Do you know smart medical devices?

November 29, 2019

Have you heard of smart medical devices ?In all times, medicine has benefited from technological advances to improve the care of patients. In two centuries, these accelerated, from the invention of the stethoscope by Dr. Laennec in 1816 (1), the first X-ray imaging (Wilhelm Röntgen in 1895 (2)) or the appearance of the blood pressure monitor “Modern” (combined sphygmomanometer and auscultation) by Nicolai Korotkoff in 1905.

All these means have contributed to making medical art a scientific discipline. Today, medicine relies on a large number of diagnostic and / or therapeutic tools and materials, whether they are devices for measuring biological parameters (blood glucose) or physiological parameters (heart rate, blood pressure). …).

In parallel with all these innovations, the development of telephony and internet on the one hand, the improvement of digital data transmission speeds on the other hand (ADSL and optical fiber), no longer make the physical presence of the caregiver at the side of the indispensable patient. Equipped with devices for remotely transmitting the collected information, these tools could be adapted into connected objects whose data can be accessible on smartphones, tablets or computers.

Introduction

Chronological reminders

Thanks to the rise of information and communication technologies, the 2000s marked a turning point in the evolution of medicine, with the trivialization of digital and as a corollary that of e-medicine.

– 1876: Alexander Graham Bell files the first patent for the telephone.– 1905: Willem Einthoven transmits an electrocardiography via a telephone line between his office and the distant hospital of 1.5km– 1969: Creation of Arpanet, forerunner of the Internet– 2017: 1.5 billion people have a mobile health app

Connected objects

This concept of coupling an object to a digital network has become widespread and has been adapted to the needs of its potential users. It is found in all areas of activity, including trade, transportation, education and health.

Currently there is no official definition for connected objects, but we can try to qualify as any electronic equipment capable of communicating with a computer, smartphone or tablet via a wireless link (Wi-Fi, Bluetooth, etc. .) that connects it to the Internet or to a local network.

Economic issues

The growth of the connected object knows a sharp increase. Their number increased from 9.1 billion in 2013 to an estimate of 28.1 billion by 2020 and the connected health objects are expected to increase from 46 million in 2015 to 161 million projected in 2020 worldwide.

Translation of this booming market, the estimated connected object (all categories combined) which was 64 million euros in 2013, is expected to reach 400 million euros in 2020. Several factors can explain such spectacular growth:• better accessibility to tools due to price reductions (connected objects and network subscriptions).• aging of the population and consequently an increase in the number of people suffering from chronic pathologies.• Partial response to increased medical deserts.

Definitions around e-health

The word e-health, appeared in 1999, during the 7th International Congress of Telemedicine. John Mitchel, author of this formulation, defined it as “the combined use of the internet and information technology for clinical, educational and administrative purposes, both locally and remotely”.

There are no clear boundaries between the different branches of e-health that tend to intersect. In order to become familiar with the subject it is necessary to know the definitions.

First of all, the definition of the word health, defined by the World Health Organization (WHO) in 1946 as “a state of complete physical, mental and social well-being and not only in the absence of disease”, should be recalled. or infirmity “

1.Connected smart health

According to the WHO, e-health “is about using information and communication technologies to support health action and related areas, including health care services. health surveillance, health literature and education, knowledge and research in health. ”In everyday language, e-health encompasses everything related to the digital health and smart health.

2. M-health or “mobile health”According to the WHO, m-health covers “medical and public health practices based on mobile devices such as mobile phones, tablets, patient monitoring systems, PDAs and other wireless devices”.

It is one of the major components of e-health. Its specificity comes from the use of mobile devices to record and transmit health data, especially for diagnosis, consultation and care management.Doctors are 65% using their smartphone to prescribe. This use increased sharply, since this use concerned only 35% of doctors in 2012 and 2013.

