This series of self-study lessons on Central Service topics was developed by the International Association of Healthcare Central Service Materiel Management (IAHCSMM). The lessons are administered by Purdue University’s Continuing Education Division.
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Central Sterile Supply personnel must assure that medical devices are processed correctly. If they do not, the affected devices must be recalled before they reach patients. In addition, manufacturers and other external parties may issue device recalls, notifications and safety alerts. Procedures to be followed when a facility is confronted with all of these challenges are addressed in this lesson.
Process failures can occur for numerous reasons. They are discovered when monitoring tools provide information about the effectiveness of the sterilization process that has been used. Not all monitoring devices indicate a failure at the same time, but all do provide clues that alert CSS technicians that a problem may have occurred. Then, when a process failure is suspected, several important questions can be asked to determine the cause. Once identified, the failure must be corrected, and sterilizer efficacy testing is undertaken in compliance with the Recommended Practices issued by the Association for the Advancement of Medical Instrumentation (AAMI).1
Several monitoring tools are used to identify load processing failures that lead to product recalls. These include:
AAMI provides recommended practices for routine use of physical, chemical and biological monitors to help assess the effectiveness of steam sterilization. All monitoring tools must have the appropriate results for loads to be released. For example, in the case of steam sterilization, loads should not be released when:
BIs detect conditions that enable spores that are more sterilization-resistant than other organisms to remain alive. Therefore, if spores are killed, other less-resistant microbes will also be killed. If a load is released before BI results are known, and the BI then reads positive to indicate sterilization process failure, all items processed since the last load with a negative BI that indicates sterilization success are considered non-sterile. These loads should, then, be recalled, retrieved and reprocessed.
Special mention must be made of BIs because, regardless of the results of other monitoring tools, the biological monitor is the definitive monitor. Therefore, analysis of processing variables since the last negative BI is required to determine why the failure occurred and what must be done to correct the cause of the failure.
It is critical that a positive BI be viewed as a sign of process failure rather than a failure of the BI itself. When a positive BI occurs, the CSS manager must ask, “What changed, and what was different about this process that led to a positive-reading BI?”
A BI in a PCD should be run weekly but, preferably, every day that a steam sterilizer is used. In addition, each type of tray configuration in routine use should be tested separately.3,4 Most CSS managers monitor sterilizer performance with BIs daily or on a more frequent basis than the minimum requirements just noted. They also obtain incubation results as soon as possible (for example, in one to three hours). Then process failures can be identified faster, instruments can be made ready for their departments’ customers more quickly, inventory and recall costs can be decreased, and quality service to customers and for the patients can be improved.
One manufacturer markets Rapid Readout BIs containing enzymes that allow living spores to be demonstrated in the test device within a shorter time period than their traditional counterparts. When used, sterilization process failures can tentatively be detected in just a few minutes. While a final negative result may not be confirmed for several hours, this time frame is still much more efficient than the one to seven days required for traditional BIs.
BIs are the only appropriate monitoring tools that integrate the required sterilization parameters for steam, dry heat, ethylene oxide (EtO), and radiation.5,6 Therefore, biological results are more significant because all critical parameters cannot be measured by physical means.7
AAMI has published recommended practices for the recall of products necessitated by a sterilization process failure.8 The objective of the recall is to expedite the return of processed items thought to be non-sterile and to ensure appropriate follow-up actions including sterilizer quarantine, physician notification and patient surveillance.
Healthcare facilities should use written polices and procedures that specify actions required to recall items from issued or stored sterilization loads that are in compliance with the Safe Medical Practices Act of 1990.9
If the reason for the process failure is immediately identified (these are usually cases of operator error) and confined to one load or to one item in the load, the problem should be corrected, and the load should be reprocessed. If the reason for the failure is not immediately determined, the load should be quarantined, and all loads back to the last negative BI should be recalled. The applicable sterilizer should also be removed from service and inspected to determine if it could be a root cause of the failure.
Recalls require immediate contact of the staff members and departments that must retrieve the devices before they reach patients. Specific steps to manage a recall follow:
Step 1 – Orally report positive BI results to the appropriate CS supervisor and infection control department personnel. They should then implement the facility’s recall policies and procedures.
Step 2 – Immediately initiate a recall order for all devices in the sterilizer since the last cycle processed with a negative BI reading. Provide important information to affected departments including:
Step 3 – Retrieve and reprocess all recalled devices.
The recall process is not completed after items have been retrieved. The next steps are to identify and correct the problem(s) that enabled the positive BI results.
What caused the process failure that created the need for the recall? The answer to this question becomes important after the device recall has been successful. There are three general causes of processing errors: human, equipment and utilities.
Examples of human error include:
Examples of equipment errors include:
Examples of utility errors include:
Recalls should be documented and applicable records must be maintained. If a computerized system is used, CSS managers may analyze numerous types of information, including items in the failed load, monitoring data results and other statistics about all loads recently processed by a specific equipment operator.
Numerous questions may be asked to help identify why a process failure occurred. Examples include:
The analysis process should determine why the process failure occurred. Then corrective action to reduce the possibility of future failures traceable to the problem creating this recall can be implemented. There are many steps that must be undertaken in a very concise and systematic way to avoid recalls.
After the processing problem is identified, action steps to correct it must be taken. Perhaps processing personnel require additional training in equipment operation, interpretation of monitoring tools, required packaging, and/or loading procedures. Other corrective actions may include, depending on the problem identified, changing the cycle times for load contents, equipment repair, and/or utility changes such as, in the case of steam sterilizers, steam quantity and quality, and water pressure and temperature.
After the problem creating a process failure is corrected, the affected sterilizer must be re-tested before being returned to use. Qualification testing recommendations are as follows:
A final step in the overall recall process is to develop a written report that summarizes the incident. This report should address:
The written report should be circulated to the Infection Control nurse, applicable quality management personnel and teams, and others who may be identified in the facility’s recall policy.
Announcements about the risks of harm from medical devices may be generated by manufacturers, distributors, the U.S. Food and Drug Administration, or other responsible parties. Healthcare facilities must respond to these device recalls, notifications and safety alerts, and applicable policies and procedures require them to do so. This is in line with The Joint Commission requirements for monitoring and acting on equipment hazards and recalls.10 Best practices for managing these external sources of information about potential risks include:
Healthcare facilities require clearly defined policies and procedures to effectively respond when suspected non-sterile devices have been released for patient use. Likewise, plans to respond when external device recalls, notifications and alerts are received are also necessary. CSS managers play a critical role in developing and implementing the facility’s responses to these events in their ongoing efforts to best assure that patient safety is never compromised.
The following resources were used to develop this lesson:
Scott Davis, CMRP, CRCST, CHMMC
Susan Klacik, ACE, CHL, CRCST, FCS
Patti Koncur, CRCST, CHMMC, ACE
Natalie Lind, CRCST, CHL
David Narance, RN, CRCST
Carol Petro, CRCST, RN, BSN
Series Writer/ Editor: