Healthcare Hygiene magazine turned to experts in the field for their insights on the importance of following instructions for use (IFU).

Our Expert: Mary Olivera, MHA, CRCST, CHL, FCS, president and CEO of OSPECS Consulting, LLC and oneSOURCE speakers’ bureau expert

How critical is it to follow manufacturer IFUs and why?
Mary Olivera (MO): Medical device manufacturers conduct tests and validations to ensure the device can be reprocessed safely. It is uncertain if after deviating from the written steps or not using the listed equipment for reprocessing the device is rendered clean or sterile. Therefore, the medical device can potentially harm the patient.

What are some examples of the consequences of failure to follow manufacturers’ IFUs?
MO: Failure to follow the appropriate steps listed in the IFU can have a negative outcome to the patient and to the organization. Processing medical devices without knowing how the device is disassembled, cleaned and sterilized is like placing a blind over your eyes being unable to see what you are doing. The goal is to provide a device that is microorganism free and that is not going to cause harm to a patient. Just to name a few failures to not follow IFUs can result in patient contamination and possibly death, hospital reputation is damaged, and litigation.

How can institutions remove these barriers and empower their SPD technicians?
MO: There must be collaboration between the SPD, the OR, infection prevention and control, purchasing and the administrative leadership. Stringent processes for medical device acquisition which includes a clinical review of the IFU prior to purchasing the equipment to ensure the SPD has all required tools to reprocess the device. This process will enable the organization to decide whether to invest in the medical device or provide the necessary resources and equipment for SPD to be able to adhere to the IFU. SPD must be encouraged and empowered to bring forth the needs without fear of retaliation.

Manufacturers must partner with hospitals SPD and perform on-site validations for reprocessing to ensure the steps listed in the IFU can be replicated in a real SPD environment. These trials should be conducted in sample facilities using categories of small, medium and large hospital size.

How can technology assist with IFU compliance?
MO: All new devices should be marked with incorporated bar code that automatically uploads the IFU. The predeter-mined code in the bar code prevents errors in choosing the wrong IFU and/or following dated IFUs. The barcode should also incorporate a video application for complex steps. Software applications can be suited to read those barcodes.

Original article printed in the Healthcare Hygiene Magazine, August 2020 issue.

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