Managing Medical Devices Failure Risk

MANAGING MEDICAL DEVICES FAILURE RISK Improving health outcomes

Medical devices are tangible assets that need to be maintained properly. They require a lot of investment, have a direct effect on human lives, are very sensitive, have high maintenance costs in a lot of cases, and some of them have short shelf lives. Medical devices play a critical role in diagnosis, treatment and rehabilitation of disease and illness. But the problem is that most hospitals fail to utilise the full potential of the technology that is currently available. Healthcare providers are gradually becoming aware of the need to secure medical devices. Only after we establish clear systems and methods for analysing device failures will we begin to have a full idea of the risks involved. Once we have better visibility and control over the functional aspects of medical devices, healthcare facilities will be able to better safeguard the safety of their patients and ensure continuity of treatment.

Sanjay Jha, Director, Colmed

Medical devices play a critical role in diagnosis, treatment and rehabilitation of disease and illness. According to estimates, over 50,000 medical devices are in use on a daily basis in healthcare facilities all over the world. Some of them are simple, while others are quite complex and combine more than pone technology. The global market of medical devices is estimated at US$150 billion, and is expected to grow at a rate of 5 per cent annually over the decade.

A critical resource in the healthcare ecosystem

Medical devices are tangible assets that need to be maintained properly. They require a lot of investment, have a direct effect on human lives, are very sensitive, have high maintenance costs in a lot of cases, and some of them have short shelf lives. According to estimates by the World Health Organization (WHO), over 50 per cent of the medical equipment in developing countries are non-functional, are not used correctly, and are not maintained by health facilities. Not only does it have far-reaching consequences for healthcare service delivery, it is also a waste of scarce and valuable resources. Unless hospitals have a proper policy in place for the management of medical devices, it is difficult to aright the situation.

This problem is further compounded by the fact that most hospitals fail to utilise the full potential of the technology that is currently available. If you pay attention to the depreciation value of medical devices from procurement to use, you will notice that it is highly non-typical. On an average, 30 per cent of depreciation occurs because of incorrect specifications and over-sophistication before the device is put to use. The value depreciates even further once it is in use due to a number of reasons. These include, but are not limited to irrational use, shortage of spare parts, lack of inspection and preventive maintenance, and repair agreements with the supplier. Owing to all these factors, the value of a device falls to about a tenth of the original investment.

As a critical component of clinical and support technologies in the healthcare ecosystem, medical equipment must be managed and used properly to produce effective medical intervention. Unfortunately lack of an optimal skill base, proper selection and acquisition, maintenance and repair

budget, support infrastructure, and managerial skills result in a waste of meagre resources, especially in healthcare facilities in tier 2 and tier 3 cities. Despite the huge amounts of money that is spent on medical devices, resource management is not considered an integral component of hospital policy. This is a major oversight on the part of hospitals as it fails to factor in future financial liabilities. It is not sustainable in the long run, considering the fact that medical device design is rapidly evolving with advancements in technology. These developments pose a new set of threats, which unless addressed beforehand, will end up becoming costly for both hospitals and patients, severely harming the reputation of the former and the safety of the latter. Medical devices fail for a number of reasons and all possible causes must be taken into consideration.

The Food & Drug Administration (FDA) of the United States has released countless warnings regarding the common vulnerabilities that plague medical devices. These vulnerabilities pose a threat to patient safety. The list not only include magnetic resonance imaging (MRI) machines and computed tomography (CT) scanners, but also other medical

According to estimates by the World Health Organization (WHO), over 50 per cent of the medical equipment in developing countries are non-functional, are not used correctly, and are not maintained by health facilities.

devices like infusion pumps, electrocardiogram (ECG) machines, and lab analysers to name a few. What complicates the situation further is the fact that clinical systems are increasingly connected to smart devices, which makes them prone to cyber attacks. If hackers or vested interests manage to tamper with the medical devices, it endangers the lives of patients.

What makes medical devices risk-prone?

