Medical Design: Deadline Looms for Home Healthcare Products
February 1, 2013
New requirements applied to all home healthcare products demand testing and certification.
Time is a-ticking.
Designers and engineers who make medical electrical equipment for use in the home healthcare environment must test and certify gear to meet IEC 60601-1-11 ahead of the June 1, 2013 U.S. national adoption deadline.
And, according to Todd Konieczny, assistant chief engineer, Americas region, and technical manager for medical at Intertek, there may be even less time as numerous manufacturers and their designers and engineers may stack up in the testing and certification process.
Adoption of the collateral standard IEC 60601-1-11 is mandatory for market access.
Covering many Technologies
As applianceDESIGN readers may know, the International Electrotechnical Commission (IEC) is a non-profit, non-governmental international standards organization that prepares and publishes international standards for all electrical, electronic and related technologies – collectively known as “electrotechnology.” IEC standards cover a vast range of technologies from power generation, transmission and distribution to home appliances and office equipment, semiconductors, fiber optics, batteries, solar energy, nanotechnology and marine energy as well as many others.
“Requirements for medical electrical equipment and medical electrical systems used in home care applications” has been published and now used to demonstrate conformity for equipment to be used in the home environment. The 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.
Urgency in Demonstrating Compliance
Konieczny adds that there is urgency in developing solutions to help demonstrate compliance ahead of the June 1, 2013 deadline, with guidance to support a designer or engineer’s understanding of the safety and regulatory requirements necessary to sell product into global markets. Testing should include:
- Electrical Safety Testing for Medical Devices
- Risk Management File Review to ISO 14971
- EMC Testing for Medical Devices
- Battery Testing for Medical Devices under CB Scheme
- What countries does the manufacturer plan to sell in
A first step: Determine if your device falls within the home healthcare scope. In order to decide whether or not the device falls within the scope of the home healthcare collateral standard, the manufacturer with consulting help needs to 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 existing device, the redesigned device or a new device will be subject to the 60601-1-11 requirements as applicable.
No doubt, home healthcare and aging in place are solid growth sectors.
As the average age of life expectancy rises, the need for affordable, reliable and convenient healthcare has become more prominent. Mainstream adoption of Internet and cell networks, home area networking, home automation, lower prices for electronics and wider use of broadband capacity all converge as some healthcare moves from hospitals and clinics to the home.
With that convergence and shift to the home, devices designed for home use carry different requirements than use in healthcare and nursing home setting, where 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. Devices, especially electric medical devices, must be safe in any anticipated situation and very easy to use, says Konieczny. In some ways, 60601-1-11 requirements address such goals.
He points out the need for risk assessment. “What is the product intended to do and then design the risk out first and foremost.” There is need, for example, for mechanical testing, shock and vibration testing. “Moving with the device adds a whole new level of testing.” Essential Performance (EP) refers to the performance necessary to achieve freedom from unacceptable risk. The standard also notes, “Essential performance is most easily understood by considering whether its absence or degradation would result in an unacceptable risk.”
A Risk-based Viewpoint
According to the Intertek executive, while most of the standard remains technical in nature, the new standard is also risk-based, focusing on what the chances are of failure in a particular situation and determining the hazard potential of that error. For instance, the probability of an oxygen generator being bumped by a visitor may be higher than the chance of its alarm system failing, but the risk formula needs to account for the much greater consequences associated with the failed alarm and resultant decreased oxygen level, i.e. failure probability compared to hazardous consequences.
In addition, testing parameters vary according to different applications and conditions. Some of these include testing against specifications for:
- Environmental conditions, for operation, such as humidity levels, temperature and atmospheric pressure
- Thermal conditions for transport and storage
- Electrical supply
- Shock potential for small or normal probing fingers
Another significant requirement is that for connection to a power source, there can be no protective earth connection except for equipment that has been permanently installed by an electrician, and equipment must be Class II (double-insulated to further prevent electric shock) or internally powered.
Ingress protection (IP) ratings are required for electrical products that are body-worn, hand-held, mobile, or portable. The IP rating considers both protection from solid foreign objects and water.
Manuals and Instructions, Too
Then there are elements such as user instructions. “There should be a lot of clear useful diagrams written in an easy to understand way. Controls should be easy to follow. It’s a matter of the usable performance process.”
Medical devices typically mandated to use the new standard include oxygen concentrators, body-worn nerve and muscle stimulators, beds, sleep apnea monitors and battery chargers prescribed for use at home.
For devices intended for home use, the new standard requires the use of a two-prong (unearthed) plug and water-resistant casings. Also, parts that are applied to a patient must be isolated from other parts of the device. Such go beyond the general 60601-1 standard. The bottom line: To comply with 60601-1, one needs to comply with a risk management file to ISO 14971.
Need More Advice?
Find more information on IEC 60601-1-11 and useful advice from Intertek.
Temperature and Humidity
For home healthcare equipment not located in well controlled professional healthcare facilities:
IEC 60601-1-11 and Usability
A usability evaluation must include: