Kick-off meeting of a DIN funding project on “More Safety in the OR” organized by a consortium managed by Steinbeis
The Steinbeis Transfer Institute of Medical Innovations and Management and the Steinbeis Transfer Institute of International Business and Risk Management are among the winners of the DIN-Connect 2019 funding program, which acknowledges innovative projects offering norming and standardization potential. Representatives from education, medicine, industry, and trade associations met up on May 2 at the Haus der Wirtschaft (House of Commerce) in Stuttgart to embark on the planning phase of the new DIN SPEC 91422. The joint aim is to safeguard quality with the integrative application of complex medical technology in the operation room.
The project team has spent the last four weeks sharing a business plan called “Planning and Safety Requirements in the Multifunctional, Technological Working Environment of Surgical Operation Rooms,” also in order to gain feedback. A variety of experts, panels, and committees have been actively approached and involved due to the strong interest in this standardization – there are many different discussion points in the areas of overlap between medicine and medical technology.
Objectives and area of application
Aside from safeguarding the quality of application when using medical technology in the operation room, DIN SPEC 91422 has another goal. The intention is to build confidence among all stakeholders, especially when it comes to the users of new technology, also strengthening trust in the long term by ensuring that it is possible to check and monitor staff training requirements, typically captured under technical standards, as well as the application of new technologies. This requires specific analysis, communication, problem-solving, and training processes, especially with respect to multimodality, complexity, and interdisciplinarity. Following intensive discussion (under the guidance of Hendrik Lüttgens, the DIN project manager) on public comments, goals, and the application area covered by the DIN specification, a business plan for the DIN SPEC was agreed unanimously at the kick-off meeting.
Focusing on the overall human-to-human and human-to-technology system
The idea of DIN SPEC 91422 is to lay down the required prerequisites during everyday interactions, especially when established and new technology come together in the OR. The DIN SPEC should lay a foundation for enhancing quality and safety with respect to evaluations, advice, planning, assembly, and the efficient operation and maintenance of multifunctional ORs. A crucial role in this is played by training given to the occupational groups involved in this area. Standard processes, roles, and responsibilities are also being defined in order to minimize the likelihood of hazardous situations arising before, during, and after operations. This should significantly enhance patient safety as well as the health and safety of people working in the OR. The DIN SPEC does not actually lay down requirements for medical products themselves. Instead it considers the overall complex system and human-to-human and human-to-technology interactions.
Steinbeis asked to manage the consortium
The DIN SPEC consortium comprises (among others) experts in medical technology, imaging, risk management, occupational health and safety, radiological protection, hygiene, and clinical issues. It was unanimously agreed that the consortium should be managed by the Steinbeis experts Prof. Dr. Oliver Meissner (manager) and Angelika Gruber (deputy). At the next meetings and workshops, the consortium members will work on the content required by specifications to enhance safety in the OR, including when this spans several specialist disciplines. DIN SPEC 91422 is scheduled for publication before the end of the year. The results could then form a basis for working up an official DIN standard.