Better design needed for reusable devices, experts say
June 20, 2017
by Lisa Chamoff, Contributing Reporter
Medical device manufacturers need to create smarter designs for reusable devices, such as flexible endoscopes, paying better attention to how health care facilities are actually reprocessing them, a pair of experts noted this week.
Alpa Patel, a senior scientist at Nelson Labs, and John Iannone, director of extractables/leachables and impurities at Albany Molecular Research Inc., spoke about the challenges of reprocessing and avoiding hospital-acquired infections during a session Tuesday at MD&M East, a medical technology trade show in New York City.
There has been a move toward using materials that reduce the formation of biofilm in medical and consumer products, though Iannone noted that many medical device manufacturers were "afraid of using novel materials."
Problems arise when solid debris cannot be removed from the crevices of endoscopes and so they cannot be properly disinfected.
Patel spoke about the importance of validating the instructions for reprocessing with realistic conditions, recalling being told while validating a method of reprocessing that she was too small to properly flush the device.
There are devices that need to be flushed hundreds of times, and employees cannot do this for an extended period of time.
"I would urge all medical device manufacturers not to increase flushes from 200 to 300, but think, 'Can I design my device better so I don't have to ask someone to go from 200 to 300 and potentially fail because they didn't adhere to those instructions,'" Iannone said.
Extensive user training should be conducted for the workers doing the reprocessing, not just their managers, Patel said. Manufacturers should also get a better idea of the detergents facilities use, because they often aren't purchasing the same products that were used to validate the cleaning process.
When asked whether the move toward single-use devices could help solve infection control problems, Patel said that there will still be companies developing methods to reprocess even disposable products.
"Even if you say this is disposable, I bet somebody will find that product and make it reusable," Patel said. "I have validated before a disposable endoscope, and it didn't work out."
Alpa Patel, a senior scientist at Nelson Labs, and John Iannone, director of extractables/leachables and impurities at Albany Molecular Research Inc., spoke about the challenges of reprocessing and avoiding hospital-acquired infections during a session Tuesday at MD&M East, a medical technology trade show in New York City.
There has been a move toward using materials that reduce the formation of biofilm in medical and consumer products, though Iannone noted that many medical device manufacturers were "afraid of using novel materials."
Problems arise when solid debris cannot be removed from the crevices of endoscopes and so they cannot be properly disinfected.
Patel spoke about the importance of validating the instructions for reprocessing with realistic conditions, recalling being told while validating a method of reprocessing that she was too small to properly flush the device.
There are devices that need to be flushed hundreds of times, and employees cannot do this for an extended period of time.
"I would urge all medical device manufacturers not to increase flushes from 200 to 300, but think, 'Can I design my device better so I don't have to ask someone to go from 200 to 300 and potentially fail because they didn't adhere to those instructions,'" Iannone said.
Extensive user training should be conducted for the workers doing the reprocessing, not just their managers, Patel said. Manufacturers should also get a better idea of the detergents facilities use, because they often aren't purchasing the same products that were used to validate the cleaning process.
When asked whether the move toward single-use devices could help solve infection control problems, Patel said that there will still be companies developing methods to reprocess even disposable products.
"Even if you say this is disposable, I bet somebody will find that product and make it reusable," Patel said. "I have validated before a disposable endoscope, and it didn't work out."