Scheme for reporting side effects from medical devices

By Published On: November 1, 2021Last Updated: November 2, 2021
Scheme for reporting side effects from medical devices

People who suspect they may have experienced a side effect from medical devices, medicines or vaccines are being encouraged to report it to the government’s Yellow Card scheme.

The scheme, which is run by the Medicines and Healthcare products Regulatory Agency (MHRA), aims to quickly detect whether the safety of medicine or medical devices may require further investigation.

It relies on the voluntary reporting of suspected side effects or medical device incidents by health professionals, patients and carers.

The MHRA will review the reports and, if necessary, take action to minimise risk.

As part of #MedSafetyWeek, the scheme is focusing on the importance of reporting suspected side effects following vaccinations.

Mick Foy, head of pharmacovigilance strategy at the MHRA, is urging people to report any suspected side effects as soon as possible.

“The most important part of our work is making sure the vaccines and medicines you and your family take are effective and acceptably safe. This campaign comes at a crucial time when millions of people in the UK are vaccinated against Covid-19 but is equally applicable to all vaccines and medicines.

“The Yellow Card scheme reports play a key role in helping the MHRA monitor the safe use of all medicines and vaccines to protect public health through effective regulation.

“Reporting suspected side effects using the Yellow Card scheme helps ensure vaccines, medicines and medical devices continue to be used in the best way and adds to the known safety information about healthcare products.”

Reports can be made for all medicines including vaccines, blood factors and immunoglobulins, herbal medicines and homeopathic remedies, all medical devices available on the UK market and reports of safety concerns associated with e-cigarette products .

The MHRA is also able to investigate counterfeit or fake medicines or devices and if necessary, take action to protect public health.

Healthcare professionals prescribing, dispensing or administering medicines or vaccines are encouraged can show support during #MedSafetyWeek by sharing the MHRA’s posts on social media. And by discussing the importance of reporting suspected side effects to the Yellow Card scheme with patients, colleagues, friends and family.

Reports can be made via the Yellow Card website.

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