Developing a Sensible Flash Policy

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Key components you need to incorporate to use this last resort properly.


Flash sterilization is considered a last resort, often performed under stress and under the gun. Doing it right comes down to three things: policies, training and monitoring of compliance. Here's how to write and implement a sensible, safe flash policy for your facility.

Flash considerations
The first thing to keep in mind when developing a policy on flash sterilization (or anything, for that matter) is that it must be achievable, as non-compliance with a policy can be considered negligence. Other considerations for establishing a policy:

  • input from clinical staff and processing personnel regarding flash sterilization practices;
  • AORN's recommended practices on sterilization and the Association for the Advancement of Medical Instrumentation's "Flash Sterilization: Steam Sterilization of Patient Care Items for Immediate Use";
  • location of flash sterilizers (in sub-sterile rooms or sterile core?) and
  • a review of chemical and biological indicators on the marker to ensure the accuracy of information achieved from biological and chemical monitoring.

When developing a flash policy, learn the recommended practices, then review your current practice. Determine what you need to improve and discuss with the staff the key issues related to proposed changes. Test the methods first to ensure your staff can comply with them.

Your policy should cover cleaning and preparing devices, monitoring sterilization, record-keeping, quality improvement, administrative duties and legal issues.

Flash Sterilization Cycles

Pre-vacuum flash cycles (270'F)
- Metal instruments, no lumens or porous materials ' three minutes' exposure
- Metal instruments, devices with lumens or porous materials ' four minutes' exposure

Gravity displacement flash cycles (270'F)
- Metal instruments, no lumens or no porous materials ' three minutes' exposure
- Metal instruments, devices with lumens or porous materials ' 10 minutes' exposure

Cleaning devices
If you're going to flash an instrument, you must first have thoroughly and properly cleaned it. Either an item is clean or it's not ' too often, instruments to be flash sterilized are rinsed off or washed in scrub sinks. But sterilization won't compensate for poor or inadequate cleaning. You probably know this already, but it's good to review the components involved in cleaning a device before flash or other sterilization.

  • Manufacturer instructions. You should have written instructions from each manufacturer of every device you reprocess. Follow these instructions for cleaning and sterilization; it's critical for patient safety because the device might not be compatible with the detergent you're using, or the device might not hold up to flash sterilization.
  • Transport. Transport soiled surgical instruments to the soiled utility room in a manner that won't contaminate the environment or the person transporting them. A plastic bin that can be cleaned and disinfected works nicely for transport.
  • Cleaning facilities. Don't use a sub-sterile room to clean items because they're designated as non-sterile rooms, usually have only one sink (which should be dedicated to hand-washing) and don't have the proper personal protective equipment in them. If the flash sterilizer is in this room and if cleaning is performed while the sterilizer door is opened (at the end of a flash cycle), the device can be cross-contaminated. Of course, in an emergency, you can clean a single item in the sub-sterile room if you take necessary precautions. The area where you regularly do cleaning should be a dedicated soiled room (clean and soiled activities may be split by walls, but not combined in one room) with negative pressure and 10 air exchanges per hour. Ensure all materials (work stations, counter tops, floors, walls) are durable and washable and that no porous materials are used, as they cannot be cleaned.
  • PPE. Proper PPE is a must ' head cover, shoe covers, impervious gown, gloves, face/eye protection. Staff shouldn't enter the soiled room without it. Remove all PPE and wash your hands when leaving the decontamination area.
  • Cleaning products. Use enzymatic detergents according to manufacturer instructions, and thoroughly clean and rinse according to those instructions. Regularly check your water quality and temperature, as they can adversely affect detergents.
  • Cleaning implements. Use soft-bristle brushes to clean instruments, paying particular attention to ratchets, serrations and joints. Perform manual cleaning while holding the instrument and the brush under the water level to prevent bacteria aerosolization.
  • Prep. Treat surgical instruments with a water-soluble lubricant (dubbed instrument milk because of the white color) to protect surfaces and potentially prolong usage life. Follow the manufacturer's instructions for mixing and assigning an expiration date. Let the lubricant air dry.

Into the autoclave
Disassemble instruments with multiple parts for cleaning, and unless directed by the manufacturer, leave them that way for flash sterilization.

You can flash a device unwrapped (most common) or with a single wrapper. One manufacturer of steam sterilizers offers a special flash sterilization cycle in which a single wrapper is used to help contain the device as it is transferred from the sterilizer to the point of use after sterilization. However, you can't process all devices in the single-wrapper cycle. There are also flash sterilization containers for during and after sterilization.

The AAMI recommends that you test flash sterilization containers to verify they permit sterilization when used in your sterilizers. The container validation process is described in the AAMI document. Get written, scientific documentation from manufacturers that their containers are suitable for flash sterilization; many containers require extended cycles.

You can flash sterilize instruments in gravity displacement or pre-vacuum sterilizers equipped for such cycles. See "Flash Sterilization Cycles" on page 51 for minimum exposure times. Place all hinged instruments in the open position; disassemble all multiple-part devices; and flush with sterile distilled water immediately before sterilizing any lumened items.

If using a flash sterilizer with an express cycle (designated for use with a single-ply wrapper), be sure to follow the sterilizer manufacturer's instructions for use. Lumened and porous items aren't recommended for express cycles.

Monitoring the sterilization cycle
Monitor administrative controls, such as charts, printouts and gauges, to verify the effectiveness of the sterilization process. At the completion of each cycle, the sterilizer operator should read and interpret the sterilizer printout (which the sterilizer operator should initial) for correlation with the proper cycle times and temperatures for items being processed. Use chemical indicators or integrators in each cycle to verify that all sterilization parameters have been met; verify with the chemical indicator manufacturer that the CI you use has been tested and is recommended for flash sterilization cycles.