3. Telemedicine

“Telemedicine is a form of remote medical practice using information and communication technologies.It connects, among themselves or with a patient, one or more health professionals, including necessarily a medical professional and, where appropriate, other professionals providing care to the patient. ”The Ministry of Health currently distinguishes 5 subcategories: 1: medical teleconsultation (remote patient consultation);2: tele-expertise (a doctor solicits one or more colleagues at a distance);3: medical telemonitoring (remote monitoring of parameters of a patient with a chronic disease);4: medical remote assistance (a doctor remotely assists a colleague);5: medical regulation.

4. Connected smart health devices and connected smart medical devices

In connected health devices, it is necessary to differentiate between connected smart medical devices and connected smart health devices.

A medical device is any instrument, device, equipment, software, material or other article, used alone or in combination, including the software intended for the manufacturer to be used specifically for diagnostic and / or therapeutic purposes, and necessary for the proper use of the device. operation of it. The medical device is intended by the manufacturer to be used in humans for the purpose of:– diagnosis, prevention, control, treatment or mitigation of a disease;– diagnosis, control, treatment, mitigation or compensation of an injury or disability;– study or replacement or modification of anatomy or physiological process;– mastery of design,and whose principal action in or on the human body is not obtained by pharmacological or immunological means or by metabolism, but whose function may be assisted by such means.

One of the important points to emphasize is that obtaining the label “medical device” is left to the choice of the manufacturer subject to meet the specifications.

In addition, the notion of “connected” implies that this same medical device will be added a connection (Wifi, Bluetooth, etc.) allowing him to communicate with his environment.

As a result, Smart Health Devices encompass any connected device that has no declared medical purpose and enters the field of well-being.

Health data & problematic

Until now, the notion of health data was not expressly defined by the texts. We were talking about personal health data, considered as sensitive and regulated by the law.

Doctors accompany the deployment of the digital tool in the health field and to adopt it in their practices, while being fully aware of the risks brought about by these new uses.

At the same time, a survey conducted by Withings® reveals that only 15% of general practitioners surveyed use smart health devices and smart medical devices in the workplace and 9% advise their patients.

Based on this observation, we wanted to carry out research on commercially available smart health devices and smart medical devices that can be used in the management of the main pathologies encountered in general medicine, in order to become better acquainted with these new tools.

CONNECTED SMART MEDICAL DEVICES

1. STETHOSCOPE:

The stethoscope had evolved little since its creation and the auscultation obtained thanks to this device remains a complex exercise where the experience and the subjectivity of the doctor play an important role in the development of a diagnosis.

The American company EKO has just launched one of the first “smart” connected stethoscopes on the market after obtaining the CE mark and the FDA (Food and Drug Administration) approval.

– Principle of operation:Auscultation is as with any conventional stethoscope. The data is transferred via a bluethooth connection to a device running IOS, ANDROID or Windows.– Improvements:. Reduction of parasitic noise. Increased auscultatory sounds. Registration of auscultation in the medical file. Visual representation of the auscultation. Sending auscultation to another health professional. Automatic analysis of auscultation using an algorithm

This last function is based on the principle of the Shazam® musical recognition application. The auscultatory sounds are automatically transmitted analyzed then classified according to algorithms allowing to connect them or not to various pathological states (functional breath, mitral insufficiency etc …).– Studies concerning connected stethoscopes:o Andrès has developed and tested a communicating and intelligent digital stethoscope to obtain a correct diagnosis in 10% more cases than an acoustic stethoscope.o Fragasso resulted in the same diagnosis in 92% of cases during a classical auscultation versus tele-auscultation.o Kocharian evaluated the sensitivity, specificity and effectiveness of an automated monitoring device for the detection and discrimination of cardiac murmurs in children with a good diagnosis rate ≥ 90%

2.TENSIOMETER:

High blood pressure affects more than millions of people. The tension variations can be numerous during the same day according to the context (example of the white coat effect).Its control is however essential in the prevention of the cardiovascular risk.Measuring devices must be simple to use and space-saving.

The connected sphygmomanometers meet these criteria provided they have a smartphone or tablet.

– Principle of operation:The device is placed around the arm like any other blood pressure monitor not connected, its particularity is to display the data on the smartphone which the patient must be equipped. Data is transferred via bluetooth to a dedicated application (specific to each manufacturer).

