Here are five mistakes to avoid when dealing with supplies and equipment specifically for a GI-driven ASC, such as detergents for scopes, disinfectants and pre-owned equipment.
1. Not checking to make sure disinfectants are legal. Not all products that are sold comply with the state and national requirements of regulatory agencies, says Jack Wagner, president of Micro-Scientific, an Illinois-based producer and distributor of antimicrobial products. Surgery centers need to ensure the disinfectant product they're using has an EPA registration number on the label. Mr. Wagner likens that number to a driver's license. If there's no registration number on the label, it's not a legal product to use.
2. Not suctioning enzymatic detergent through the suction channels. Shaun Sweeney, vice president of sales and marketing for Cygnus Medical, explains ASCs should follow manufacturer recommendations, which may include using approximately 500 mL of enzymatic detergent and water to suction and flush out channels. Skipping the first step of suctioning enzymatic detergent through the suction channels will not only affect the efficacy of the channels being properly reprocessed but will also release high volumes of gross contamination into the soaking stage. "High-level disinfection is dependent on every stage being performed properly," he says. "A breakdown early on can affect the efficacy of the process later."
3. Reusing enzymatic detergent for scope cleaning. No matter what type of enzymatic detergent your ASC uses to soak scopes in, Mr. Sweeney stresses the importance of changing — not reusing — detergents after each use for optimal effectiveness. Just as a household member would refill a sink with new water and new detergent to clean dirty dishes, ASCs should also be mindful of changing water and enzymatic detergent because detergent will break down, he says.
"This may be a case of someone not paying attention to the manufacturer's recommendations or trying to save money, but ASCs must not reuse enzymatic detergent with multiple scopes. Detergents absolutely break down and lose integrity after each use," he says. "ASCs will sometimes reuse a brush to clean a scope too, but they have to remember that there are disposable kinds and reusable kinds. If you use a single-use item, you're supposed to use that item just one time."
4. Quantifying a certain number of times to brush a scope. Mr. Sweeney says another quality pitfall of GI/endoscopy-driven ASCs is brushing scopes with a preconceived notion of how many times to brush. Some manufacturers present this as a marketing benefit, suggesting a brush only needs one pass through a channel. The number of passes of the brush will depend on a multitude of factors, such as the amount of contamination, size of the brush, number of bristles and density of the bristles. Considering the variance in brush features and given that there is no published standard on how many times to brush a scope, Mr. Sweeney says GI/endoscopy-driven ASCs shouldn't quantify the number of times to brush but instead brush until there is no more debris exiting the scope.
"When you look at Society of Gastroenterology Nurses and Associates' video, they make it very clear not to pre-quantify the number of passes," Mr. Sweeney says. "Brushing is done underwater, so while you are brushing your scope, you can see if anything is coming out because it will float around in the water. Brushing underwater allows some visibility, and that's a standard that each manager of an endoscopy suites needs to address with their decontamination technicians."
5. Not checking if pre-owned equipment is still supported by the original manufacturer. Making sure pre-owned equipment is in good condition before using it is imperative in preventing infection at your ASC, says Ray Midlam, product manager, certified pre-owned equipment for Olympus America. Be sure to find out if the model is still supported by the original equipment manufacturer, otherwise you may end up with a product with no access to replacement parts. And don't be lulled into complacency by a product sporting a "certified" or "CPO" label, he says. This is an unregulated term with no standards to support it. So ask the supplier what exactly the "certified" label means and how the product was repaired.
For an endoscope, make sure it underwent a rigorous refurbishment process with all parts inspected. Also ensure the insertion tube and other worn or damaged parts replaced with OEM parts. If not, buyers beware: A scope that has been altered with third-party parts — even those purporting to be reverse engineered or "OEM-like" — is no longer FDA 510(k) compliant, which means it is no longer validated for reprocessing.
