Staff Compliance with Manufacturers' Instructions is Not Optional

By Nancy Chobin, RN, AAS, ACSP, CSPM

Q: With all the emphasis on following sterilization instructions, we have found there are many different exposure times for various devices.  A suggestion was made that we should identify the longest exposure time recommended and then just sterilize all items at that time to lessen the chance that an employee will make a mistake. As a matter of fact, we have our cycles locked so employees cannot change them. What is the best course of action to take?

A:  The entire processing issue has been under scrutiny for some time and rightly so as this is a patient safety concern. According to the Association for the Advancement of Medical Instrumentation (AAMI)'s ST-79 and the Food and Drug Administration (FDA), “Users are responsible for verifying that appropriate written instructions are supplied with the device; if no instructions or incomplete instructions are provided, the user should contact the manufacturer requesting this information.” When a facility fails to comply with instructions for use (IFU), they are liable for any issue with patient injury or acquired infection. AAMI and the FDA recommend that all devices be cleaned, disinfected and/or sterilized according to the instructions for use provided by the device manufacturer. Unless this information is obtained and followed, ineffective cleaning and/or sterilization may result. 

Each device’s manufacturer’s instructions for use should be reviewed for accuracy. A staff reference guide or other reference tool should be developed and posted in the Decontamination Area as a reference for the recommended cleaning protocols and a second reference for sterilization instructions posted in the Sterilization Area. In-service the staff to ensure the devices/instruments will be cleaned and sterilized according to the instructions. Many orthopedic sets require extended ultrasonic cleaning cycles (15 to 20 minutes or more). These instructions must be followed every time. Compliance should be carefully monitored.  
It should be noted that when manufacturers' instructions require the use of an extended sterilization cycle (e.g. extended cycle of 6, 8, 10 minutes) other items should not be included in the same load because the other device manufacturers did not validate their devices for the extended cycles. Furthermore, many packaging materials and chemical indicators/integrators have not been validated for extended cycles. Only the cycle type (gravity or pre-vacuum) and the exposure time recommended by the device manufacturer are to be used.  This is not optional and must be inserviced, implemented and monitored for compliance.

In order to follow these instructions, the sterile processing department (SPD) staff should be thoroughly trained with competencies verified.  Staff should be knowledgeable in selecting the recommended cycle type and exposure time.

There should be a quality assurance process in place where the sterilizer printout(s) from the previous day are checked by a supervisor or other designated staff member to ensure all recommended sterilization instructions were followed.

Staff compliance with manufacturers' instructions is not optional. Failure to comply with the cleaning protocols is a patient safety issue as well as a legal liability for the facility. The Joint Commission and the Centers for Medicare and Medicaid Services (CMS) are focusing on compliance with manufacturer’s instructions and will ask for the IFUs of various devices. All IFUs should be dated when received. All general IFUs should be updated every two years or upon receipt (if item reordered); orthopedic IFUs at least annually. If a company fails to provide the needed information, the device/instruments should not be used and the company reported to the FDA. Staff compliance should be closely monitored.

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

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