A medical device is, simply defined, any item used to diagnose, treat, or prevent disease, injury, or any other condition that is not a drug, biologic, or food.
Medical devices range from items as simple as tongue depressors to more complex devices, such as ventilators. They represent some of the most innovative technologies developed in recent years, especially in sterilisation training.
Yet regardless of how novel a device may be, the public expects, and regulations require that medical devices be safe, effective, and manufactured in accordance with current manufacturing practices.
All manufacturers must register their establishment, list any type of device they plan to market, and assure that their device is labelled in accordance with the MHRA’s (Medicines and Healthcare products Regulatory Agency) labelling regulations, before marketing clearance is given.
Despite premarket studies required of high risk devices, such as ventilators, safety concerns may arise with a device once it is on the market. Thus the MHRA must rely on manufacturers and device users to recognise and report problems that may contribute to poor patient outcomes.
Lower risk devices, such as infusion pumps and physiological monitors, require only documentation that they are as safe and effective as similar devices already on the market before receiving marketing clearance.
This all ensures that the medical devices you use in your industry and place of work are safe to be used.