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Article Contamination Of Insufflators August 2009

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1) Endoscopic surgery procedures like cholecystectomies and hysterectomies are increasing rapidly and require the use of an insufflator to produce pneumoperitoneum. 2) Insufflators risk contaminating patients if their internal gas circuits become contaminated with fluids from a prior patient. Hydrophobic filters that meet certain particulate retention and hydrophobicity standards are necessary to prevent cross contamination. 3) NBS Group Supply recommends insufflation filters rated at 99.99% particulate retention at 0.1 micron with a hydrophobicity rating of 50mm Hg in order to ensure retention of particulates and fluids under operating pressures. They customize filters and tubing

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OF INSUFFLATORS - AUGUST/2009 ENDOSCOPY SURGERY? BY: CHARLES E. MEISCH ENDOSCOPIC CONSULTANT NBS GROUP SUPPLY 257 LIVINGSTON AVENUE, NEW BRUNSWICK, NJ 08901, USA 1-732-610-2042 As the U.S. and Europe continue to see the breakthrough use of Endoscopic Surgery versus conventional surgery in all areas, it appears the procedures increasing most rapidly are cholecystectomies, female sterilization, lap bariatric, bowel resection, hernia repair, hysterectomy, appendectomy, anti-reflux, and nephrectomy, most of which require the use of an insufflator. Usually electronic in design, insufflators are differentiated by flow rates, ranging from 9.9 LPM to 45LPM at 1 PSI or lower. They are also pressure-limited gas flow regulators used In January of 1996, the Medical Devices to produce a pneumoperitoneum. Agency released a Safety Notice stating that patient fluid contamination continues to be found in the internal gas circuits of laparoscopic insufflators and that practitioners According to AORN's 1995 Standards and should, "ensure that any bacterial filter/liquid Recommended Practices, "Insufflator trap assembly provided and recommended by equipment should include a disposable the manufacturer of the insufflator be used hydrophobic (liquid blocking) filter." Over the and disposed of appropriately." In May of past few years, health care providers in the 1992, The Emergency Care Research Institute United States have come to the consensus (ECRI) released a statement which warned, that filter devices are a necessary part of all "blood was being delivered to a patient via an laparoscopic procedures that employ insufflator." This blood apparently came from insufflation. The need for filters for the a prior patient. Manufacturers and various retention of particulates such as hospital clinic engineers confirm this is a inorganic debris, rust, metal filings and common occurrence. The right hydrophobic Teflon has been recognized by the filter (liquid trap) stops the reflux (backflow) majority of practitioners. However, it is of blood and other body fluids as well as important to choose a filter which also particulates, preventing contamination of the prevents body fluids from entering insufflators and cross contamination between insufflators. For this purpose, the filter patients. must be hydrophobic.
N OF INSUFFLATORS - AUGUST/2009 IN ENDOSCOPY SURGERY? Because of this dual hazard, it is important to specify both the particle retention rating and the level of hydrophobicity required when selecting a filter for use with insufflation. NBS Group Supply recommends that an insufflation filter be rated at 99.99% (particle retention), 0.1 micron, and should have a hydrophobicity rating of 50mm Hg. NBS Group Supply offers a wide range of media and connectors to address the specific needs of your application. These specifications ensure not only the retention of particulate, but under operating conditions, the retention of aqueous fluids as well. PARTICULATE RETENTION The particle retention specification of a filter designates what percentage of particulate of a certain size or greater will be trapped by that filter. HOW MUCH HYDROPHOBICITY IS ENOUGH? Recently the Canadian Government issued a warning in their alert to all hospital administrators basically stating that once the internal gas circuit of an insufflator is contaminated with liquids or gases from the patient cavity, a potential hazard of cross contamination is usually created. In one of the incidents reported, a filter had been used, but it failed to provide protection against liquid backflow. Subsequent discussions with the manufacturer revealed that the filter was not recommended for the purpose of backflow preventions.
