UL Exec Discusses Pros/Cons Of Home-Use Device Mark

Most people understand what to do when they see the symbols for recycling, Wi-Fi and no smoking. Could a symbol for home-use devices be equally effective?

With more and more patients migrating from the hospital to the home, manufacturers are starting to design devices specifically for that environment. The problem is “the home-use market is different from the clinical market,” said Anil Patel, vice president and chief marketing officer for Underwriters Laboratories’ Life and Health Business Unit.

“The question that comes up is how do you communicate to an ordinary user that a particular device is intended for home use?” he said.

Patel gave an example of a device whose instructions say it is intended for home use, but that has a tag on it saying “for use in [the] presence of a licensed physician.”

“Clearly there is a problem,” Patel told attendees during a Wednesday session of the AAMI/FDA Summit on Healthcare Technology in Nonclinical Settings in Herndon, Va.

Symbolism tends to “resonate well” with people, Patel said, suggesting a possible home-use symbol on devices similar to the energy star symbol on appliances to signal they are energy-efficient.

There are some key questions surrounding any home-use device marking, the first being who decides which devices receive the symbol, Patel said. That could be regulators or a private entity.

Another issue is buy-in, Patel said. “Will the regulators require it, or will the manufacturers embrace it?”

He later told D&DL that the incentive for devicemakers lies in risk mitigation. “Clearly having a product that is easy to use and well-designed and intended for the [home] environment helps to mitigate their business risks, protect their brand,” he said.

The FDA has worked to improve awareness surrounding home devices. The agency put out draft guidance late last year recommending manufacturers develop a risk-management plan for home use devices that describes the process for identifying hazards and evaluating and controlling known risks (D&DL, Dec. 17, 2012).

Patel said that topics like home-use device marking are being considered by the agency. — Robert King