• Devices
  • India steps up certification training for medical device makers

    High quality medical devices are imperatives for healthcare. It may become more important as Africa’s health systems adopt more Internet of Things (IoT) initiatives. India’s first state-of-the-art medical devices manufacturing park in Visakhapatnam, the Andhra Pradesh MedTech Zone (AMTZ), organised a two-day industry training programme on quality certification. The aim’s to shorten the time and cost of achieving globally recognised quality certification for India’s medical device makers.

    A report in eHealth Magazine says the course was organised by Quality Council of India(QCI)  National Accreditation Board for Certification Bodies (NABCB) and Association of Indian Medical Device Industry. (AIMED). Medical device manufacturers, medical professionals and industry stakeholders were participants.

    There’s a need to fill the regulatory space in quality certification for India’s medical devices in the country.  The main themes included:

    ·       Interpretations and understanding of Conformité Européene (CE),  the European Commission (EC) the  labrynthine guidelines and regulations and product marking

    ·       Industry Indian Certification for Medical Devices (ICMED) certification 9000 and 13485

    ·       New Medical Device Rules 2017

    This could be a template for equivalent events for Africa’s device makers and users. As IoT expands, devices will have to keep up. Regulations and training are a vital ways to achieve it.

  • A microchip can regenerate cells

    A research team at Ohio State University Wexner Centre has set out its’ achievements that will revolutionise regenerative medicine. Using Tissue Nanotransfection (TNT), they can generate any cell type in patients’ own bodies. The technology can repair injured tissue or restore aging tissue’s functions, including organs, blood vessels and nerve cells.

    Injured or compromised organs can be replaced using TNT. The team’s successfully shown that skin can be fertile, and used to grow any cell type for a failing organ. Two organisations collaborated. Dr Chandan Sen led the team from Ohio State’s Center for Regenerative Medicine & Cell Based Therapies and Ohio State’s Nanoscale Science and Engineering Center in the College of Engineering. Its results are in Nature Nanotechnology.

    After studying mice and pigs in these experiments, the team reprogramed skin cells to become vascular cells in badly injured legs that lacked blood flow. Within a week, active blood vessels appeared in the injured leg. By the second week, the injury was saved. Lab tests showed reprogramed skin cells in a live body into nerve cells that were injected into brain-injured mice to help them recover from strokes.

    This breakthrough has huge implications for Africa’s health systems. Nano-technology programmes should find a firm place in their eHealth strategies, or have their own strategies. The benefits for patients, families and communities are considerable. The technologies tractor needs sustained, increasing benefits to secure the achievable sustained benefits.

  • A healthcare equipment tracking seizure shows eHealth’s risks

    eHealth’s never easy. Combining technical ICT with changing organisations’ and people’s behaviour’s always difficult. A project at the US Department of Veterans (sic) Affairs (VA) has come against these.

    A recent report from the DVA’s Office of the Inspector General (OIG) set out serious deficiencies in the way medical equipment was managed. They included:

    • No effective inventory system for managing medical equipment and supplies availability
    • No effective system to stop the use of supplies and equipment with patient safety recalls
    • Over 70% of 25 sterile satellite storage areas for supplies were dirty
    • Over $150m of equipment or supplies weren’t inventoried, so not accounted for
    • A lease on large warehouse of non-inventoried equipment, materials and supplies had a very short remaining, but subsequent accommodation was planned
    • Senior staff vacancies inhibit prompt solutions.

    Now, an eHealth solution started in 2012 track medical equipment’s seized up. Worth $543m, the contract with Hewlett-Packard Enterprise Services, now DXC Technology, offered a Real-Time Locating System (RTLS), a type of Internet of Things (IoT) that should be able to resolve some the OIG’s concerns. A report in My Statesman says in 2016, some four years later, the pilot was facing “catastrophic failure".  The VA and DXC say it’s due the change challenges of big-scale ICT projects. 

    This’s a routine eHealth phenomenon with healthcare as a Complex Adaptive System (CAS), so not an unexpected challenge. My Statesman also discovered two other factors. VA’s ICT spending seldom realises its benefits, and bureaucratic barriers often stifle innovation. 

