03 Dec 2013

What are the challenges the home environment can present when related to medical devices?

When designing a medical device for home use, have you thought about the challenges the home environment presents?

While the acute care setting is a controlled, professional environment, the use of medical devices in the home presents unique challenges, many of which have the potential to impact patient safety. For example, home use medical devices may be exposed to environmental risks that may adversely affect performance. These risks can include:

  • Space limitations;
  • Presence of children or pets;
  • Electromagnetic interference;
  • Sanitation issues (e.g. vermin or dirty household items);
  • Safety hazards such as clutter;
  • Location of the home (e.g., elevation, urban versus rural, etc.);
  • Noise levels inside and outside of the home; and
  • Air quality, temperature and humidity levels.

Based on these potential risks, the following tests need to be conducted to show that the medical product is robust for use in the home environment. These tests include:

  • Environmental conditions for operation: humidity levels, temperature, atmospheric pressure;
  • Thermal conditions for transport and storage;
  • Shock potential for normal or small probing fingers; and
  • Vibration and drop testing.

So, how does your design stack up with the mandatory IEC 60601-1-11 collateral standard for U.S., Canadian and European market access? Please leave a comment below and one of our medical device experts will get back to you.

Headshot of Todd R. Konieczny
Todd R. Konieczny

Assistant Chief Engineer, Intertek Americas Region

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