Did you read confusing STATIM information in the old APP Procedure Manual? (prior to 2013 edition)

• STATIM in the old APP Procedure Manual
  • The wrong impression?
  • Important sterilization facts
  • Correcting the misunderstanding:

STATIM in the old APP Procedure Manual

In the current 2013 edition of the APP Procedure Manual, I helped correct the previously confusing references to Statim autoclaves.

The current 2013 version of the guidelines refer to the Statim and the acceptable use of unwrapped sterilization methods.

Quotes from the 2013 APP procedure manual:

Sterilization Methods:

Benchtop Sterilization

• Steam under pressure (saturated steam/steam autoclave): 220-270 kpa pressure at 132° Centigrade (270° Fahrenheit) for 3-40 minutes depending on cycle.
  • Steam autoclave process types
    • Steam flush-pressure pulse (type S):
      “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 132°C to 135°C with 3 to 4 minutes exposure time for porous loads and instruments.” The Statim is an example of a type S steam flush pressure pulse autoclave, which is acceptable for sterilization.

 

Aseptic Field

The actual procedure surface is referred to as an “aseptic field,” and is a sterilized surface that becomes exposed to air contact only at the beginning of the piercing procedure. The aseptic field used by most piercers is the sterile inside surface of a freshly opened large autoclave or sterile glove package, Statim cassette, rigid sterilization container, or sterilized tray. Once the package is opened, sterile tools, needles, jewelry, and disposables can be dropped onto the inside surface for use. The exterior of sterilized packages such as those containing the jewelry should not touch the aseptic field; the contents should be carefully dispensed onto it.

DISPOSABLE SUPPLIES

To minimize the risk of cross-contamination and to ensure that piercing room procedures are as clean as possible, many components of the tray setup must be disposable. Unless supplies are purchased presterilized* or will be sterilized in an autoclave immediately prior to the procedure, all disposables must be individually packaged in autoclave bags, sterilized, and remain intact in their pouches stored in enclosed, nonporous drawers or containers until use. Disposable materials that must be sterilized include: marking implements, piercing needles, corks or synthetic stoppers, elastic bands, swabs, and gauze.

* This includes only FDA-cleared items that are commercially sterilized according to accepted medical standards. The supplier must make documentation of appropriate sterilization available.

The following is to clarify the inconsistencies in the previous editions: 

From the deprecated 2005 APP manual:

Statim

Some piercing studios use steam-flush pressure-pulse autoclaves (such as Statim autoclaves) for sterilization. The sterilization process in this type of autoclave facilitates air removal and steam penetration, and has an extremely short processing time. The steam-flush pressure-pulse autoclave is acceptable for sterilization in the piercing studio as long as certain guidelines are followed:

• Due to the high number of cycles run each day, these autoclaves must be spore tested weekly.
• Daily, weekly and monthly maintenance of steam, pressure-pulse autoclaves is required.

This type of autoclave requires a more rigorous maintenance schedule than traditional autoclaves and a written log of all maintenance should be kept.

The Statim has three sterilization cycles, each designed to sterilize a specific type of instrument.

• Unwrapped cycle – 275 F for 3.5 minutes
• Wrapped cycle – 275 F for 10 minutes
• Rubber and plastic cycle – 250 F for 15 minutes

The following can be sterilized in the Statim:

Nylon, polycarbonate (Lexan), polypropylene, PFTE (Teflon), acetal (Delrin) polysulfone (Udel), polyetherimide (Ultem) silicone rubber, and polyester.

The following cannot be sterilized in the Statim on any cycle:

Polyethylene, ABS, styrene, cellulosics, PVC, acrylic (Plexiglas), PPO (Noryl) latex, neoprene, and similar materials.

If you are not sure, do not load items until you have checked with the manufacturer. Processing of these materials may lead to instrument or equipment damage.

Do not mix instrument types (i.e. plastics and unwrapped tools) in the same Statim load. APP 2005 procedure manual

The wrong impression?

Dispelling common misunderstandings in regards to the use and purpose of the Statim autoclave sterilizer family will help simplify our jobs as body artists and the regulatory work of Health Officials. To clarify, a definitive explanation of basic appropriate Statim sterilizer usage follows.

