Creating a Highly Reliable Respiratory Therapy Department That Meets Regulatory, Manufacturer's, and Infection Prevention Requirements

      This paper is only available as a PDF. To read, Please Download here.


      Concerns regarding compliance with manufacturer's instructions for use for (M-IFUs) for high level disinfection (HLD), low level disinfection (LLD), equipment preassembly and storage of Respiratory Therapy (RT) equipment were identified. In-line temperature probes were not being HLD after use per M-IFUs. Additionally, M-IFUs were not reviewed for equipment compatibility with current hospital approved disinfectants for low level disinfection following patient use. Finally, equipment was found pre-assembled and stored without consideration for expiration or maintaining contamination free storage.


      Gap analysis between practices, regulatory requirements and M-IFUs was performed regarding disinfection, pre-assembly, and storage processes of RT equipment. A collaborative team of RT, Sterile Processing Department, and Infection Prevention (IP) was formed to review all requirements per M-IFUs.


      Gap analysis revealed a disparity between current practice, regulatory requirements and M-IFUs. A step by step process for high level disinfection of temperature probes was created for respiratory therapy staff and the sterile processing department to ensure pre-cleaning, transport, and reprocessing met M-IFUs and regulatory requirements. A full equipment reference library was established to assist staff in identifying the appropriate disinfectant for each piece of equipment and ensures compatibility with current hospital approved disinfectants. Guidelines were established with the RT department to ensure pre-assembled equipment is properly disinfected, stored to maintain cleanliness, and formal date the pre-assembled equipment must be used by to minimize risk for contamination once placed in to use.


      Our review demonstrates the need to evaluate RT department's processes to ensure HLD, LLD, and pre-assembly and storage of equipment is aligned with M-IFUs, regulatory, and infection prevention recommendations. Building collaborative relationships between the RT Department, Sterile Processing Department, and Infection Prevention is crucial to establishing and maintaining processes that improve patient safety, insure regulatory compliance, and reduce the risk of infection.
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to American Journal of Infection Control
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect