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.