The PPE Device That Doesn’t Need MHRA Approval

We have all probably seen in the news the fates of innovators such as Dyson, Red Bull F1, Aston Martin and Renault who rallied to the NHS’s appeal for more ventilators. They innovated new ventilator designs to Government specifications, only to find out that MHRA approval would take too long for the devices to be useful in the current Covid 19 pandemic. Subsequently orders conditional on approval were cancelled.

Medic-Safe does not fall into this category. It is innovative but it is not a medical device. We have had this confirmed by MHRA. It is not connected to the patient in any way, and even if the unit fails, will have no medical impact on the patient. The Medic-Safe is there to protect the medics on the Covid 19 wards. As such it requires no approval. There are no PPE standards or regulations for this radically new piece of equipment. The most relevant standard is: BS-EN 12469. We have already validation tested Medic-Safe against this standard and comply with the minimum performance requirements for air velocities and filter exhaust particle counting. For these reasons we can claim a typical protection factor of 100,000 as read across from this standard for Class 1 safety cabinets. By contrast, the PPE the medics are currently using might have a protection factor between 2 and 10.

The Medic-Safe is now in production and whilst we would welcome any third party type testing, it is not necessary in order for this product to go into service and start saving medics’ lives.

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