Reprocessing Recommendations

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Assessing Reprocessing Procedures,

Reprocessing Failures & Outbreaks

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.

Multisociety, 2016

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).

HICPAC, 2016

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.

AORN, 2016

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).

ANSI/AAMI ST91, 2015

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).

APIC/JCR, 2017

Develop a recall policy and procedure than can be implemented in the event of process failure.

CMS, 2016

Hospital should have policies and procedures outlining hospital response in the event of a reprocessing failure.

TJC Booster Pak, 2015

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.

Guideline Details

How do you know if an endoscope has been properly cleaned? Here’s an easy-to-use reference.