At Patient Safety, Damien Berg, Past President, International Association of Healthcare Central Service Materiel Management (IAHCSMM); Regional Manager Sterile Processing, UCHealth, Colorado, U.S. will discuss his unconventional sterile processing journey – from a sterile processing tech in the military in the early 2000s, to a past president of IAHCSMM, a member of ISO, and an international speaker and traveller, who continues to be an operational manager.

In an interview with Omnia Health Magazine, he said: “I love what I do and don't want to get out of this field. At Patient Safety, I am looking forward to sharing my unconventional journey of leadership and development with the world. I often get asked what are some takeaways? How did you get where you are? And how can I get there? What are some tips? So, that's what I'm going to present with passion.”

Currently, Berg runs the day-to-day operations of two large hospitals in northern Colorado, and a surgery centre. “I got bit by the sterile processing bug early. Over the years, I have been writing policies and procedures for the industry and have immersed myself in all the regulatory aspects of sterile processing. I have also received Lean training, which I have applied to sterile processing,” he shared.

His stint as the president of IAHCSMM began in 2017 and ended in May this year, but he continues to work closely with the agency as well as others around the world.

“I do everything that all the other sterile processing managers do,” he said. “But in my spare time, I give lectures, write papers, do reviews and work with AAMI and ISO. It's just a non-stop passion for me! My passion is also to highlight the need to invest in people and departments that do such a critical job to save patients’ lives behind-the-scenes and provide world-class reprocessing. I am working with international organisations and being an “ambassador” for sterile processing and hope to share the global as well as the U.S. perspective with my counterparts around the world.”

Impact of COVID-19 on sterile processing

When COVID-19 struck initially, operating rooms essentially shut down for elective surgeries. The impact was immense, said Berg, as from 40 to 50 surgeries a day at each of his facilities, it came down to doing three to five. There were also questions about how to de-contaminate effectively. “We got those answers relatively quickly based on science and evidence-based practices. We were able to be that resource for the hospital to say that we have got this covered and that they don't need to worry about sterile processing as our practices and processes will render this Instruments safe.”

He said that due to the shortage of PPE and the impacts on the supply chain, hospitals had to get inventive and formed alliances with other hospitals. Berg elaborated: “I reached out to competitor hospitals said I have got a surplus of this stuff. What do you have? As they may have what I needed. So, we did a little trading and it worked out well. It changed how we thought about sterile processing – not working in silos just in our department but working for the whole hospital. We also put our technicians in other departments to help with cleaning and disinfection and getting the equipment back to the patient's bedside quickly, which allowed our care providers to focus solely on taking care of patients.”

Tech to the rescue

Berg emphasised that one of the things that everybody was tasked with across the globe was how to reprocess N95 masks. To achieve this, a lot of methods were discussed such as low-temperature vaporization peroxide, UV sterilisation, steam or heat, or dry heat. But there was not a lot of research or studies available nor was there clearance from the U.S. FDA for that type of reprocessing of that device.

“We took advantage of modern technology, but used it in different applications, based off the science, studies and researches that were available at the time,” he said. “I was part of a whitepaper review in Europe regarding trying to test different method modalities on the N95 mask. What technologies can kill COVID-19? Is it safe for the end-user to breathe? Will the mask start to deteriorate from UV processing? Or will it lose its fit through steam? I think when we discuss advancements in technology, what we need to do is look at our existing technologies differently.”

He explained that the emergency use authorization from the FDA allowed hospitals to do things they normally wouldn't be able to do because it was either that or nothing. Also, 3D printed devices were another breakthrough in the fight against COVID-19. “Brilliant minds around the world started coming up with concepts such as a 3D printed COVID-19 swabs and it raised questions around how could these be sterilised? I am working with different companies trying to figure that out. I am excited about the future that will be shaped by these technologies.”

Berg will be speaking on ‘The unconventional CSSD journey – Lessons in leadership and development’, on Saturday, 7 November at Patient Safety

At the upcoming virtual Patient Safety event, Geraldine McNulty MSc, Decontamination Lead/Medical Device & ISO 13485:2016 Hospital Representative, Kings College Hospital, Dubai Hills, Dubai, will be presenting a step-by-step guide that will give a better insight into how to achieve ISO 13485:2016 in a Clinical Sterile Services Department (CSSD) hospital setting.

Hailing from Galway, Ireland, McNulty told Omnia Health Magazine that she has always had an obsession for cleanliness and attention to detail. She always advocates the phrase ‘Quality is not an Act, it’s a Habit, the Patient Thanks You’.\

Between 1989-1993, she lived in London and was employed by several North London Hospitals such as Edgware General, Northwick Park, Stanmore Orthopaedic and Ealing Hospital, as a Care Assistant/CSSD Tech under the Mayfield Nursing Agency. She returned to Ireland in late 1993 and commenced a full-time CSSD Technician’s post at Bon Secours Hospital, Galway, Ireland, Bon Secours being the largest private Healthcare Group in Ireland.

In 2000, McNulty began a four-year Bachelor of Science in Sterile Service Management Degree in ITT Dublin. She became a CSSD Manager in 2005 and was instrumental in designing and opening a new purpose-built and fully functional ISO 8 Cleanroom & CSSD at Bon Secours. In 2008, she began a four-year, Master of Science in Microbiology at the National University of Ireland, Galway. In 2015 she completed a course on Auditing by SQT Ireland. And in 2017, she began and completed the Decontamination Lead Course, Roles & Responsibilities at Eastwood Park Training Centre, UK.

She highlighted that Bon Secours first achieved ISO 13485:2004 Certification in 2011 becoming the first CSSD Department in Ireland to do so under the National Standard Authority of Ireland (NSAI) Notified Body and again achieved ISO 13485:2016 in 2017.

In 2018, McNulty moved to Dubai where she has been working with Kings College Hospital, Dubai Hills since the design stage. She said: “We opened our doors to Patients in January 2019 and completed Stage 1 ISO 13485 audit with BSI in January 2020. Stage 2 was deferred until recently due to COVID-19 but was completed in October and was recommended for certification by BSI. We are due to receive our ISO 13485:2016 Certification, presented by BSI Notified Body in November 2020.”

As a CSSD veteran, when asked about the impact of COVID-19 on the department, McNulty said: “The pandemic has increased the health and safety awareness of the staff and put an increased focus on infection control, PPEs, decontamination of N95s, donning and doffing, and ensuring that proven validated biocidal detergents/disinfectants are in use.”

Furthermore, she emphasised that some of the technological advancements in sterile processing over the last few years include software traceability, barcoding, and aligning real-time equipment data to track and trace. Some others include validation on equipment, challenging and monitoring equipment; how to reduce and eliminate risks, develop controlled ISO 8 Cleanrooms where inspection and packaging tasks are carried out and revalidation of Cleanrooms; and quarterly Environmental Monitoring where reusable medical devices are exposed to the environment.

Quality control

The future of the CSSD, she said, would involve more intricate medical devices, for example, robotic surgery, and the importance of creating and maintaining Medical Device Files for each device, incorporating pictorials of the device, pictorials of tray assembly, IFUs, on-going training and competencies. “CSSDs are becoming more like a manufacturing plant with strict controls and monitoring in place. I encourage every CSSD department to strive for the Gold Standard ISO 13485:2016 and achieve it,” she added.

“All CSSDs should strive to achieve ISO 13485 Quality Management System, equal to manufactures of Medical Devices,” said McNulty. “CSSDs have the potential to become a revenue making Dept. and not just a service Dept. but to achieve this reprocessing must be maintained effectively and efficiently. Be organised, responsible and accountable as managers, continue personnel and staff development, listen to your staff, lead with integrity and encourage your staff to question every task.”

McNulty expressed that her work has brought her to some interesting places. She was one of the Directors of an Irish Registered Charity ‘Friends of Albania’ from 2005 -2017 and organised two weeks of medical supplies for surgeries and CSSD Training Programmes yearly at Mother Theresa’s Hospital Tirana.

She shared: “I travelled back and forth to Tripoli, Libya nine times from 2011-2014 and worked in two major hospitals there, developing and upgrading CSSDs and providing Training Programmes. I love a challenge both in work and in my personal life, hence my happiest place is when I’m on the summit of a mountain, whether it’s the Andes, Himalayas, Alps, Atlas, the Moreeb sand dune in Liwa etc., or in the midst of an ISO Audit. My motto in life is “let it all unfold as it’s supposed to” and my favourite word is “contentment”.

McNulty will be giving ‘An introduction to ISO 13485 requirements in a CSSD setting’ on Saturday 7 November at Patient Safety

Keeping patients safe is intrinsic to the work of healthcare professionals. It is at the core of all we strive to achieve, but unfortunately, modern medicine still sometimes falls short. There are identified gaps in the way patient information is recorded, with fragmented and “siloed” information. But thankfully, as technology plays an ever-increasing role in healthcare, it is helping to keep our patients safe.

As a doctor and a human being, I don’t know what I don’t know! There are inevitably pieces of information that are missing – from my Electronic Medical Records (EMR) system and from my patient’s memory. But as data-driven patient safety emerges, we have access to better tools, to achieve better patient outcomes. As demonstrated globally, Health Information Exchange (HIE) platforms allow healthcare professionals to safely and securely share a patient’s most important medical information, digitally. The technology allows us, as care providers, to securely share information in a way that was not possible before. The introduction of Malaffi is a strategic effort by the Department of Health Abu Dhabi towards a digital transformation of the healthcare ecosystem and is helping to further improve the quality of healthcare services and ensure patients’ safety. Knowledge really is power and by filling in inconsistencies in information, I can make better-informed decisions, which ultimately puts safety first.

Material and psychological benefits to safety

Within a clinical setting, HIEs offer both material and psychological advantages to safety, for both the healthcare professionals and the patient. Materially, HIEs provide access to a structured presentation of data including current and significant past medical conditions. I have the data on my EMR, but what an HIE provides is what is missing from this picture – filling critical knowledge gaps to aid clinical decision-making.

If we look at the psychological advantages, HIEs empower both the patient and the provider. Patients can be confident that the most informed decisions are being made about their care, based on accurate information from their individual health journey and avoid preventable errors. I have had patients say to me ‘Dr, I’ve seen my endocrinologist, you must have the results. Tell me what’s next’. This is a fantastic attitude for patients to have. This type of transparency and patient engagement makes sure we both invest in their safety, right from the start. As a doctor, I often got a very fragmented view of a patient care summary. There are gaps and grey areas. But HIEs provide a credible, holistic view, in an organised format. They give a comprehensive picture of my patient’s history, even if they have been seen outside of my network. By filling the gaps, it gives us detailed information on critical information, and this helps ensure safety is at the forefront of all my clinical practice.

Critical pieces of information

It is thought that up to 18% of patient safety errors and as many as 70% of adverse drug reactions could be eliminated if the right information, about the right patient, was made available. With the use of HIEs, this is possible. Critical pieces of missing information include details of any known allergies and current prescriptions, meaning that we can prevent potentially dangerous drug interactions or allergic reactions, and duplicate prescribing can be avoided. I can then add a note to a patient file to make sure any medications that are likely to cause adverse reactions aren’t included in any future prescriptions. Since I began using Malaffi in 2019, I have witnessed many instances where potential harm to the patient has been avoided because of the information that I have access to. For example, I saw a patient recently who was taking thyroxine for his condition. He didn’t realise, but he was actually taking a double dose. He had been prescribed the same medication twice, by different doctors, with two different brand names. Malaffi helped me spot and correct that error, saving the patient from potential significant side effects.

Invasive tests and harmful exposure

HIEs prevent unnecessary and repetitive diagnostic tests by presenting relevant recent results to all clinicians involved in patient care, hence reducing the exposure to radiation (scans etc) and other invasive procedures.

A better coordination of care

Arguably the ultimate benefit of an HIE is in the coordination of care, offering a better healthcare experience and improving outcomes. For example, if a patient is admitted to hospital to receive treatment for an acute condition, and he returns to me, as his family physician for follow up, I can see what they were admitted for, what tests and investigations were carried out, what the diagnosis was, and any prescribed medications. Historically, medical records are often fractured, illegible, and as a clinician I felt a duty to check everything, to ensure my patient's safety. This often caused a critical delay in patient care, as waiting for information or results to be shared caused valuable time to be lost.

Malaffi’s role in Abu Dhabi’s COVID response

The absolute requirement for healthcare systems to have accurate, complete data on public health available to them, when and where it is needed, was never more apparent than during the recent pandemic. In countries like Singapore, where lessons had been learnt from the SARS experience almost twenty years ago, the use of their tech-driven health system helped shape the countries disaster preparedness. In the UAE, as an immediate response, Malaffi integrated all lab services in the Emirate providing access to real-time results which weren’t subject to manual delays. Access to medical history and information on any underlying health conditions enabled HCPs to triage patients quickly and effectively. Malaffi plays a critical tool in containing the virus and helps keep us all safe, particularly those most at-risk. 

The future of patient safety

Looking at the bigger picture, I see huge opportunities for HIEs to improve patient safety further and to support health management of the community. Never before have we had access to credible, reliable, clinical data, on such a large scale. I would like to see the UAE develop chronic condition registers. By monitoring certain criteria for every patient that we see, we can not only improve outcomes but ensure that the DoH can focus their resources on areas that really need improvement. It allows a better picture of public health to be formed. With credible data, we can strategise accurately for the health and safety of our community.

References available on request

Dr Goyal will be speaking on  ‘Improving patient safety by bridging the information gap – The case of health information exchange’ on Friday, 6 November at Patient Safety

Named as one of the Most Powerful Persons in Modern Healthcare, Prof. David Nash, founding dean emeritus of the Jefferson College of Population Health (JCPH) of Thomas Jefferson University and the Dr Raymond C. and Doris N. Grandon Professor of Health Policy, Philadelphia, U.S., will be participating at the upcoming Patient Safety virtual event. Prof. Nash has achieved wide acclaim for his COVID-19 thought leadership and will be speaking at the session titled ‘Population Health BC and AC – Before COVID & After COVID’.

