Information regarding the use of Simethicone and other non-water-soluble additives with PENTAX Medical flexible endoscopy equipment
Dear Valued Customers,
This letter is intended to provide information regarding the use of Simethicone and other non-water-soluble additives with PENTAX Medical flexible endoscopy equipment.
As outlined in our Instructions for Use (IFU), PENTAX Medical does not recommend the use of Simethicone and other non-water-soluble additives with our flexible endoscopes. Due to the nature of these products, residue remains in or on the scope and is difficult to remove during manual cleaning. Furthermore, an environment is created on the scope for the formation of biofilm, and this can reduce the efficacy of the overall reprocessing procedure. Solutions containing Simethicone, such as infant gas drops, often contain sugars, thickeners, and other binding agents which can exacerbate the creation of biofilm and support microbial growth. Additionally, use of non-water-soluble products could eventually lead to residual silicone build-up, which can result in decreased performance and/or malfunction of the equipment. High concentrations of Simethicone may be difficult to remove from PENTAX Medical endoscopes despite strict adherence to the PENTAX Medical reprocessing instructions.
Simethicone is often used by clinicians during procedures or as part of pre-procedural bowel preparation in order to improve visualization and reduce bubbling that may occur on the patient's mucosa. If your facility has determined that the benefit of using Simethicone or a non-water-soluble product outweighs the risk of potential reprocessing difficulties, please consider the following suggestions. Administer Simethicone either orally or via the biopsy port of the endoscope, as the biopsy channel is manually brushed during reprocessing. Avoid administering Simethicone via the forward water jet bottle or flushing pump. Sparingly use these products by diluting them in order to achieve the desired clinical result. If residue or debris is observed on the endoscope after complete reprocessing, PENTAX Medical recommends their removal from circulation, followed by repeated cleaning and high-level disinfection. Residue can be removed by repeating manual cleaning until it is no longer visible. If residue or debris is found on the endoscope despite repeated reprocessing, PENTAX Medical recommends that the facility send their scopes to PENTAX Medical for immediate inspection and/or repair.
Healthcare facilities that continue to employ the use of Simethicone and other non-water-soluble additives during gastroenterology procedures or pre-procedure preparation should also consider the current position statements and guidelines published by various professional societies:
“…we recommend following the instruction-for-use of endoscopes released by the manufacturers, to adhere to strict high-level reprocessing protocols, and to consider performing regular microbiological surveillance. We also suggest that endoscopy units reconsider the routine addition of Simethicone to the water pump used during procedures. Finally, if health practitioners are to use Simethicone, the lowest effective volume should be used.”1
“Simethicone often used during endoscopy procedures, may foster microbial growth and biofilm development despite proper reprocessing because it contains sugars and thickeners. Minimize use of Simethicone pending further studies.”2
“…it is advised that Simethicone is administered either orally or via the biopsy port of endoscopes and NOT via either the water bottle or flushing pump devices. This will ensure that manual brushing or relevant channels can take place post-procedure. The strength of the dilutant should also be kept to a minimum to achieve the desired effect.”3
Please note, the use of Simethicone can result in the build-up of residue in the endoscope regardless of how it is administered, resulting in damage to the endoscope that could require a Major Service Repair. PENTAX Medical has recently added additional steps to our repair, maintenance and inspection process. PENTAX Medical will be thoroughly inspecting scopes for any signs of Simethicone build-up or accumulation. If any microscopic evidence of Simethicone is observed anywhere on the endoscope, our service department will do its best to clean the affected area. This cleaning service will be included as part of the Platinum Service contracts.
If you have any questions regarding your service contract or this position statement, please contact our Customer Service department firstname.lastname@example.org more information.
PENTAX Medical – Canada
- Benmassaoud A, Parent J. CAG Position Statement: The Impact of Simethicone on Endoscope Reprocessing. CAG [Internet]. 2017 Jul [cited 2020 June 24]; [4 p.]. Available from: https://www.cag-acg.org/images/publications/CAG_Position_Simethicone_2017_FINAL.pdf
- Guidelines for Use of High-Level Disinfectants & Sterilants in the Gastroenterology Setting. The Soc of Gastro Nurses and Assoc., Inc. [Internet]. 2017 [cited 2020 June 24]; [13 p.]. Available from: https://www.sgna.org/Portals/0/HLD__FINAL.pdf
- Griffiths H, Guidance on Decontamination of Equipment for Gastrointestinal Endoscopy: 2017 Edition: Simethicone Residual in Endoscopes. Brit Soc of Gastro [Internet] 2017 Mar [cited 2020 June 24]; [approx. 4 p.]. Available from: https://www.bsg.org.uk/clinical-resource/guidance-on-decontamination-of-equipment-for-gastrointestinal-endoscopy-2017-edition/
MKGEN-2419EN-C Rev 2
STERIS® Revital-OxTM Resert® XL HLD High Level Disinfectant and PENTAX Medical Flexible Endoscopes (United States, Canada, and Latin America)
Dear Health Care Professional:
This letter provides information on STERIS® Revital-OxTM Resert® XL HLD High Level Disinfectant with regard to its material compatibility with PENTAX Medical flexible endoscopes and the resulting impact on both device functionality and conformance to their statements of intended use. PENTAX Medical does not list this high level disinfectant as compatible with its flexible endoscopes. PENTAX Medical has determined through examination of flexible endoscopes exposed to STERIS® Revital-OxTM Resert® XL HLD that this product negatively impacts the ability of PENTAX Medical flexible endoscopes to conform to their statements of intended use. As a result, the use of this product will void the PENTAX Medical equipment new product warranty against chemically induced damage. Conditions such as, among other things, degradation of adhesives, removal of marking paint, insertion tube alterations (e.g., delamination, deterioration, floppiness, or peeling) and unexplained fluid invasion into the endoscope resulting from the use of STERIS® Revital-OxTM Resert® XL HLD will not be covered under warranty or existing service agreements.
PENTAX Medical assumes no liability for customer use of STERIS® Revital-OxTM Resert® XL HLD with its flexible endoscopes. Any customer utilizing this product with a PENTAX Medical flexible endoscope will assume the risk that the instrument might not be able to conform to its statement of intended use. As a result, PENTAX Medical cannot be held responsible for any adverse events that might occur.
NON-PENTAX MEDICAL REPAIRS
If a product is repaired by a non-PENTAX Medical facility, the corresponding product warranty is void. PENTAX Medical cannot guarantee that any PENTAX Medical flexible endoscope that is repaired by a non-PENTAX Medical facility will be compatible with any detergent or liquid chemical germicide, nor can it guarantee that the endoscope can be considered to be biocompatible. In the event that your equipment has been repaired by a non-PENTAX Medical facility, please contact the repair facility directly for material compatibility information related to detergents and liquid chemical germicides, as well as laboratory data to support biocompatibility (e.g., cytotoxicity, irritation, and sensitization). Finally, the repair facility should also be contacted for validation data supporting that the instrument and any replaced component parts will
perform in accordance with their statements of intended use. If you have any questions, please contact your local PENTAX Medical sales representative or the PENTAX Medical Technical Assistance Center at (800) 736-8293 (United States) or (800) 750-5558 (Canada).
PENTAX Medical Americas
MK-404 Rev: A