Important sterilization facts

1. Effective sterilization requires that all instruments are pre-cleaned and inspected prior to sterilization by sealed, validated ultrasonic or automated washer process such as the Hydrim.
2. Instruments should always be sterilized prior to use or storage, and handled with gloves whether wrapped or unwrapped.
3. Statim autoclaves are all designed to sterilize contaminated instruments, whether hollow, porous, solid or mixed loads as needed for procedures in as short as 6 minutes unwrapped, 10 minutes wrapped.
4. Statim autoclaves are all suitable for use as a sole or primary means of sterilization; If a Statim is used for sterilization, then no other autoclave is needed.
5. Statim autoclaves can all sterilize and dry bulk loose instruments or cassette organizers unwrapped for decontaminated sub-sterile storage.
6. Statim autoclaves can all sterilize and dry as needed for procedures such instruments selected from decontaminated sub-sterile storage.
7. Statim models 2000 and larger can all be used to sterilize wrapped equipment in a sealed sterile barrier system such as an autoclave pouch to be stored until needed.
8. All autoclaves should be installed and handled to avoid contamination of their exteriors.
9. All autoclaves must be cleaned and maintained according to the manufacturer recommendations.
10. Statim cassettes can be cleaned and disinfected or sterilized if contaminated.
11. All autoclaves must be spore tested and otherwise validated according to the manufacturer and legal recommendations.
12. Statim autoclaves can all self-diagnose any fault in the sterilization cycle for easy maintenance.

Correcting the misunderstanding:

The STATIM section of “CLEANING, DISINFECTION & STERILIZATION” on Page 17 of the old 2005 APP Procedural Manual follows with comments:

Statim

Some piercing studios are also using steam-flushing pressure-pulse autoclaves (such as Statim autoclaves) for sterilization.

This next statement is from the previous 2002 procedural manual, and was misleading and biased, so please note the updates and corrections.

The sterilization process in this type of autoclave facilitates air removal and steam penetration and provides sufficient lethality to flash-sterilize either nonporous or porous items in the recommended exposure time of 3 minutes at 132° C to 135° C (270° F to 275° F).

The Statim is not a flash-cycle autoclave, it is defined as a steam-flush pressure-pulse autoclave suitable for hollow, solid, porous, wrapped or mixed loads including rubber and plastics.

Updated in 2005 to read:

The sterilization process in this type of autoclave facilitates air removal and steam penetration, and has an extremely short processing time. The steam-flush pressure-pulse autoclave is acceptable for sterilization in the piercing studio as long as certain guidelines are followed:

This biased statement from the 2002 manual was removed:

These autoclaves can be a great asset to the piercing facility, but are by no means required.

These true statements were removed:

The short cycle time can enable a piercer to sterilize all supplies and the jewelry for a procedure directly before the piercing.

The Statim “cassettes” give the piercer a contained sterile field from which to work.

This statement and the requirement of a second autoclave are both false and were removed:

However, this type of equipment is not adequate as a sole method of sterilization in a studio. A regular autoclave is also necessary.

Using a Statim autoclave for contaminated instruments does not require first processing instruments in a separate type of autoclave.

This was false and biased, and has been removed:

These units do not take the place of the steam sterilizer (autoclave) referenced above that is necessary to process all contaminated equipment and jewelry.

Statim autoclaves can take the place of another autoclave, and are designed to be safely used alone or as the primary form of sterilization in body art, as in many dental and surgical settings. The Statim sterilization cycles are proven more thorough than a familiar type N gravity displacement autoclave as mentioned above. Almost every type of item that can be sterilized in a class B autoclave can be sterilized in a Statim. Many types of items can be sterilized in the Statim because of the short cycle time and thorough air removal. See more detail in an article published in The Point, October 1999, issue 16. “Statim effective on all accounts” https://safepiercing.org/publications/the-point/back-issues/

This generalization applies to any autoclave, and was removed:

A Statim should be located in a “clean” area and not adjacent to the contaminated tools. It should be handled only with clean gloves.

This also applies to any autoclave based on the recommendations of CDC and many other organizations:

• Due to the high number of cycles run each day, these autoclaves must be spore tested weekly.

This is true but was removed:

Some new autoclaves come conveniently equipped with a printer that provides a sheet to document the sterilization cycle of each load.

Newer model autoclaves and washers do have printer or data ports for documentation of cycle validation. This is currently required in many areas for record keeping.

