Flash Sterilization

Overview.

“Flash” steam sterilization was originally defined by Underwood and Perkins as sterilization of an unwrapped object at 132°C 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 Table 8). 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 132°C);^{846, 847} used biological indicators that provide results in 1 hour for flash-sterilized items;^{846, 847} and used protective packaging that permits steam penetration.^{812, 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. Sterilization cycle parameters for flash sterilization are shown in Table 8.

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 sterilized.⁸⁴⁹ 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 burns.⁸⁵⁰ 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).

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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).

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