Medical Batteries

Medical Batteries

Did you know that batteries used in your medical device are regulated under Medical Devices Regulation and the Food and Drugs Act in Canada? The batteries are classified as class I or class II depending on which device they are being used in. Therefore, manufacturers of class I may need a medical device establishment licence (MDEL). Manufacturers of class II batteries must have a medical device licence (MDL) before they can be sold in Canada. Class I batteries are used in a class I devices, and class II batteries are used for class II to IV. 

The class system in Canada rates devices based on the harm they could cause a patient or user, where class I is the lowest risk, and Class IV is the highest risk. Some examples of these devices include:

Class I – Exam Light, Blood Pressure Monitor

Class II – Thermometers, Electrocardiographs

Class III – Vital Signs Monitors, Infusion Pumps

Class IV – Anaesthetic Machines, Defibrillators 

How you take care of your medical batteries is a little bit different than what you normally think when it comes to taking care of the battery in your phone where you want to deplete your battery almost completely before recharging. With the batteries used in medical devices, it is recommended to have them plugged in at all times, when able, to prolong the health of your battery and keep it in good working condition for when you really need it. 

 It is also recommended that you get your batteries changed regularly depending on the type of battery your device is using, for example, three years for lithium-ion batteries and two years for sealed lead acid unless otherwise stated in the manufacturer’s recommendations. In addition, we at TRH services test your batteries during preventative maintenance checks by verifying their output voltage and their ability to hold a sufficient charge while the device is being used. We also keep track of when your batteries were last replaced and can provide you with new ones when the time comes.

Some Batteries that we typically carry are, and have in stock are:

References 

Canada, H. (2016, August 5). Government of Canada. Canada.ca. Retrieved October 28, 2021, from https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/announcements/medical-batteries.html. 

BatteriesInAFlash. (2013, June 5). How to maintain a sealed lead-acid (SLA) Battery System. BatteriesInAFlash Blog. Retrieved October 28, 2021, from http://www.batteriesinaflash.com/blog/how-to-maintain-a-sealed-lead-acid-sla-battery-system/. 

K., C. A. Y. (2016). Biomedical device technology principles and design. Charles C. Thomas, Publisher, LTD. 

Written By: Caitlin Vanderkwaak
Edit By: Tyler Hasenpflug