Related Articles on Gastroenterology:
Central Illinois Endoscopy Center Gets 95% Patient Satisfaction Rate
Apollo Endosurgery Raises $47.6M in New Financing
U.S. Endoscopy Announces Full Market Release of Torrent Irrigation Tubing
1. Not checking to make sure disinfectants are legal. Not all products that are sold comply with the state and national requirements of regulatory agencies, says Jack Wagner, president of Micro-Scientific, an Illinois-based producer and distributor of antimicrobial products. Surgery centers need to ensure the disinfectant product they're using has an EPA registration number on the label. Mr. Wagner likens that number to a driver's license. If there's no registration number on the label, it's not a legal product to use.
2. Not suctioning enzymatic detergent through the suction channels. Shaun Sweeney, vice president of sales and marketing for Cygnus Medical, explains ASCs should follow manufacturer recommendations, which may include using approximately 500 mL of enzymatic detergent and water to suction and flush out channels. Skipping the first step of suctioning enzymatic detergent through the suction channels will not only affect the efficacy of the channels being properly reprocessed but will also release high volumes of gross contamination into the soaking stage. "High-level disinfection is dependent on every stage being performed properly," he says. "A breakdown early on can affect the efficacy of the process later."
3. Reusing enzymatic detergent for scope cleaning. No matter what type of enzymatic detergent your ASC uses to soak scopes in, Mr. Sweeney stresses the importance of changing — not reusing — detergents after each use for optimal effectiveness. Just as a household member would refill a sink with new water and new detergent to clean dirty dishes, ASCs should also be mindful of changing water and enzymatic detergent because detergent will break down, he says.
"This may be a case of someone not paying attention to the manufacturer's recommendations or trying to save money, but ASCs must not reuse enzymatic detergent with multiple scopes. Detergents absolutely break down and lose integrity after each use," he says. "ASCs will sometimes reuse a brush to clean a scope too, but they have to remember that there are disposable kinds and reusable kinds. If you use a single-use item, you're supposed to use that item just one time."
4. Quantifying a certain number of times to brush a scope. Mr. Sweeney says another quality pitfall of GI/endoscopy-driven ASCs is brushing scopes with a preconceived notion of how many times to brush. Some manufacturers present this as a marketing benefit, suggesting a brush only needs one pass through a channel. The number of passes of the brush will depend on a multitude of factors, such as the amount of contamination, size of the brush, number of bristles and density of the bristles. Considering the variance in brush features and given that there is no published standard on how many times to brush a scope, Mr. Sweeney says GI/endoscopy-driven ASCs shouldn't quantify the number of times to brush but instead brush until there is no more debris exiting the scope.
"When you look at Society of Gastroenterology Nurses and Associates' video, they make it very clear not to pre-quantify the number of passes," Mr. Sweeney says. "Brushing is done underwater, so while you are brushing your scope, you can see if anything is coming out because it will float around in the water. Brushing underwater allows some visibility, and that's a standard that each manager of an endoscopy suites needs to address with their decontamination technicians."
5. Not checking if pre-owned equipment is still supported by the original manufacturer. Making sure pre-owned equipment is in good condition before using it is imperative in preventing infection at your ASC, says Ray Midlam, product manager, certified pre-owned equipment for Olympus America. Be sure to find out if the model is still supported by the original equipment manufacturer, otherwise you may end up with a product with no access to replacement parts. And don't be lulled into complacency by a product sporting a "certified" or "CPO" label, he says. This is an unregulated term with no standards to support it. So ask the supplier what exactly the "certified" label means and how the product was repaired.
For an endoscope, make sure it underwent a rigorous refurbishment process with all parts inspected. Also ensure the insertion tube and other worn or damaged parts replaced with OEM parts. If not, buyers beware: A scope that has been altered with third-party parts — even those purporting to be reverse engineered or "OEM-like" — is no longer FDA 510(k) compliant, which means it is no longer validated for reprocessing.
Related Articles on Gastroenterology:
Central Illinois Endoscopy Center Gets 95% Patient Satisfaction Rate
Apollo Endosurgery Raises $47.6M in New Financing
U.S. Endoscopy Announces Full Market Release of Torrent Irrigation Tubing