Here is another installment of Sterile Supply Processing information for anyone interested, ideally hopefully the Body Modification world will review this carefully. As a number of artists love using certain forms of flash sterilization cycles while doing their procedures.

Things piercers should note while reading this are: 1) Piercing Needles are Lumens 2) Receiver Tubes are Lumens and 3) If you use Implant Grade specified jewelry, there are specific policies and procedures for re-processing them.

When doing flash sterilization cycles (any sterilization cycle really) you also need to be utilizing the appropriate monitoring controls such as: 1) Utilizing Indicators and Integrators during the cycle. 2) If you have anything Implant Grade specified, you should be doing a biological spore test 3) If you have a pre-vacuum sterilizer you must run a bowie-dick test daily and finally 4) There must be a record log book with all the details of each load used.

The fun I’ve noticed over the years with the Body Modification community is that they enjoy making claims about Doctors and Dentists, when it comes to discussing Sterilization and Processing/Re-Processing. The issue with that is that although Doctors and Dentists are taught about Sterilization Re-Processing, they are in fact not specialists in those fields. So when you are running sterilizer loads and researching/learning about Sterilization Re-Processing, shops (artists) should look to Sterile Supply Processing Specialists and their Policies and Procedures for processing and re-processing instruments and jewelry, not Doctors or Dentists.

Without further adieu here is the section on Flash Sterilization Cycles taken from the Point Of Use Processing chapter of Central Service Technical Manual 7th Edition (pages 268-270):

Flash Sterilization of Implants:

Accordin to the Food and Drug Administration, an implantable device is one that is placed into a surgically-or naturally-formed body cavity with the intention of remaining there for a period of 30 days or more. A few examples include: cranial aneurysm clips, hip and breast prostheses, plates and screws.

AORN standards do not recognize flash sterilization for implants because the process increases the risk of surgical site infection: a leading cause of healthcare facility-associated infections. Instead, it suggests careful planning, inventory management, and cooperation with suppliers.

AAMI also specifies that implantable medical devices should not be flash sterilized. If they are, and they are then placed into a patient before biological indicator results are known, documentation must be completed for premature release of implantable devices. Also, an Exception Form for Premature Release of Implantable Devices must be completed.

- Central Service Technical Manual 7th Edition (pages 268-270)

Additional information on Implants:

ANSI/AAMI ST79:2006 recommends that every load containing implantable devices should be monitored with a PCD (Process Challenge Devices) and quarantined until the results of the BI testing are available. An implantable device should not be released before the BI results are known, and this should be documented. As with all cycles, the sterilizers operator should review the sterilizer chart/printout, and the results of other indicators used to monitor the sterilization process.

- Central Service Techncial Manual 7th Edition (Page 319)

Flash Sterilization Cycles:

Flash sterilization can be accomplished with three types of cycles: gravity displacement, pre-vacuum, and Express. Gravity cycles are traditionally called “flash” cycles, and they may be pre-programmed into the control systes of steam sterilizers. Pre-Vacuum cycles were added to sterilizers used in operating rooms when more complex operating room instrumentation were manufacturered to permit gravity and pre-vacuum sterilization. The Express Cycle is a limited application cycle for a single instrument wrapped in a single-layer wrap.

Regardless of the type of cycle used, all steam sterilization cycles proceed through the same phases: Conditioning, Exposure, and exhaust and/drying. In the conditioning phase, steam enters the chamber as air is removed through the drain. Pressure increases inside as the chamber reaches the sterilizing temperature. The exposure phase begins when the thermocouple senses the constant pre-set cycle temperature. During the exhaust phase, filtered air enters, steam is removed from the chamber, and the pressure inside the chamber returns to atmospheric pressure. There is typically only one minute of drying time programmed into flash cycles, While this assists in removing steam from the chamber, it is not sufficient to completely dry the device(s) being sterilized.

The gravity displacement cycle uses gravity in the conditioning and exhaust phases to displace the air, and to replace it with steam. Both porous and non-porous items can be flash sterilized in a gravity displacement sterilizer if the appropriate times and temperatures are used for each. Gravity flash sterilizers were the only type available for operating room use for many years, and they are still in common use.

If the flash sterilization load consists of a single instrument comprised of metal and without lumens, a three-minute cycle at 270F (132C) should be used. If the load includes complex or lumened instruments, mixed materials (example: rubber and plastic) , or multiple instruments, a 10-minute cycle at 270F (132C) should be used. Gravity flash cycles have abbreviated cycle times, so strict adherence to the sterilizer’s and instrument manufacturer’s instructions is necessary. Gravity flash cycles do not typically include drying time.

Unlike gravity flash cycles, pre-vacuum flash cycles are standard sterilization cycles with a limited drying time. The typical pre-set pre-vacuum flash cycle drying time (usually one minute) helps decrease steam in the chamber, but it does not dry the instrument. The limited drying time makes the processed item unsuitable for storage, and it defines the pre-vacuum cycle as a flash cycle. During a pre-vacuum flash cycle, air and steam are mechanically injected and removed during the conditioning phases. Both non-porous and porous items within wraps, pouches, or containers can be sterilized in pre-vacuum cycles if the appropriate times and temperatures are used for each. A pre-vacuum load that consists of mixed materials or items with lumens must be processed for four minutes at 270F (132C).

Complex medical devices may require longer exposure times. However, the exposure times should never be less than the minimum recommended flash exposure time. Cycle parameters cited in the AAMI standard, in the AORN Recommended Practices, and in the Sterilizers Manufactures’ Operating Instructions, provide minimum exposure requirements. The manufacturers of these more complex medical devices must provide recommended cycle and exposure times for flash sterilization. If these are not included in the operator’s manual, the information should be requested in writing from the manufacturer. Additional cycles can be programmed into many sterilizers control systems for any medical devices requiring different exposure times.

The Express cycle has a limited application. This cycle should only be used for simple, all-metal, non-porous instruments without lumens that are not constructed of mixed materials. A reusable or disposable single-layer wrap is the only recommended packaging to be used, and it protects sterile goods during transfer to the point of use after sterilization.

The Express cycle is preset by the manufacturer for four minutes at 270F (132C) with three minutes of drying time, and a total cycle time of 12 minutes. Express cycles are abbreviated pre-vacuum cycles. They feature two mechanical steam pulses and vacuum pulls in the contrast with four pulses and pulls for a standard pre-vacuum, and this is the reason for their limited processing capabilities. The Express cycle is a just-in-time process with no shelf life. The recommended procedure is to handle the instruments as though no-wrapper exists. The operator should wear sterile gloves and use sterile towels to hold the tray. He/she should place the wrapped tray on a sterile impervious surface (one that liquids cannot pass through), and the tray should not be placed on a working sterile field while opening it. Even though this cycle has a short drying time, the single wrapper may still be damp, and aseptic technique is important.

- Central Service Technical Manual 7th Edition (pages 268-270)