In an interview with Omnia Health Magazine, Dr Nash shared that the presentation will cover four key topics. “During the height of the pandemic, some of the hospitals in the U.S. were using an incident command structure, which is essentially an emergency structure that has several important themes built into it. This includes a daily huddle, or multiple times a day, where all the leaders get on a call together to talk about how things are going. Another component of the structure is issuing regular guidelines for care, as they are important in day-to-day quality and safety to improve performance. Evaluation, feedback, closure of the feedback loop, all of these things are very relevant to the quality and safety agenda.”

He highlighted that in the U.S. there has been some evidence of diffusion of an incident command culture, post-COVID-19. This means that things that worked can be carried over in non-emergency situations as well to improve patient outcomes.

Secondly, the U.S. is going to see a growth in integrated delivery systems and hospital mergers. “Many hospitals suffered terrible economic losses and layoffs,” he said. “It’s ironic that in the middle of a public health emergency, hospitals were laying off people. As a result of the financial strain, we’re going to see weaker hospitals join larger systems. But this does not guarantee that quality and safety will improve.”

Thirdly, there needs to be a recognition of the social determinants of health, factors that have affected the society the most in the COVID-19 era and have had a huge impact on health. This is especially true for poor countries that might not have the resources to tackle the pandemic, and the people who have suffered the most are the poor and minority communities in almost every country. “The impact of COVID-19 can’t just be determined by tests, procedures and laboratory results. It has to do more with poverty, lack of education, crime, drug abuse, depression, and loneliness, among other factors. Global recognition of the social determinants of health is paramount,” he added.

Lastly, the session will also touch on the struggle between public health and the healthcare system. Dr Nash explained: “When public health is working, we don’t pay any attention to it. This refers to access to clean water, ensuring restaurants are safe, the air is clean, people have vaccines for all the previous infectious diseases, so public health operates quietly in the background. But it’s severely underfunded, especially in the U.S. For example, the national U.S. healthcare spending per person is roughly US$10,000 per person, including children annually, while total public health spending per person in the U.S., in 2019, was US$275. That’s why it is no surprise that the public health system got crushed by COVID-19. It failed because it was destined to as it was so severely underfunded and under-appreciated. We are now hoping for a convergence of the public health and healthcare system in the post-COVID world.”

Army of first preventers

Dr Nash has been an advocate of creating an “army of first preventers”, people who work in the community and are focused on prevention. “It means we should focus on preventing illness rather than always taking care of people after they’re sick. The focus should always be on prevention. So, instead of first responders, we should be speaking to our first preventers,” he explained.

He also spoke about contact tracing and how most people hadn’t heard of until the pandemic.

“Contact tracing has been around for more than a century. It’s a proven technology and a well-established basic tool for improving public health. Unfortunately, the U.S. was totally unprepared to do contact tracing,” stressed Dr Nash. “People had not been trained, and most people were scared of it, as it seemed too intrusive.”

He gave the example of China, where one of the reasons for their success was the contact tracing they carried out through technology, with their cell phones. An average Chinese citizen would be tracked and photographed every day, which citizens in the U.S. would never tolerate. “We would view it as a totalitarian state. On the other hand, it’s a very successful tool for isolation and quarantine. Do you want your freedom, or do you want to stop COVID-19? It’s a culture clash,” he added.

Digital transformation

Telemedicine is a big new market that can greatly help with mental health, especially in the U.S. where there is an acute shortage of mental health workers, said Dr Nash. “During the pandemic, there was a real exponential increase in people accessing telehealth. It is a big business now, which was pretty sleepy before the pandemic.”

He also shared that the Jefferson College of Population Health has a population health intelligence course, a broad term that includes big data, analytics and predictive analytics. “While we need the collection and analysis of the data, we also need actionable items from it,” he stressed. “You need to get information from the data. The tools to derive actionable information include artificial intelligence and predictive analytics. Multiple companies in the U.S are taking advantage of this, which is exciting. I think it’ll be far more widespread in 2021 and 2022 than it is now.”

When asked about how the post-COVID-19 world should look like, he concluded: “We need better leadership; people who can put their ego aside and stimulate teams. We need people who are optimistic about the future, despite the challenges. We need leaders who can look beyond the immediate situation and have a long-term vision.

“I hope that we can have better international cooperation to fight the next pandemic, which will inevitably occur. I am hoping for improved communication and cooperation and better preparedness. We will also see a greater interest in public health.”

Dr Nash will be in conversation with Dr Samer Ellahham, Regional Chair, Middle East Patient Safety Movement Foundation; Director, Accreditation; Cardiology Consultant, Cleveland Clinic Care Giver, Cleveland Clinic Abu Dhabi, at a session titled ‘Population Health BC and AC – Before COVID & After COVID’, on Thursday, November 5, at Patient Safety

Patient Safety, organised by Informa Markets, is the only congress in the region that integrates multiple disciplines relating to patient safety, healthcare epidemiology, public health, risk management and infection control and prevention. Running virtually, the theme of the event is ‘Embracing the new normal – repositioning patient safety in the era of COVID-19’. The event aims to connect healthcare leaders and practitioners worldwide while sharing best practice and driving patient safety in the new normal.

