Medical equipment in the digital era

How to ensure safety of state-of-the-art medical equipment

By Claire Marchand

People live longer today than ever before. There are however major variations in life expectancy between continents and countries. Even within a given country, there may be differences between wealthier and poorer regions.

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Huge differences

According to the World Health Organization (WHO), life expectancy at birth of the global population averaged 71,4 years in 2015. As far as individual countries are concerned, Japan tops the list (83,7 years), followed by Switzerland (83,3) and Singapore (83,1). At the other end, some African countries have a life expectancy that is just above 50 years. 

These variations between different parts of the world are caused mainly by differences in public health, medical care, and diet. The HIV/AIDS epidemic in particular has taken its toll on the African continent. 

It is nevertheless worth noting that while the gap with low-income countries is still important, they have made the greatest progress, with an average increase in life expectancy by 9 years from 1990 to 2012. 

Major innovations

Although better food and cleaner water have had an impact on people’s life expectancy, the most important evolution occurred in fighting diseases unrelated to water quality and malnutrition. Over the past century, many effective medicines were discovered and brought to market, thus helping cure many diseases. Not to forget technological innovations in medical equipment: those have had a major impact on increasing life expectancy. 

Since the appearance of the first sticking plaster in the 1920s and the first magnetic resonance imaging (MRI) devices in the 1970s, many other developments have helped move medicine forward. The medical sector has changed drastically, to the point at which, with the aid of robots and other IT advances, doctors can diagnose patients who may be located on the other side of the world. 

A new era

The digital revolution has changed our lives forever. It has also impacted the medical sector: Technological advances such as robotics, nanotechnology, telemedicine, among others, allow medical professionals to better manage diseases and improve the quality of lives for their patients. 

The doctor-patient relationship is no longer confined only to the medical practice or the hospital. Physicians can reach patients that live in remote areas. 

Medical robotics plays a growing role in surgery and beyond. Robots can provide assistance in rehabilitation and also be used as caregivers assisting elderly people. This is of particular interest as the life expectancy of the population is increasing. (see articles in the Technology focus section) 

Adhering to IEC International Standards

Regulations and legislation affecting medical devices are increasingly enacted throughout the world, with a growing emphasis on quality management systems and standards. Consequently, it becomes more and more important that manufacturers of medical electrical and electronic equipment ensure that their products meet the safety, reliability and performance requirements of the industry as well as adhering to the standards, IEC International Standards in particular, which apply to them. 

IECEE Certification complies with IEC International Standards 

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 scheme 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. IECEE has placed special emphasis on this sector in the last few years. 

Medical equipment has its own product category, MED or electrical equipment for medical use, comprising dozens of IEC International Standards against which products are to be tested and certified in the IECEE CB (Certification Body) Scheme. It includes the IEC 60601 series of Standards on the safety and performance of medical electrical equipment. 

Greater focus on managing risk

Medical technology may be speeding ahead but IECEE is close behind in terms of managing the risks associated with new technologies. In 2007 it set up the Medical Electrical Equipment Task Force  (IECEE MEE ) whose responsibility is to deal with 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, published in 2005 (Consolidated edition 3.1 of IEC 60601-1 published in 2012). 

The Task Force is also responsible for:

  • establishing a consensus with acceptable methods for determining compliance with all the relevant clauses (in relation to ISO 14971) of IEC 60601-1
  • developing a checklist aimed at assisting the medical equipment industry, official authorities and stakeholders around the world to test appropriately
  • acting as an Advisory Group on the common understanding of ISO 14971 with respect to IEC 60601-1
  • organizing specific training sessions dealing with risk management issues

IECEE focuses on the marketplace 

Showing the marketplace that a product is tested and certified can help well-established multinational companies as well as small and medium enterprises (SMEs) as IECEE is recognized in all member countries and beyond, thereby aiding in reducing costs and time to market and in eliminating the need for multiple testing. 

Mutual recognition

IECEE certification, based on the principle of mutual recognition (reciprocal acceptance) by its members, is also essential in facilitating international trade and allowing direct access to the marketplace for regulators, vendors, retailers and buyers. 

Since 1985, the IECEE has positioned itself as the global testing and certification system for electrotechnical equipment, issuing more than a million certificates that are recognized worldwide. The System is still developing new programmes to provide manufacturers and consumers alike with the highest possible levels of safety, performance and reliability. 

More information:

Doctors working with Da Vinci medical robots Robots are increasingly used in surgery and also in rehab or as caregivers to assist the elderly
Patient receiving health care through telecommunication and information technologies With telemedicine, physicians can reach patients that cannot leave their home or live in remote areas
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