Sterile processing (SP) professionals must abide by manufacturer instructions for use (IFU) when reprocessing instruments and devices – but today that’s no easy task. Lack of a standard IFU format and terminology, confusing or incomplete information, and even differing font from IFU to IFU adds to the already tremendous challenges facing SP teams as they work to complete reprocessing steps efficiently, effectively, and safely.
Industry stakeholders have attempted to drive IFU standardization. For example, the Association for the Advancement of Medical Instrumentation (AAMI) TIR12:2020 working group convened end users, manufacturers, and testing labs to review IFU commonalities and differences. Based on their work, they published TIR12:2020, a guide to help manufacturers standardize their IFUs, in September 2020. Despite their efforts, SP professionals are still struggling with IFU inconsistencies.
HPN reached out to the SP community and asked the professionals what is on their manufacturer IFU wish list. Based on their responses, we present a “Top 5 List” of requested improvements.
Additionally, we contacted these IFU industry thought leaders in the SP field for their perspectives on the road ahead and progress made to date: Healthcare Sterile Processing Association (HSPA) President Monique L. Jelks, BA, MSOL, CRCST; HSPA Vice President of Strategic Initiatives and AAMI Fellow Damien Berg; and Certified ISO 9001 Lead Auditor, DNV, Lisa McKown, DrPHc, MBA, CRCST, CIS, CHL, MBTI.
Top 5 IFU improvement requests
Unsurprisingly, requests for IFU standardization topped the list, including standardized formatting, language, and font across manufacturers. Multiple SP professionals pointed to data safety sheets (SDS) as a model for IFU standardization.
“There should be a ‘model’ IFU so that they are all compiled in the same form, in particular for the decontamination instructions,” said David I. Hill, PGCert MDD, MIDSc (Chtd), Head of Decontamination at NHS Lothian in Edinburgh, Scotland, UK. “There should be an acknowledgement about purpose, so disinfection has agreed criteria that the IFU has to describe compatibility with. No more 90 deg for 5 mins or 93 for 3 mins. 90 deg for 1 minute and that's it. The same with sterilization time x temp.”
Rebecca T. Alvino, System Director, Sterile Processing, UCSF Health, San Francisco, stated, “If a nutrition label on the side of a cereal box, a bag of potato chips, and even a soda needs the same information provided in the same standardized fashion, certainly medical device IFUs could be required to adhere to a standard format.”
Lack of accessibility to manufacturer IFUs was voiced as a concern by many of the SP professionals who weighed in on the topic. Regardless of whether an SP team has access to an IFU electronic database, respondents expressed the desire to access IFUs from manufacturer websites. They expressed frustration about having to track down updated IFUs when manufacturers should make them readily available.
“Calling the manufacturer or looking online is a waste of valuable time,” said Keicha Brock, CSPM, CFER, MBA, CEO: Eyes to See Management & Consulting. “Some vendors want you to contact the sales rep and sometimes they are not aware of what is in the IFU.”
Sarah B. Cruz, CSPDT, CRCST, CHL, CIS, CS Quality & Education Program Development Coordinator, The Bone & Joint Institute at Hartford Hospital, in Hartford, Conn., called on manufacturers to provide QR codes that link to PDF versions of their IFUs that can then be linked to the instrument or device in an electronic tracking system.
“Scanning, cropping, and enlarging is tedious and outdated,” said Cruz. “This could be a great opportunity for those who do not have access to an IFU electronic database.”
SP professionals cited “vague” or “gray” areas that exist in manufacturer IFUs today, requesting clarity of language and clarity of instructions, particularly those associated with complex processes, and clarity of revisions and the dates they were made.
“Clear language,” said Janene McGlynn, CRCST, CIS, CER, CHL, Sterile Processing Lead, Cleveland Clinic in Cleveland. “You can do x, y, z; you cannot do x, y, z. There is such a gray area. On top of that, depending on who is reading the MIFU, it can be interpreted differently.”
4. Real world considerations
A major concern among the SP professionals commenting on this topic was how manufacturers do not have the end user in mind, including real world conditions, when developing their IFUs. There were calls for manufacturers to involve SP professionals in IFU development to make them more representative of the true reprocessing environment.
“Too often IFUs describe what was validated (and) that bears no relation to 'normal' CDU parameters or process capabilities without tedious variations in machine programming that achieve nothing other than compliance with a poorly written IFU,” Hill commented.
“Maybe have a technician who actually has to process the instruments there,” said Veronica Holder, CRCST II, CHL, Endoscopy and Reprocessing Technician. “Then maybe they would get a better understanding of what it takes to process instruments from the decontamination room to the prep and pack side.”
Shawn M. Flynn, Co-Founder and CEO of Bedrock Surgical, suggested manufacturers add “work instructions that can be specific to the location in the workflow.” He added, “Make it part of the labeling requirement, which includes standard formatting and rev control.”
5. Charts and graphics
SP professionals also called for the inclusion of charts, graphs, and other images in IFUs to help the end user interpret instructions at each stage of reprocessing.
Michael West, CRCST, CER, Quality and Education Coordinator, SPD, UVA Health, Charlottesville, Va., proposed manufacturers include wording and pictographs similar to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) for SDS.
