Flexible Endoscope Sampling Kit
Flexible Endoscope Sampling Kit

Endoscope manufacturers, regulatory bodies and healthcare facilities are increasingly concerned about the spread of communicable diseases, including clinically relevant microorganisms, on reprocessed medical devices. Healthmark Industries and Nelson Laboratories have joined forces to create an endoscope sampling kit for the purpose of monitoring and reporting objective results from clinical scopes. Everything necessary to collect and send a sample from a reprocessed endoscope for testing to determine the presence of objectionable microorganisms will be provided in the kit offered by Healthmark. The sample will be sent by the healthcare facility to Nelson Labs for independent testing of the sample for the presence of any microorganisms. If present, the organisms will be identified and quantified. The Endoscope Sampling Kit is intended to be used as a proficiency assessment for healthcare practices and not as a safety assessment for the reprocessed scope (not a “fitness for use” test). This surveillance assessment is important to help the clinical user determine if their scope is safe for use, requires additional reprocessing, requires additional testing or should be quarantined. The kit and related tests are intended as another help to assess the adequacy of healthcare facility scope reprocessing.
Support Documents
Duodenoscope Sampling Kit IFUFlexible Endoscope Incident Report May 2019 Volume I
Healthmark Flexible Scope Verification Product
Use of Healthmark Industries’ Products to Comply with the AAMI ST91 Standard for Reprocessing of Flexible Endoscopes
Endoscope Reprocessing Quality Assurance Recommendations
Flexible Endoscope Sampling Kit Information
Flexible Endoscope Sampling Kit IFU
Leak Tester Tester IFU
DE Broth IFU
Flexible Endoscope Incident Report October 2019 Volume II