Updating medical equipment is a complicated process. Hospitals often take a lot of time before they receive the final patches. The heavy patient load also means that they have to wait to apply the patches to the equipment. To add to the woes, many healthcare facilities operate legacy systems that no longer support the new patches. A lot of medical devices have to be retrofitted for networking purposes, facilitating real time data sharing and process automation so that the device can be managed remotely by the vendors. It is essential for healthcare providers to prioritise this because if a product is not receiving updates to fix vulnerabilities, it can give unscrupulous elements an entry point into the provider’s network, which can put patient safety at risk.

Rogue hackers can also intrude the internal network of hospitals and take control of connected devices and steal sensitive data. One of the most famous examples in recent memory was the WannaCry ransomware attack of 2017, which targeted National Health Services (NHS) hospitals in Scotland and England, affecting close to 70,000 medical devices. Many NHS services refused emergency cases, and even ambulances had to be diverted. If not for the built in kill switch, the magnitude of the attack would have been a lot worse. Another study found that 36 out of every 10,000 heart attacks occurred every year as a result of cyber attacks that caused a delay in treatments. According to the researchers, it took approximately 3 minutes for patients who suffered a heart attack to get an electrocardiogram after a cyber attack.

Even a simple intrusion into a hospital’s IT network can have a negative impact on the regular operations of medical devices because of their inherent vulnerability. As a matter of fact, it does not even require specialised expertise or sophisticated software to get the job done. Even a reasonably educated patient can learn about the control codes of machines and hack into these Devices. There is no denying that this is a serious risk that is only set to increase in magnitude in future.

The need for transparency

Another dimension to the problem is the lack of accurate repository and documentation of device failure. Healthcare providers fail to monitor the performance of medical devices and report the problems in time. Even if we somehow manage to build a report of injuries caused by device malfunctions, it will be difficult to tell how many of the faults were caused due to network tampering. Moreover, medical device failures fall between IT departments and biomedical engineering. So unless healthcare facilities are prepared to make the information public, it is difficult to get a realistic assessment of the impact.

To address this problem, healthcare facilities must maintain a central repository of all the medical devices. Automated systems can be used to maintain an up to

date inventory. Clinical workflows must incorporate the role of medical devices to estimate the impact of malfunctioning devices on the quality of patient care. The system must also be used to monitor device communications to identify anomalies in case of an intrusion.

Healthcare providers are gradually becoming aware of the need to secure medical devices. Only after we establish clear systems and methods for analysing device failures will be begin to have a full idea of the risks involved. Once we have better visibility and control over the functional aspects of medical devices, healthcare facilities will be able to better safeguard the safety of their patients and ensure continuity of treatment.

AUTHOR BIO

Sanjay Jha, IIT Kharagpur and INSEAD alumni , presently a director at Colmed, is an experienced entrepreneur with a decorated history in the medical device industry, aiming towards bring the quality of healthcare up and cost of healthcare down. In his past stints at various reputed companies like johnson and johnsons and GE Healthcare, he is known for his unparalleled skills in business strategy and business development, market analysis ,operations, innovation and entrepreneurship. He has 3 US Patents on his name.

Mr. Sanjay Jha is a perceptive and informed leader and wears a charismatic personality. He is well known for his resources, networking and contacts-a trait which every successful entrepreneur is required to possess- not just to build a world class team but also to reach out to investors, partners in customers as well. He is tenacious, having strong build drive with nerve of steels. he plansmeticulas;y, reacts quickly and react quickly and adapt to constant feedback from the market.

Healthcare Industry Needs More than Patient Satisfaction Surveys

The healthcare industry has been asking patients how they feel for over a decade. But patient satisfaction surveys only go so far — to really move the needle on the patient experience, it’s time the industry embraced experience management.

Susan Haufe, Healthcare Chief Industry Advisor, Qualtrics

We all are in the business of experience. Healthcare is no different. Taking care of patients all day, every day, means we deliver experiences with patients, family members, providers, volunteers - anyone who interacts within our healthcare system.

The high quality, safe, compassionate care we deliver at the lowest cost and/or value is often difficult and something we need to understand and manage closely. As a result, experience management needs to become incorporated into the day to day operations across an organisation.

