Medical device regulation: the need for clinical vigilance and oversight.
In this editorial, the authors address the (lack of) regulation of the medical device industry. The process for certification of medical devices is variable around the world – there are currently 29 notified bodies in Europe for example that assess and certify devices for clinical use. Low risk devices may be approved without a separate clinical trial if they are deemed to be equivalent to another currently approved device.
The authors suggest that as clinicians we should remain vigilant when using new or changed devices and ask questions regarding the evidence regarding their safety and efficacy. More robust clinical studies of medical devices may be needed before their introduction into clinical practice. Post-market clinical follow up may also be needed. This is particularly relevant for implants such as pacemakers and joints. New European Union regulations for medical devices are due in 2020.
A very topical and thought provoking read.
Reviewed by: Dr Stephanie Aplin