THE CONTAMINATION OF INSUFFLATORS THE NEXT MAJOR PROBLEM IN ENDOSCOPY SURGER Hydrophobicity is only a relative characteristic and must be accompanied by a specific pressure and time designation to be valid. For example, the claim "this filter is hydrophobic" would be more valid if it read "this filter has a hydrophobicity rating of 50mm Hg pressure." CUSTOMIZATION NBS Group Supply offers a wide range of options to ensure the correct performance of an insufflator. The filter specification, retention rating, level of hydrophobicity, sterile or non-sterile, labeling, tube length, connectors, and packaging are all calculated to be used with most insulators. It is important to remember insufflation tubing in the U.S. falls under a Class I status. This means that any company can take a common Hydrophobicity is the characteristic of a filter medical gas filter, assemble it to tubing, and media, which allows it to repel water, or call it an insufflation tubing set. All that is water based substances such as body fluids. required is to register with the FDA and To provide protection against reflux during comply with the FDA's cGMP's, but not insufflation, a filter must have a necessarily submit for premarket approval. hydrophobicity rating above the pressure Under these criteria, the set may or may not that can be exerted in a reverse direction. work with your insufflator. NBS Group Supply For insufflation, that rating is 50mm Hg for specifically tests filters so that they meet all 10 minutes. In the above example, the necessary medical and FDA criteria. Unlike filter being discussed was considered to be other companies, our tubing sets go beyond "hydrophobic", but it did not carry a hydrophobic rating strong enough to retain what is required by the FDA and have been submitted to the FDA for premarket approval body fluids under these conditions. as Class II devices. This means not only the Every hydrophobic filter media has a product, but the packaging, the method of pressure level at which aqueous liquids can sterilization and the labeling are all carefully be forced through the pores. This level is reviewed. The FDA has reviewed our the "water breakthrough" pressure. application and has approved it for the Water breakthrough is also affected by the intended use thereby removing any doubt that length of time the pressure is applied. While our sets are truly manufactured as insufflation many filters are hydrophobic, this statement tubing sets and not just gas filtering systems. does not mean that the filter will be We feel this is important for you to know. For hydrophobic at all pressures, or that it is a copy of the approval, please contact our hydrophobic enough for a particular corporate office in New Brunswick, NJ. application.

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Article Contamination Of Insufflators August 2009

  • 1. OF INSUFFLATORS - AUGUST/2009 ENDOSCOPY SURGERY? BY: CHARLES E. MEISCH ENDOSCOPIC CONSULTANT NBS GROUP SUPPLY 257 LIVINGSTON AVENUE, NEW BRUNSWICK, NJ 08901, USA 1-732-610-2042 As the U.S. and Europe continue to see the breakthrough use of Endoscopic Surgery versus conventional surgery in all areas, it appears the procedures increasing most rapidly are cholecystectomies, female sterilization, lap bariatric, bowel resection, hernia repair, hysterectomy, appendectomy, anti-reflux, and nephrectomy, most of which require the use of an insufflator. Usually electronic in design, insufflators are differentiated by flow rates, ranging from 9.9 LPM to 45LPM at 1 PSI or lower. They are also pressure-limited gas flow regulators used In January of 1996, the Medical Devices to produce a pneumoperitoneum. Agency released a Safety Notice stating that patient fluid contamination continues to be found in the internal gas circuits of laparoscopic insufflators and that practitioners According to AORN's 1995 Standards and should, "ensure that any bacterial filter/liquid Recommended Practices, "Insufflator trap assembly provided and recommended by equipment should include a disposable the manufacturer of the insufflator be used hydrophobic (liquid blocking) filter." Over the and disposed of appropriately." In May of past few years, health care providers in the 1992, The Emergency Care Research Institute United States have come to the consensus (ECRI) released a statement which warned, that filter devices are a necessary part of all "blood was being delivered to a patient via an laparoscopic procedures that employ insufflator." This blood apparently came from insufflation. The need for filters for the a prior patient. Manufacturers and various retention of particulates such as hospital clinic engineers confirm this is a inorganic debris, rust, metal filings and common occurrence. The right hydrophobic Teflon has been recognized by the filter (liquid trap) stops the reflux (backflow) majority of practitioners. However, it is of blood and other body fluids as well as important to choose a filter which also particulates, preventing contamination of the prevents body fluids from entering insufflators and cross contamination between insufflators. For this purpose, the filter patients. must be hydrophobic.
