Skip to main content
Welcome to the cutting edge of safety science—Learn more about our rebrand.
  • Feature Story

4 Physical Safety Considerations of Medical Wearable Devices

4 Physical Safety Considerations of Medical Wearable Devices

September 22, 2015

Medical wearable technology is dramatically changing the healthcare industry, as medical professionals seek to increasingly use this technology to obtain accurate, real-time information about their patients, improving diagnoses and treatments.

The global market for wireless health technologies, such as tablet computers, smart phones and other devices to record and retrieve real-time patient information, is expected to reach over $38.5 billion by 2016. Due to significant progress in research and development, medical wearable technology will likely be a large percentage of this growth. At least one estimate puts potential sales for wearable technology devices incorporating advanced body sensors for healthcare applications at more than $1 trillion annually within 20 to 30 years.

The growing wearable technology device market offers promising new benefits to medical professionals and their patients. However, the success of the industry depends on ensuring the safety and security of the products. The complexities of medical wearable technology devices could harbor unknown risks and safety concerns, including physical harm to patients.

Since medical or wellness wearable devices may be in close contact with patients’ bodies for extended periods of time, physical harm is a concern, and if developed without sufficient risk analysis from the start, wearables can carry these potential risks:

1. Chemical Reactions
Materials used in the construction of medical wearable technology products, such as certain metals and synthetic fabrics, may cause a reaction when they come in extended contact with the skin, resulting in rashes or other allergic responses. In addition, the prolonged use of such devices can sometimes produce sensitivity to synthetic materials or cause bacterial buildup. Lastly, reactions, such as galvanic corrosion, can also occur when sweat mixes with electrical currents, which is sometimes seen in certain instances, such as when sensing electrodes are a component of the wearable.

2. Electrical Shock
Many energized devices can pose a risk of electrical shock due to excessive leakage currents, which may result from worn or defective circuitry or accidentally exposed components. When a device is designed such that it may be worn while connected to electrical mains for charging, the risk of unsafe electrical shock is clearly more significant.

3. Burns
The temperature of components in electrical devices often increases through the length of their use. In addition, wearable technology products typically incorporate powerful microprocessors and other computing components in a compact form factor that may produce elevated operating temperatures due to high switching speeds, and extended exposure to temperatures that may be fine for intermittent contact may cause damage to human tissue.

4. Acoustic Sound Pressure
Hearing aid components and other optic interfaces incorporated into wearable technologies can produce unsafe sound pressure levels / amplitudes or frequencies when improperly designed, calibrated, or operating under fault conditions, potentially leading to a temporary or permanent loss of hearing.

As wearable devices used for wellness and medical applications transform the healthcare industry, potential physical harm can be prevented through precautionary design and testing measures. Specific tests can be designed to identify the root cause of the harm that may occur before that potentially injurious component or material is built into a device.

Without proper safety measures, products that hold vast potential to improve patients’ health could also injure them. Wearable technology manufacturers should be aware of the potential physical harm that could be caused, and take steps to incorporate safety into every stage of product development.

Originally published by Medical Design Technology