Patient Safety Officers, Infection Preventionists, Infection Control Managers, Infectious Disease Consultants, CSSD Technicians, and Nurses from across the globe will be tuning in to stay up-to-date on relevant topics impacting patient safety, decontamination and infection control.

Taking place from 5 to 7 November, the event will provide attendees with the opportunity to do business remotely and network with global suppliers such as Advanced Sterilization Products (ASP), BD, Kiwi Medical Supplies, Steelco, and Al Fahim Healthcare Solutions to name a few. Plus, attendees can earn up to 30 CME credits from 24 webinars. All the conference sessions are built to suit global time zones, which allows attendees to tune in live or rewind back with on-demand webinars.

One such session is going to be led by M. Robert De Jong, RDMS, RVT, FAIUM, FSDMS. Owner & Independent Consultant, Bob DeJong, LLC, Baltimore, Maryland, U.S., on Thursday, 5 November. He will be discussing the ‘Importance of high-level disinfection for ultrasound probe’.

In an interview with Omnia Health Magazine, he gives a sneak peek into his talk. He shared: “The main focus of my talk is going to be on high-level disinfection in ultrasound. A lot is coming to light about how ultrasound transducers have different pathogens on them and how we’re potentially causing our patients to get infected. There are a couple of articles that have already shown issues with ultrasound contaminating patients, and the research is still ongoing. We still have a long way to go to understand how ultrasound could potentially be causing harm to patients.”

Disinfection is key

De Jong stresses that one of the tenets of patient safety is making sure all of the equipment is properly disinfected. “Unfortunately, in some instances, people rush and don’t do the disinfection process thoroughly,” he said. “That leaves our next patient open to getting infected. As healthcare workers, we have to make sure we’re protecting ourselves and our patients, by washing our hands properly. I think if we had taken the disinfection process more seriously, then COVID-19 might not have spread as quickly. We need to take a step back and say, I know it takes extra time, but we have to do that to protect our patients, ourselves and our families.”

Robert De Jong

When it comes to disinfecting ultrasound equipment, he highlighted that when scanning through intact skin and if the patient doesn’t have a surgical post-op wound or open sores, low-level disinfection can be done. However, if the transducer touches body fluids or mucous membranes, then high-level disinfection would need to be carried out even if a transducer cover was used.

“I am a firm believer that all transducers whenever possible should receive high-level disinfection because this stuff lasts for weeks on surfaces. We can’t continue to wipe the transducer with a cloth thinking we did a good job, when, in fact, we didn’t follow the instructions properly,” De Jong emphasised.

When asked if technology could help in making ultrasound safer, he shared the example of a device available in the market today that uses sophisticated hydrogen peroxide to disinfect. It allows you to put the transducer into a cabinet, press the button and seven minutes later you’ve got a high-level disinfected transducer. The important thing about this device is that it also disinfects the handle, which can be contaminated and is often neglected.

He concluded: “I think the ultrasound community needs to start taking disinfection more seriously. There are still some factions that don’t believe they are infecting their patients and are still doing low-level disinfection when they ideally should be carrying out high-level disinfection.”

Other key topics that will be discussed at Patient Safety include the expedited role of high technology and AI in patient safety; lean management practices in CSSD; and blockchain technology for patient safety, among others.

For more info visit: www.patientsafety-me.com

While the novelty of asserting that the global pandemic has rapidly accelerated the uptake of telemedicine and remote second opinion services has by now worn off, insights into the current state of cross-border distance health services remain much less common. As of October 2020, the U.S. continues to maintain entry restrictions for foreign nationals who are traveling from certain countries – regardless of visa status – and routine visa services are still suspended at many American consular posts worldwide. Prospective international patients wishing to receive care at American hospitals may face significant administrative hurdles when trying to obtain a visa or when attempting to travel to the U.S. As such, U.S. hospitals with international programs have recognized both the need to scale up their international digital health offerings as well as the importance of working with their global partners when travel to the U.S. may not be possible.

The US Cooperative for International Patient Programs (USCIPP) – a program of the National Center for Healthcare Leadership, a Chicago-based 501(c)(3) nonprofit organization – recently conducted a survey of 40 U.S. hospitals and health systems with international services divisions to find out more about their international telemedicine and remote second opinion (RSO) programs. Figure 1 contains USCIPP’s standard definitions for both telemedicine and remote second opinions as well as further subclassifications for both telemedicine and remote second opinions.

Figure 1

 

According to the survey, the top specialties for international telemedicine or RSO services provided by U.S. hospitals in 2020 were oncology, neurology, and cardiology. These results are unsurprising and mirror the hospitals’ top service lines for international patient care delivered in person. Moreover, numerous American hospitals also reported that they regularly receive requests for cross-border distance health services involving multidisciplinary team case review.