    Fierce Healthcare has also highlighted VA’s plans to replace Veterans Information Systems and Technology Architecture (VISTA) with a Cerner EHR, another change challenge. A review by a House Oversight committee recently says the VA was ranked F on its data centre consolidation and ICT portfolio savings. In addition, the OIG had found “material weaknesses” in the VA’s cyber-security.

    This string of events shows that converting large healthcare organisations into fleet-of foot eHealth users isn’t easy. Without the transformation, eHealth risks rocket, bot salutary lessons for Africa’s health systems and their eHealth programmes.

  • Technology is key for South Africa’s healthcare future

    South Africans generally evaluate their health positively. This is what the annual Future Health Index found. Released by Royal Philips, most South Africans, 80%, rate their health “good, very good or excellent.” Healthcare professionals on the other hand are less optimistic. Roughly 33% of healthcare professionals agree that the overall health of the population in the country is positive says an article in IT-Online

    The discrepancy between the two views is vast. They likely stem from healthcare professionals perceptions of access to healthcare. Results suggest that both groups perceive more access to healthcare than the system provides. It seems to offer a requirement and an opportunity to improve healthcare access.

    “Through the Future Health Index, (FHI) we are examining current realities of how well the healthcare system is set up for the future in order to quantify the readiness of health systems across five continents to meet future healthcare challenges,” says Jasper Westerink, CEO of Philips Africa. “The FHI has uncovered a number of significant areas where our healthcare system must transform if we are going to succeed in delivering long-term value based care.”

    The report says both the general population and healthcare professionals in South Africa acknowledge the importance of connected care technology in preventing medical issues and contributing to the population’s health. Most participants believe that technology and innovations are underutilised, providing opportunities to increase healthcare’s effectiveness. eHealth and mHealth investment’s essential to set up a modern healthcare system for South Africa’s future.

  • Medical devices’ cyber-security testing’s not good enough

    As cyber-attacks expand, and since the alarm bells after WannaCry, reported on eHNA, cyber-security’s priority should’ve increased dramatically. It seems it’s starting from a low baseline for medical devices.

    A survey by Ponemon Institute for Synopsis says device suppliers think the chances of cyber-attacks on their products are 67%. US healthcare organisations as users think the probability’s 56%. These may be a bit low, but despite this, the survey shows only 5% of healthcare providers test their medical devices at least once a year. More alarmingly, 53% don’t test their cyber-security at all.

    A similar deficit prevails with device makers. Only 9% say they test their devices at least once a year. About 43% don’t test their device’s cyber-security. This highlights an important procurement criterion for Africa’s health systems.

    These are vulnerabilities that Africa’s health systems should address too. It’s especially critical when 80% of medical device makers and users say medical devices are very difficult to secure. Another vulnerability’s revealed by only 25% of respondents who say cyber-security protocols or architecture inside devices provide adequate protection for clinicians and patients.

    Medical Device Security: An Industry Under Attack and Unprepared to Defend says patients have already suffered from cyber-attacks and adverse events. About 31% of device makers and 40% of healthcare providers say they are aware of these. Of these, 38% of providers say inappropriate therapy or treatment was provided to patients. About 39% of device makers say cyber-attacks have taken control of their medical devices.             

    Ponemon’s report sets out a string of risks. They’re:

    • Device makers and users low confidence that patients and clinicians are protected
    • Using mobile devices affects healthcare organisations’ cyber-security’s risk postures. Clinicians depend upon their mobile devices to more efficiently serve patients
    • Budget increases to improve medical devices’ cyber-security often happen after a serious breach
    • Medical device security practices aren’t the most effective, relying on cyber-security requirements instead thorough practices such as testing
    • Most organisations don’t encrypt traffic between Internet of Thins (IoT) devices
    • Medical devices contain vulnerable code because of a lack of quality assurance and testing procedures and a rush to release
    • Testing rarely occurs, with only 9% of makers and 5% of users testing at least once a year
    • Accountability medical devices’ cyber-security is lacking
    • Makers and users aren’t aligned on current cyber-security risks, with healthcare providers more likely to be concerned about their devices’ cyber-security and risks, and suppliers’ lack of action to protect patients and users
    • Insufficient compliance with regulatory advice and guidance
    • Most makers and users don’t disclose their medical devices’ privacy and security risks. 

