Manufacturers Instructions for Use - Addressing Conflicts Amongst IFUs for Different Equipment and Products

Reprocessing equipment and supplies involves use of multiple products and, often other devices. What should organizations do when they identify a conflict amongst the IFUs for different equipment and products?

Any examples are for illustrative purposes only.

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 product, if applicable, to determine if they can provide additional information regarding compatibility.   When contacting a manufacture to determine if alternative products may be used, organizations should include a discussion of biological, chemical, and functional compatibilities.  Organizations may also wish to consider the impact of their decision on liability, warranty and long-term maintenance of the item.  If clear compatibility information is not able to be obtained, the organization should clearly identify the risks, the strategies to mitigate those risks, and implement their risk mitigation plan.

Examples are for illustrative purposes only:
Scenarios - These scenarios are meant to be helpful and may not necessarily be required by Joint Commission standards:
An organization has contacted the manufacturer to determine if an alternative high-level disinfectant can be used.  They received correspondence that the alternative product is acceptable, and the organization provides it to the surveyor.  The manufacturer has stated that the alternative has been validated and is compatible but also provided important safety information to its customers.  The manufacturer states that if soaking exceeds the alternative product instructions for use, temporary structural changes to the item may occur and organizations are advised not to use the equipment until the item is completely dry.   The surveyor could ask what systems or processes have been put in place to ensure risk to the patient is mitigated.

The manufacturer instructions state that a specific cleaning chemical may result in damage to the surface of the equipment.  However, the item cannot be used on subsequent patients without using the cleaning chemical in question because it would not be adequately disinfected if the manufacturer’s instructions were followed.  The organization contacts the manufacturer to determine what type of damage could be anticipated, reads FDA MAUDE reports, ECRI alerts, etc.  They form a multidisciplinary team and determine that although they will need to replace the item in a shorter time it is the only way to protect patients from exposure to potential pathogens.  To mitigate the risk, they identify clear rejection criteria for use of the equipment and staff is trained on those criteria.  In addition, the item is added to a checklist for biomedical engineering to review on a quarterly basis.

For deemed organizations, the Centers for Medicare and Medicaid Services requires that “Hospital policies address steps to take when there are discrepancies between a device manufacturer’s instructions and automated high-level disinfection equipment manufacturer’s instruction for completing high-level disinfection” or “the sterilizer manufacturer’s instruction for completing sterilization.” *** 

Please note:  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).

*** Centers for Medicare & Medicaid Services. Hospital Infection Control Worksheet.  Cite at 42 CFR 482.42(a) (Tag A-0749)
Last updated on April 15, 2020
Manual: Laboratory
Chapter: Infection Prevention and Control IC

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