Endoscope manufacturers, regulatory bodies, and health care facilities are increasingly concerned about the spread of communicable diseases, including clinically relevant microorganisms, on processed medical devices. Healthmark Industries and Nelson Labs have partnered to create an endoscope sampling kit for use with flexible endoscopes with a purpose of monitoring and reporting objective microbiological results from processed clinical scopes.
The Flexible Endoscope Sampling Kit is sold by Healthmark Industries and test services are provided by Nelson Labs as a full-service kit.
To order a flexible endoscope sample kit contact Healthmark Industries:
Heathmark Industries Company, Inc.
+1 (800) 521-6224 x6005
[email protected]
http://www.hmark.com/samplingkit.php
The kit fee includes the testing supplies needed and the test services that include quantitative microbial counts and up to two organism identifications with a memo that interprets the results. 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. If multiple organism identifications are required, the clinic can opt to purchase those as needed for a fee as quoted by Healthmark.
We also offer Scope Processing Validation tests which validates a manufacturer’s cleaning procedure to ensure a diagnostic device can be used in a medical setting.
Applicable Standards
- CDC
- US FDA
