Devices (31)

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.

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.

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.

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.

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 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:

  1. Negligible: inconvenience or temporary discomfort
  2. Minor: results in temporary injury or impairment not requiring professional medical intervention
  3. Serious: results in injury or impairment requiring professional medical intervention
  4. Critical: results in permanent impairment or life-threatening injury
  5. 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.

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.

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.

It may be about time the technology of the stethoscope, derived from the Greek for chest exploration, was upgraded. It was invented in 1816, the years that the Mfecane wars started in South East Africa. That’s when Rene Theophile Hyacinthe Laennec, a young French physician at the Hôpital Necker-Enfants malades in Paris, was examining a young female patient. It seems he was too embarrassed to place his ear to her chest to listen to its revealing sounds, a technique known as immediate auscultation, a form of listening, and used by physicians of the time. Instead, he invented the stethoscope and with it, clinical auscultation.

Now, Dr Marie Johnson, a USA engineer, has invented CADence, a digital device to do the job, and described it at Royal Society of Medicine (RSM) Innovation Summit in September.

Her company, AUM Cardiovascular has a core goal of diagnosing obstructive coronary artery disease in patients with chest pain and two or more risk factors. AUM is a Sanskrit syllable meaning “to make a continuous low humming sound.” CADence is a hand-held, fast, affordable device that picks these low frequency noises from feeble diastolic murmurs that conventional stethoscopes don’t pick up. The motivation for CADence is direct experience of personal, unexpected cardiovascular tragedies.

It take about twelve minutes to have a reading from CADence’s algorithms, about eight minutes for measurement, then four minutes for data transmission, using WiFI and Bluetooth. CADence is used in 25 sites, is available in the USA, and is awaiting Food and Drugs Administration (FDA) approval. It could be several years before it’s on sale in Africa, but it’ll soon replace Laennec’s techology

mHealth’s revolutionising healthcare. Dr Ralph Weissleder and Dr Hakho Lee from the Center for Systems Biology at Massachusetts General Hospital are making a huge transformation. They’re responsible for creating the D3 system, an mhealth solution for digital diffraction diagnosis. Born of Dr. Weissleder’s efforts to improve healthcare in remote parts of Africa, D3 is said to be convenient, efficient and easy to use. The device attaches to a smartphone, allowing the phone to take images of cells and samples and provide an accurate diagnosis within an hour. It drastically cuts waiting times and has the potential to save countless lives.

An article in Massachusetts General Hospital explains how the D3 system works. First, a doctor collects cells from a patient, either from a blood sample, a fine needle biopsy or, if cervical cancer is suspected, a Pap smear. The cells are then loaded onto a tiny slide, which is pushed into the D3 imaging system using a clip-on device attached to the smartphone. D3’s imaging module with a battery-powered LED light uses the smartphone’s camera to record a high-resolution image. It has more power than a traditional microscope.

The idea for 3D originated a few years ago, when Dr. Weissleder was in South Africa to learn how technology could improve healthcare for people living in remote areas. Many African countries have too few pathologists, and lab results are often delayed. Even in developed countries, like the US, biopsy results can take over a week to get back.

When Dr. Weissleder saw that even in Africa’s remote areas, people were using smartphones, he realised mobiles can improve and support healthcare. Work on D3 started soon after. The team added a coin-sized battery to address the sporadic electricity supply, a common challenge for providers in Africa.

There have been two pilot studies. At Massachusetts General, D3 reliably and rapidly reported whether cervical biopsy samples were high-risk, low-risk or benign. The results showed that D3 performed as accurately as pathologists. D3 also fared well in a second pilot study, where it correctly recorded the difference between samples from four patients who had lymphoma and four who had benign tumors.

D3 works by processing blood or tissue by sending tiny antibodies to find cancer-related molecules. When these antibodies detect cancer, they light up. “The smartphone picks up the shining of the antibodies when the photo is snapped. And researchers can use this signal to diagnosis a patient with cancer,” Dr. Weissleder says.

Dr. Weissleder envisages D3 having many applications for many different settings. In a large hospital, D3 could provide faster test results for patients. At home, it might help patients monitor their diabetes or detect sexually transmitted diseases. The technology could be used for other diseases in Africa and help track malaria, TB, HIV and avian flu outbreaks.

Cell phones have changed the world says Dr. Lee says, adding, “The next big push will be healthcare applications, and we are excited to lead the way.” The team’s about to receive funding from the National Institutes of Health for a large clinical trial in Africa.