Question to the Department of Health and Social Care:
To ask His Majesty's Government what steps they are taking to ensure that medical-grade probe covers are used in ultrasound procedures instead of non-medical materials, such as condoms.
The Medicines and Healthcare products Regulatory Agency (MHRA) is the regulator of medical devices in the United Kingdom. It works to make sure that medicines and healthcare products available in the UK are safe and effective. We would expect the use of probes that are medical devices to be within their intended purpose as defined by their manufacturer. Use of a medical device outside of its intended purpose can be done at the discretion of a healthcare professional.
The MHRA does not have a role in regulating healthcare practitioners in clinical settings. The MHRA has issued guidance on the off-label use of medical devices, which sets out that an individual should use medical devices as described by the manufacturer in the instructions. If you use the device in any other way, it’s considered ‘off-label’ use.