Medical Sterilizers: Routine Care & Maintenance
Ensuring the reliability and effectiveness of steam sterilizers is paramount in any healthcare setting, as these devices play a crucial role in preventing infections and maintaining patient safety. In this blog, we delve into the essential practices of preventative maintenance and calibration of steam sterilizers, guided by the standards set forth in AAMI ST79.
Routine Care
Routine care is essential for the proper operation of steam sterilizers. Daily maintenance tasks performed by users, such as cleaning filters, checking seals, and inspecting for any signs of wear or malfunction, help to prevent the accumulation of residues that could compromise the sterilization process. Additionally, these routine checks can identify and address minor issues before they escalate into major malfunctions, thereby minimizing downtime and costly repairs. Always ensuring that sterilizers function optimally not only upholds stringent healthcare standards but also protects patients and healthcare providers from the risks associated with improperly sterilized instruments.
Items that should be inspected and cleaned daily include:
1. Printers
2. Printer ink ribbons
3. Door gaskets
4. The chamber drain screen
5. Internal/External surfaces
6. Any other items mentioned in the manufacturer's written IFU or the operator’s and technical manuals that accompany your equipment.
Routinely cleaning the chamber drain screen is of particular importance. A clogged strainer may prevent condensate from adequately draining from the sterilizer chamber. This can cause issues such as wet packs. Additionally, any debris that makes it past the strainer could cause serious damage to down-stream components. While this task might be difficult to accomplish on your own, depending on the location of the drain screen on your sterilizer, make sure to work with your maintenance team to structure a plan that works. There are safety considerations when completing this task.
Maintenance and Calibration
In addition to routine care, regular maintenance and calibration is also required. These practices not only extend the lifespan of these critical devices but also ensure their optimal performance. After maintenance work is completed on a sterilizer, it is also important to document the work and perform qualification testing on the machine.
1. Preventative Maintenance: AAMI ST79 emphasizes the importance of adhering to a regular preventative maintenance schedule to ensure the reliable performance of steam sterilizers. This includes following the manufacturer’s guidelines for routine inspections, cleaning, lubrication, and replacement of parts. Preventative maintenance tasks should be documented and performed by qualified personnel to maintain the effectiveness and safety of the sterilization process.
2. Calibration: Regular calibration of critical sterilizer components, such as temperature probes and pressure sensors, is required to ensure that they operate within specified parameters. Calibration should be performed according to the manufacturer’s instructions and at intervals defined by the manufacturer, regulatory requirements, or based on usage patterns. Accurate calibration is crucial for maintaining the consistency and reliability of the sterilization cycles.
3. Record Keeping: Documentation of all maintenance and calibration activities is a critical component of AAMI ST79. Records should include details of the maintenance performed, parts replaced, calibration results, and the personnel involved. These records are essential for tracking the sterilizer's performance over time and for compliance with regulatory standards.
The following information should be included in each maintenance record:
a) The date on which service was requested
b) The model and serial number of the sterilizer
c) The location of the equipment (facility identification, if applicable)
d) The name of the individual from the health care facility who requested and authorized the service
e) The reason for the service request
f) A description of the service performed (e.g., calibration, repair)
g) The types and quantities of parts replaced
h) The name of the person who performed the service
4. Qualification Testing: After maintenance or calibration, qualification testing (e.g., biological, and chemical indicator testing) should be conducted to verify that the sterilizer is functioning correctly. This ensures that any adjustments or repairs have not adversely affected the sterilizer's ability to achieve effective sterilization. Qualification testing guidelines are provided in AAMI ST79 and by your manufacturer. These tests should also be documented.
References
Association for the Advancement of Medical Instrumentation. Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79:2017. Arlington, VA: AAMI; 2017.