We need to simplify the IFU process and make it far easier for healthcare stakeholders to access this information .
The challenge is achieving a more standardized format and then determining what the collective process is when IFUs need to be updated , and those updates communicated to healthcare stakeholders .” new framework that can reduce patient harm while at the same time eliminating wasted time and money from the existing inefficient process .”
Jopp continues , “ The challenges of IFU compliance have been a problem for a long time ,” Jopp says . “ This topic is a little bit of a public policy unicorn , in that everybody agrees that it ’ s not working right , and nobody is satisfied with it . But because of the complexity involved , the number of stakeholders involved , this problem looks too big to ‘ solve ,’ but it doesn ’ t need to be that way . We ’ ve heard from many members struggling with this in their organizations and are spending an inordinate amount of time and energy on IFU compliance . We decided to tackle this issue to help figure out a way forward and identify solutions relating to how each critical stakeholder can address this issue , including industry , healthcare organizations , standards development organizations , and regulatory entities such as the FDA . We want to get a game plan together that all can take collective action on together .”
Taking that level of action requires ownership of the issue , and for some time , there has been a lack of clear oversight on who or what can lead the drive for meaningful change in IFUs . Some would say the FDA has purview because of its role in the 510K pre-market process for medical devices , while others point to AAMI ’ s many standards and technical information reports for guidance . Others say ISO standards provide that kind of top-tier instruction .
“ We do acknowledge that there is some work being done that we can evaluate how to incorporate into an overall strategy , with ISO having developed a standard to specify requirements to assist manufacturers of medical devices in providing detailed processing instructions ( ISO 17664-1:2021 ),” Jopp says . “ However , this is only a small portion of what is needed . It ’ s one thing to have a standard and another to deploy it uniformly and ensure that the information is accurate , up-to-date and easily accessible . Today , hospitals are paying subscriptions to access systems that attempt to cobble this information together , so that ’ s another cost that healthcare organizations have to absorb . Even with these paid subscriptions , the data isn ’ t necessarily always available or accurate . Additionally , there are challenges in the regulatory review process to make it easier for manufacturers to innovate their products and update their instructions for use , to stay current with those innovations . The lack of standards , systems and regulatory gridlock makes this all hugely problematic .”
As we have seen , manufacturers share the responsibility of making IFUs implementable by SPD techs . As part of the FDA 510 ( k ) clearance process for a medical device is an obligation for labeling that must include validation data regarding cleaning , disinfection and sterilization . It ’ s important to note that in late 2016 , the 21st Century Cures Act was signed into law and requires the FDA to publish in the Federal Register a notice listing reusable device types that must include validated IFU and validation data regarding cleaning , disinfection and sterilization in their 510 ( k ) submissions .
But healthcare facilities must ensure that their SPDs have access to the most current , validated manufacturers ’ IFU documents for facilitating safe and effective reprocessing of medical devices and equipment , and that they follow the IFUs carefully . As AAMI emphasizes , “ These items could pose a very real threat to the health and safety of both patients and staff if processes are not carried out in accordance with the procedures outlined in the manufacturer ’ s validated IFU .”
Accountability cuts both ways but the blame game often persists . APIC ’ s Jopp believes that manufacturers have a better handle on the problem than they are given credit for .
“ I have talked to manufacturers and companies we work with and all of them are frustrated by the current IFU environment ,” he says . “ I talked to one manufacturer whose product is labeled in a certain way continues to maintain an old product because the challenges in updating the IFU are so laborious . I actually think manufacturers will be advocates for change and will in fact be significant allies in the effort to bring needed change to bear . It ’ s a situation that everyone agrees is not working .”
Jopp continues , “ If you have an old DVD player from the 1990s , in many cases you can Google it and find the appropriate instructions for use , but we can ’ t seem to do this with healthcare . We need to simplify the IFU process and make it far easier for healthcare stakeholders to access this information . Ultimately , there are many details we have to work through , such as the balancing act between how frequent updates need to done . This is where a multi-stakeholder strategy is important to ensure all voices are heard .”
A significant aspect to improving IFUs is addressing the conflicting information often contained in the instructions themselves . The Joint Commission ( 2021 ) acknowledges that processing medical equipment and instruments involves use of multiple products and other devices , and it is common to encounter a conflict among the IFUs for different equipment and products . It expects healthcare facilities to reach out to the manufacturers for guidance .
As The Joint Commission ( 2021 ) explains , “ Manufacturers are the experts on their products and , for certain devices or products , are required to submit their instructions for use to the FDA or EPA for approval . The Joint Commission expects that when conflicts with the manufacturer recommended instructions or products are identified , the organization contacts the manufacturer ’ s technical services to resolve these conflicts . This resolution should also include contacting the manufacturer of the alternative
16 may 2023 • www . healthcarehygienemagazine . com