Mersey Burns app is registered with the MHRA as a Class I medical device

A UK first: Mersey Burns app is registered with the MHRA as a Class I medical device

To mark this important milestone for UK health app regulation, d4 asked Rowan Pritchard-Jones MD FRCS(Plast), the clinician behind the app, to tell us more.

Mersey Burns is a clinical tool for estimating burn area percentages, prescribing fluids using Parkland, background fluids and recording patients’ details. The app works on the Apple iPad™, iPhone® and iPod Touch®, and was developed within the Mersey Plastic Surgery Unit.

The inspiration for the app came after supervising junior doctors’ calculation of fluid protocols for burn patients, which requires the calculation of a complex formula under different scenarios. One of the principal difficulties in these cases is accurately calculating the percentage of the body surface area burned.

With the Mersey Burns app, a doctor can graphically highlight the areas of the patient that are burned and enter some basic statistics such as their age, height and weight. The app then calculates the necessary fluids protocol to be administered over the 24 hours following burn injury. The information entered and the results calculated can then be emailed for example, from an outlying hospital to a specialist Burns Unit

Mersey Burns was developed by plastic surgeons at Whiston Hospital with a PhD Computer Scientist. Once a prototype of the app was made, it was tested against current paper-based methods of burn assessment to confirm accuracy and reproducibility.

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.

The research confirmed that the Mersey Burns Tool App is an appropriate tool for calculating the TBSA and fluid management of burn injured patients. Furthermore, it delivers improved accuracy with respect to resuscitation and background fluid calculation. It is hoped therefore that the app will improve patient outcomes.

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.

A couple of months ago we mentioned Mersey Burns, an app which enables a quick, accurate calculation of the amount of fluids to be administered after burn injuries. Now this software is the first app to have received approval as a medical device from the UK Medicines and Healthcare products Regulatory Agency.

Mersey Burns was created by Chris Seaton from the University of Manchester: it was developed further within the Mersey Plastic Surgery Unit. The app is available for iPad, iPhone and iPod Touch. To calculate the fluid protocol, the app requires input of the areas that are burned and patient information such as weight, height and age. Down below you can see a video on how the app works.

Source : http://blog.d4.org.uk/2012/01/a-uk-first-mersey-burns-app-is-registered-with-the-mhra-as-a-class-i-medical-device.html

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