When comparing the period from January–July 2020 to the same period in 2019, the survey results showed that nearly all types of international telemedicine and RSO services increased, with the total volume of real-time telemedicine encounters ballooning by 636%.

UAE case study

According to USCIPP’s proprietary research and its cross-border collaborations dashboard, the UAE ranks as the country with the second greatest total number of international healthcare collaborations (after China). There are at least 100 documented collaborations in the UAE. (Note that the dashboard typically does not include collaborations involving tech companies, insurance providers, NGOs, medical facilitators, or two governmental entities)

Of the 100 Emirati collaborations known to USCIPP, some 62 are between American hospitals and Emirati organizations in both the public and private sectors. Indeed, the UAE is one of the most important partner countries for U.S. hospitals, both for international patient care – the UAE consistently ranks as one of the top countries of home origin for medical travelers receiving treatment in the U.S. – and in terms of cross-border education and training programs, management services agreements, advisory and consulting services, joint ventures, distance health services agreements, etc.

During the pandemic, U.S. hospitals and health systems have continued to work closely with their Emirati colleagues, including the International Patient Care (IPC) division at the Department of Health – Abu Dhabi (DOH). DOH formally halted IPC services in March 2020 due to the pandemic; as of August 2020, IPC services remain suspended, “with the exception of urgent cases whose treatment is not available in the UAE”. Given the restrictions, several U.S. hospitals have reported that they are working with DOH and Emirati providers to offer telemedicine and RSO services to Emirati patients.

The UAE regulatory framework in relation to telemedicine has broadened in recent years, as technology advances and healthcare providers and consumers respectively seek more convenient ways to provide and access treatment. Regulations surrounding telemedicine naturally fall into two areas: 1) regulating the provision of care and 2) regulating the protection of data. The UAE is keen to promote the option of accessing care remotely to patients, a trend which has only become more apparent and important during the current pandemic. In 2019, the UAE Cabinet issued a set of Controls and Conditions of Providing Remote Health Services as part of Resolution 40 of 2019 on Medical Liability, a federal ruling largely tracked DOH’s recent release of its Standards on Tele-Medicine and the Dubai Health Authority’s Standards for Telehealth Services. Facilities wishing to offer telemedicine must be licensed, with the DOH offering six distinct new activities, including Tele-Prescription, Tele-Medical Interventions, Tele-Counselling, and Tele-Consultation. Practitioners will not require any additional licensing beyond their current DOH accreditation.

While the regulations and directions regarding the provision of care might appear to signal opportunities for U.S.-based providers to offer telemedicine to UAE-based consumers, the data protection framework gives cause for caution.

The DOH Standard on Patient Healthcare Data Privacy states that “entities shall perform a privacy risk assessment to understand and implement the controls as appropriate”, while also stating that “no entity is permitted to store, develop, or transfer [patient health information] outside the UAE that is related to health services provided within Abu Dhabi”.

This directly reflects UAE Federal Law No. 2 of 2019 on the Use of the Information and Communication Technology in Health Fields. The law provides that the regulatory authorities may give permission for the transfer or processing of health data outside of the UAE, but as of yet the authorities have not publicly issued any guidance on how to obtain this permission or what might be required to do so.

Given this absence of an authorization mechanism, the absolute prescription on the international transfer of health data by UAE entities stands, making it theoretically prohibited for UAE-based physicians to share information in order for professionals elsewhere to provide second opinions or even for UAE healthcare providers to store patient data on company servers based outside of the UAE. Notwithstanding this, IPC services are conducted in conjunction with the DOH, and the US hospitals working with DOH to provide services to Emiratis who would otherwise seek permission to travel for non-urgent treatment will have structured the patient care in such a way as to be in compliance with the law or will have been granted the proper approvals to carry out this work.

The UAE healthcare market is an attractive one to international providers, with a working-age population, compulsory private health cover, and relative affluence among a large proportion of locals and expats. Those providers that wish to access the market but don’t benefit from an IPC agreement with the DOH and/or other facilities may find that the best course of action is to establish a local entity with UAE-based professionals and, crucially, UAE-based record-management systems or to market themselves so as to reach residents and citizens without needing to establish a domestic presence.

Dr Graccho Alvim, Director, Hospital Association of Rio de Janeiro, Brazil, dons many hats. He’s a physician and doctor, who graduated in 1987 from the Federal University of Rio de Janeiro and worked for about 30 years as a director of private hospitals. In the last five years, he was instrumental in setting up an international healthcare consulting firm. He is also a representative of Global Health Accreditation (GHA), a leading medical travel accreditation for hospitals and clinics worldwide and has founded an organisation involved in medical tourism.

