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6/22/2017 » 6/25/2017
2017 OSAP Annual Conference

FAQ - Instrument Processing - 2016
 FAQ - Instrument Processing - 2016

 

 

So when a semi critical instrument is processed unwrapped to be used immediately or within a short time, how would we label the item?  Or do these items not need a label?


Regarding the sterilization of unwrapped instruments,
Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 states:

Flash Sterilization

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 sterilizer843. 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 132oC)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).

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 time 817. 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, record keeping (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). 1

From Policy to Practice: OSAP’s Guide to the Guidelines states:

What about “Flash” Cycles?

For routine instrument processing, always package items and use standard sterilization cycles. Efficient inventory management should eliminate the need to flash-sterilize dental instruments.

The “flash” cycle on a steam sterilizer processes items to be used immediately after the cycle, for example, if an instrument is dropped during the treatment and no replacement is available. Manufacturer-programmed into the unit, flash cycles are shorter than the standard cycle.

To allow immediate contact with the steam, the instrument is not wrapped.

Flash sterilization is not intended for routine instrument processing. It should only be used when an urgent need arises for an instrument that will be used immediately after the cycle.

When the flash cycle is warranted:

1.      Thoroughly clean and dry the instrument.

2.      Log all parameters (mechanical, chemical, biological) for each cycle.

3.      Handle instruments carefully to avoid thermal burns.

4.      Immediately and aseptically transport flash-sterilized items to the point of use.

Never flash sterilize implantable devices. 2

Additionally, the American Dental Association states:

Flash Sterilization. Flash sterilization is a method for sterilizing unwrapped instruments for immediate use. This cycle operates at a higher temperature for a shorter period of time than the normal sterilization cycle. The CDC* recommends that flash sterilization not be used routinely in the dental office to sterilize patient instruments—this process should only be used in unavoidable situations. 3

Any further questions on this topic should be directed to your state dental board/dental licensing agency and/or your state public health agency (i.e., state health department). It should be noted that there may also be state specific requirements.

Resources

1)     US Centers for Disease Control and Prevention. Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf  Accessed on September 20, 2016.

2)     Organization for Safety, Asepsis and Prevention. CDC Guidelines: From Policy to Practice by OSAP. Published by OSAP. 2012. Page 51.

3)     American Dental Association. Sterilization and Disinfection of Dental Instruments. http://www.ada.org/~/media/ADA/Member%20Center/FIles/cdc_sterilization.ashx    Accessed on September 20, 2016. 

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