MassDevice
The Medical Device Business Journal — Medical Device News & Articles | MassDevice
September 1, 2022 By
by Clarissa Benfield, Global Director of Medical & Laboratory Equipment, Intertek
Medical devices have been used in the home for many years to monitor vital statistics such as weight, blood pressure, fluid intake, oxygen saturation rate, etc. For many reasons, the market for these and other home-use medical devices has grown significantly, especially within the last several years, and they are bringing the convenience of home-based healthcare to patients who could previously only access these services in a clinical setting.
Some factors currently driving the growing marketing for home healthcare technology include an aging population, rising healthcare costs, the growing acceptance/use of telemedicine, and advances in home healthcare technology. During the COVID-19 pandemic, many patients were forced to receive treatments at home for a variety of ailments and conditions (non-COVID related) due to the restrictions of hospitals and professional healthcare environments. We saw the launch of more wireless and connected medical devices, as well as new “apps” that enabled communication with doctors and nurses and other caregivers.
At the same time, the growing market for home healthcare devices has experienced its share of challenges. Chief among them has been the use of devices that were not designed to be supported in the home, as well as the fact that home settings are less controlled than clinical settings and subsequently introduce greater risk due to user error/improper use, interference, external factors (dust, temperature, power quality, etc.), and more.
All of these risk factors can potentially impact the successful/intended use of home healthcare devices and resultant patient safety. Based on the uncontrolled electrical installations of the home environment, the lack of formal training of the lay operator, their comprehension and level of education, potential language barriers, and many other factors, the home healthcare environment requires that extra safety, communication, and operational precautions are put in place to prevent harm from occurring to patients, bystanders, and property.
Products that are normally tested and certified to IEC 60601-1 for electrical safety must now also be reviewed against 60601-1-11 for home healthcare, specifically. In addition to electrical safety, other environmental risks that could adversely impact the product’s performance must be considered, including space limitations, presence of children or pets, electromagnetic interference from appliances and consumer electronics, sanitation issues in the home, safety issues such as clutter, the location of the home (high elevations), inside and outside noise levels, and air quality (temp and humidity).
These considerations could lead to additional testing requirements that include environmental condition for operation (humidity, temp, atmospheric pressure), thermal conditions for transporting and storage, electrical shock potential for adult- and child-sized fingers, and vibration and drop testing.
The development and continued upkeep of a detailed Risk Management File is always going to be the best defense against any “potential risk”. Understanding the environments where the product will be used, how it could be used (or misused), and how others in addition to patients and caregivers might interact with the device is critical knowledge when creating the Risk Management File. There may be the need for additional labeling or instructions provided – maybe even something that impacts the product design itself – but taking into account all the potential risks and then mitigating them are the responsibility of the device manufacturer.
The times we live in present a number of incredible technological advancements, efficiencies, and opportunities. To fully capitalize on these opportunities we must continue to balance progress with safety and risk. When those are in balance the market can evolve and flourish to the benefit of both patients/caregivers as well as manufacturers.
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