MHRA has liaised with ArjoHuntleigh to confirm risk mitigation factors are appropriate and are working to communicate important healthcare information to healthcare professionals and the public through established alert systems. MHRA were also aware of and highlighted the work undertaken by the National Patient Safety Agency (NPSA) in 2007 regarding emollients. (AI summary)
View full response
Medicines & Healthcare products MHRA Requlating Medicine; and Hedical Devices Regulatory Agency We aim to have completed our review by the end of 2017 and will consider the need for publication of any additional safety advice at this time in conjunction with our medicine colleagues. Additionally; we have worked with manufacturers to raise awareness of this potential risk. This work highlighted the need for risk of fire to be included in their product risk analysis and ensuring warnings of the potential risk were placed either on packaging or included in the device's instructions for use We have previously issued warnings regarding the dangers around smoking and bed fires (MDA2013/073). Medical devices must be CE marked before are placed on the market in the UK and throughout the EU. MHRA's expectation is that; when CE marking and placing a medical device on the market, manufacturers will have evaluated the potential risks that could occur; including that of The CE mark demonstrates that the medical device is fit for its stated intended purpose and meets legislation relating to safety: This requires the manufacturer t0 demonstrate their medical device meets the requirements in the Medical Devices Directive (MDD) by carrying out a conformity assessment. Additionally, higher risk medical devices require certification from a third party conformity assessment body ("Notified Body") prior to placed on the market; MHRA is responsible for the oversight of UK Notified Bodies and has a post-market role in investigating reported safety issues. Emollients may fall into any of the risk classes according to their constituents and mode of action. The paraffin content of these products varies over a wide range, also, from as little as 5%, in some cases and has no bearing on whether the product is classed as a device or as a medicine This difference is due to their mode of action_ In Spring 2017 MHRA wrote to UK manufacturers of Class medical devices (the lowest risk category) directly and asked them to undertake a review of their products. In addition; we asked the UK Notified Bodies to ensure that a review and risk assessment was undertaken by manufacturers of higher risk classification medical devices_ We also brought the issue to the notice of European regulatory colleagues to highlight the dangers internationally: AIl European Competent Authorities were asked to share the letter mentioned above with Notified Bodies they oversee to ensure coverage of all manufacturers with products in the European market The issue has been raised with NHS Improvement and Medical Device Safety Officers (MDSOs): The latter are individuals in each NHS Trust in England who ensure safety information is made available to relevant staff. MHRA is also liaising with the Care Quality Commission to highlight the potential dangers to users within the care community: The therapeutic benefits of the mattress system will generally have been found to outweigh the likelihood and consequences of a fire, in part mitigated by the labelling and instructions for use, advising against smoking or using naked flames whilst in bed. Polyurethane (PU) is the industry standard cover material on most types of healthcare mattress, including pressure reduction mattress systems, such as the ArjoHuntleigh Nimbus 3. The cover they : fire. being
Medicines & Healthcare products MHRA Regulating Medicines and Medkal Devices Regulatory Agency material of healthcare mattresses has to withstand heavy use, must be impervious to liquid ingress and withstand frequent exposure to decontamination agents. MHRA has contacted the manufacturer, ArjoHuntleigh, to confirm that their current risk mitigation factors are appropriate. This includes meeting the standard BS7175:1989, (Methods of test for the ignitability of bedcovers and pillows by smouldering and flaming ignition sources) and the product labelling and instructions for use, which contain the warning about fire risk MHRA is continually reviewing methods of communicating important healthcare information to healthcare professionals and members of the public. However, communication t0 the general public is a challenging area for all aspects of healthcare. The MHRA does publish Medical Device Alerts and Drug Alerts issued via the Central Alerting System (CAS) Within CAS there are thousands of subscribers from organisations in the independentlprivate sectors, with frequent requests received at the helpdesk to add new subscribers and alter existing records This is a well-established and effective mechanism for communicating important safety information to healthcare professionals throughout the NHS and private health sectors.