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
- Proformance Brochure
- DE Broth IFU
- Duodenoscope Sampling Kit IFU
- Endoscope Reprocessing Quality Assurance Recommendations
- Flexible Endoscope Incident Report May 2019 Volume I
- Flexible Endoscope Incident Report April 2021 Volume IV
- Flexible Endoscope Incident Report August 2021 Volume IV
- Flexible Endoscope Incident Report January 2022 Volume IV
- Flexible Endoscope Incident Report July 2020 Volume III
- Flexible Endoscope Incident Report October 2019 Volume II
- Flexible Endoscope Incident Report October 2020 Volume III
- Flexible Endoscope Incident Report October 2021 Volume IV
- Flexible Endoscope Sampling Kit IFU
- Flexible Endoscope Sampling Kit Information
- Sample Extraction Tools IFU
- Use of Healthmark Industries Products to Comply with Multisociety Guideline
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