“In a hospital you have an electrically clean environment, so to speak,” Baldwin says. “By contrast, in homes you have a variety of possible environments that can increase risk—for example, carpet that can build up static electricity.”
These variables have inspired the move to protect medical equipment from electrostatic discharge—because a healthcare product has to work every time.
“You can’t just zap it and run to RadioShack for a new power supply,” Baldwin says.
In many cases, designers building new products intended for home use are exceeding the EMC 4th edition requirements. Baldwin says customers who only need to meet 15,000V, for example, are asking for 18,000-20,000V ratings.SL Power is working to help bring new devices up to standard, but at the same time, the company is contacting medical device clients to upgrade power supplies for any products that have been released in the last three years.
It is going to be an ongoing project. “The good news about the requirements is that new products must comply immediately, but products already on the market can be grandfathered in when they need other upgrades,” says Baldwin.
But he does ask that companies who want to comply with requirements for electrostatic discharge in home care products take some time to really understand how their power supply works. “It sounds strange, but many companies don’t actually understand the power interaction of their own systems.”
Baldwin notes that location and power supply routing don’t necessarily work the way medtech companies think they do. Still, those factors make a big difference. “A solution might be easy, especially if the power supply is external. Internal power supplies are often more challenging.”
Baldwin also recommends that companies ask for help as soon as possible from power supply designers, because they may be able to help provide a better layout to optimize power design.
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* This article was updated February 27, 2017, to reflect FDA’s extension of the implementation date from April 1, 2017, to December 31, 2018.