IPs are telling us that IFUs are a burden , but they are trying to help the SPD by being a source for information , helping personnel and SPD managers navigate the IFU process , and then serve as an advocate for improvement to the current process .”
• Copies of IFUs maintained electronically
• Subscribing to web-based resources that maintain IFUs
• Educating staff on how to conduct internet searches to retrieve product IFUs
• Educating staff on how to read and implement IFUs
• Incorporating IFUs into policies / procedures and / or standard operating procedures ( SOPs )
A secret weapon not listed by The Joint Commission in this list is the infection preventionist .
“ IPs have a front row seat to this topic ,” Jopp confirms , noting that they can be an excellent driver of change even with the most complicated situations in healthcare , including IFUs . IPs are telling us that IFUs are a burden , but they are trying to help the SPD by being a source for information , helping personnel and SPD managers navigate the IFU process , and then serve as an advocate for improvement to the current process . IPs know what it ’ s like to call a vendor about an IFU and not have anyone respond back to them . IPs are trying to work within the existing system , but it ’ s time to make some change here to fix this for all stakeholders .”
Jopp continues , “ At the end of the day , compliance with IFUs mitigates patient harm . It helps keep our patients safe . But it doesn ’ t need to be this hard . Standardizing this kind of information has been achieved in other sectors , so we know this is possible for healthcare , and it can happen if we work together .”
References :
AAMI TIR12:2010 . Designing , testing , and labeling reusable medical devices for reprocessing in health care facilities : A guide for medical device manufacturers . Arlington , VA : Association for the Advancement of Medical Instrumentation .
Basile R . AAMI TIR12 and the Future of Device Processing Instructions . Biomedical Instrumentation & Technology . Jan ./ Feb . 2019 . https :// doi . org / 10.2345 / 0899-8205-53.1.67
Centers for Medicare & Medicaid Services ( CMS ). Hospital Infection Control Worksheet . Cite at 42 CFR 482.42 ( a ) ( Tag A-0749 ).
ISO 17664:2017 . Processing of healthcare products — information to be provided by the medical device manufacturer for the processing of medical devices . Geneva : International Organization for Standardization .
ISO 17664-1:2021 . Processing of healthcare products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1 : Critical and semi-critical medical devices .
Stallard B . AAMI Guidance Helps ‘ Clean Up ’ Medical Device Instructions for Use . Feb . 9 , 2021 . AAMI News .
The Joint Commission . Manufacturers ’ Instructions for Use - Addressing Conflicts Amongst IFUs for Different Equipment and Products . 2021 .
The Joint Commission . Manufacturers ’ Instructions For Use - Responsibility for Ensuring Availability . 2019 .
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