Where do we stand today?
HSPA President Monique L. Jelks, BA, MSOL, CRCST; and HSPA Vice President of Strategic Initiatives and AAMI Fellow Damien Berg spoke about progress made to date on IFU improvements, and emerging initiatives to harmonize IFUs on a global level.
Current standing with AAMI TIR12:2020
According to Berg, the published TIR12 has been recognized by the U.S. Food and Drug Administration (FDA), and IFUs for newly FDA-cleared products are already starting to follow the new format that TIR12 recommends. However, TIR12 does not reach backwards, as Berg explained:
“When a manufacturer is developing an IFU for a new product as part of the 510(k)-clearance process, the FDA recommends they follow TIR12 as a blueprint for its design. If a manufacturer has older IFUs prior to the TIR12 release date, there is no requirement to update the IFUs unless there is a safety issue. The burden to update them would be too great for the manufacturer given they would essentially have to go through the 510(k) clearance again.”
Berg noted how the FDA has always worked very closely with medical device manufacturers and third-party testing labs for the clearance of their IFUs. The manufacturer must prove that they have validated their instructions and testing methods in the lab environment through the FDA process. What’s been missing is end-user input. But that is changing.
“The FDA has reached out to the HSPA because they want to get more feedback and input from IFU end users so they are better informed when overseeing manufacturers and testing labs on IFU development and verification,” said Berg.
Berg added how, in 2024, the HSPA is working on efforts to get subject matter expert (SME) end users in front of the FDA. When asked how SP professionals can voice their concerns with manufacturer IFUs, Berg stated:
“For IFUs that are vague, reach out to your medical device manufacturer and talk to the people in their quality/regulatory department to see if they can help with clarification. More importantly, explain to them why it is important to have an IFU that is cleared for hospital cycles. Manufacturers can clear their device IFUs in a testing lab with whatever technique the lab uses, but that isn’t something we have in the hospital.”
“Conversely, if there is truly a safety concern with the IFU, there are avenues to the FDA to help rectify the issue, such as the Manufacturer and User Facility Device Experience (MAUDE) reporting system,” Berg added. “The FDA wants to know about IFU safety issues and HSPA does too.”
Emerging global initiatives
“Standardizing IFU would be a tremendous benefit to the world of sterile processing—and I mean ‘world’ literally,” said Jelks. “We must consider that manufacturers of surgical instruments and medical devices exist around the world. The goal of IFU standardization should pertain to all human beings receiving medical and surgical care, regardless of where they live in the world.”
On the global front, AAMI TIR12 has a “mirrored group” in ISO called Working Group 12. Representatives from the FDA, testing labs, medical device manufacturers and the HSPA sit on the ISO working group as U.S. experts, with Berg serving as AAMI TIR12 co-chair and Working Group 12 end-user expert. Together, these stakeholders are collaborating with their counterparts in other countries to define a path to global IFU harmonization.
Berg noted, “A manufacturer that sells its product in the U.S. must gain FDA clearance but if it also sells that same product in Germany or Japan they must work with regulators for those countries/regions to gain clearance there. We've all seen those long, unfolding IFUs in many different languages. AAMI and ISO are saying, why don’t we harmonize globally? Let’s all come together and identify what makes sense from an IFU standardization standpoint.”
Jelks noted how IFU standardization was a “hot topic” at this year's World Sterilization Congress in Brussels, hosted by the World Federation of Hospital Sterilisation Sciences.
“Professional sterile processing organizations, including the HSPA, and leaders of manufacturing organizations understand the importance and huge undertaking associated with standardizing IFU,” said Jelks. “Discussions and plans were shared for how manufacturers and world leaders of infection prevention (World Health Organization and the international infection control branch) will soon be meeting to explore opportunities to standardize information and reprocessing standards to improve patient safety globally.”
Where do we go from here?
Lisa McKown, DrPHc, MBA, CRCST, CIS, CHL, MBTI, Certified ISO 9001 Lead Auditor, DNV, offered her perspective on the road ahead for IFU improvements.
“There had been a general assumption that because manufacturers’ devices were so complex and diverse IFUs should be too,” said McKown. “Now, I think everything is coming to a head because there is a lot more awareness of the issue. This has led to a big push on the grassroots end for standardization.”
“I think the answer is multifaceted,” she added. “Part of the answer will be on the manufacturer side where there might be some policy levers from the FDA that can help shape more of an IFU framework and how it should look. I also believe there will be continued shaping from the AAMI perspective.”
“Standardizing IFUs will also require the advancement of technology,” McKown continued. “There is a race going on among many players to utilize AI technology and computer vision to assist where the gaps exist today. But again, even with technology, which can do wonders as we know, we must have good data from the manufacturers. Because if there are gaps in the instructions, then even advanced technology won’t be able to have inferences into that.”
When asked who needs to make the first move, McKown acknowledged that while the heaviest weight of responsibility falls on the manufacturers’ shoulders, she believes there could be opportunities for SP technicians (aka ‘users’) to have some input into that process.
In conclusion, she stated, “manufacturers need to be listening and pay attention to this call” from SP professionals.