Why we are on the trades.
Population growth, an increasing rate of chronic disease and economic factors are behind the growing demand for medical electrical equipment for use in home settings. Concurrently, the level of knowledge or understanding by the patient or caregiver, environmental factors and unpredictable factors are placing greater demands on the safety, durability and operability of medical equipment used in home settings.
First introduced in 2010, IEC 60601-1-11 is the current version of collateral standard IEC 60601-1 that applies to the basic safety and essential performance of medical electrical equipment used in home settings. Effective June 30, 2013 in the European Union and December 31, 2013 in the U.S., the new standard differs from the previous edition(s) in several key ways. It now requires a ‘Class II’ electrical categorization of medical equipment and systems for home use and expands the definition of the ‘home environment’ to include European nursing homes. As a result of these changes, manufacturers will now need to re-evaluate the design of legacy products and in many cases, re-design those and future products to meet these new and evolving standards.
The FDA defines a home use medical device as “a device intended for users in a non-clinical or transitory environment, which is managed partly or wholly by the user, requires adequate labeling for the user, and may require training for the user by a healthcare professional in order to be used safely and effectively. This includes permanently and temporarily implanted devices and any type of equipment that a person may use to recover and rehabilitate.” Because healthcare recipients expect to be able to stay independent, mobile, and active, the term “home use” extends beyond the home, per se, to encompass all environments in which a person plans to use his or her medical device in day-to-day life.
Issues with home healthcare
Because the home healthcare environment is fundamentally different than the clinical environment, home use of medical devices presents a variety of unique challenges, many of which have the potential to impact patient safety. For instance, a home’s age, structure and location may not have the electrical outlets required for some medical devices. Large equipment may not fit in smaller, older homes with narrower doors, hallways, etc. Additionally, pets and children may directly interfere with device operation, by tugging on, removing or ripping cords; changing settings; and more. Sanitation issues need to be taken into consideration such as managing medical waste and plumbing (city vs. well water, for instance). Finally, other items such as temperature extremes, dust, ventilation, fire and tripping hazards, electromagnetic interference, lighting, and more need to be considered. A hospital or facility will have taken care of all of these things already but it is completely different in the home.