Home healthcare 

Also known as: E-Health, Connected Health, Telemedicine, TeleHealth, Digital Health

New international standard for home healthcare safety published

EC/DIS 60601-1-11 "Requirements for medical electrical equipment and medical electrical systems used in home care applications." has been published and can now be used to demonstrate conformity for equipment to be used in the home environment. This collateral standard is aligned with the 3rd edition of IEC 60601-1.  While the -1-11 standard can be used as a design guide in conjunction with 2nd edition based IEC 60601-1 harmonized standards, certification can only be achieved when evaluated as part of an IEC 60601-1 3rd edition harmonized standard investigation.  With increasing visibility by FDA and other regulatory agencies, medical device manufacturers can look to UL to provide assessments to the applicable standards for home healthcare.

If you think your device falls under the scope of 60601-1-11

• 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.   
• Get UL involved early in the design process.   UL experts can assess your design specifications for conformity to the requirements so your team has a better understanding of the requirements, and gaps between clinical use and home use applications.  Knowing the differences up front can help you meet your scheduled completion date and avoid costly delays.

UL services for devices intended for home use:

• Gap Analysis for devices being used in clinical environments
• Proactive review for devices in the design or redesign stage of development
• Informative test reports which can serve as evidence in submissions to regulatory authorities such as CE Mark
• Certification marks to demonstrate conformity to 60601-1-11

Why home healthcare?

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

Additional Resources

• *NEW* UL white paper on Home Healthcare Equipment 
• Link to FDA Home Healthcare initiative web page.