Development of Device-and Service-Profiles for a Safe and Secure Interconnection of Medical Devices in the Integrated Open OR

Abstract

AbstractToday’s integrated OR systems are closed and proprietary, so that the interconnection of components from third-party vendors is only possible with high time and cost effort. An integrated operating theatre with open interfaces, giving clinical operators the opportunity to choose individual medical devices from different manufacturers, would be advantageous for both hospital operators and small and medium-sized manufacturers of medical devices. Actual standards and concepts regarding technical feasibility and accreditation process do not cope with the requirements for modular integration based on an open standard. Therefore, strategies as well as device-and service-profiles to enable a procedure for risk management and certification capability are in the focus of the BMBF-funded OR.NET-project. The use of standardized device-and service-profiles shall allow the manufacturers to integrate their medical devices without disclosing the medical devices’ risk analysis and related confidential expertise or proprietary information.KeywordsAccreditation strategiesMedical device integrationDynamic interconnectionOpen standardsInteroperabilityOR.net projectRisk managementUsability engineeringDevice-and service-profiles