At Omnia Health Live Americas, Dr Alvim will put the spotlight on medical tourism in the Latin Americas region. In an interview with Omnia Health Magazine, he said that the event is a great platform for healthcare practitioners to exchange ideas and learn from each other and will provide the perfect opportunity to connect with organisations involved in medical tourism. “We research medical tourism programmes from countries around the world such as Thailand, Costa Rica, UAE and Germany, among others, to identify the best solutions for Brazil. Due to COVID-19, we can’t meet in person, therefore, at Omnia Health Live Americas we are going to discuss how medical tourism has been impacted by the pandemic.”

He said that Latin American countries such as Ecuador, Peru, Colombia, Argentina, and Chile have been seriously affected by COVID-19. In fact, Brazil saw more than 150,000 deaths from the disease.

“We had some challenges in the region such as the low number of tests carried out and underreporting of cases,” he elaborated. “All the private hospitals cancelled elective surgeries and only treated emergencies, leading to a large drop in revenue in hospitals. Treatment of patients with chronic diseases was also put on hold leading to a backlog of critical patients in need of care. However, Brazil has a strong public healthcare system and has been able to control the disease and received support for funding and infrastructural challenges.”

These factors have played an important role in increasing medical tourism in Brazil. For instance, people in remote areas of the country have been travelling to city centres to receive treatments. Moreover, Brazil has also been receiving a high volume of COVID-19 patients from South American countries such as Paraguay, Colombia and Peru for treatments in certain renowned hospitals in Rio de Janeiro and Sao Paulo.

He highlighted: “Domestic medical tourism has increased dramatically and become more effective and a less expensive choice to treat people living in remote areas without proper resource. We saw people renting planes and boats to come to get treated at the bigger centres in Brazil.”

Positive changes

Dr Alvim said that before the pandemic telemedicine was allowed only in radiology in Brazil. However, since March, there has been a steady rise in teleconsultations from patients looking to get advice from doctors, nurses, psychologists, and nutritionists. Also, healthcare companies have developed the latest proprietary systems, equipment’s and gadgets to attend to the patients and treat them efficiently.

“This has had a big impact on medical tourism. While these modifications are in place specifically during the pandemic, I believe positive changes will continue to occur to treat patients better remotely, especially in resource-constrained areas,” he added.

The doctor stressed that COVID-19 is a disease that won’t go away quickly. Therefore, it is important for hospitals to keep some areas COVID-19 free for emergency patients and to have better tests and analyse such cases separately. Also, it is essential to identify non-susceptible staff to treat these patients.

He also mentioned that it is essential to reduce contamination and establish and monitor better protocols in therapy to control the disease. It is also important to coordinate contact tracing with relevant to authorities and monitor cross infections inside the unit.

He concluded: “Last but not least, the world needs to come together to establish protocols to deal with the virus. Unfortunately, another such virus might be around the corner and we need to come together for the interest and well-being of everybody.

Dr Alvim will be a panellist at the ‘Global strategies for medical tourism in the COVID world’ on Friday, Nov 6 at Omnia Health Live Americas

Recognised as one of Fortunes’ 40 under 40 leaders in Healthcare for 2020, Amir Barsoum, CEO & Co-founder, Vezeeta, aims to empower consumers to make more informed healthcare decisions. With the digital healthcare booking platform, he has redefined the future of healthcare in the MENA with cutting-edge digital solutions.

Vezeeta has a network of 21,000 locally licensed doctors across 41 medical specialities and operates across six countries – Egypt, Saudi Arabia, Kenya, Nigeria, Jordan and Lebanon. Its digital healthcare product portfolio includes online booking for doctors’ appointments, teleconsultations, doctors’ home visits, and online ordering and delivery of medications.

In an interview with Omnia Health Magazine, Barsoum said: “Vezeeta was started in late 2012 when we realised how isolated healthcare providers were and how everybody was operating in a silo. Due to this, patients were suffering from a lack of data transparency and connection between healthcare providers. We came up with the vision of connecting different players together and offering this platform to the patients so that they could access healthcare easily. The first product that we launched after conducting different trials was helping patients access face-to-face doctor consultations. That has expanded with time to more products that are especially relevant today.”

Responding to COVID-19

By constantly innovating the digital healthcare roadmap to serve over six million patients across six countries during a pandemic, the CEO has guided Vezeeta’s success by enabling quality healthcare to the millions of underserved communities by optimising artificial intelligence (AI)-powered tools to make the patients’ healthcare journey easier.

COVID-19 caused a major shift in the way healthcare is accessed. Since people were homebound due to the pandemic, Vezeeta introduced three initiatives to serve its community better. First was teleconsultation, while the second was home visits where the platform helped doctors and nurses visit the patients at home. The third initiative was the online pharmacy, which was introduced in certain areas in Cairo, and has been growing well, shared Barsoum.

“Instead of taking patients to providers, we helped them give the care that they need from the comfort of their homes, or, in some cases, helped bring the providers to their doorstep,” he added.

Amir Barsoum

Tech acceleration

While COVID-19 accelerated the adoption of telemedicine, it remains to be seen whether patients will continue using these technologies or if it would fade away once things normalise, he stressed.

