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astuteanalyticablog · 6 months

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Everything About Wearable Electrocardiography (ECG) Devices

An electrocardiogram (ECG) is a test that is used to scan the functioning of the heart by estimating the rhythm of the heart to catch heart attack, blood clots, risk of stroke, high blood pressure, and also, high cholesterol level among others.

A wearable electrocardiography device is used to observe the electric activity of the heart, this device can be worn as a watch or a band or can be attached as a patch to the one's body. Wearable electrocardiography devices are built for in-clinic and remote patient observing applications, the multi-function cardiac patch can live stream numerous parameters to the cloud or a mobile device. It is rechargeable, reusable, and is also capable of recording the data even in the event of network trouble. It is also used in numerous studies like coronary artery disease, AF detection, stress and depression, and more.

The main elements accountable for the growth in the demand for the wearable electrocardiography (ECG) devices market are the declining cost of wearable technologies and the rising prevalence of atrial fibrillation. In addition to this, according to the research report of Astute Analytica, the global Wearable Electrocardiography (ECG) Devices Market is growing at a compound annual growth rate (CAGR) of 25.5% during the forecast period 2022-2027.

What are the benefits of wearable electrocardiography (ECG) devices?

Lightweight and portable

In comparison to electrocardiography machines, wearable devices are considered to be portable and lightweight. There is no need for patients to plan an appointment with their doctor to get a fast analysis of their heart activity. It is done practically anywhere and at any time with the help of wearables.

Early potential problem identification

Taking an electro-cardiology test at the clinic may not deliver a full picture of the health condition of the patient. But a wearable device permits one to record heart activity more conveniently and also, for a longer period. This allows doctors to determine any movements that may show problems.

What are the types of wearable electrocardiography (ECG) devices?

Smartwatches and fitness trackers

Fitness trackers and smartwatches come with an electrocardiology function that can track the heart rate of the user. This can also detect signs of arrhythmia which is a reason for stroke.

ECG patches

ECG or electrocardiology patches are small, extremely portable devices that are connected to the body. They are used to obtain and send electrical signals of the heart activity of the user.

Chest strap

A chest strap electrocardiology has a movable sensor connected to a strap. The user can wear it under their shirt to track the heart rate.

Factors to keep in mind while choosing wearable electrocardiography (ECG) devices

Comfort

The wearable device will come into contact with the body of the user during the analysis. Therefore, it is important to confirm that it is comfortable to wear and also, capable of functioning with minimal disturbance to one’s daily activities.

Data sharing and storage

Patients who need to share readings with their doctors should check devices that have data-sharing and storage capabilities. This allows the storage of prior reports and readings that can be easily shared with others.

Recording duration

Various wearable devices come with varying maximum recording durations. A device that has a longer recording duration is more capable of detecting any transient or asymptomatic arrhythmias.

Content Source: Everything About Wearable Electrocardiography (ECG) Devices

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elexesofficalblog · 5 years

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Wearable ECG Monitor: Regulations, Standards and Guidance

Wearable ECG monitors have changed the face of cardiac patient care. The device provides patients with mobility, increased freedom, convenience, and the ability to record ECG within a minute.

It eliminates the critical time needed to attach the lead wires, and the issue of false alarms due to their entanglement, and is very helpful for clinicians and paramedics in case of emergencies.

The wearable ECG monitor band typically has 3 electrodes and a user interface with a button to switch on the system.

It has a display to show the time remaining to complete an ECG examination and the patient’s heart rate.

The system also includes a micro-USB port to be connected to a tablet or laptop to retrieve, view, and print the ECG obtained during an examination. A wearable ECG monitor can be used to capture arrhythmia in patients.

Regulation, Guidance and Standards:

Country: USA

Device Class: Class II

Regulation Number: 870.2340, Prod code - DPS

Regulation Description: Electrocardiograph

Submission Type and Requirements: 510(k), Est registration and listing, 21 CFR Part 820

Country: Canada

Device Class: Class II

Regulation Number: CMDR SOR/98-282

Regulation Description: Canadian Medical Device Regulations

Submission Type and Requirements: MDL, MDSAP, and MDEL registration

Country: Australia

Device Class: Class IIb

Regulation Number: Classification rule 4.3

Regulation Description: Therapeutic Goods (Medical Devices) Regulations

Submission Type and Requirements: Technical File, inclusion of the device on ARTG

Country: Europe

Device Class: Class IIb

Regulation Number: Rule 10

Regulation Description: MDR

Submission Type and Requirements: Conformity assessment (CE Marking) based on a quality management system (QMS) and on assessment of technical documentation

FDA provides guidance on the review and premarket 510(k) application through its Diagnostic ECG guidance (Including non-alarming ST-segment measurement) document. In addition to complying with the test requirements, the manufacturer should comply with the following controls to get 510(k) clearance;

21 CFR 801- Labelling

21 CFR 807- Registration and listing

21 CFR 803- Medical device-related adverse event reporting

21 CFR 820- Quality system regulation

Regulatory Bodies should be made aware of any adverse events that are deemed reportable.

To ensure that the product is manufactured to meet its specifications, the manufacturer must show compliance with 21 CFR 820, Quality system regulation. FDA does not mandate ISO 13485:2016 International standard for Quality Management Systems however, several countries require it. Instead of ISO 13485:2016 certificate, Canada requires an MDSAP certificate to market devices in Canada.

Benefits and Risks:

Some common benefits and risks associated with a wearable ECG are listed below.

3.1 Benefits:

Help screen and diagnose a variety of cardiac problems such as arrhythmias, heart defects, heart inflammation, cardiac arrest, poor blood supply, coronary artery disease, or heart attack.

Helps monitor existing heart diseases

3.2 Risks:

User error

Device sensing problem

Software issues

Testing Requirements:

The following are required testing that needs to be completed before submissions:

IEC 60601-1-2 Medical Electrical Equipment-Part 1-2

IEC 60601-1-11 Medical Electrical Equipment-Part 1-11

ISO 6601-2-47 Medical Electrical Equipment- Part 2-47

ISO 10993-5 Biological Evaluation of Medical Devices-Part 5

ISO 10993-10 Biological Evaluation of Medical Devices-Part 10

ASTM D4169- 09, Standard Practice for Performance Testing of Shipping Containers and Systems

IEC 60601-2-25: 2011 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs

For all such devices, conducting thorough testing and evaluation is the key to speedy market entry. For any questions/comments please write to [email protected]

#MedicalDevice FDA CEMarking Wearable ECG WearableECG #wearable tech #medical devices

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