Safety Standards for Home Healthcare Devices

Health cost has been rising over the years and so has life expectancy.

Health care/medical providers have been looking at ways of providing better quality care at a reduced cost. One of the ways to do this is to provide treatment and monitoring at home. There is a growing need for affordable, reliable and convenient professional medical services at home. Most who benefit from this type of care are patients who would prefer to recuperate at home to save money, those who are disabled, or patients with complex treatment or chronic diseases that require use of medical equipment and/or medication monitoring. Regulatory agencies have identified that there are unique risks and implications that need to be considered with powered medical equipment. Standards specifically defining the requirements for the home healthcare environment were published in 2010. Requirements for medical electrical equipment and medical electrical systems must be incorporated into home environment use devices, along with other applicable standards in the IEC60601. The market for home health care devices and equipment is expected to grow exponentially as the delivery of health care shifts from a clinical environment to a home setting in the coming years.

Until as recently as 2010, many manufacturers of healthcare equipment intended for use in the home have been required to demonstrate compliance with the provisions of IEC 60601-1 “Medical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance”.

As originally developed, this standard was intended to apply to medical devices used in clinical settings by trained medical professionals. To obtain certification for their products, manufacturers of Home Healthcare Devices have been required to comply with the provisions of IEC 60601-1, and to demonstrate that their product design effectively mitigates the risks associated with use in the home by patients or caregivers.

IEC 60601-1-11 and Home Healthcare Devices

In April 2010, the US Food and Drug Administration (FDA) and the Center for Devices and Radiological Health (CDRH) published documents to outline the Medical Device Home Use Initiative. Late in 2010, International Standard IEC 60601-1 “Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in Home Care Applications” was published. IEC 60601-1-11 is a collateral standard, meaning that it directly references provisions in IEC 60601-1, and is used in conjunction with IEC 60601-1 for the certification of Home Healthcare Devices.

IEC 60601-1-11, deals specifically with the requirements applicable to medical devices intended for use in the home environment. Under its provisions, manufacturers must identify the specific product safety risks associated with the use of their equipment in uncontrolled environments by untrained users. To achieve certification, manufacturers must mitigate those risks through a combination of appropriate product design, user instructions and training, and maintenance protocols. While IEC 60601-1-11 is intended to cover most home healthcare equipment, it is important to note that some devices may still be subject to the requirements of other standards. For example, UL 1431 “Personal Hygiene and Health Care Appliances” covers household electric products for hygiene or other healthcare applications rated at 250 volts or less.

IEC60601-1-11 deals with general requirements, testing requirements, classification, identification, marking, documentation, protection against hazards, protection against strangulation/asphyxiation, and Electromagnetic Emissions.

Classification of Medical Equipment and Medical System

In addition to the requirements of the general standard, unless the Medical Equipment intended for the Home Healthcare Environment is permanently installed, it:

• Shall be CLASS II (2 wire AC input – no ground connection at the input) or internally powered.
• Shall not have a functional earth terminal.
• If equipped with APPLIED PARTS, shall have either TYPE BF APPLIED PARTS or TYPE CF APPLIED PARTS.

Compliance is checked by inspection. In addition, the input voltage range is increased, requiring the medical device to operate from a lower input voltage, 80% or 85% of the nominal rated voltage depending on the type of medical application as well as increased immunity to electromagnetic disturbances from other devices in the environment.

Class II

There are considerable numbers of houses both in the US and Europe which were built before 1950 that do not have reliable earth ground wire. IEC 60601-1-11 requires that all medical devices for home use which are not permanently installed by licensed personnel have class II AC input. The safety from electrical shock in Class II power supply comes from the construction. Where additional insulation and spacings are needed, two layers of insulation or a single layer of reinforced insulation must be provided between the user and current carrying conductors.

Related Post: What is the Difference Between IEC Class I and Class II Input?

Added protection

In addition to existing general medical standards, when performing the usability engineering process, the risks associated with usability in the home healthcare environment for operator profiles, including a lay operator, shall include consideration of at least:

• Changes of controls
• Unexpected movement
• Potential for misconnection
• Potential for improper operation, or unsafe use
• Potential for confusion as to current operational mode
• Change in the transfer of energy or substance
• Exposure to environmental conditions specified in this standard
• Exposure to biological materials
• Small parts being inhaled or swallowed

Power supply, interruption and interference

Essential performance criteria for IEC60601-1-11 are to be able to provide safety backup should there be power interruptions. In case of a power outage the medical equipment should be able to provide back up for life sustaining medical equipment to be operational until an alternative supply is deployed. Power supply features such as bidirectional communication and higher hold up time will be useful to integrate the backup power source in case of power loss.

An updated version IEC60601-1-11: 2015 was released in 2015 which superseded and replaced the old IEC60601-1-11: 2010. Some of the key requirements of IEC 60601- 1-11 relate to the power supply being used for this equipment. A power supply that meets the home health care standards can be easily integrated into medical equipment for the home healthcare environment.

As the home healthcare medical equipment market expands due to an increase in home based medical needs, understanding the safety standards IEC 60601-1-11 healthcare is very important to quickly access this market.