Ensuring Safety and Essential Performance: Medical Devices Used in the Home

Medical devices used for home healthcare are designed to specifically to ensure safety.

18 November 2013

Have you ever wondered about how a medical device in the home is defined?

IEC 60601-11 defines Healthcare Environment as: "Dwelling place in which a patient lives or other places where patients are present, excluding professional healthcare facility environments where operators with medical training are continually available when patients are present."

Because care recipients expect to be able to stay independent, mobile, and active, the term "home use" extends beyond the home, to encompass all environments in which a person plans to use his or her medical device in day-to-day life. Whether jogging, camping, skiing, or biking, the device must be capable of safely accommodating the many needs of the person using it. The standard, therefore, goes beyond 60601-1 3rd Edition.

Key design considerations include:

  • All cord connected home healthcare products need to use a two-prong (unearthed) plug classified as Class II equipment, in accordance with 60601-1, Third Edition, which means the use of a protective earth conductor is not allowed as a means of protection. This is due to the fact that some homes still don't have a reliable protective earth connection.
  • A means to prevent accidental or unauthorized changes to controls is required. This needs to be more stringent in the home healthcare environment then in a hospital since children could be around the device and possibly change a setting that would affect its basic safety and essential performance.
  • Medical devices used in the home must be tested to withstand mechanical shock, vibration, impact from dropping and a range of environmental conditions.
  • The risk of airway constraint is increased in the home healthcare environment since children and/or pets may be near a device. One way to help reduce this hazard is to provide a retention device.

What questions do you have regarding home healthcare product safety and quality? Please leave your comment or questions below and one of our experts will get back with you.

Today's expert blogger is Todd R. Konieczny, Assistant Chief Engineer, Intertek Americas Region. Todd is located in the Boxborough, Massachusetts office.