Most medical and surgical devices used in healthcare facilities are made of materials that are heat stable and therefore undergo heat, primarily steam, sterilization. However, since 1950, there has been an increase in medical devices and instruments made of materials (e.g., plastics) that require low-temperature sterilization. Ethylene oxide gas has been used since the 1950s for heat- and moisture-sensitive medical devices. Within the past 15 years, a number of new, low-temperature sterilization systems (e.g., hydrogen peroxide gas plasma, peracetic acid immersion, ozone) have been developed and are being used to sterilize medical devices. This section reviews sterilization technologies used in healthcare and makes recommendations for their optimum performance in the processing of medical devices
Sterilization destroys all microorganisms on the surface of an article or in a fluid to prevent disease transmission associated with the use of that item. While the use of inadequately sterilized critical items represents a high risk of transmitting pathogens, documented transmission of pathogens associated with an inadequately sterilized critical item is exceedingly rare 821, 822. This is likely due to the wide margin of safety associated with the sterilization processes used in healthcare facilities. The concept of what constitutes “sterile” is measured as a probability of sterility for each item to be sterilized. This probability is commonly referred to as the sterility assurance level (SAL) of the product and is defined as the probability of a single viable microorganism occurring on a product after sterilization. SAL is normally expressed a 10-n. For example, if the probability of a spore surviving were one in one million, the SAL would be 10-6 823, 824. In short, a SAL is an estimate of lethality of the entire sterilization process and is a conservative calculation. Dual SALs (e.g., 10-3 SAL for blood culture tubes, drainage bags; 10-6 SAL for scalpels, implants) have been used in the United States for many years and the choice of a 10-6 SAL was strictly arbitrary and not associated with any adverse outcomes
Medical devices that have contact with sterile body tissues or fluids are considered critical items. These items should be sterile when used because any microbial contamination could result in disease transmission. Such items include surgical instruments, biopsy forceps, and implanted medical devices. If these items are heat resistant, the recommended sterilization process is steam sterilization, because it has the largest margin of safety due to its reliability, consistency, and lethality. However, reprocessing heat- and moisture-sensitive items requires use of a low-temperature sterilization technology (e.g., ethylene oxide, hydrogen peroxide gas plasma, peracetic acid)
Overview. Of all the methods available for sterilization, moist heat in the form of saturated steam under pressure is the most widely used and the most dependable. Steam sterilization is nontoxic, inexpensive 826, rapidly microbicidal, sporicidal, and rapidly heats and penetrates fabrics (Table 6)827. Like all sterilization processes, steam sterilization has some deleterious effects on some materials, including corrosion and combustion of lubricants associated with dental handpieces 212; reduction in ability to transmit light associated with laryngoscopes828; and increased hardening time (5.6 fold) with plaster-cast
The basic principle of steam sterilization, as accomplished in an autoclave, is to expose each item to direct steam contact at the required temperature and pressure for the specified time. Thus, there are four parameters of steam sterilization: steam, pressure, temperature, and time. The ideal steam for sterilization is dry saturated steam and entrained water (dryness fraction ≥97%)813, 819. Pressure serves as a means to obtain the high temperatures necessary to quickly kill microorganisms. Specific temperatures must be obtained to ensure the microbicidal activity. The two common steam-sterilizing temperatures are 121oC (250oF) and 132oC (270oF). These temperatures (and other high temperatures) 830 must be maintained for a minimal time to kill microorganisms. Recognized minimum exposure periods for sterilization of wrapped healthcare supplies are 30 minutes at 121oC (250oF) in a gravity displacement sterilizer or 4 minutes at 132oC (270oC) in a prevacuum sterilizer (Table7). At constant temperatures, sterilization times vary depending on the type of item (e.g., metal versus rubber, plastic, items with lumens), whether the item is wrapped or unwrapped, and the sterilizer type.
