Only the lucky few get through life in continuous good health, free from the pains and aches of growing older. Not many of us escape painful and debilitating ailments, such as sore joints that eventually require artificial replacements, and most of us, at some time or other, have to resort to health professionals and the healthcare industry in search of cures.
And it is reasonable for us to expect that those healthcare solutions and treatments will return us to our lives as healthier people, feeling better and fit for daily tasks. We put our trust in health professionals when we are at our most vulnerable and the health professionals, for their part, try to ensure that patient safety is paramount and aspire to best practices to reduce medical errors.
Cost of healthcare
The healthcare sector is one of the world’s fastest-growing industries, comprising medical science, biotechnology, medical devices, services and pharmaceuticals. Research by The Economist Intelligence Unit and Deloitte indicates that while global annual health spending reached USD 7.077 trillion in 2015, this figure will soar to USD 8.734 trillion by 2020. The data shows that “a growing elderly population in both the United States and abroad, coupled with the high average cost of providing quality healthcare to members of these groups, suggests that it will drive heightened expenses in healthcare”.
According to Forbes magazine, between 2015 and 2030, the number of people in the world aged 60 or over is expected to grow by 56 %, from just over 900 million to nearly 1.5 billion. By 2050, the global population of people over 60 is predicted to jump to 2 billion. In the USA alone, the number of citizens over 65 should reach nearly 100 million by 2060.
This is a lot of older people, with older-people ailments, that will present the healthcare industry with huge challenges. Populations worldwide are ageing – but not all are ageing equally. Diets high in processed foods have led to an increase in western diseases, such as obesity, heart disease and diabetes, and the healthcare industry will have to come up with creative solutions to the issue of chronic disease.
When healthcare systems come under pressure, it is important to ensure that patient safety remains at the same high level. Nevertheless, error and adverse events can always occur in medical procedures. World Health Organization (WHO) data and statistics for the European Union, for example, show that “medical errors and healthcare-related adverse events occur in 8 % to 12 % of hospitalizations”. According to the WHO, infections associated with healthcare also take their toll with, on average, an estimated one in 20 hospital patients affected every year (estimated at 4.1 million patients overall). The UK’s National Audit Office has estimated the cost of such infections at one billion pounds a year.
No room for errors
A bleak picture was also painted in the US. A study by Makary and Daniel sparked controversy when it claimed that medical error was the country’s third leading cause of death. One positive result of the controversy, however, is that it shed fresh light on a serious topic, making patient safety a public concern. This was thrown into sharp focus again recently with the publication of The Implant Files, a global investigation by the International Consortium of Investigative Journalists (ICIJ) into medical implants – such as metal hips, vaginal meshes and pacemakers – and their effect on patients.
The investigation was triggered by concerns over adequate regulations for medical implants, some of which, it is claimed, had not been tested before being marketed. Medical devices, however, are becoming increasingly important in healthcare and can significantly improve people’s lives, especially for the elderly. And in the era of the so-called Fourth Industrial Revolution, new technologies are not only enabling innovations in medical implants and devices but also raising concerns about cybersecurity and data privacy and making healthcare risk management even more complex.
All of this underscores the need for efficient risk management systems. What tools are at hand to reduce the risks associated with medical devices, including the risk of human error? Many ISO standards are involved in risk management in the healthcare industry – three of these are highlighted in this article. ISO 14971 is a standard for the application of risk management to the design and manufacture of medical devices. According to Jos van Vroonhoven, Senior Manager Standardization at electronics multinational Philips, the standard is globally recognized by regulatory authorities as the best standard for risk management of medical devices. This is, he says, one of the major benefits for companies like Philips of using ISO 14971.
Cutting down the challenges
Van Vroonhoven regards the trend for stricter regulatory requirements as posing a big challenge for the industry. He cites as an example the Medical Device Regulation (EU) 2017/745 in the European Union, which, he says, “poses more and stricter requirements, not only on the risk management process but also among others on reporting and post-market surveillance activities”. He goes on to say that the next edition of ISO 14971 has more precise and more accurate requirements for the risk management process, which are in line with those changing regulatory requirements. “Thus, ISO 14971 will assist manufacturers in demonstrating compliance with the regulatory requirements for risk management,” he adds.
