Have you missed something important?
Safety alerts for medical products and equipment are numerous and it’s fair to say that not many of them often relate to dentistry. However, it is vital to keep tabs on these alerts as there have recently been two important ones that are very relevant and being reviewed by inspectors…
The first is a safety recall by Physio-Control that has led to the Medicines and Healthcare products Regulatory Agency (MHRA) issuing a Medical Device Alert.
The automatic external defibrillator (AED) models affected are LIFEPAK CR Plus and LIFEPAK EXPRESS. The manufacturer has discovered a fault means some may not deliver an electric shock to the heart to someone who is in cardiac arrest. Approximately 2,577 devices are defective. All dental practices are required to have immediate access to an automatic external defibrillator (AED) – with many having them on site – so it is important to check whether your model is affected.
The second is a recall by the manufacturer of GlucaGen HypoKit (glucagon 1mg) as seven batches have a small number of needles that have been found to be detached from the syringe.
All dental practices should check their medical emergency kit as glucagon 1mg is a mandatory item as outlined by the British National Formulary. If you have an affected batch you must return it to your community pharmacy for a replacement as a detached needle would delay emergency treatment of severe hypoglycaemia.
All CODE members have access to the Safety Alerts Policy (M 233-SAL) and iComply members are prompted to review this policy annually, checking that team members are following the process. We recommend that all practices in England sign up for MHRA alerts here and CAS alerts by emailing their practice details to email@example.com.