The two basic types of steam sterilizers (autoclaves) are the gravity displacement autoclave and the high-speed prevacuum sterilizer. In the former, steam is admitted at the top or the sides of the sterilizing chamber and, because the steam is lighter than air, forces air out the bottom of the chamber through the drain vent. The gravity displacement autoclaves are primarily used to process laboratory media, water, pharmaceutical products, regulated medical waste, and nonporous articles whose surfaces have direct steam contact. For gravity displacement sterilizers the penetration time into porous items is prolonged because of incomplete air elimination. This point is illustrated with the decontamination of 10 lbs of microbiological waste, which requires at least 45 minutes at 121oC because the entrapped air remaining in a load of waste greatly retards steam permeation and heating efficiency 831, 832. The high-speed prevacuum sterilizers are similar to the gravity displacement sterilizers except they are fitted with a vacuum pump (or ejector) to ensure air removal from the sterilizing chamber and load before the steam is admitted. The advantage of using a vacuum pump is that there is nearly instantaneous steam penetration even into porous loads. The Bowie-Dick test is used to detect air leaks and inadequate air removal and consists of folded 100% cotton surgical towels that are clean and preconditioned. A commercially available Bowie-Dick-type test sheet should be placed in the center of the pack. The test pack should be placed horizontally in the front, bottom section of the sterilizer rack, near the door and over the drain, in an otherwise empty chamber and run at 134oC for 3.5 minutes 813, 819. The test is used each day the vacuum-type steam sterilizer is used, before the first processed load. Air that is not removed from the chamber will interfere with steam contact. Smaller disposable test packs (or process challenge devices) have been devised to replace the stack of folded surgical towels for testing the efficacy of the vacuum system in a prevacuum sterilizer. 833 These devices are “designed to simulate product to be sterilized and to constitute a defined challenge to the sterilization process” 819, 834. They should be representative of the load and simulate the greatest challenge to the load 835. Sterilizer vacuum performance is acceptable if the sheet inside the test pack shows a uniform color change. Entrapped air will cause a spot to appear on the test sheet, due to the inability of the steam to reach the chemical indicator. If the sterilizer fails the Bowie-Dick test, do not use the sterilizer until it is inspected by the sterilizer maintenance personnel and passes the Bowie-Dick test
Another design in steam sterilization is a steam flush-pressure pulsing process, which removes air rapidly by repeatedly alternating a steam flush and a pressure pulse above atmospheric pressure. Air is rapidly removed from the load as with the prevacuum sterilizer, but air leaks do not affect this process because the steam in the sterilizing chamber is always above atmospheric pressure. Typical sterilization temperatures and times are 132oC to 135oC with 3 to 4 minutes exposure time for porous loads and instruments
Like other sterilization systems, the steam cycle is monitored by mechanical, chemical, and biological monitors. Steam sterilizers usually are monitored using a printout (or graphically) by measuring temperature, the time at the temperature, and pressure. Typically, chemical indicators are affixed to the outside and incorporated into the pack to monitor the temperature or time and temperature. The effectiveness of steam sterilization is monitored with a biological indicator containing spores of Geobacillus stearothermophilus (formerly Bacillus stearothermophilus). Positive spore test results are a relatively rare event 838 and can be attributed to operator error, inadequate steam delivery 839, or equipment malfunction.
Portable (table-top) steam sterilizers are used in outpatient, dental, and rural clinics 840. These sterilizers are designed for small instruments, such as hypodermic syringes and needles and dental instruments. The ability of the sterilizer to reach physical parameters necessary to achieve sterilization should be monitored by mechanical, chemical, and biological indicators.
Microbicidal Activity. The oldest and most recognized agent for inactivation of microorganisms is heat. D-values (time to reduce the surviving population by 90% or 1 log10) allow a direct comparison of the heat resistance of microorganisms. Because a D-value can be determined at various temperatures, a subscript is used to designate the exposure temperature (i.e., D121C). D121C-values for Geobacillus stearothermophilus used to monitor the steam sterilization process range from 1 to 2 minutes. Heat-resistant nonspore-forming bacteria, yeasts, and fungi have such low D121C values that they cannot be experimentally measured
Mode of Action. Moist heat destroys microorganisms by the irreversible coagulation and denaturation of enzymes and structural proteins. In support of this fact, it has been found that the presence of moisture significantly affects the coagulation temperature of proteins and the temperature at which microorganisms are destroyed.
