This page includes summaries that should not be used to create policies and procedures. Please refer to the original source documents for exact language. Links can be found here.
Environmental sampling if a chemical or infectious etiology is suspected. Send samples to a send-out lab that specializes in environmental organisms. Report outbreak to infection prevention department, public health (state or local, as required by state law), the FDA's MedWatch program (www.fda.gov/medwatch), and the manufacturers of the endoscope, disinfectant/sterilant, and AER (if used).
If bacterial contamination is suspected after reprocessing, HCP to file a voluntary report via MedWatch, the FDA Safety and Adverse Reporting program. If a patient may have been exposed, decide whether the patient should be notified in collaboration with infection prevention and State and Local health departments.
Report outbreak to infection prevention department, public health (state or local, as required by state law), FDA's MedWatch program (www.fda.gov/medwatch), and the manufacturers of the endoscope, disinfectant/sterilant, and AER (if used).
Report outbreak to infection prevention department, public health (state or local, as required by state law), FDA's MedWatch program (www.fda.gov/medwatch), and the manufacturers of the endoscope, disinfectant/sterilant, and AER (if used).
Develop a recall policy and procedure than can be implemented in the event of process failure.
Hospital should have policies and procedures outlining hospital response in the event of a reprocessing failure.
Leaders are responsible for designing high-level disinfection and sterilization work processes that focus on safety and quality to prevent breaches that could pose infectious risks to patients.
How do you know if an endoscope has been properly cleaned? Here’s an easy-to-use reference.