Operationalizing the IFU Statement Related to Processing of Vendor Sets

By Nancy Chobin, RN, AAS, ACSP, CSPM, CFER

Q: We have a question regarding operationalizing the instructions for use (IFU) statement related to instrument processing. Many of the vendors have enzyme soak and ultrasonic times listed in their IFUs. How do you follow those IFUs successfully with respect to vendor sets? For instance, we have a system vendor policy that requires the vendor to deliver the sets needed at least 24 hours prior to the scheduled case. Most of the time it’s not an issue, however, when a case is added for the same day, that presents a challenge to get the instruments prepared, or is there is a turnover situation when you must reprocess for a subsequent case. Any tips are greatly appreciated.

A:  Your issue with loaner sets is not unique to your facility. That is why your loaner policy should address all such issues. The policy and procedure should include information regarding the ordering, receipt, processing, inspection, inventorying, post-use processing, post-use inventorying, and return to the vendor or manufacturer. The policy should specify who has the authority to order the loaner instruments and the notification of the sterile processing department (SPD) of the arrival of the instruments (date of arrival and how the instruments will arrive (e.g., by courier, sales representative, delivery service).

The SPD should then track the instruments to ensure they are processed in time for the scheduled case. If arrival information is not communicated to SPD, case delays can occur. The policy should also address the condition of the loaner containers (e.g., not broken, no sharp edges) and the condition of the instruments (not rusted, pitted, or damaged). Damaged containers can lead to compromise of the packaging integrity, which can lead to a delayed case. Any instruments that are pitted, rusted, or in otherwise poor condition should not be used. The vendor and the OR should be contacted regarding the problems so that they can be corrected before the scheduled case. Furthermore, the facility should require vendor compliance with the Association for the Advancement of Medical Instrumentation (AAMI) recommendation that the maximum weight of each set, including the container, should not exceed 25 pounds.

As you know, the Food and Drug Administration (FDA) requires that all manufacturers provide detailed instructions for use for their devices. It is the responsibility of SPD management or designee to obtain manufacturers’ IFUs and to ensure that the most current IFU information is available for use. Manufacturers constantly update IFUs therefore, it is important to continually update the information. The IFU should be dated when received.

At the time of receipt, the IFU should be reviewed to ensure the following:
• The decontamination recommendations provide for thorough cleaning and defined microbial lethality
• The procedures can be performed in the healthcare facility using commonly available chemicals, supplies, and equipment
• The procedures can be duplicated by healthcare personnel
• The procedures can be easily understood by the user. (For example, diagrams and step-by-step instructions are helpful to personnel)
• The procedures are in alignment with the recommendations of professional organizations and with OSHA regulations for minimizing occupational exposure to bloodborne pathogens (21 CFR 1910.1030).
• The instructions include a method by which users can verify effective decontamination
• The instructions for use for the cleaning agent include the dilution/concentration that should be used, the temperature, the water quality (such as pH, hardness), and the exposure time (soaking or contact)
• The type and necessary quality of the water are specified (e.g., distilled water, deionized water, water treated by reverse osmosis, filtered water, hard or softened tap water)
• The type and quality of cleaning agents and cleaning accessories that should be used are specified
• There are instructions for the handling and preparation of the device for cleaning
• Instructions are provided for the manual or mechanical method that should be used for cleaning, rinsing and drying
• The time-at-temperature and water pressure parameters for mechanical cleaning equipment are specified
• Instructions are provided for any necessary testing of function and cleanliness that should be performed after the decontamination process
• Any necessary additives (e.g., lubricants) that should be used in reassembly are specified
• The compatibility of packaging with device materials is described
• Instructions are provided on the use of packaging materials commercially available to healthcare facilities
• The compatibility of the packaging technique with existing packaging practices is described
• The compatibility of the wrapped device with the planned sterilization process is described

Healthcare personnel are responsible for ensuring that the cleaning, packaging, and sterilization methods recommended by the device manufacturer can be duplicated in their environment and that the manufacturer’s instructions are followed correctly every time. At no time should the IFUs be circumvented or short cuts taken for the sake of scheduling. Non-compliance with a policy can result in legal liability should an infection result. 

Sterile processing is caught in the middle. The surgeon has the right to add on cases and to request different or additional loaner items for a case; however, the surgeon also needs to understand that all the IFUs must be followed before the sets can be released to protect the patient and the surgeon.

In summary, the importance of compliance with IFUs should be addressed with infection prevention and risk management as well as the operating room. When you release a set (or device) to the end user, you are, in effect, telling them it is safe to use or you would not have released it. Yet, if the IFUs were not followed, how can the set be considered safe?  All stakeholders should meet to determine how these circumstances will be addressed so that patient safety is not adversely affected.

Nancy Chobin, RN, AAS, ACSP, CSPM, CFER, is a sterile processing consultant and educator.

ANSI/AAMI:  ST79:2010 & A1:2010 & A2:2011 & A3:2012   A4:2013Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities.

Basics of Sterile Processing 6th Edition.  Sterile Processing University, LLC.  Lebanon, N.J.