For the first time IEC has published a standard specifically defining the requirements for devices used in the home healthcare environment. IEC 60601-1-11 (2010) must now be incorporated into the design and verification of a wide range of home use and point of care medical devices along with other applicable standards in the IEC 60601 third edition series.
Mandatory dates for IEC 60601-1-11
The mandatory date for implementation of the EN European version of the standard is June 1, 2013. Health Canada and the US FDA require mandatory use of the entire IEC 60601 third edition series including -1-11 by June 1, 2012 and June 30, 2013 respectively. The North American agencies only require these standards to be adhered to for new device submissions, while the EU is taking a more severe approach. The EU requires all applicable devices placed on the market to take the home healthcare standard into consideration. As a result, manufacturers need to design or redesign devices to meet this standard now.
Scope of IEC 60601-1-11
The scope of the standard defines the Home 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.”
While this definition includes outdoors and in vehicles, what may be surprising is that nursing homes are also considered a Home Healthcare Environment. The standard applies whether the device is used by a ‘Lay Operator’ or by trained healthcare personnel. Examples of device types that would typically use this new standard are devices prescribed for home use such as oxygen concentrators, body worn nerve and muscle stimulators, beds, sleep apnea monitors, and associated battery chargers. The standard does not apply to home use in vitro diagnostic devices such as blood glucose meters. In vitro devices use the more lenient IEC 61010 series, yet they are being used under the same environmental conditions and by the same patients.
How to comply with IEC 60601-1-11
In order to comply, there are significant areas in which the standard differs from the general IEC 60601-1 in both construction and test requirements. The device operator, who is often the patient or a member of the patient’s family, is obviously different from the better-trained and educated specialist in a hospital. Risk Management also has to take into account children, pets, and the various locations the device can be used in the home that are not present in a hospital (such as near a fireplace). With the home environment in mind, controls relating to safety and performance must be protected from accidental or unauthorized changes or adjustments.
Additional requirements for cleaning, disinfection, and sterilization of the device places a particular emphasis on the manufacturer’s usability engineering process and file. This is due to the lay operator’s involvement in these activities. The standard assumes a maximum of eight years of education for the lay operator, so the instructions, markings, and device should be designed around that level of education or less.
Usability for the device must meet the requirements of the collateral standard IEC 60601-1-6, preferably the 2010 third edition. It is our experience that manufacturer’s Risk Management Files often lack usability in comparison to those of better-understood phenomena such as electric shock and biological hazards.
Hardware requirements of IEC 60601-1-11
On the hardware side the standard requires the use of a two-prong (unearthed) plug, patient applied parts that are isolated from other parts of the device, and an enclosure that is resistant to rain and fluid spills. Failure to adequately prevent water ingress is common, so a pretest of the enclosure design is recommended in the prototype stage.
Home healthcare devices have added requirements for mechanical shock, vibration, and impact from dropping that are typical for devices outside of the more controlled environment of a healthcare facility. Compliance is determined by verifying that safety and essential performance are maintained. These requirements are unlike anything in the general 60601-1 standard.
Review of existing devices recommended
In summary, a thorough review of existing devices on the European market or new designs to be placed on the market in several countries is recommended. In order to meet the dates required for North America and the EU, this activity should be started now.
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Medical Device Team
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