SPD Techs , IPs Agree on IFUs Being a Significant Challenge
In
Healthcare Hygiene magazine ’ s survey on manufacturers ’ instructions for use ( IFUs ), conducted online April 1-20 , 2023 , 100 percent of survey respondents said that manufacturers should be compelled to do a better job of writing their IFUs so they are easier to understand and comply with . Sterile processing professionals comprised 72 percent of the survey respondents , followed by infection preventionists ( IPs ) at 15 percent , quality and safety managers at 12 percent , and healthcare biomedical engineers at 1 percent .
We asked respondents to tell us what were some of the specific challenges relating to IFUs , including that they are unclear / poorly written ( 10 percent ); they are contradictory ( 7 percent ); they are incomplete or they require use of products / tools not available within the SPD ( 1 percent ); they are difficult to find / access ( 7 percent ) or all of the above ( 75 percent ).
When asked if they thought IFUs should be regulated by the Food and Drug Administration ( FDA ) or other similar agency , 90 percent said yes ; 5 percent said no ; and 5 percent were uncertain .
Among the survey respondents who worked in a sterile processing department , 100 percent of them said they have personally experienced difficulty following and complying with an IFU . Among these same respondents , 20 percent said that failure to follow an IFU properly resulted in a patient infection or adverse event , while 50 percent said it did not , and 30 percent were uncertain .
One hundred percent of all respondents said they supported efforts by medical societies to drive improvement in IFU development and compliance . Eighty-eight percent said they believed that the issue of problematic IFUs can be solved in the future , while 2 percent said it cannot , and 10 percent were uncertain .
Survey Respondents
1 % Healthcare Biomedical Engineers
7 % Difficult to Find / Access
72 %
Sterile Processing Professionals
12 %
Infection Preventionists
Quality and Safety Managers
Specific Challenges Relating to IFUs
75 % All of the Above
15 %
1 % Incomplete Or They Require Use Of Products / Tools Not Available Within the SPD
7 % Contradictory
10 % Unclear / Poorly Written
Should IFUs be regulated by the Food and Drug Administration ( FDA ) or other similar agency ?
5 %
No
90 %
Yes
5 %
Uncertain
Compliance with IFUs should also be an integral part of initial and ongoing staff education , policy / procedure development , and training / competency assessments .”
equipment manufacturer ’ s instruction for completing high-level disinfection ” or “ the sterilizer manufacturer ’ s instruction for completing sterilization .”
The Joint Commission ( 2021 ) emphasizes that “ All organizations are responsible to meet the minimum reprocessing requirements as specified by how the device is used ( e . g ., per Spaulding classification system , a device that enters the vascular system must be sterilized ).”
To that end , the FDA has been looked to as an arbiter in the IFU situation since it already regulates so much of the medical device industry .
Jopp concurs , adding , “ If the FDA changed the IFU process , including the data collection requirements and the review process then I think you would get more cooperation from the manufacturing sector . I think it ’ s going to take the FDA overhauling this process to ensure absolute compliance across industry . Standards-development organizations like The Joint Commission play a significant role in also being advocates for change . Standards-development organizations are charged with working within the existing system , but surveyors see first-hand the challenges that healthcare organizations have in trying to comply .”
Jopp continues , “ One nuance to this , for example , is what happens if an IP reaches out to a manufacturer and doesn ’ t hear back ? We ’ ve heard from The Joint Commission that if you document that you sent a letter to the manufacturer , that helps establish compliance . In certain cases , facilities are contacting the FDA , trying to get assistance with IFUs . It all points to the fact that we are spending tremendous labor , time and energy on an inefficient and onerous process that ’ s creating busy-work for those trying to guide compliance in our healthcare organizations , and that might not really be advancing patient safety and quality .”
The Joint Commission ( 2019 ) states that “ Because of the complexities associated with use of equipment and devices , leadership is responsible to ensure that IFUs are available and used by staff to ensure consistency among all staff involved in these processes . Compliance with IFUs should also be an integral part of initial and ongoing staff education , policy / procedure development , and training / competency assessments .”
Examples of ways leadership can support the use of IFUs may include , but are not limited to :
• Resource manuals provided by product and device manufacturers
• Providing an alert to staff if specific equipment cannot be cleaned or disinfected with the commonly available disinfectant
18 may 2023 • www . healthcarehygienemagazine . com