– Improvements:. Automatic integration on the smartphone / tablet of the patient. Help with data interpretation. Transmission of results to a health professional

– Studies concerning connected sphygmomanometers:o Mazoteras et al. demonstrated the reliability and effectiveness of a connected blood pressure monitor and its mobile application compared to a standard blood pressure monitoro Milani et al. demonstrated a decrease in blood pressure of 14 / 5mmHg (systolic / diastolic) in hypertensive patients receiving digital home-based tools compared to a group of patients undergoing standard follow-up

3. ELECTROCARDIOGRAM (ECG):

The ECG connected to the meaning of the definition has existed for many years with devices for performing acts of teleconferences. The French company VIOSMED® through its subsidiary BewellConnect® won the first prize at Consumer Electronics Show (CES) Las Vegas 2016 in the biotech category for the development of its ECG. The peculiarities of this new type of device are wireless use and reduced size.

ELECTROCARDIOGRAM (ECG):

The ECG connected to the meaning of the definition has existed for many years with devices for performing acts of teleconferences. The French company VIOSMED® through its subsidiary BewellConnect® won the first prize at Consumer Electronics Show (CES) Las Vegas 2016 in the biotech category for the development of its ECG. The peculiarities of this new type of device are wireless use and reduced size.

– Principle of operation:

the patient places 2 fingers of each hand on the device, the acquisition is done in a few seconds, without wires and without electrodes. The results are displayed directly on the smartphone or tablet by bluetooth (MyECG) or ultrasound (Kardiamobile).

– Improvements:. No wired connection. Small dimensions. Saving the ECG trace. Easy sharing of registration with or between health professionals

NB: this kind of connected ECG is not suitable for the diagnosis of ischemic heart attacks.

– Studies concerning the connected ECG:o Joshi et al. demonstrated the effectiveness of a mobile telemetry device for the automated detection of atrial fibrillation outpatients.o Halcox et al. diagnosed 19 cases of atrial fibrillation in a group of 500 individuals with the use of a home-connected ECG over a 12-month period versus 5 cases of atrial fibrillation with a standard care pathway.o Magnusson et al. have implemented an outpatient protocol for atrial fibrillation screening in patients with cryptogenic ischemic stroke (ongoing study, results not available).

4.THERMOMETER

The thermometer is the essential tool for measuring body temperature. If the reference method remains the measurement rectally we find more and more infrared thermometer with a temperature measurement at the temporal level.Connected thermometers mark a new turning point in monitoring and temperature measurement.

– Principle of operation:These are usually infrared thermometers, measuring the temperature at the temporal level. The result can be transferred to smartphone by bluetooth through an application specific to each manufacturer.– Improvements:. Color code in green or red orange depending on the temperature (apyretic, to be monitored, fever). Saving measurements on the smartphone. Temperature monitoring curve. Transfer of data to a health professional

– Studies concerning connected thermometers:o Christakis conducted a descriptive study in the United States suggesting that the use of connected thermometers could predict and prevent certain contagious diseases.o Miller et al. estimated that the use of connected thermometers could track the evolution of influenza in real time and up to 3 weeks in advance.

5.GLUCOMETER:

The glucometer is currently the only way for a diabetic patient to know his blood sugar level at any time of the day. Abbott® with its new connected device aims to revolutionize this practice with Free Freestyle, which won the 201 Trophy in the category of connected object dedicated to diabetes at the 5th edition of the Mobile Health Trophies

– Principle of operation:This device consists of a patch to be applied to the posterior aspect of the arm and measuring the level of interstitial glucose continuously. The result is obtained with the non-contact blood glucose meter thanks to the flash system. It is also possible to scan the patch with a smartphone with NFC (Near Field Communication) technology. The patch can stay in place 14 days and is water resistant.

