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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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Lesson Plan CRCST 110
Medical Device Recall Procedures
[Reprinted from Communiqué: January/February 2010]

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

Objective 1: Discuss monitoring tools that can suggest possible load processing failures.

Several monitoring tools are used to identify load processing failures that lead to product recalls. These include:

• Physical monitors built into sterilizers
• Indicators, such as Bowie-Dick tests, that check the efficiency of the air removal system for sterilizers with a pre-vacuum cycle.
• External or internal chemical indicators that routinely monitor each package, tray or rigid sterilizer container to detect sterilization process failures.
• Class 5 integrating indicators in a process challenge device (PCD) that monitor all sterilization cycle parameters and correlate to the outcome of a biological indicator (BI).
• Biological indicators in test packs or PCDs.

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:

• The equipment’s physical monitors indicate that the required cycle conditions including time, temperature, pressure, and vacuum were not met, or when the load was processed in the incorrect cycles. The external chemical indicator provides evidence that packages were not exposed to the physical conditions present within the sterilizer.
• The Class 5 integrating indicator in the test pack/PCD shows a reject or incomplete color change result.
• The BI in the test pack/PCD is positive; in other words, the spores were not destroyed.²

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

Objective 2: Explain necessary product recall procedures to retrieve products sent to user departments.

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:

• Why devices are being recalled.
• Which devices are being recalled. Indicate load label data, including sterilizer load and number, along with processing data.
• To whom, when and how to return the recalled devices to the CSS department.

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.

Objective 3: Review procedures to identify and correct reasons for sterilization failure.

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:

• Incorrect use and/or analysis of monitoring tools
• Improper cycle for load content
• Inappropriate packaging materials or packaging
• techniques
• Incorrect sterilizer loading

Examples of equipment errors include:

• Malfunctioning equipment
• Utility problems
• Ethylene oxide concentration when this sterilization method is used

Examples of utility errors include:

• Boiler malfunctions
• Clogged steam lines
• Wet steam due to improper insulation of steam lines
• Malfunction of trap in steam line or no trap in steam line
• Malfunction of drain check
• Poorly engineered piping
• Excessive utility demands

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:

• What is the history of positive BIs in the department? When, why and who was involved? What were the causes?
• What were the results of the monitoring tools used for the loads in question? If known, CSS managers might learn about differences between the load that failed and those that were processed before and after it.
• Did the failure occur in one or all sterilizers? If more than one sterilizer failed, the failure is more likely to have resulted from something besides equipment failure, such as a utility-related problem.
• Do all physical monitoring data yield information about potential problems? If data indicates proper equipment operation, this suggests but doesn’t confirm that the problem was not caused by the specific equipment item.
• Were all instructions for proper use of the BI test pack/PCD followed?
• Was the correct type of BI and/or Class 5 integrating indicator test pack/PCD used for the sterilizer and its load parameters?

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.

Objective 4: Indicate procedures to re-test sterilizers that have been involved in process failures and return them to use.

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:

• After a major repair for dynamic-air-removal steam sterilizers: run three consecutive empty cycles with BI test packs/PCDs, followed by three consecutive empty chamber cycles with Bowie-Dick test packs.
• For gravity steam sterilizers: run three consecutive empty cycles with BI test packs/PCDS.
• For EtO sterilizers: one or more PCDs should be run in simulated loads for three consecutive cycles.
• For table-top steam sterilizers: fully-loaded chambers with BI test packs/PCDs are processed.

A final step in the overall recall process is to develop a written report that summarizes the incident. This report should address:

• The situation that created the need for a recall.
• The percentage of recall devices actually retrieved: total number of products retrieved (÷) total number of devices recalled.
• Surveillance tactics in place if some devices could not be retrieved and were used on patients. Note: this is performed by infection control personnel.
• Confirmation that retrieved devices were reprocessed.
• Corrective actions taken to prevent reoccurrence of the problem leading to the recall.
• Who was contacted during the recall process.

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.

Objective 5. Describe recommended procedures for managing responses to medical device recalls, notifications and safety alerts.

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:

• Clearly specifying who is responsible for routing the information to applicable departments and indicating these persons’ exact responsibilities.
• Using current terminology for the devices to enable facility personnel to determine if the devices are in the facility’s inventory.
• Utilizing an approved list of sources for recall notices, hazard alerts, and other related data to help staff properly address the reported problems.
• Assuring that a process exists and is consistently used to route the correct information to the correct persons so the appropriate response can be made.
• Using a follow-up process that indicates the steps taken to manage the recall, notification or alert.

In Conclusion

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.

Endmotes

1. 1 ANSI/AAMI ST79: 2006 and A1:2008, A2:2009. Comprehensive guide to steam sterilization and sterility assurance in health care facilities. Information about product recalls is found in Section 10.11.
2. See reference 1
3. See reference 1
4. AAMI TIR31:2008. Process challenge devices/test packs for use in health care facilities.
5. ANSI/AAMI/ TIR17665-2:2009. Sterilization of health care products – Moist heat – Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1.
6. ANSI/AAMI/ISO 11135-1:2007.
7. PDA Journal of Pharmaceutical Science and Technology 58, No. 2. March/April, 2004.
8. See reference 1
9. Food and Drug Administration. Medical Device Reporting Regulations of 21 CFR 803. July 13, 2005.
10. The Joint Commission. Environment of Care Standard EC6.10. 2009.

Resources

The following resources were used to develop this lesson:

• Young, M. Product Recall. Managing Infection Control. December, 2005.
• Havrilla, G., et al. Troubleshooting Steam Sterilization Process Failures: A Series of Unfortunate Events. Managing Infection Control. October, 2005.
• Havrilla, G. and Young, M. Positive Biological Indicators. Managing Infection Control. September, 2006.
• ANSI/AAMI ST79:2006/A2:2009. Comprehensive guide to steam sterilization and sterility assurance in health care facilities, Amendment 2.

CRCST 110 QUIZ