Home healthcare
Also known as: E-Health, Connected Health, Telemedicine, TeleHealth, Digital Health
As the average age of life expectancy rises, the need for more affordable, reliable and convenient healthcare has become more prominent. Mainstream technology adoption of internet and cell networks, lower prices for electronics and wide use of broadband capacity have all opened the doors for moving healthcare from the hospital and clinics to the home.
Historically, the assumption for assessing conformity of medical devices is that they will be operated by educated healthcare professionals, trained in the procedures in which the equipment will be used. As healthcare equipment moves outside of the institutions and into the home environment, there are several considerations that need to be addressed including:
- Education and training for the patient
- Caregiver Competency (Health, Strength, Knowledge, Agility)
- Environment
- Privacy
- Interoperability
- Data integrity
- Infrastructure and power back-up availability
- Maintenance schedule/requirements
UL involved in home healthcare international standards development
UL participates in the development of the international collateral standard for basic electrical safety and essential performance - IEC/DIS 60601-1-11 "Requirements for medical electrical equipment and medical electrical systems used in home care applications." The standard is still under development, however, once issued and in effect, the 60601-1-11 standard will potentially become a necessary part of a medical devices' compliance life.
Determine if your device falls within the home healthcare scope
In order to determine whether or not the device falls within the scope of the home healthcare collateral standard, the manufacturer and UL will review the intended use and/or indications for use of the medical device. The intended use, to a significant extent, is based on the manufacturer's stated uses and places of use. If the device falls within the home healthcare scope, the device will be subject to the 60601-1-11 requirements as applicable.
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