• Devices
  • 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:

    Reviews use cases and system architectures in which electronic information exchanges about device-patient associations may and may not be beneficialDiscusses risk analysis approaches that may be appropriate for institutions reviewing their risks of data misdirection due to incomplete, incorrect or untimely DPA assumptionsSuggests 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.

  • US FDA issues cyber-security guideline for medical devices

    As cyber-criminals find new ways into eHealth, the US Food and Drug Administration (FDA) seeks to minimise the holes and risks in medical devices, many of which are part of eHealth networks. Its guidance in Postmarket Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff sets out obligation on manufacturers by encouraging them to address cyber-security throughout device lifecycles. It extends across pre-market and post-market activities, so “Design, development, production, distribution, deployment and maintenance.”

    It’s both realistic and practical. The guidance recognises that the constantly evolving cyber-security risks to medical devices make it impossible to mitigate risks completely by pre-market controls alone. A core action’s for manufacturers to implement comprehensive cyber-security risk management programmes and documentation. The focus of assessing the risk of patient harm should consider:

    Exploitability of cyber-security vulnerabilitiesSeverity of patient harm if vulnerabilities are exploited.

    An example of these assessments is using the Common Vulnerability Scoring System (CVVS) Version 3.0. It has several factors that combine to provide numerical ratings of high, medium and low exploitability levels, including: 

    Attack vector as physical, local, adjacent or  networkAttack complexity as high or lowPrivileges required as (none, low or highUser Interactions as none or requiredScope as changed or unchangedConfidentiality Impact as high, low or noneIntegrity Impact as none, low or highAvailability Impact as high, low or, noneExploit code maturity as high, functional, proof-of-concept or unprovenRemediation level as unavailable, work-around, temporary fix, official fix or, not definedReport confidence as confirmed, reasonable, unknown or not defined.

    As Africa’s eHealth steps up its cyber-security and regulations, the FDA’s guidance provides a constructive reminder that medical devices can’t be ignored. It’s a good starting point for Africa’s health systems to consult on and set the required eHealth regulations in place.

  • 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.

  • India has a smart diagnostic device for CHWs

    In rural areas, results from diagnostic tests can take an age. Device Talk has a post saying India Swasthya (Health) Slate’s here to help.  A device has been used as a mobile platform connecting to a digital thermometer, blood pressure monitor, heart rate sensor, 3-lead ECG system, blood sugar monitor and a water quality meter.

    Now, the unit uses Bluetooth to communicate with a Swasthya Slate app on an Android phone or tablet to run 33 diagnostic tests. They extended range includes rapid pregnancy, urine protein, rapid typhoid test, dengue and HIV 1 and HIV 2 testing. It stores data in the cloud very easily and quickly and doesn’t need an Internet connection. It can use SMSs to upload data, and results are back in a few minutes. It’s already being used in Nigeria. 

    The average learning time to first correctly use the device is claimed as ten minutes. By 45 minutes, users can use the apps with less than 1% errors arising from slips like accidental button pressing. A You Tube video has a demonstration.

    Swasthya Slate also has value for health and epidemiological research. This increases its value as a tool for patients and rural CHWs. At a price of about US$600, it’s not hard to see how it offers good value for money.

    Kanov Kahol, a team leader of Affordable Health Technologies Division, Public Health Foundation of India, is credited with conceiving the device. He was previously an assistant professor in the School of Biological and Health Systems Engineering, Arizona State University, and held a similar post at the an assistant professor adjunct in Mayo Clinic, which has a major site in Phoenix.

  • Tanzania has a new diabetes management device

    Diabetes is a huge and growing problem, and the costs to society are high and escalating. The disease’s reaching epidemic proportions the world over, so includes Africa. In 2013, approximately 19.6 million people suffered from diabetes in Africa, says the International Diabetes Federation (IDF). It estimates that there’ll be more people suffering, around 41.5 million by 2035.

    In 2013, Tanzania had 1.7 million people living with diabetes, the fourth highest in Africa. To address the problem, the country’s launching an innovative device to help people with diabetes manage their condition better.

    Thousands of Tanzanians with diabetes will now be able to send their glucose levels to doctors using a smart technology device introduced by Cumii International to ensure efficient diabetes management. The device will be launched within the next month, says an article in All Africa. 

    It’ll utilise the Internet of Things (IOT), It’s expected to revolutionise the existing smart technology market in Tanzania, as it provides a practical and essential solution to consumers in both urban and rural areas.

    Norman Moyo, the CEO of Cumii International, said he’s excited about the possibilities of IoT. "Africa is on the threshold of a new era of innovation and change with the convergence of industry powered by computing, analytics, low cost sensing and higher level of connectivity. This is bringing a profound transformation to many aspects of daily life and our ways of working".

    Tanzania is part of Cumii International's key Pan African markets that includes Kenya, Zambia, Rwanda, Zimbabwe, South Africa, DRC, Uganda and Nigeria rolling out connected services as part of its suite of IOT services in Africa.

