezo technology can fully demon- strate its strengths: extremely fast rise time during continuous pressure changes between in- and exhaling allow an ideally natural function of a non-independently functioning lung. Exhaling, in turn,requiresahigh owrate.At the same time, a permanent basic pressure has to be set, which is adjusted very nely and may only have a minimal variation. Owing to the extremely low power input it is furthermore possible to increase battery life in mobile or emergency operation mode and thereby raise operational safety to a level conventional valve technology can only realise with additional effort,” reports Michael Mack. And as these perfor- mance-de ning components, of which even three are installed in each device, virtually don’t gener- ate any heat, a much smaller ven- tilator can be used. “Combined with the valve’s noiseless switch- ing and regulation, the operating noise of the device is enormously reduced, which in turn positively affects the baby’s recovery”.
Piezo valves for eye surgery
Eye surgery is a further eld of use for piezo valve technology. Here, it optimises delicate processes. Different uids and gases have to be conveyed during eye surgery. Festo developed proportional valves and piezo valves, as well as integrated sensors. These allow “the precise delivery of vitreous humour replacement solution, help with the vacuum-assisted removal of microparticles and drive all kinds of surgical tools”. A further application for the piezo valve is in the treatment of chronic obstructive pulmonary disease (COPD), affecting around 600 million people around the
Technical Papers
ITAtube Journal No3/October 2018
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