  • 2. N OF INSUFFLATORS - AUGUST/2009 IN ENDOSCOPY SURGERY? Because of this dual hazard, it is important to specify both the particle retention rating and the level of hydrophobicity required when selecting a filter for use with insufflation. NBS Group Supply recommends that an insufflation filter be rated at 99.99% (particle retention), 0.1 micron, and should have a hydrophobicity rating of 50mm Hg. NBS Group Supply offers a wide range of media and connectors to address the specific needs of your application. These specifications ensure not only the retention of particulate, but under operating conditions, the retention of aqueous fluids as well. PARTICULATE RETENTION The particle retention specification of a filter designates what percentage of particulate of a certain size or greater will be trapped by that filter. HOW MUCH HYDROPHOBICITY IS ENOUGH? Recently the Canadian Government issued a warning in their alert to all hospital administrators basically stating that once the internal gas circuit of an insufflator is contaminated with liquids or gases from the patient cavity, a potential hazard of cross contamination is usually created. In one of the incidents reported, a filter had been used, but it failed to provide protection against liquid backflow. Subsequent discussions with the manufacturer revealed that the filter was not recommended for the purpose of backflow preventions.
  • 3. THE CONTAMINATION OF INSUFFLATORS THE NEXT MAJOR PROBLEM IN ENDOSCOPY SURGER Hydrophobicity is only a relative characteristic and must be accompanied by a specific pressure and time designation to be valid. For example, the claim "this filter is hydrophobic" would be more valid if it read "this filter has a hydrophobicity rating of 50mm Hg pressure." CUSTOMIZATION NBS Group Supply offers a wide range of options to ensure the correct performance of an insufflator. The filter specification, retention rating, level of hydrophobicity, sterile or non-sterile, labeling, tube length, connectors, and packaging are all calculated to be used with most insulators. It is important to remember insufflation tubing in the U.S. falls under a Class I status. This means that any company can take a common Hydrophobicity is the characteristic of a filter medical gas filter, assemble it to tubing, and media, which allows it to repel water, or call it an insufflation tubing set. All that is water based substances such as body fluids. required is to register with the FDA and To provide protection against reflux during comply with the FDA's cGMP's, but not insufflation, a filter must have a necessarily submit for premarket approval. hydrophobicity rating above the pressure Under these criteria, the set may or may not that can be exerted in a reverse direction. work with your insufflator. NBS Group Supply For insufflation, that rating is 50mm Hg for specifically tests filters so that they meet all 10 minutes. In the above example, the necessary medical and FDA criteria. Unlike filter being discussed was considered to be other companies, our tubing sets go beyond "hydrophobic", but it did not carry a hydrophobic rating strong enough to retain what is required by the FDA and have been submitted to the FDA for premarket approval body fluids under these conditions. as Class II devices. This means not only the Every hydrophobic filter media has a product, but the packaging, the method of pressure level at which aqueous liquids can sterilization and the labeling are all carefully be forced through the pores. This level is reviewed. The FDA has reviewed our the "water breakthrough" pressure. application and has approved it for the Water breakthrough is also affected by the intended use thereby removing any doubt that length of time the pressure is applied. While our sets are truly manufactured as insufflation many filters are hydrophobic, this statement tubing sets and not just gas filtering systems. does not mean that the filter will be We feel this is important for you to know. For hydrophobic at all pressures, or that it is a copy of the approval, please contact our hydrophobic enough for a particular corporate office in New Brunswick, NJ. application.