Digital technology and healthcare go hand in hand
The information technology integrated into self-care medical devices is changing the healthcare landscape, its systems and how services are delivered. On the wellness front, wearable bracelets and watches allow us to see how many steps we take each day, monitor exercise, food, weight and sleep. These devices track blood pressure, body temperature, measure blood glucose levels, improve hearing, remind us to take medication and more. In addition to self-monitoring, this technology is used in telemedicine, where data gathered can be sent directly to healthcare professionals in hospitals or clinics and patients can be treated at a distance, via email, webcam or phone.
According to a report by TechNavio, the global self-care medical devices market will grow at a compound annual growth rate of 9% between 2016 and 2020. This is thanks to increased awareness and knowledge people have of their health, and the ease of use and convenience of this technology.
How can we be sure self-monitoring medical devices are safe?
As world populations age and many more people become susceptible to disease and health conditions that need regular monitoring and treatments, this technology will greatly help over-stressed healthcare services, especially for people who are less mobile or live in remote locations.
Many people using these devices to monitor key aspects of their health expect the equipment to be safe and reliable, especially since they may not have a medical background or training.
IECEE, the IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components, ensures that electrical and electronic devices and equipment are reliable and meet expectations in terms of performance, safety, reliability and other criteria. The System applies not only to the medical electrical equipment itself but also covers risks to patients, those who operate the equipment – doctors, nurses and technicians, for instance – and maintenance personnel.
Many IEC International Standards are used to test and certify medical equipment or electrical equipment for medical use in the IECEE CB (Certification Body) Scheme. This includes the IEC 60601 series of Standards on the safety and performance of medical electrical equipment.
In order to address rapidly developing technologies, the IECEE established the Medical Electrical Equipment Task Force (IECEE MEE), which is responsible for handling the implementation of risk management requirements as set out in the third edition of IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. The third edition of IEC 60601-1 was published in 2005 and a Consolidated Version including amendment 1 was issued in 2012.
…and medical data is secure?
As with any technology connecting to the Internet, there is always the possibility of cyberthreats and the added need to protect confidential information, such as personal medical files. Together with several other Technical Committees, the IEC Conformity Assessment Board (CAB) set up Working Group WG 17, and IECEE established a Policy and Strategy (PSC) WG, both focusing on cybersecurity for the medical industry.