    Ponemon says makers and users say cyber-security’s hard to achieve. It suffers from accidental coding errors, lack of knowledge and training for secure coding practices and pressure on development teams to meet product deadlines. It seems that the clichéd paradigm shift’s needed.

  • Philips helps to accelerate healthcare in Kenya

    Transforming Africa’s healthcare’s a generic goal. Philips is partnering with Kenya’s government and the United Nations to transform the country’s primary healthcare. The initiative focuses on gaps in human resources, healthcare financing, essential medicines, medical supplies, health information, and using technology, says an article in IT News Africa.

    Philips is the first private sector company to collaborate on this type of initiative and establish a Sustainable Development Goals (SDG) Partnership Platform. The company will support the platform to establish a common knowledge base on primary healthcare by assessing current and future healthcare needs. It’ll enables platform members to work together to identify, design and implement initiatives.

    This project brings together executive leadership from government, development partners, private sector organisations and civil society. They'll investigate opportunities to accelerate universal access to Kenya's primary healthcare.The country’s constitution “Guarantees the rights to health as contained under article 43. The Council of Governors of Kenya is looking forward to closely collaborating with the SDG Partnership Platform to help accelerate universal access to primary healthcare in Kenya’s 47 counties through unlocking transformative public-private partnership investments,” said Mrs. Jacqueline Mogeni, CEO, Council of Governors, Kenya.

    Kenya’s been implementing healthcare technologies for some years. This partnership aims to accelerate its impact by making better use of healthcare information. It should help healthcare providers and policy makers make more informed, so better decisions.

  • IHE’s point of care ID management

    Accurate unique patients’ IDs are more than essential. Deviations from them can cause harm when using electronic sensors to observe patients’ physiological states are a common part of clinical treatment of patients, especially those critically ill. Recognising the importance of correct patient IDs in this context, the IHE Patient Care Device Technical Committee has published Point-of-Care Identity Management, a white paper for consultation. It considered comments submitted by 26 February 2017 and will now be moving on to finalise the proposals.

    With devices providing routine and regular mission-critical data, clinicians must be able to rely on the accuracy, currency, completeness and routing of eMessages between these devices and systems. Where this fails, treatment may be harmful rather than helpful. The IHE concept of Device-Patient Association (DPA) is consistent with the five rights of medication administration, the right patient, drug, dose, route and time.

    For devices, it translates into the right patient, devices and time. Every measurement must go to the right chart, every chart must have every measurement, and every device command affecting a patient must be sent to the correct device acting on that patient.

    The white paper:

    1. Reviews use cases and system architectures in which electronic information exchanges about device-patient associations may and may not be beneficial
    2. Discusses risk analysis approaches that may be appropriate for institutions reviewing their risks of data misdirection due to incomplete, incorrect or untimely DPA assumptions
    3. Suggests basic eMessaging formats for reporting, collecting, disseminating and querying DPAs.

    As Africa’s health systems expands in EHRs, mHealth and medical device investments, adopting and applying the IHE’s standards are crucial. The white paper’s a lot more than just essential reading.

  • IHE wants comments on endoscopy

    Four aspects of endoscopy can be seen as the instrument, the technique, a diagnostic tool and minimally invasive surgery. It’s a very valuable medical technology. Looking inside people is a clever way to avoid cutting them open.

    Endoscope’s aren’t a modern idea. Primed Canada says its inventor identified by most medical historians is Philip Bozzini. In 1805, he used a tube, lichtleiter, a light guiding instrument, he created, to examine urinary tracts. Antoine Jean Desormeaux, a French surgeon renamed it the endoscope. It’s claimed that in 1868, Adolph Kussmaul was the first person to use an endoscope to see the inside of a stomach of a living person. In 1878, two doctors, Max Nitze and Josef Leiter, invented an endoscope to inspect the urinary tract and bladder.

    None of these men concerned themselves with the informatics or eHealth standards and interoperability of their innovations. Integrating the Healthcare Enterprise (IHE) does. It’s released for consultation two supplements:

    Endoscopy Image Archiving (EIA)

    Endoscopy Ordering Workflow (EWF).

    The IHE Endoscopy Technical Committee wanted comments on these by 18 January 2017. They will now complete the supplements as part of the planned IHE Endoscopy Technical Framework.

