Regulation and validation of smartphone applications in plastic surgery: It's the Wild West out there

Abstract

Background and purpose: The use of smartphone applications is ubiquitous within healthcare. Over recent years there have been multiple applications developed within the field of plastic surgery. In the UK, applications with a medical purpose should be registered with the Medicines and Healthcare products Regulatory Authority (MHRA) as a medical device. The aim of this study was to evaluate plastic surgery specific smartphone applications designed for healthcare professional usage, and determine what proportion meet the criteria of a medical device and are suitably certified.

Methods: A systematic review of the Apple and Google Play App stores was carried out using search terms relevant to plastic surgery. Data was extracted from the app store listing, developer website and the contents of each application. Each application was evaluated against the criteria given by the MHRA to determine whether it constituted a medical device.

Results: 215 applications for plastic surgery healthcare professionals were identified, of which 22 met the definition of a medical device. Only 14% (n = 3) of these applications were appropriately certified, 14% (n = 3) were validated in peer-reviewed literature and 45% (n = 10) had documented medical professional involvement.

Conclusion: Most applications with a medical purpose were not certified as a medical device, had not been validated in any peer-reviewed research, and did not have any documented involvement of medical professionals. The potential consequences of such applications operating incorrectly are stark and represent a risk to patient safety. Usage of multiple applications in a single patient encounter may compound error and safety of clinical care.

Keywords: Apps; Medical device; Smartphone; mhealth.