CH-18-C029 -- Constructing Operating Room HVAC With Performance Assurances; An Alternate Approach PDF

This paper presents an innovative approach to procuring operating room HVAC systems: the operating room will be designed, built, and then tested for sterile performance. Much of the innovation lies in the final test, which is designed toassure that the built operating room achieves sterility prior to the owner’s acceptance. Such performance tests of operating rooms are not uncommon in Europe; however, this delivery approach is the first of its kind in the United States.

In the current market, several vendors offer integrated operating room ceiling solutions, adapting the design and construction technology from the clean room industry. This owner solicited proposals, interviewed vendors, and selected two vendors to provide operating room ceilings on future projects. The resulting agreements between the owner and the vendors includes a test of the operating room to meet ISO 14644 Class 6 and microbial contamination not to exceed 10 CFU/m3. These tests shall be conducted before the close-out phase of the project after the operating room is cleaned and sterilized per the applicable protocols.

This paper also describes the process of selecting the performance criteria. Because there is no specific clinical or medical evidence pointing to a certain level of cleanliness, the owner selected ISO Class 6 based on a comparisons of international standards, known studies of U.S. operating room performance, and coordination with internal stakeholders.