ECRI outlines some of the challenges that can hinder problemreporting , including the fact that device users may be focused on patient care and unable to interrupt a time-sensitive task to submit a report . Also , they may be unfamiliar with reporting methods , or they may see little benefit to reporting , particularly if no harm was observed .”
Underreporting Device-related Issues
The No . 10 item on ECRI ’ s list dovetails with the previously discussed No . 2 issue , in that underreporting device-related issues jeopardizes patient safety as much as faulty devices do . As ECRI ( 2023 ) explains , “ Reporting medical-device-related problems is crucial for keeping patients and staff safe . Unfortunately , problems aren ’ t always reported through appropriate channels , if at all .”
ECRI outlines some of the challenges that can hinder problem-reporting , including the fact that device users may be focused on patient care and unable to interrupt a time-sensitive task to submit a report . Also , they may be unfamiliar with reporting methods , or they may see little benefit to reporting , particularly if no harm was observed . Healthcare professionals also may fear disciplinary action or other personal consequences that may hamper the willingness to report .
“ Ideally , medical devices that are found to be broken , malfunctioning , or otherwise deficient would be reported through appropriate channels and remedied before clinician workflows or patient care are affected ,” Schluth says . “ This does not always occur , however . The challenge for healthcare organizations is to identify why that is and to institute measures to increase reporting . One common barrier is that reporting takes time , and clinicians are busy with patient-care activities . The task for the organization , then , is to make the reporting process as easy as possible : they need a streamlined , easy-to-use , and readily accessible method for clinicians and other staff to report device-related problems , and for those reports to be distributed to clinical engineering and risk management .”
Regarding some of the other barriers noted by ECRI , Schluth says that educational initiatives can help staff members who may be unfamiliar with the method for reporting , and that staff who see little benefit to reporting can be kept informed about the status of their report , as well as by promoting the “ wins ,” such as when a report leads to meaningful improvements , he adds . “ Promoting a culture of safety and learning is key to addressing staff who fear disciplinary action or other consequences .”
Without proactive reporting , ECRI ( 2023 ) notes that “… broken , malfunctioning , poorly manufactured , or poorly designed devices may remain in use . Attempting to use faulty devices can , at the very least , waste clinician time as users try to effect workarounds or to quickly locate replacement equipment . More significantly , continuing to use deficient equipment can lead to patient harm . In contrast , when problems are reported as soon as they are noticed , they can often be remedied before patient care is affected .”
In instances when a user suspects that a medical device may have contributed to an adverse incident , additional steps ( beyond reporting ) are warranted . In its 2014 report , Don ’ t Lose the Evidence — Sequestering Equipment After an Incident , ECRI laments that “… clinical staff often neglect to preserve all equipment involved in an incident , especially accessories , disposable devices , associated packaging , and identifying data . The resulting problems involving evidence and incident-related medical devices can significantly complicate subsequent investigations .”
ECRI encourages healthcare institutions to ensure that proper procedures are followed :
• Sequester all capital equipment until a decision for further investigation is made .
• Sequester all accessories and disposables associated with the device .
• Secure all evidence in a locked area that is separate from normal clinical supplies .
• Maintain a log of all persons handling or accessing the sequestered equipment .
• Photograph the equipment , room , and injuries as soon as possible .
• Do not adjust any control settings ( unless necessary to avoid further injury ).
• Maintain power to the device so that log files and other important data are stored .
• Do not clean or sterilize devices , accessories , or disposables .
• Store in a location that will not cause further damage to the device .
• Only return a device to service once it has been tested and eliminated as a possible cause of patient injury .
Ventilator Cleaning and Disinfection
The No . 7 item on ECRI ’ s 2023 hazards list is confusion surrounding ventilator cleaning and disinfection requirements that can lead to cross-contamination . As ECRI ( 2023 ) explains , “ The importance of effectively cleaning and disinfecting ventilators is obvious : Ventilator components can become contaminated by exhaled gases and , potentially , by airway excretions . Unfortunately , the reprocessing instructions provided by ventilator manufacturers are , in some cases , incomplete or confusing ; and even guidance from regulatory authorities is not always clear . The result is that reprocessing staff may be confused about which ventilator components need cleaning / disinfection , how to carry out the process , and how frequently it should be done .”
ECRI explains further that lack of clear guidance can lead to ineffective reprocessing of ventilator components , thus increasing the risk for cross-contamination , what ECRI ( 2023 ) says is “ an otherwise preventable occurrence that can lead to the spread of infectious disease .”
As Schluth notes , “ For instance , the Centers for Disease Control and Prevention ( CDC ) reprocessing guidelines specify that device components that touch mucous membranes or nonintact skin require , at minimum , high-level disinfection . But what about