– Improvements:. Continuous measurement of blood glucose. Absence of puncture. Possibility of obtaining the result through the clothes. Minimalist dimensions (patch of the size of a coin of 2 euros and smartphone are enough)

– Studies concerning the connected freestyle meter:o Massa et al. Demonstrated Reliable Blood Glucose Measurements Using Free Freestyle Glucometer in Children and Adolescents with Type 1 Diabetes

o Bolinder et al. demonstrated a 38% reduction in hypoglycemia time in type 1 diabetic patients using the Freestyle Free reader compared to a conventional capillary glucose meter.

o Dunn et al. analyzed free blood glucose monitoring data across Europe in real-life conditions, showing an increase in the number of self-monitoring blood glucose levels, an improvement in HBA1c and a decrease in the number of hypoglycaemias.

6.Pillbox

The smart pillbox plays a central role in the management of chronic diseases by providing assistance in the management of drug intake. With its connected version, IMEDIPAC received the innovation award in the health category at CES Las Vegas 2014.

– Principle of operation:The weekly pillbox is prepared at home or in a pharmacy. It operates via the GPRS 3G mobile network and synchronizes with the Medissimo® network.

– Improvements:. Ringing at the time of medication. Lighting the box to take. SMS reminder in case of forgetfulness. Sending SMS to the entourage and parametrizable doctor.

– Studies related to connected pilluliers:o Hayakawa et al. have found a patient’s acceptability of setting up a system for monitoring drug intake.o Vervloet et al. found an improvement in adherence of 15% over the long term by sending an SMS to type 2 diabetics who forgot medication.

7.OXYMETER:

The oximeter makes it possible to know in real time the pulse oxygen saturation in the blood circulation (SpO2) as well as the heart rate. This device is useful in the monitoring of cardiorespiratory pathologies.

– Principle of operation:Simply insert a finger inside the device, surface of the nail directed upwards. The result is displayed on the oximeter and is also transferred to the smartphone by bluetooth.

– Improvements:. Recording measures for better monitoring. Callback setting to track its saturation and heart rate. Transfer of data to a health professional

– Studies concerning connected oximeters:o Benzo et al. demonstrated the feasibility of an ambulatory pulmonary rehabilitation program in COPD patients using a connected oximeter.o Shah et al. have highlighted the possibility of predicting and identifying COPD exacerbations using a connected oximeter.o Tomlinson et al. found a similar measurement efficiency between an oximeter connected to a smartphone and a standard hospital oximeter in a healthy pediatric population.

CONNECTED SMART HEALTH DEVICES

1. SCALES

The scales are not part or medical device in the legislative sense of the term. However, they remain indispensable for monitoring the weight of patients.

– Principle of operation:The weight poster is directly on the scale and can also be done on the smartphone by bluetooth or wifi.

– Improvements:. Saving and synchronizing measurements on smartphone / tablet with a weight and BMI curve. Transfer of data to a health professional (doctor / nutritionist).

– Studies concerning connected scales:o Eschalier developed a telemonitoring system for patients with stage III and IV heart failure who more than halved the number of deaths and readmissions compared to standard care.o Ong could not show any significant difference in reducing the number of readmissions of heart failure patientsbenefiting from a remote monitoring program.

2. SMART HEALTH WATCH / BRACELET

Many models exist on the market :

– Principle of operation:These devices are placed around the wrist and record the activity according to the sensors that compose them (heart rate, GPS, accelerometer, etc.). The recorded data is usually communicated to the smartphone by bluetooth.– Improvements:. Daily monitoring of physiological parameters. Recording of performances

– Studies concerning connected watches / bracelets:o Thabouillot has detected atrial fibrillation with a connected wristband in a patient with amnesia during a 10km run.o Wile was able to differentiate between essential tremors of Parkinson’s disease using the accelerometer of a connected watch.o Moreno-Alsasua found an inverse relationship between the number of daily steps and high blood pressure.

Integration within the medical practice

The majority of the smart health devices and smart medical devices that we have just presented find their place in the patient’s home. MEDEO® has launched a new tool, Kligo, for doctors.Its principle is simple. Smart health devices and smart medical devices synchronize with bluetooth using a USB key connected to the computer. Each measurement is automatically integrated into the patient’s file, limiting errors and omissions.