  • Arclight makes eye exams cheaper and more accessible

    A simple eye examining device offers a cheap way to improve medical care and training in developing countries. It’s been successfully tested in Africa. Arclight is a pocket-sized ophthalmoscope, a medical instrument used to see inside patients' eyes, equipped with an LED to provide light, a magnifying lens and a rechargeable battery says an article in allAfrica.

    The device costs around US$8, and can help health workers detect eye diseases such as trachoma and glaucoma, say its developers at the Fred Hollows Foundation in Australia. Arclight can also be used in training for eye doctors and clinicians in developing countries. It’s small size makes it easy to carry around. Richard Le Mesurier, the foundation's medical director, says it’s small enough to fit snuggly in a pocket or be clipped to a lanyard.

    In developing countries, "health budgets are too small to accommodate the high costs of diagnostic instruments designed and produced for the well-resourced richer countries", Le Mesurier says. "We are doing what we can to bring the costs down to something much more affordable while maintaining quality."

    The device has been tested in Australia, Ethiopia, Fiji, Kenya, Tanzania, Malawi, Rwanda and the Solomon Islands. It has an inbuilt solar charger so users can recharge its battery in areas off the electricity grid.

    Ciku Mathenge, director of training at Dr Argawal's Eye Hospital in Rwanda, was involved in testing the device. She says that providing ophthalmoscopes to students is crucial to improve eye healthcare in resource-poor settings. "When I started my training, all I wanted was to afford my own ophthalmoscope, but I couldn't. The Arclight, provide all optomitrist students the opportunity to own their own ophthalmoscopes.

    But Cochrane, the global, independent research body sounds a note of caution, saying better diagnosis isn’t enough. Patients in poor countries need access to specialists too. "Referral pathways need to be established to ensure that when an eye problem presents, the patient can be sent to the appropriate eye care practitioner.". This can apply to many mHealth services in poor countries and insufficnet healthcare resources.

    A simple mHealth system helping healthcare workers identify the nearest or most appropriate specialist could be valuable in linking patients to doctors. Vulamobile, an mHealth system, can help to close this gap.

    The current version of Arclight comes with an otoscope attachment so it can be used for ear examinations. The inventors plan to release an updated version this year. It’ill include an inbuilt memory stick with training materials for student optometrists.

  • Why is medical device innovation so tough?

    Innovation in medicine is generally incremental, says Bill Betten, director of business solutions at Devicix. Generally speaking you build around what has been done before and develop the concept further or bring in a new innovative aspect.

    While leapfrogging in innovation can and does happen in medicine, it is rare says an article in Qmed. Betten’s top five reasons for this are:

    Financial Constraints

    Medical device companies often face considerable financial constraints that make it difficult to create revolutionary products, or even produce devices that are substantially less expensive but functionally equivalent to older technology.

    Regulatory Challenges

    While product development in itself is an expensive undertaking, it is especially so in a highly regulated environment such as the medical device industry. Regulatory costs run in the tens of millions of dollars for most 510(k) products, according to a report on AdvaMed’s website.

    Most technologies that are truly novel and groundbreaking must be approved via the PMA process in the United States. This route typically requires considerable clinical data. It can end up taking several years or even more than a decade to get a device to the U.S. market via the PMA program. In 2014, it cost an average of $94 million to market a medical device under the PMA program.

    Sociological Hurdles and Potential Litigation Costs

    The culture in the United States is relatively litigious when compared with that of many other developed nations. “In our society, we tend to worry more about killing one patient than we do about saving thousands,” Betten says, referring to the fact that there is often little attention given to the large number of devices that work as they are intended and that medical device companies routinely shell out tens or hundreds of millions of dollars to settle product liability lawsuits.

    The Challenge of Making Products That Cut Costs

    Despite the huge need to develop medical products that are less expensive than traditional technologies, there are relatively few companies developing such products. There are exceptions of course.

    Why Not Fast, Better, and Cheaper?

    In the healthcare field promising to create technology that is faster, better and cheaper tends to raise eyebrows. People are cautious of these initiatives. Most often, when it seems to good to be true it usually is.

    While his insights draw from his experience working in the US, similar innovation obstacles are faced the world over. African countries grapple with these constraints as well as a host of other challenges, which slow down innovation in healthcare.