infection prevention
By Margaret Miller , BS , MT ( ASCP ) M , CIC , FAPIC ; Mairead Smith ; and Amanda Sivek , PhD
Applying Infection Prevention to Endoscope Evaluations
Endoscopy is a valuable diagnostic and therapeutic tool for many clinical specialties , but the technology presents a particular challenge to infection prevention . Long , flexible endoscopes with internal working channels or intricate mechanical elevator mechanisms can harbor contaminants and microorganisms despite best efforts to clean and disinfect them .
Reprocessing can include hundreds of individual steps . The steps are broadly grouped into « point of use » pre-cleaning , leak testing , inspection , manual cleaning ( brushing ), high-level disinfection or sterilization , rinsing , drying , and finally , storage . Improper handling and storage practices at any point can re-contaminate previously disinfected scopes , heightening the risk of patient infections .
Often , these critical tasks are performed by healthcare workers ( HCWs ) with limited time , resources and tools , working in cramped spaces with poor ergonomics . Although the Food and Drug Administration ( FDA ) and experts have repeatedly emphasized the need to adhere closely to a manufacturer ’ s reprocessing instructions , gaps and variations in practices are common .
Endoscope Reprocessing in the Real World Through consultations with medical facilities , ECRI has observed some recurring issues , including :
● Confusion regarding expiration dates on test strips – specifically , the shelf life of sealed , unopened test strips as compared to shelf life after packaging has been opened
● Lack of separation between clean and dirty areas in endoscope reprocessing rooms
● Insufficient HCW education and training , including rationale for essential steps
● Use of brushes not recommended by a manufacturer - for example , a toothbrush
● Too few scopes to meet demand
● Failure to plan to replace scopes at the end of their useful life . Scopes require maintenance to remain functional and intact . Damage may inhibit reprocessing and clinical functionality .
● Failure to routinely clean the scope storage cabinets , and
● Storage of endoscopes in procedure rooms – for convenience , or lack of another appropriate storage area .
In addition , ECRI surveyed HCWs who perform duodenoscope pre-cleaning and manual cleaning about their experience . Three-hundred forty-one HCWs responded . Responses showed that :
● Approximately 8 percent of respondents did not have the required equipment to perform their work
● 12 percent of respondents ’ facilities do not have a procedure for situations when manual cleaning is delayed ; another 12 percent did not know if their facility had a procedure
● Greater than 50 percent of respondents reported experiencing moderate , significant , or excessive discomfort in each of the following areas : lower back , neck , shoulders , and mid-back
To combat these challenges , ECRI recommends that facilities establish reprocessing protocols and policies for HCWs based on professional association guidelines . This will support a safe environment for HCWs and help reduce the risk of infection for patients . All endoscopes are to be cleaned and high-level disinfected or sterilized according to the manufacturer ’ s instructions for use ( IFUs ).
Further , HCWs should be trained in standard infection prevention and control practices as well as model-specific cleaning and high-level disinfection processes for each endoscope type . Make the IFUs understandable and accessible to your HCWs by posting checklists , graphics , and other memory aids for helping in times of stress ( like high production pressure ), and for tasks that are not performed often . And remember that IFUs change as suppliers update their recommendations . Consider having the endoscope manufacturer provide annual training or an onsite update when a new reprocessing technique or accessory is introduced . The goal is to have a safe scope to use for every patient .
Possible Technological Solutions to Consider
Publicized outbreaks of multidrug-resistant organisms , linked to ineffective reprocessing of duodenoscopes over the last decade , have helped to drive technological and practice changes across the endoscope landscape . Beginning in 2015 , the U . S . Food and Drug Administration ( FDA ) required manufacturers to conduct post-market surveillance studies to understand duodenoscope cross-contamination . Since then , major duodenoscope manufacturers have introduced new models with single-use endcaps , intended to improve access to the difficult-to-clean elevator mechanism . Other manufacturers have introduced fully single-use models .
In 2022 ,
FDA recommended that healthcare facilities transition to these newer duodenoscope models . ECRI has found that single-use endoscopes can offer advantages for :
● Patients with compromised immune systems
● Patients with a known infection
● Situations when scope reprocessing is unavailable ( for example , after hours )
● Facilities that perform endoscope procedures infrequently
However , the cost of single-use endoscopes may be prohibitive for facilities that perform a high volume of procedures , and in some cases , physicians may need advanced features that are not currently supported by single-use models .