Mersey Burns is a clinical tool for estimating burn area percentages, prescribing fluids using Parkland, background fluids and recording patients’ details.
The app allows a doctor to quickly highlight areas of the patient which are burned using multitouch gestures.
The app then combines user input patient information such as height, weight and age with a range of formulas and presents the user with the necessary fluids protocol to be administered over the 24 hours following burn injury.
Furthermore, the information entered and the results calculated can then be exported via email. This app has become the first app to be registered with the MHRA as a Class I medical device as per the EU Medical Device Directive.
d4, a non-profit organization focused on improving patient care by placing modern technology in the hands of doctors, nurses and other health care professionals highlighted the process by which Mersey Burns received its accreditation:
Twenty staff, ten from each of plastic surgery/A&E departments at Whiston Hospital were given a photograph of a burn-injured child and asked to calculate total body surface area (TBSA), Fluid Resuscitation and maintenance fluids using paper or app. There was no significant difference between the app or paper TBSA assessment, but there was significantly less variance in the app assessment compared to paper assessment with respect to total fluid, and background fluid requirements.
Furthermore, d4 has created a guidance document, Regulation of health apps: a practical guide, which makes the following recommendations:
- Health professionals should carefully consider the risks when using apps to determine a patient’s care.
- Developers should test their apps thoroughly and maintain adequate technical documentation to evidence this.
- Publishers should ensure compliance with the necessary regulations before releasing apps on to the market.
- Organizations should investigate ways to manage the use of apps by their employees, and put in place mechanisms to identify those apps that are deemed fit for professional use.
- Patients should examine carefully the source of the apps they use to manage their health. Within Europe, health apps that influence a patient’s treatment should carry the CE mark to demonstrate their conformity with the appropriate regulation.
A declaration of conformity has been accepted by the MHRA to demonstrate that the software medical device is compliant with the essential requirements and other relevant provisions of Medical Devices Directive 93/42/EEC. Medicapps Ltd can therefore be found listed on the MHRA register as the manufacturer of the Burns Assessment medical device.