But what is experience management? Experience Management (XM) is the discipline of using both experience data (X-data) and operational data (O-data) to measure and improve the four core experiences of any business: customer, employee, product and brand.

As healthcare faces the challenge of meeting consumer expectations with a workforce that is being asked to do more with less every day, compounded by an environment of changing regulations, it’s clear our industry must focus on human beings and increase our ability to adapt. This is where the discipline of XM comes into play.

XM enables an organisation to succeed in this environment by enabling them to do three things: 1. Continuously Learn - understanding how the experiences you deliver affect all the people (employees, customers, caregivers, etc.) that interact with your organisation. Learning how these experiences impact your brand and culture help you implement processes that address customer service interactions.

2. Propagate Insights - put the right information in the right form and in front of the right people to help them make better decisions. 3. Rapidly Adapt - building the capabilities to be able to respond to insights quickly and make changes to improve the experience.

To date, patient satisfaction surveys have been the industry’s primary tool for trying to understand and manage the experiences being delivered — but their impact is limited. To truly transform experiences, it’s time to look beyond patient satisfaction surveys and move towards a more holistic approach to accurately measure and glean insights from timely, role and site-based feedback - and then use these insights to make patients feel known and understood and help systems achieve financial health and improve quality and wellness outcomes.

How can healthcare better listen to patients today?

In healthcare, we have a long history of asking for feedback from our patients and families about their perception of their experience. Recognising that patients and families do not have the clinical training to truly and effectively evaluate the clinical quality of care, asking about their service experience has traditionally been a proxy for a patient’s perception of quality.

Healthcare providers feel constrained when it comes to changing this listening strategy or adding to it in innovative and creative ways. Quite frankly, healthcare providers are stuck and frustrated with their current methodology, yet lost on what to do next.

The current patient satisfaction surveys fail to give organisations the right data, at the right time, and in the right form to surface predictive insights that matter most across the patient experience and activate the entire organisation for improved outcomes.

Healthcare needs a different way to continuously listen.

What could a different approach look like?

It’s critical to start with clearly identifying the gap that needs to be closed. Gaps exist in experiences when there is a difference between what patients and families expect and what their actual experience looks and feels like.

To understand where those gaps exist, you can use journey maps to identify all of the touchpoints impacting a patient’s experience. Using this method, you can create a roadmap for effectively capturing relevant feedback about the moments that matter the most from your patients

Once you know the key moments in the patient journey, it’s time to gather insights into what’s working, what’s not and where to make improvements By adding ‘listening posts’ at each critical moment of the patient journey, you can then identify where to focus your energy and resources for the greatest impact. You can decide where best to start - that might be within your contact center, through digital intercepts on your website or mobile app, or soliciting feedback after an appointment through SMS or touch screens installed on-premise.

Depending on your health system’s needs, the issues identified by your patients, and your strategies

With 20 years of experience combining the tools, discipline, expertise, and passion to design and drive a customer-centric culture, Susan Haufe is known for organisational transformation built on brand promise, purpose, and values. She currently serves as the Chief Experience Officer, Healthcare Practice at Qualtrics. Prior to joining Qualtrics, Susan served as the inaugural Chief Experience Officer for Yale New Haven Health. AUTHOR BIO

and goals, you can nimbly listen, adjust, and modify what your listening posts capture to help answer questions about the gaps that exist.

Modern feedback tools are different from the patient satisfaction surveys we have known. Questionnaires can be administered in real-time and are quick to complete. They ask a few insightful questions and are powered by artificial intelligence to create meaningful feedback experiences that strengthen the relationship with your customers (here at Qualtrics, we call this having Smart Conversations).

The approach is facile, so as you learn more about the experiences of the people that matter most (not only your patients and families, but also your staff, providers and communities you serve), you can mold and adjust your data collection to gain deeper understanding. Results are collected on a single platform allowing for deeper analytics and insight delivered in real-time.

Listening leads to insights and action.

Once you have comprehensive experience data (X-data) from a variety of sources, you can begin to layer that data with your operational data (O-data) to transform how this information leads to powerful, clarifying insights.