Barsoum said that at Vezeeta, AI and machine learning are being used to improve current processes. For instance, the company has adopted machine learning in the pharmacy space. So, when a patient takes a copy or photo of the prescription, the app automatically converts that into data. “This improves the quality of healthcare, and eliminates or reduces the human error,” he highlighted.

Moreover, machine learning is helping to create patient-provider matchmaking. Barsoum explained that this introduces patients, based on the profiling in their system, with a doctor who would be more relevant to the patient, in terms of carrying out follow up visits, etc. “Machine learning is here to stay in healthcare,” he said. “It’s an industry that’s full of data, that is super sensitive. I think machine learning could do a lot there. But most probably, it would jump into the spaces where you would need to improve what’s already been done.”

He concluded: “We are going to continue to cement our presence in existing markets and expand our offerings. But in the near future, our goal is to launch new products and are also looking to enter the UAE and Pakistan markets.”

Rapid COVID-19 diagnostic testing in the UK has generated good results, despite challenges - and much of this was because of effective collaboration across the nation, according to emergency medicine specialist Professor Rick Body.

He was providing an update on testing in Britain, along with achievements and learnings to date, during an Omnia Health Live Americas session moderated by Carlos Eduardo dos Santos Ferreira, President of the Brazilian Society of Clinical Pathologists (Sociedade Brasileira de Patologia Clinica).

Prof Body leads the COVID-19 National DiagnOstic Research and Evaluation Platform (CONDOR) in the UK, a publicly-funded programme that creates a single path for evaluating new diagnostic tests in hospitals.

He revealed the UK's testing strategy that comprises four pillars, including swab testing in hospitals for those with clinical need; serology testing for COVID-19 antibodies; swab testing in the wider population; and serology & swab testing for national surveillance, before sharing an update on tests to date.

In short, "the UK is doing a lot of tests," he said, showing a chart depicting daily new COVID-19 tests per 1,000 people, "and some of that is because we're in the middle of a second wave." 

The chart shows the UK in highest place worldwide for rolling 7 day average  as of 26 October 2020, ahead of France, the US, Germany, Canada, Australia, India and South Korea.

While the UK has a reasonable testing capacity, the question remains as to whether testing is done in the right way and at the right time to inform the pandemic response.

Diagnostic testing: what to evaluate

Prof Body suggested the following for consideration ahead of any new COVID-19 testing: mapping out current care pathways; identifying how POCT may be used to improve current pathways; and agreeing on the new care pathway. 

In addition it was important to establish strong analytical validation of tests through limit of detection; estimating accuracy in stored/contrived samples; and evaluating biosafety.

Most importantly, the diagnostic accuracy of tests must be assessed, through prospective study, appropriate reference standard and appropriate statistical power.

The last point for consideration, Prof Body highlighted, was usability or human factors. If people can't use the test properly, it won't have the desired impact - especially for rapid tests, in nursing homes for example.

The CONDOR programme was set up to establish validation needs through a nationwide collaboration. 

Funded from 1 June, it proceeded with generating as much evidence for new tests as possible through setting up multiple workstreams.

FALCON study

Within CONDOR a multi-centre study named FALCON (Facilitating AcceLerated Clinical validation Of novel diagnostics for COVID-19) was set up to look at diagnostic accuracy in hospitals, funded by Asthma UK and the National Institute for Health Research (NIHR), with Prof Body as Chief Investigator.

Currently there are 40-50 sites across the UK, and patients provide their consent to having extra samples taken.

It quickly became evident that the volume coming through hospitals was insufficient. The FALCON study aimed to gather evidence faster and therefore the programme was extended to include community testing centres across the country, alongside hospitals.

People in the community who had tested positive for COVID-19 were invited to the testing centre to evaluate sensitivity of lateral flow tests.

It was, Prof Body acknowledged, "a very successful method" - in little more than a month, 850 patients participated in testing centres. This was down in part to collaboration across the country that was "humbling", and project management support from Deloitte in its rapid delivery of workstreams.

Challenges

In August 2020, a group of senior politicians informed by scientists developed a white paper, "Taking the UK's Testing Strategy to the Next Level", calling on the UK government to change its testing strategy - and this has changed the UK's approach to testing, especially test evaluation. 

This made planning "very tricky", Prof Body said. Samples sizes - and target product profiles that suggest what they should be - are usually set up in advance. But what's happening is that they are changing in the course of the evaluation - making it difficult to plan a strategy for clinical evidence. 

In addition, it takes time to obtain prospective data in busy hospitals, and for diagnostic research. CONDOR relies on a network of clinical research nurses across the country who have been "outstanding" in getting this data quickly. 

Prof Body questioned whether diagnostic research was budgeted appropriately, highlighting how it doesn't appear to receive the same attention as vaccine research or treatment research.