patient safety & quality
By J . Hudson Garrett Jr ., Ph . D ., MSN , MPH , MBA , FNP-BC , IP-BC , PLNC , CFER , AS-BC , VA-BC , BC-MSLcert™ , NCEE , NREMT , MSL-BC , DICO-C , TR-C , CPPS , CPHQ , CPXP , FACDONA , FAAPM , FNAP , FSHEA , FIDSA
The Road to Safer Flexible Endoscopies : Elimination of Medical Device-Associated Risks
Millions of endoscopies are performed annually across the world to both diagnose and treat a wide variety of medical conditions in many different anatomical sites within the human body . Surgical site infection ( SSI ) risk factors can mostly be controlled , but they are the top cause of nosocomial infections in the perioperative setting . These infections are preventable , and the reprocessing of reusable flexible endoscopes has been repeatedly implicated in both outbreaks and unfortunately patient deaths due to reprocessing failures . Sadly , based on published reports of device-related outbreaks and also FDA MAUDE reports , thousands of patients have contracted infections from these devices and some patients have died because of flexible endoscope contamination .
There are some important questions that must be asked by the healthcare team to ensure that all possible preventable risks are mitigated :
• What does the patient bring to the table at the time of the procedure in the form of microorganism colonization or active infection ? What about existing co-morbidities ?
• What risks can we as the Healthcare Team mitigate or engineer out of the reprocessing process ?
• What risks are there to perioperative and reprocessing personnel ? Have these risks increased due to the ongoing COVID-19 pandemic ?
• Does our facility currently assess the cleanliness of our flexible endoscope fleet ?
There are certain risks that we can control , but sadly others that are beyond our control as healthcare providers :
What we CAN Control as a Healthcare Team
Device reprocessing efforts
Personnel training and competency management
Continuous quality improvement
Flexible endoscope device monitoring such as culturing and visual observation of reprocessing
What we CANNOT Control
Patient co-morbidities
Previous usage of loaner flexible endoscope devices
Patient pre-existing colonization
Patient compliance to established treatment regimens
Recently , the Food and Drug Administration ( FDA ) has published three different safety alerts for flexible endoscopes used in gastroenterology , pulmonology , and urology healthcare settings . These safety alerts must serve as an important alarm for healthcare facilities that are reprocessing these devices and the inherent risk associated with reprocessing . These recent FDA
Recently , the Food and Drug Administration ( FDA ) has published three different safety alerts for flexible endoscopes used in gastroenterology , pulmonology , and urology healthcare settings .
These safety alerts must serve as an important alarm for healthcare facilities that are reprocessing these devices and the inherent risk associated with reprocessing .”
analyses have identified several core trends that , as a profession , must be addressed to maintain patient safety . First , Post-market design changes that do not account for how they impact the ability to properly clean and disinfect the device . There is a general lack of communication between manufacturers and / or between manufacturers and device users when medical devices / equipment used for reprocessing are modified and instructions are revised . Third party servicing and accessories that are not typically validated by the original equipment manufacturer ( OEM ) of the flexible endoscope or inspected by the FDA . Finally , there may be a lack of standardized Clinical Value Analysis processes for complex medical devices in some healthcare settings .
During the analysis of the FDA ’ s Medical Device Adverse Event reports for flexible endoscopes , the FDA and Centers for Disease Control and Prevention ( CDC ) have compiled a list of problematic design aspects of most reusable flexible endoscopes . These potential hazards include :
● Long , narrow interior channels ( lumens ), including those with internal surfaces that are not smooth , have ridges or sharp angles , or are too small to permit a brush to pass-through
● Hinges
● Sleeves surrounding rods , blades , activators , inserters , etc .
● Adjacent device surfaces between which debris can be forced or caught during use
● O-rings
● Valves that regulate the flow of fluid through a device ( stopcocks )
● Devices with these or other design features that cannot be disassembled for reprocessing to successfully and reliably mitigate risks associated with the reprocessing process for flexible endoscopes , healthcare leaders should prioritize the