Most non invasive medical devices fall into an area called Class I (the same area as stethoscopes, hoists and walking aids). Renray Healthcare reasons that pressure care surfaces should be held to a higher standard and is considered an ‘active therapeutic device’ which would place dynamic mattresses under the next level of class IIa. This important distinction raises the bar for both care providers, patients and residents.
The challenge? Class I devices are ‘self certified’ which means they are effectively unregulated. Which could potentially lead to more harm than good.
Class IIa devices (like our own ranges) ARE highly regulated. This means we have had all our Technical Files (i.e. Risk Management File; Clinical Evaluation Report; Post-Market Clinical Follow-up; Biocompatibility; Essential Requirements checklist etc.) As well as, any safety or performance claims are independently audited by an authorised Body.
Ultimately it shows that all our claims are based in evidenced fact and are true.
Furthermore, we must implement a quality management system to ensure ongoing compliance with regulatory standards and provide post-market surveillance by monitoring its performance and safety, reporting any adverse events to regulatory authorities. Which shows our dedication to continual improvement.
Not every provider of dynamic mattresses can say this. And it is thought that most of the market is under regulated. Regulation enforces immutable standards on medical equipment which serves purely to assist vulnerable people, and not harm them.
By prioritising safety, comfort, and compliance with healthcare standards, these mattresses play a vital role in enhancing the quality of care. For healthcare facilities looking to improve patient outcomes while managing costs, investing in Class IIa mattresses is a wise and impactful decision. As we continue to advance in healthcare, let’s ensure that our patients receive the best possible support for their health and well-being.
As we mentioned, all our dynamic mattresses are fully regulated and you can view our range here…