Uses. Steam sterilization should be used whenever possible on all critical and semicritical items that are heat and moisture resistant (e.g., steam sterilizable respiratory therapy and anesthesia equipment), even when not essential to prevent pathogen transmission. Steam sterilizers also are used in healthcare facilities to decontaminate microbiological waste and sharps containers 831, 832, 842 but additional exposure time is required in the gravity displacement sterilizer for these items.
Overview. “Flash” steam sterilization was originally defined by Underwood and Perkins as sterilization of an unwrapped object at 132oC for 3 minutes at 27-28 lbs. of pressure in a gravity displacement sterilizer 843. Currently, the time required for flash sterilization depends on the type of sterilizer and the type of item (i.e., porous vs non-porous items)(see Table8). Although the wrapped method of sterilization is preferred for the reasons listed below, correctly performed flash sterilization is an effective process for the sterilization of critical medical devices 844, 845. Flash sterilization is a modification of conventional steam sterilization (either gravity, prevacuum, or steam-flush pressure-pulse) in which the flashed item is placed in an open tray or is placed in a specially designed, covered, rigid container to allow for rapid penetration of steam. Historically, it is not recommended as a routine sterilization method because of the lack of timely biological indicators to monitor performance, absence of protective packaging following sterilization, possibility for contamination of processed items during transportation to the operating rooms, and the sterilization cycle parameters (i.e., time, temperature, pressure) are minimal. To address some of these concerns, many healthcare facilities have done the following: placed equipment for flash sterilization in close proximity to operating rooms to facilitate aseptic delivery to the point of use (usually the sterile field in an ongoing surgical procedure); extended the exposure time to ensure lethality comparable to sterilized wrapped items (e.g., 4 minutes at 132oC)846, 847; used biological indicators that provide results in 1 hour for flash-sterilized items846, 847; and used protective packaging that permits steam penetration812, 817-819, 845, 848. Further, some rigid, reusable sterilization container systems have been designed and validated by the container manufacturer for use with flash cycles. When sterile items are open to air, they will eventually become contaminated. Thus, the longer a sterile item is exposed to air, the greater the number of microorganisms that will settle on it.
A few adverse events have been associated with flash sterilization. When evaluating an increased incidence of neurosurgical infections, the investigators noted that surgical instruments were flash sterilized between cases and 2 of 3 craniotomy infections involved plate implants that were flash sterilized849. A report of two patients who received burns during surgery from instruments that had been flash sterilized reinforced the need to develop policies and educate staff to prevent the use of instruments hot enough to cause clinical burns850. Staff should use precautions to prevent burns with potentially hot instruments (e.g., transport tray using heat-protective gloves). Patient burns may be prevented by either air-cooling the instruments or immersion in sterile liquid (e.g., saline).
Uses. Flash sterilization is considered acceptable for processing cleaned patient-care items that cannot be packaged, sterilized, and stored before use. It also is used when there is insufficient time to sterilize an item by the preferred package method. Flash sterilization should not be used for reasons of convenience, as an alternative to purchasing additional instrument sets, or to save time817. Because of the potential for serious infections, flash sterilization is not recommended for implantable devices (i.e., devices placed into a surgically or naturally formed cavity of the human body); however, flash sterilization may be unavoidable for some devices (e.g., orthopedic screw, plates). If flash sterilization of an implantable device is unavoidable, recordkeeping (i.e., load identification, patient’s name/hospital identifier, and biological indicator result) is essential for epidemiological tracking (e.g., of surgical site infection, tracing results of biological indicators to patients who received the item to document sterility), and for an assessment of the reliability of the sterilization process (e.g., evaluation of biological monitoring records and sterilization maintenance records noting preventive maintenance and repairs with dates).