With your X- and O-data combined, you have the tools to start making improvements with real impact. You know what you need to fix and what impact it will have on your most important metrics, whether it’s patient satisfaction, clinical outcomes, or business metrics like revenue and profit. By prioritising your investments in effectively measuring patient experience, you gain the insights you need to demonstrate the impact of your improvements across the organisation.

This is what XM looks like. As you strengthen the discipline of XM across your organisation, you develop habits of continuously listening, propagating insights and rapidly adapting, ultimately improving experiences.

For more information about how healthcare providers can move beyond the norm to better listen to patients, healthcare workers, and clinicians to drive maximum impact Watch webinar series - Prioritising healthcare in a world of change.

Epidemics and Society From the Black Death to the Present

Author(s): Frank M Snowden No of Pages: 600 Year of Publishing: October 22, 2019

Description:

A “brilliant and sobering” (Paul Kennedy, Wall Street Journal) look at the history and human costs of pandemic outbreaks The World Economic Forum #1 book to read for context on the coronavirus outbreak This sweeping exploration of the impact of epidemic diseases looks at how mass infectious outbreaks have shaped society, from the Black Death to today. In a clear and accessible style, Frank M. Snowden reveals the ways that diseases have not only influenced medical science and public health, but also transformed the arts, religion, intellectual history, and warfare. A multidisciplinary and comparative investigation of the medical and social history of the major epidemics, this volume touches on themes such as the evolution of medical therapy, plague literature, poverty, the environment, and mass hysteria.

Viruses: A Very Short Introduction

Author(s): Dorothy H. Crawford No of Pages: 176 Year of Publishing: 22 March 2018

Description:

Viruses are big news. From pandemics such as HIV, to swine flu, and SARS, we are constantly being bombarded with information about new lethal infections. In this Very Short Introduction Dorothy Crawford demonstrates how clever these entities really are. From their discovery and the unravelling of their intricate structures, Crawford demonstrates how these tiny parasites are by far the most abundant life forms on the planet. In this fully updated edition, Crawford recounts stories of renowned killer viruses such as the recent Ebola and Zika epidemics, as well as Middle East Respiratory Syndrome, and considers the importance of air travel in facilitating the international spread of viruses in the twenty first century. Discussing the impact of global warming, which is increasing the range of vector-transmitted viruses such as dengue, yellow fever, and West Nile virus, she also considers the effect this will have on native populations in subtropical and temperate climates of the Americas, Australasia, and Europe. By examining our lifestyle in the 21st century, Crawford looks to the future to ask whether we can ever live in harmony with emerging viruses with devastating consequences.

The Pandemic Century, One Hundred Years of Panic, Hysteria, and Hubris

Author(s): Mark Honigsbaum No of Pages: 464 Year of Publishing: April 9, 2019

Description:

In The Pandemic Century, a lively account of scares both infamous and less known, Mark Honigsbaum combines reportage with the history of science and medical sociology to artfully reconstruct epidemiological mysteries and the ecology of infectious diseases. We meet dedicated disease detectives, obstructive or incompetent public health officials, and brilliant scientists often blinded by their own knowledge of bacteria and viruses. We also see how fear of disease often exacerbates racial, religious, and ethnic tensions—even though, as the epidemiologists Malik Peiris and Yi Guan write, “‘nature’ remains the greatest bioterrorist threat of all.” Like man-eating sharks, predatory pathogens are always present in nature, waiting to strike; when one is seemingly vanquished, others appear in its place. These pandemics remind us of the limits of scientific knowledge, as well as the role that human behavior and technologies play in the emergence and spread of microbial diseases.

