For the first time, IEC 60601 has published a standard specifically defining the requirements for devices used in the home healthcare environment. IEC 60601-1-11:2010 Medical Electrical Equipment now must 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.
The mandatory date for implementation of the EN European version of the standard is June 1, 2013. The U.S. FDA requires the use of its version of the standard on June 30, 2013, while Health Canada recently extended the required date from June 2012 to April 2013 for the Canadian edition. The North American agencies will only require these standards for new device submissions; the EU will take the more severe approach of requiring all applicable devices being placed on the market to consider the home healthcare standard. As a result, the time to design or redesign your device to the new standard is now.
The scope of the IEC standard defines the home healthcare environment as a “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.” What may be surprising is that nursing homes are considered a home healthcare environment. The standard applies regardless of whether the device is used by a lay operator or a trained healthcare professional.
The European EN and Canadian CSA versions of the standard are identical to the IEC standard. However, according to the recent publication of the U.S. national version of the standard, ANSI/AAMI HA60601-1-11, the application of the standard does not apply to the nursing-home environment. In the United States, nursing facilities are considered to be environments providing professional healthcare.
The U.S. version of the new standard also places greater emphasis on a requirement which states that “inspection of the usability engineering file reinforces that the usability engineering process is necessary for validation of the instructions for use.” Devices typically mandated to use the new standard include oxygen concentrators, body-worn nerve and muscle stimulators, beds, sleep apnea monitors, and associated battery chargers prescribed for use at home. Although In Vitro Diagnostic devices such as blood glucose meters are being used by patients at home, the standard does not apply because these devices remain under the jurisdiction of the more lenient IEC 61010 series.
There are significant areas in which the standard differs from the general IEC 60601-1 in both construction and test requirements. The home device operator, usually a family member or the patient himself, obviously differs from a better-trained, highly educated hospital specialist.
Other issues of concern which must be considered for purposes of risk management are children and pets living in the home as well as various places posing possible hazards (such as proximity to a fireplace) which are not found in a hospital but where a device might be used in a home. These unique and diverse users and environments necessitate that safety and performance controls be strictly protected from accidental or unauthorized changes or adjustments.
Because ordinary people are in the serious situation of using medical devices at home, additional requirements for cleaning, disinfection, and sterilization place particular emphasis on the manufacturer’s usability engineering process and file. The standard assumes that a lay operator has completed a maximum education of eight years, mandating that instructions, markings, and the device itself shall be designed for 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. This edition is mandatory in the EU as of April 1, 2013. Unfortunately, the vital importance of the usability aspects included in a manufacturer’s Risk Management File is lacking in comparison to the dangers of better-understood phenomena such as electric shock and biological hazards.
Regarding hardware, the standard requires the use of a two-prong (unearthed) plug, that parts to be applied by a patient are isolated from other parts of the device, and that an enclosure must be resistant to rain and fluid spills. Failure to adequately prevent water ingress is common so a pre-test of the enclosure design is recommended in the prototype stage.
Home healthcare devices have added requirements for a greater range of environmental conditions as well as tests for mechanical shock, vibration, and possible impacts from dropping which might occur 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. As a result, many devices that were not specifically designed for the mechanical shock and vibration requirements and the more severe range of environmental conditions of temperature and humidity are not meeting the requirements.
In addition to IEC 60601-1-11, the IEC 60601 third-edition series has changed considerably in the past year and will continue to do so for a few years to come. Amendment 1 to IEC 60601-1 has been issued, which favorably modifies some of the requirements and clarifies others. There also have been so many new particular requirement standards recently published that the third-edition series should more likely than not provide all the standards that apply to a given device.
Even when changes are properly planned and introduced, most medical device manufacturers still are not well prepared. This is particularly true in fulfilling some of the more stringent mechanical requirements and more detailed patient/operator isolation requirements and ultimately apparent in the lack of mandatory detail in the Risk Management File.
For the latter, it’s no longer enough that manufacturers address only the very general applicable risk concerns identified in ISO 14971: Application of Risk Management to Medical Devices. IEC 60601 now demands more specific detail, especially for hardware-related aspects. A review of a manufacturer’s design by a testing laboratory can be a great way to help ensure compliance with the entire set of new applicable standards and better prepare for changes to come.
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About the Author
Robert Burek is the global medical device technical manager at SGS Consumer Testing Services. He has 20 years of experience evaluating active medical devices according to the 60601 series and is a member of the Association for the Advancement of Medical Instrumentation. Burek holds a B.S. in electrical engineering. [email protected]
