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Watlow White Paper lays out NextGen thermal system demands for home medical device safety
The latest White Paper from internationally renowned industrial thermal solutions specialist Watlow highlights the demands that home medical devices and patient safety will make on NextGen thermal systems.
Authored by Watlow Chief Systems Designer Andy Selvy, the technical article Smaller, Safer Medical Devices Require a Next Generation Thermal System explains that because home medical devices must meet higher safety standards, the thermal solutions incorporated into them must form part of a holistic design, using a system approach.
While the post-Covid trend to move patients to home care settings to reduce the burden on hospitals has driven new demand for medical devices suitable for domestic use, it has also led to ramped up regulatory scrutiny of devices and more stringent safety standards.
Since 2020, the ISO health care technology standard IEC 60601-1-11 has required manufacturers of home medical devices to identify specific product safety risks associated with untrained users using equipment in “uncontrolled” environments and mitigate those risks by building safety precautions into the overall design.
Effective design also has to resolve the tensions ensuring safety compliance and market demands for devices that are smaller, cheaper and easier to use.
“This is an area where innovation in thermal solutions, including heaters, sensors, temperature controllers, power controllers and supporting software working together as an integrated system, can make a difference,” the paper notes.
Topics and takeaways
Detailed issues discussed in the paper include:
- Thermal System Safety: Many medical devices require fluid warming heaters whose power requirements raise possibilities of current leakage and risk of electrocution, highlighted as an area where evolving technology can combine modern consumer tastes with assured safety
- Safety vs. Miniaturization: The importance of incorporating overall system parameters (e.g. a global current leakage ‘budget’) into the system design to ensure specifying appropriate heating components
- Systems Approach examples: Instances of particularly applications for the new generation of thermal solutions including use of FLUENT® in-line heaters in home hemodialysis machines and ceramic ULTRAMIC® heaters to maintain oxygen flow in respiratory devices.
A key take away from the White Paper is that correctly chosen thermal components can make home medical devices more effective and more comfortable for the patient, while simultaneously meeting safety standards and minimizing cost and space requirements, provided they are incorporated as part of a whole system approach to design.
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