Sterilization: would your facility pass a standards audit? 1.7 [e]

AORN Journal,  Jan, 2008  by Chuck Hughes

• E-mail
• Print
• Link

Proper sterilization of reusable medical instruments, supplies, and devices and maintaining the sterility of these items until they are used are critical aspects of infection control. To minimize infection risk, facility managers should perform detailed sterilization audits to test their facilities beyond the generalized inspection for accreditation performed by the Joint Commission.

The Association for the Advancement of Medical Instrumentation (AAMI) has created sterilization guidelines that are updated annually and have been adopted as national standards by the American National Standards Institute. (1) Members of the AAMI sterilization committee include representatives from health care organizations, government agencies, medical device manufacturers, and testing laboratories. Recommended practices for sterilization (2-5) also are developed by AORN's Recommended Practices Committee and then must be approved by the AORN Board of Directors. A facility sterilization standards audit for compliance with the AAMI standards and AORN recommended practices should review three main components: facility design, personnel education, and sterilization processing procedures.

This article guides the reader through a systematic, comprehensive, sterilization audit. If put to the test, would your facility pass?

FACILITY DESIGN

Facility design is the foundation for proper sterility assurance on which additional factors rely. Facility design consists of physical construction, temperature and humidity control, and cleaning and disinfecting practices for the physical structure.

PHYSICAL CONSTRUCTION. Functional work areas should be physically separated by walls or partitions. (1) Air contaminants must not be allowed to enter clean areas; therefore, doors and pass-through windows should be kept closed when they are not in use because ventilation patterns affect the spread of potentially dangerous microorganisms.

Floors should be level and constructed of materials that will withstand daily or more frequent cleaning. Carpet should not be used in work areas. Furthermore, ceilings and wall surfaces should be constructed of nonshedding materials to limit condensation and dust accumulation.

TEMPERATURE AND HUMIDITY CONTROL. To comply with standards, facility personnel should record temperature and humidity control readings daily. Maintenance of these factors is important for staff member comfort and the containment of microbial growth, especially mold. Humidity levels for all areas can safely range from 30% to 70%; however, optimal temperature ranges differ from location to location (1) (Table 1). It is important to note that commercial fans and reservoir-type water humidifiers should not be used to maintain temperature and humidity levels because fans circulate dust and reservoir-type humidifiers are easily contaminated. Organizational policies should be developed regarding air filtration requirements and positive air-flow pressures (ie, the pressure gradient is greater so air flows away from the area [eg, OR suite]) versus negative air-flow pressures (ie, the pressure gradient is less so air flows into the the area [eg, decontamination areas]).

CLEANING AND DISINFECTING PRACTICES. Floors and horizontal work surfaces should be cleaned at least daily to remove soil and microbes, reducing the possibility of infectious transmissions. (3) Moreover, food, drink, and shipping boxes should never enter any of the processing areas.

On May 12, 2006, Modern Healthcare's Daily Dose reported the following:

   A California hospital has asked two facility
   managers to resign after the fungus Aspergillus
   was found in the hospital's ventilation
   system in March. The managers were asked
   to leave because they did not follow maintenance
   schedules put in place more than five
   years ago after a similar outbreak was linked
   to a patient's death. Aspergillus, commonly
   found in insulating material, walls, and ceilings,
   is harmless to healthy individuals but
   can be lethal if inhaled by patients with
   weakened immune systems. In this situation,
   the fungus was found before it could develop
   spores that could become airborne and before
   any patients became ill. (6)

This speaks to the necessity of having facility-wide policies and procedures that reflect evidence-based requirements and the need to follow them. Controlling environmental contaminants and bioburden is essential to the effectiveness of the sterilization process. (1)

EDUCATION OF PERSONNEL

Only authorized personnel should be allowed within processing areas. Furthermore, it is the responsibility of management personnel to ensure that all perioperative personnel are educated regarding hand washing, personal protective equipment (PPE) and personal attire, and the importance of certification.

HAND WASHING. Hand washing is the single most important action for preventing health care-associated infections in patients and staff members. (7) Washing facilities should be conveniently located to promote hand washing before and after eating, after touching one's face, before and after using the toilet, after handling contaminated items, after removing gloves, and before leaving the decontamination area. Key locations are lounges, personnel changing areas and bathrooms, and entrances and exits to reprocessing areas. Sinks and waterless, alcohol-based agents encourage this vital practice in personal care.