Van Vroonhoven says the revised ISO 14971 will remain the globally recognized standard for risk management of medical devices and “the description of the risk management process is improved in several aspects”. One improvement, he claims, concerns the more accurate description of the evaluation of overall residual risk. “It is explained that the contributions of all residual risks together must be taken into account and evaluated in relation to the benefits of the intended use of the medical device.”
Risk management in the healthcare industry also extends to medical laboratories, which are a key component in healthcare. Essential work is done in these laboratories in testing clinical specimens to get information about the health of a patient regarding the diagnosis, treatment and prevention of disease. The credibility of medical laboratories is paramount to the health and safety of the patients relying on the testing services provided by these labs.
ISO 22367 (in development), which deals with the reduction of error in medical laboratories through risk management and continual improvement, is the second standard. Willem Huisman, registered in Europe as a medical laboratory specialist in clinical chemistry, is an expert on the standard, being responsible for evaluating and incorporating any revisions suggested by the project team and responding to comments received during the various voting stages.
Huisman explains that the new edition of ISO 22367 lays out quite extensively in its annexes how risk management can be applied in the medical laboratory. “It helps to understand,” he says, “how the risk management approach can really contribute to patient safety without spending more money and efforts than is necessary. It helps to focus on the processes that are most risky and to be more lenient on others.” He cites as an example the frequency of internal quality control samples: frequent where needed and less frequent where possible. The end results, he says, “can lead to lower costs in total with higher quality for patients”.
All about technology
In vitro diagnostics is an important sector of the global healthcare industry, which is undergoing rapid growth fuelled by technological advancements. These medical devices and accessories help to detect infection, diagnose a medical condition and prevent disease. Huisman goes on to say that the new standard is more explicit and more in accordance with the risk management standard for manufacturers of in vitro diagnostic medical devices. This stresses the shared responsibility for reliable laboratory results. He points out, too, that the name of the standard is “intentionally changed to risk management for medical laboratories instead of tests in the medical laboratory”. It clearly stresses, he says, the importance of the processes before the examination in the laboratory (taking samples in a proper way; transport conditions).
Huisman sums up by saying: “The new ISO 22367 will clearly show the medical laboratories how the concept of risk management will help to focus on all processes in the laboratory which need attention, to deliver the service their patients deserve, and be aware that, in some other processes, they can be more lenient. It helps the laboratories to be more cost-efficient.” This, in turn, enhances the well-being of the general public.
The third standard, ISO 35001, which is under development, focuses on management of biorisks, namely the management of risks that organizations confront when handling biological agents and toxins. As well as manufacturers of in vitro medical devices, relevant organizations also include medical centres, hospitals and clinics, universities and research institutes, and veterinary diagnostic laboratories and animal facilities.
Gary Burns is a Biosafety and Biosecurity Consultant and Convenor of working group WG 5, Laboratory biorisk management, of technical committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems. He points to the rapid growth of biotechnology applications, particularly in developing countries: “Technical capabilities that were previously concentrated in highly developed countries are increasingly being employed in other countries around the world. This expansion is driven in large part by the need to combat naturally occurring infectious diseases, which do not recognize national borders.”
Tackling toxins and other risks
To address these risks, Burns says the proposed standard will support organizations to “continually improve performance and comply with legal requirements through a voluntary biorisk management policy and process; implement globally accepted approaches to identify and control biorisks; monitor and evaluate the effectiveness of biorisk control measures; and assist management in decision making regarding biorisks”.
Other benefits to organizations in implementing the standard, he says, include a reduction in accident and incident rates, compliance with legal obligations and an ability to demonstrate to external partners a commitment to a high standard in biorisk management. Another plus is that “organizations will have the flexibility to implement the standard in a manner that is appropriate for their size and complexity” – good news for small organizations as well as large.
Burns says: “The risks are also constantly evolving, as novel pathogens continually emerge”. He cites recent examples of the emerging biological agents that have caused disease outbreaks in humans, which include “several pathogenic influenza A virus strains (H1N1, H5N1, and H7N9), a novel coronavirus that is the causative agent of Middle East Respiratory Syndrome (MERS), and a novel coronavirus that was the cause of Severe Acute Respiratory Syndrome (SARS)”.
As the number of organizations that work with biological agents and toxins and the scope of international collaboration among these organizations continue to grow, Burns says there will be continued and increasing demand for an international biorisk management standard.