Sterile processing professionals are always reminded to follow instructions for use diligently and consistently — to the letter , with no shortcuts or missed skips ever being acceptable .
Certainly ,
IFUs are essential and must always be readily available and carefully followed , but many sterile processing professionals can also attest that understanding and following IFUs can be challenging .”
— Damien Berg , CRCST , AAMIF
Or techs do not use the extended cycles provided in the manufacturer ’ s IFUs because they take too long . Conversely , techs may place instruments sets not validated for extended cycles in an extended cycle , which could reduce the instruments functionality and use life .
“ Sterile processing professionals are always reminded to follow instructions for use diligently and consistently — to the letter , with no shortcuts or missed skips ever being acceptable ,” emphasizes Damien Berg , CRCST , AAMIF , vice president of strategic initiatives for the Healthcare Sterile Processing Association ( HSPA ). “ Certainly , IFUs are essential and must always be readily available and carefully followed , but many sterile processing professionals can also attest that understanding and following IFUs can be challenging . We know that some IFUs are vague , confusing and , at times , even conflicting with other recommendations and IFUs . Whenever questions about IFU arise , sterile processing professionals should contact the device or equipment manufacturer for clarification and further guidance . It is critical that IFU for every instrument , device , piece of processing equipment , chemical , and all other supplies are followed to ensure safety and processing effectiveness .”
Berg continues , “ If a device ’ s IFU conflicts with processing equipment IFUs , for example , both manufacturers should be contacted for guidance . Beyond that , sterile processing leaders should ensure they have the most current version of IFUs for all products , instruments and equipment in use , and they should keep those on file and readily accessible by all technicians . If any items arrive in the SPD ( including loaned devices ) but do not have the accompanying IFU , those items should not be processed or used until the IFU have been obtained , are well understood and able to be followed . If IFUs are unclear , inadequate , or missing altogether — and if the manufacturer fails to provide them and any other necessary guidance — the device or equipment should not be processed or used . Medical device safety issues , including those pertaining to IFU , can be reported to the FDA through the Manufacturer and User Facility Device Experience ( MAUDE ).”
The issue has been addressed in AAMI ’ s technical information report ( TIR ) 12 , which provides guidance for manufacturers relating to the myriad challenges that SPD techs face when processing reusable medical instruments and devices . It also provides manufacturers with information they may use to reassess the labeling of existing products to ensure they have all the information needed by the healthcare facility . AAMI TIR12 emphasizes the importance that manufacturers validate cleaning , packaging , and sterilization parameters that can be reproduced in a healthcare facility .
AAMI TIR12 makes it clear that manufacturers must provide one fully validated mechanical and / or manual cleaning process , using commonly available cleaning agents , equipment , and methods that can be replicated easily in a healthcare facility and that can help users recognize whether cleaning was effective for all device surfaces . The challenge for manufacturers is that they continue to evolve and advance their validation testing for different cleaning procedures , packaging , and steam and low-temperature sterilization cycles – a laborious and expensive undertaking . Therefore , they cannot validate every combination of cycles and packaging that could possibly exist , but AAMI says what they do validate needs to be communicated to healthcare personnel on a timely basis .
TIR12 ’ s influence was seen in 2015 , when the Food and Drug Administration ( FDA ) published an update to its 1996 guidance . The FDA document was again updated in 2017 , providing additional guidance related to complex devices identified as particularly difficult to clean — and thus requiring even more detail in validated IFUs , according to Basile ( 2019 ).
In 2019 , TIR12 underwent a significant rewriting so that it could provide standard cleaning protocols as well as serve as a guidance document in support of ISO 17664 ; that standard was eventually updated by ISO 17664-1:2021 . This ISO standard specifies requirements for the information to be provided by the medical device manufacturer for the processing of critical or semi-critical medical devices ( i . e ., a medical device that enters normally sterile parts of the human body or a medical device that contacts mucous membranes or non-intact skin ) or medical devices that are intended to be sterilized . ISO 17664- 1:2021 specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of initial treatment at the point of use ; preparation before cleaning ; cleaning ; disinfection ; drying ; inspection and maintenance ; packaging ; sterilization ; storage ; and transportation . It is important to note that ISO 17664-1:2021 excludes processing of non-critical medical devices unless they are intended to be sterilized ; textile devices used in patient draping systems or surgical clothing ; and medical devices specified by the manufacturer for single use only and supplied ready for use .
Basile ( 2019 ) addresses why the establishment of standard cleaning protocols through TIR12 was such an important step forward : “ Visit the sterile processing department in any healthcare facility and ask them to show you all the IFUs they need to follow . If they plan to show the IFUs in print , then step back , because you are about to be flooded by paper . The reality is that the sheer diversity of IFUs makes complying with any of them almost impossible . In part , the diversity of IFUs comes from the complexity of modern medical devices . The complexity is two dimensional : One dimension is that the devices are becoming more complex , while the other is related to the diversity of devices . Therefore , even if each device was designed as simple to clean , the sheer diversity of devices — both in terms of their designs and IFUs — complicates things for sterile processing .”
14 may 2023 • www . healthcarehygienemagazine . com