Special Edition on Sterile Processing Imperatives Special Edition- Sterile Processing Imperatives | Page 22

Instructions for Use: Q & A Insights and Advice from the Experts Healthcare Hygiene magazine turned to experts in the field for their insights on the importance of following instructions for use (IFU). Our experts are: Casey Czarnowski, sterile processing educator at Stanford Health Care and oneSOURCE speakers’ bureau expert Mary Olivera, MHA, CRCST, CHL, FCS, president and CEO of OSPECS Consulting, LLC and oneSOURCE speakers’ bureau expert Jonathan Wilder, PhD, managing director at  Quality Processing Resource Group and oneSOURCE speakers’ bureau expert HHM 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. HHM What are some examples of the consequences of failure to follow manufacturers’ IFUs? Casey Czarnowski (CC): A great example of the consequences of not following a manufacturer’s IFU is an ultrasound probe. Ultrasound probes can cost $15,000 to $20,000, and the damage done by incorrect leak testing is often not repairable. The IFU shows the process, which must be carefully trained and strictly followed to avoid having to replace the instrument. If technicians are not trained to the IFU, great cost may be incurred by the facility, and patient care may be impacted by instruments being down for repair. 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. Jonathan Wilder (JW): For instruments that have complex structures, not following IFUs will result in improper cleaning and potential patient-to-patient soil transmission. In addition, the instrument may be ruined by soil remaining Expert Casey Czarnowski says that an example of the conse- quences of not following a manufac- turer’s IFU is an ultrasound probe. Ultrasound probes can cost $15,000 to $20,000, and the damage done by incorrect leak testing is often not repairable. 22 Sterile Processing Imperatives 2020 • www.healthcarehygienemagazine.com