The Psychology of Pandemics, Preparing for the Next Global Outbreak of Infectious Disease

Author(s): Steven Taylor No of Pages: 178 Year of Publishing: 16 October 2019

Description:

Pandemics are large-scale epidemics that spread throughout the world. Virologists predict that the next pandemic could occur in the coming years, probably from some form of influenza, with potentially devastating consequences. Vaccinations, if available, and behavioral methods are vital for stemming the spread of infection. Psychological factors are important for many reasons. They play a role in nonadherence to vaccination and hygiene programs, and play an important role in how people cope with the threat of infection and associated losses. Psychological factors are important for understanding and managing societal problems associated with pandemics, such as the spreading of excessive fear, stigmatization, and xenophobia that occur when people are threatened with infection. This book offers the first comprehensive analysis of the psychology of pandemics. It describes the psychological reactions to pandemics, including maladaptive behaviors, emotions, and defensive reactions, and reviews the psychological vulnerability factors that contribute to the spreading of disease and distress. It also considers empirically supported methods for addressing these problems, and outlines the implications for public health planning.

On Pandemics: Deadly Diseases from Bubonic Plague to Coronavirus

Author(s): David Waltner-Toews No of Pages: 248 Year of Publishing: 28 May 2020

Description:

Authored by a leading epidemiologist, this engrossing book answers our questions about animal diseases that jump to humans—called zoonoses—including what attracts them to humans, why they have become more common in recent history, and how we can keep them at bay. Almost all pandemics and epidemics have been caused by diseases that come to us from animals, including SARS, mad cow disease, and—now—Covid-19. Chapters are broken into short, dynamic explainers, each one tackling a different disease. Readers will discover: • Why zoonotic diseases jump from animals to humans—and why some decide to stick around for good. • How governments have responded to pandemics and epidemics throughout history, for better or for worse. • The role of climate change, industrialized farming, cultural practices, biodiversity loss, and globalization in making these diseases not only possible, but inevitable outcomes of our modern lifestyles.

COVID-19: The Pandemic that Never Should Have Happened and How to Stop the Next On

Author(s): Debora MacKenzie No of Pages: 288 Year of Publishing: 1 June 2020

Description:

Debora MacKenzie has been reporting on emerging diseases for more than three decades, and she draws on that experience to explain how COVID-19 went from a potentially manageable outbreak to a global pandemic. Offering a compelling history of the most significant recent outbreaks, including SARS, MERS, H1N1, Zika, and Ebola, she gives a crash course in Epidemiology 101--how viruses spread and how pandemics end--and outlines the lessons we failed to learn from each past crisis. In vivid detail, she takes us through the arrival and spread of COVID-19, making clear the steps that governments knew they could have taken to prevent or at least prepare for this. Looking forward, MacKenzie makes a bold, optimistic argument: this pandemic might finally galvanize the world to take viruses seriously. Fighting this pandemic and preventing the next one will take political action of all kinds, globally, from governments, the scientific community, and individuals--but it is possible.

PRODUCTS & SERVICES

Company.............................................. Page No.

HEALTHCARE MANAGEMENT Fotona d. d .............................................................................. 03 HNC Expo................................................................................ 29 International Assistance Group............................................... 05 NHS Foundation Trust ............................................................. 07 United Nations Careers........................................................... 23

DIAGNOSTICS Coris BioConcept..................................................................... 13 Fotona d.d ............................................................................... 03

Company.............................................. Page No.

MEDICAL SCIENCES NHS Foundation Trust ............................................................. 07

TECHNOLOGY, EQUIPMENT & DEVICES Europlasma NV ....................................................................... 17 Fotona d. d .............................................................................. 03 NHS Foundation Trust ............................................................. 07

INFORMATION TECHNOLOGY Qualtrics ............................................................................ 60-61 United Nations Careers........................................................... 23

SUPPLIERS GUIDE

Company.............................................. Page No.

Clinivantage Healthcare Technologies .................................... 25

http://clinivantage.com/

Coris BioConcept..................................................................... 13

www.corisbio.com

Europlasma NV ....................................................................... 17

www.Europlasma.be

Fotona d. d .............................................................................. 03

www.fotona.com

HNC Expo................................................................................ 29

www.hncexpo.com

Company.............................................. Page No.

International Assistance Group............................................... 05

www.international-assistance-group.com

NHS Foundation Trust ............................................................. 07

www.guysandstthomasevents.co.uk/AsianHHM

Qualtrics ............................................................................ 60-61

www.qualtrics.com

United Nations Careers........................................................... 23

https://careers.un.org/

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