Compliance Conscious Suppliers Enhance Patient Safety
Q: How are supply partners to medical device OEMs aiding in ensuring patient safety with home healthcare devices?
As a strategic supplier to medical OEMs, it is vital that Watlow remains knowledgeable of changes in market needs and regulations. This allows us to design and develop products in a rapid fashion that meet the unique requirements of the medical equipment market.
As a recent example, Watlow’s applied insight into UL 60601 (more specifically IEC60601-2-39 for peritoneal dialysis equipment) helped design a UL-compliant heating element for creepage distance, clearance, and dielectric requirements for a manufacturer of home healthcare peritoneal dialysis equipment. These requirements could easily have been overlooked and required expensive and time-intensive redesign much later in the process, thereby delaying release of next generation equipment into the market. Understanding the regulatory environment for medical device OEMs is critical in the support of safer product design.
This deep knowledge also enables the development of new products targeted for medical devices. In response to the third edition of the UL 60601 standard (more specifically EN60601-1-11 for home healthcare), Watlow developed a double insulated, low leakage, flow-through heater that delivers the performance needed for fluid warming. The low-current leakage allows the OEM to optimize the rest of the system’s leakage budget for potentially enhanced safety. Additionally, Watlow’s ULTRAMIC advanced ceramic heater was designed to meet these UL 60601-1 requirements in an extremely small package. Supplying all the heat required for a hypothermia blanket application in just a 25 mm square footprint, the ULTRAMIC heater passes the required 4,000 VAC hipot test requirement, which eliminates the need for isolation transformers in the system. Both of these solutions share a common value proposition of enabling fewer components, yielding a lighter, more portable, more efficient, and ultimately safer system.