Perform biological monitoring at least weekly and preferably daily (depending on the volume of all sterilization). The organism used to test for steam sterilization is Geobacillus stearothermophilus. The manufacturer of the biological monitor you use should provide documentation that the product has been tested and is indicated for flash sterilization cycles.

Conventional steam flash biological monitors require 24 hours of incubation at 132.8'F. The tests are self-contained and can easily be performed in the surgical suite or an office setting. Newer biological tests are now available that provide a reading within one hour (for flash cycles). You need an unsterilized control vial to validate that the organisms were viable. Record and maintain results of the BI testing and control vials with the sterilization records.

Recording the information
Document all flashed items on a flash sterilization log (see "A Sample Flash Log") maintain a log at each flash sterilizer and change it daily. You need this record to meet the requirements for tracing items in the event of a sterilizer malfunction. Keep all sterilization logs with the charts and/or printouts for each day so they can be easily retrieved. The log should document that the device was cleaned and the reason the item needed flash sterilizing. Retain the sterilization records (logs and BI test results) in accordance with your legal advisor's recommendations (usually seven years).

You should monitor the flash sterilization process for improvements. Provide initial and continuing education for all sterilizer operators to ensure proper use of the equipment. Ensure all biological and chemical monitoring is interpreted and verified before the instruments are used. Perform annual competency testing on the critical aspects of flash sterilization, such as interpretation of the printout. In addition, staff members should be able to replace the paper in the printout and change the ink cartridge to ensure printouts can be interpreted.

A Sample Flash Log

Date

Description of item in load

Doctor

Room #

Item cleaned

Exposure time

Result of CI

BI Run? (Y/N)

Reason Item(s) Flashed

ID #

Patient

Removed By

 

 

 

Flashing and Prions

Although the incidence of Creutzfeldt-Jakob Disease is low, certain types of tissue ' brain, spinal cord and eye ' are considered high-risk for transmission of prions. In outpatient surgical facilities, eye surgery cases are of great concern because sets are commonly flashed between cases.

But you should be cautious in such an undertaking, because flash sterilization is not recommended for prion-contaminated Items. At this time, the recommended exposure time for items contaminated with prions is 18 minutes at 270'F.

You should also have a process to screen patients for possible CJD or vCJD. Any instruments used on such patients should be cleaned as usual; however, lumened devices should be replaced with single-use versions for the case. This will prevent any issues with cleaning difficult lumens.

Administrative duties
The nurse manager, along with the OR staff and administration, should work to develop a sensible flash sterilization policy. In a hospital setting, this can be jointly developed by the OR manager and staff with input from the sterile processing managers. The SPD manager can provide valuable information about sterilization policies and requirements. However, in an outpatient surgery facility, this entire responsibility usually rests with the nurse manager.

Begin by determining how the OR will provide the same standard of care to each patient who requires sterile instrumentation (as opposed to disinfected instrumentation, such as flexible endoscopes). In these times of declining financial reimbursement and increased pressure for fast turnaround time, the emphasis must remain on best practice. Here are ways to provide your organization with best practice policies and procedures:

  • Perform a surgical instrument inventory, including the number of each and every instrument and instrument set you own (often will be performed by a prime vendor at no cost).
  • Identify your consignment inventory.
  • Schedule cases based on the number of instrument sets available.
  • Use an automated scheduling system to provide conflict-checking with instrument sets.
  • Identify procedures that are scheduled later in the day that require the instruments in limited supply.
  • Check to determine whether it's possible to get loaner sets the day before such procedures to allow sufficient time for cleaning and sterilization.
  • Develop a strategy for scheduling a different procedure in between other procedures to allow adequate time for decontamination and sterilization of the instruments in demand.
  • Develop a process improvement plan to collect data on instruments that require flash sterilization.
  • Determine if additional instrumentation is needed to reduce flash sterilization and improve turnaround times.
  • Use the sterilization log form to document the items frequently flashed and to question and challenge the use of flash sterilization.
  • Maintain a record of the turnaround times for instrument sets to permit correct booking of cases.

Favorable outcomes ahead
If your policy on flash sterilization indicates it's only performed in emergency situations, and you don't comply with your own policy, then you could be found negligent by an accreditation body or in the event of a surgical site infection. If a device is flash sterilized, and the device manufacturer never validated the item for flash, you bear full responsibility for the safety of the device. Many device manufacturers no longer provide flash sterilization instructions or have extended their cycle times. Also, verify with your flash sterilizer's user manual if entire sets or just single instruments were validated.

You must ensure that patient outcomes are favorable and that patient safety is paramount. Under ideal conditions, you'd always have sufficient surgical instrumentation to let you properly decontaminate and terminal sterilize. However, if you must flash sterilize, all personnel should follow the proper protocols. Practitioners must ensure policies and procedures are developed to ensure all steps in the flash sterilization process are followed correctly and that continuous quality improvement monitors are developed to verify efficacy. Without these processes in place, both patient and practitioner are at risk. OSM

References
1. Perkins, John. Principles and Methods of Sterilization in Health Sciences. Springfield, IL: Charles Thomas, 1982
2. Standards and Recommended Practices. Denver, CO: Association of Operating Room Nurses.
3. Flash Sterilization: Steam Sterilization of Patient Care Items for Immediate Use. Washington, DC: Association for the Advancement of Medical Instrumentation, ST-37. 1996

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