  • Medical devices need securing

    Medical devices offer a way into healthcare information for hackers. To combat them, the USA Food and Drug Agency (FDA) has published its draft cyber-security guidance and measures. The report, Postmarket Management of Cybersecurity in Medical Devices Draft Guidance for Industry and Food and Drug Administration Staff, is essential reading for Africa’s health systems to learn from.

    A FDA press release set out some of the main initiatives as:

    Apply the 2014 National Institute of Standards and Technology (NIST) voluntary Framework for Improving Critical Infrastructure Cybersecurity, which includes the core principles of identify, protect, detect, respond and recover Monitor cyber-security information sources to identify and detect cyber-security vulnerabilities and risk Understand, assess and detect the presence and impact of a vulnerability Establish and communicate processes for vulnerability intake and handling Clearly define essential clinical performance to develop mitigations that protect, respond and recover from cyber-security risks Adopt a coordinated vulnerability disclosure policy and practices Deploy mitigations that address cyber-security risk early and before exploitation.

    The draft has five categories of the severity cyber-threat impact. They confirm the importance of preventative action, being:

    Negligible: inconvenience or temporary discomfort Minor: results in temporary injury or impairment not requiring professional medical intervention Serious: results in injury or impairment requiring professional medical intervention Critical: results in permanent impairment or life-threatening injury Catastrophic: results in patient death. 

    For Africa, the task is huge, and confirms the need for information sharing and collaboration. It’s appropriate for each Regional Economic Community (REC) to start the ball rolling. The first step’s to share the FDA’s ideas. A follow-on’s to start to create an eHealth regulatory environment where REC members can apply them.

  • Deaftronics Solar Ear innovation changes lives

    Botswana-based Deaftronics is an innovative company helping to transform lives. It has manufactured the first solar-powered hearing aid unit, Solar Ear, says an article in How we made it in Africa. In a country where there are only twelve audiologists and five audiology centres, this technology is life-changing.

    Deaftonics says 278 million people are affected by moderate to profound hearing loss worldwide. About 80% of these live in low-and middle-income countries. HHearing aids production’s less than one tenth of the global need. Not only are there not enough hearing aids, they are expensive too, making them unaffordable to many people who desperately need them. Hearing impairment negatively impacts social interaction, education and finding meaningful employment, so increasing supply’s crucial. 

    Deaftronics Solar Ear is a rechargeable hearing aid that’s ten times cheaper than conventional hearing aids. Each Solar Ear unit includes a digital hearing aid, a solar battery charger, and four rechargeable batteries. The batteries can also be used in 80% of hearing aids currently present in the market, and are fully charged after two to five hours in the sun. They can last up to four days. Users can also reuse a battery up to 500 times before having to replace it. The invention reduces the amount of visits patients are typically required to make to care centres, saving time, while the reusable, solar rechargeable batteries dramatically cuts down on patients’ and health systems’ costs. 

    The need for technological innovation presents companies with the opportunity to design products that address real needs in Africa. Deaftonics’s doing just that with over 1,000 units already sold in sub–Sharan Africa. More mHealth and eHealth solutions are needed too, and can help address some of the shortcomings of health systems across Africa.

  • Thousands of medical devices aren't secure

    It’s possible to understand, but not condone, the reason why cyber-criminals go after money. Like the bank robber Willie Sutton allegedly replied to the question why’d you rob banks? “Because that’s where the money is” was his justification. Sutton’s total haul of his criminal activities was some £2m, so reflects some of the scale of cyber-criminals.

    What’s harder to grasp is why they’d hack into medical devices. Scott Erven and Mark Collao presented their findings on this phenomenon, “Medical Devices: Pwnage and Honeypots” at hacker conference Derbycon. Urban dictionary says Pwnage’s Pure Ownage, an online gaming term to stress your superiority on all levels. It’s spawned from the root word pwn, which originated as a misspelling of the word own.

    They set up a fake MRI machine to see if it would attract hackers, and it did. There were loads of attempted log-ins. Connecting interfaces were available through Shodan, a search engine designed for devices that connect to the Internet. They say thousands of critical medical systems, like MRI machines, are vulnerable for hackers to access online. Some 68,000 medical systems from a large unnamed USA health group have been exposed. They’ve reported several vulnerabilities to well-known medical device manufacturers over the last year.

    Hospitals whose networking equipment and administrative computers are exposed online, risk attacks and the exposure of patient data, and this’s the goal. Attackers can then build up details and profiles on health organisations, including exactly where medical devices are located. Then, they can simply send a smart, bogus email to people who have access to the devices with a payload that will run on the machines. Some medical devices have already been compromised.

    It’s starting to feel that eHealth is short for easy pickings. Africa’s health systems need to step up cyber security on two fronts: health information systems and medical devices as part of the Internet of Things (IoT). It’s a job for more than one life.