FAQ: What Are IFUs?
CS Medical LLC
Developing, manufacturing, and marketing medical devices that are designed to provide high-level disinfection.
FAQ: What Are IFUs?
Every time a new supply of disinfectant is delivered or a new medical device is opened, you may be tempted to grab the seemingly innumerable flyers, leaflets, and instructions from the box and toss them in the trash. Especially when it comes to familiar products, instructions for use (IFUs) all seem unnecessary. You’ve used the product a hundred times before, so what’s the point of keeping all that trash?
In the first place, it’s a regulatory issue. IFUs are actually mandated and controlled by the Food and Drug Administration (FDA). The FDA requires that all medical manufacturers provide detailed IFUs to consumers. According to Infection Control Today, this is also a standard set by the Association for the Advancement of Medical Instrumentation (AAMI): “ANSI/AAMI ST79:2017 states that the current written IFU should be accessible, reviewed and followed. It is noted that if no specific written IFU is available, the manufacturer should be contacted and requested to provide a documented method of cleaning.” The Joint Commission also requires IFUs to be accessible and followed to the letter.
These instructions not only walk users through all the steps to use the product, but also should list material compatibility with the devices they can be used in conjunction with. It is vital that IFUs be reviewed whenever they are received to ensure that a change has not been made to the product which would impact its use.
We can imagine a scenario where a slight change in IFUs could make a big difference. Say you have always used Spray A, a hard surface disinfectant spray which needed to sit for five minutes before being wiped off. Unbeknownst to you, the manufacturer strengthened their formula to Spray B which only requires three minutes before needing to be wiped off. Because the IFUs were not carefully read, Spray B is left for a full five minutes, despite the update. If that stronger formula is left to sit for an additional two minutes at every use, that could result in damage to the surfaces being disinfected. This damage could create microfractures which create places for bacteria to take hold and grow into biofilm. Not only does this put patients at risk of infection, but it also means damage to expensive equipment. Alternatively, if the original IFU indicated a five minute contact time and staff only allowed three minutes of contact time, bacteria could survive which would result in potential staff or patient exposure.
In another scenario, a facility has always used TD-5 to disinfect TEE probes in their TEEClean? Automated TEE Probe Cleaner Disinfector. An alternative to TD-5 is found and used in the TEEClean. The new disinfectant’s IFUs do not indicate that it is compatible with the probe being disinfected nor do they say that this disinfectant can be used in the TEEClean. As a result, the TEEClean could be irreparably damaged within and the TEE probe could be inadequately disinfected. This means that the TEEClean would need to be replaced, the TEE probe might need repair, and an unclean probe could be used on a patient, resulting in an HAI. The IFUs written for high-level disinfectants are critical and must be followed. Not all disinfectants are the same; temperature and contact time are important. In this example, if the alternative chemical does not have the right concentration or is not designed for use at high temperatures, the outcome could be terrible for the disinfector, the TEE probe, and the patient.
Not keeping up to date with all the IFUs for all the products your facility uses can have very serious consequences ranging from damage to equipment, to the spread of an HAI, to the destruction of the facility’s reputation and even financial stability. If IFUs for a product are ever unclear or lost, contact the manufacturer to get clarification or a new copy.
CSWS.0038.220519
About CS Medical
CS Medical LLC has pioneered the automated disinfection process for Transesophageal ultrasound probes with the development and release of the TD 100? Automated TEE Probe Disinfector. In 2005, the TD 100 was the first FDA cleared automated disinfection process with printed verification for Transesophageal ultrasound probes. During the disinfection process, the TEE probe receives high-level disinfection in (5) five minutes from TD-5? or TD-8? followed by (5) five complete rinse cycles before disinfection confirmation is acknowledged and a report is printed. The verification report indicates probe contact time with the high-level disinfectant as well as the average temperature of the single-use disinfectant during each cycle.
For more than 15 years and over 4 million high-level disinfections, the TD 100 Automated TEE Probe Disinfector has eliminated manual reprocessing of delicate and expensive TEE ultrasound probes while also providing a repeatable and FDA cleared disinfection process. The TEEClean? Automated TEE Probe Cleaner Disinfector will continue the TD 100's work by automating the required cleaning process for the TEE probe before high-level disinfection. TEEClean, with electronic record data logging, printed verification reporting, FDA cleared cleaning, and high-level disinfection will be the standard of care for TEE ultrasound probes.
CS Medical's TEE Complete Care? products provide quality device care and storage by minimizing healthcare operational costs, improving service readiness and increasing regulatory compliance.
CSWS.0038.190520
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