This applies to any autoclave and requires further explanation according to the manufacturers recommendations:

• Daily, weekly and monthly maintenance of steam, pressure-pulse autoclaves is required. This type of autoclave requires a more rigorous maintenance schedule than traditional autoclaves and a written log of all maintenance should be kept.

Any autoclave requires a more rigorous maintenance when more frequently used, and a maintenance log should be kept for all equipment: autoclaves, ultrasonics, washers, etc.

Each Statim comes with an easy to follow maintenance poster in English, French and Spanish, as well as a regularly updated operators manual, the most current are available at https://statim.us/info/downloads/

The following should not be included in the procedural manual, as different models have different cycles:

The Statim has three sterilization cycles, each designed to sterilize a specific type of instrument.

• Unwrapped cycle – 275 F for 3.5 minutes
• Wrapped cycle – 275 F for 10 minutes
• Rubber and plastic cycle – 250 F for 15 minutes

The SciCan approved list of materials that can commonly be sterilized or that might be damaged by steam sterilization is updated regularly, and mainly relates to equipment that is not used in body art:

The following can be sterilized in the Statim 2000: Nylon, polycarbonate (Lexan), polypropylene, PFTE (Teflon), acetal (Delrin) polysulfone (Udel), polyetherimide (Ultem) silicone rubber, and polyester.

The following cannot be sterilized in the Statim 2000 on any cycle: Polyethylene, ABS, styrene, cellulosics, PVC, acrylic (Plexiglas), PPO (Noryl) latex, neoprene, and similar materials.

Statim autoclaves can sterilize almost every material used for body art equipment, more than any other autoclave. The list of some but not all piercing related items that we have sterilized with proper results includes anything that can be sterilized in any other autoclave, such as metal equipment, even long small bore needles, hollow fine gauge jewelry, Tygon surgical tubing, precious metals and stones such as gold, silver, opals and pearls.

Don’t autoclave materials that could be damaged by heat such as horn, bone, fossilized ivory and wood. (As a side note, most tattoo equipment such as needle configurations, tubes, rubber and silicone grips, clip cords, some ink cups and trays, and even machines themselves can be sterilized in Statim autoclaves.)

When loading rubber and plastic instruments in the tray, leave a space between the instruments and the cassette walls. This ensures that steam reaches all surfaces, and will promote drying.

The Statim is suitable for the sterilization of dental and medical instruments designed to withstand steam sterilization. The Statim is not designed to sterilize liquids, cloth loads, biomedical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and / or damage to the autoclave. For more information about instrument suitability for steam sterilization, consult the manufacturers’ reprocessing instructions.

STATIM 2000/5000 Operator’s Manual 95-108027 Rev 5.0.

This is true:

If you are not sure, do not load items until you have checked with the manufacturer. Processing of these materials may lead to instrument or equipment damage.

This is false and should be removed, because Statim autoclaves can sterilize mixed loads:

Do not mix instrument types (i.e. plastics and unwrapped tools) in the same Statim load.

This can be included from the updated Statim operator’s manual for clarification:

The Statim is NOT intended for sterilizing textiles, liquids or biomedical waste. Instruments will remain sterile after a successful cycle until the cassette is disengaged from the unit. Unwrapped instruments, once exposed to ambient or external conditions, cannot be maintained in a sterile state. If sterile storage is desired, wrap the instruments to be sterilized in autoclave bags, according to the instrument manufacturer’s instructions, and then allow the wrapped cycle to run until the air-dry phase is complete. 

STATIM 2000/5000 Operator’s Manual 95-108027 Rev 5.0.

Small amounts of gauze or swabs can be sterilized, but the drying time may be extended or if too many are sterilized they may not dry completely.

Equipment should never be stored dirty, and round chamber autoclaves take too long to sterilize equipment on an as-needed basis, so most people working with those machines always package items once cleaned and dried. Items may also be sterilized unwrapped for storage to avoid spoilage and waste packaging. The decontaminated items may be organized in a clean sealed container safely and sterilized again when needed for a procedure. When working with a STATIM, it is such a fast sterilizer that you do not need to wrap anything, unless you want to.

Best Practice: Allow instruments (wrapped or unwrapped) to dry completely prior to handling. Wrapped or pouched instruments must not touch each other to promote drying and enable effective sterilization.

SciCan recommends the final user carefully choose the most appropriate sterilization cycle according to the recommendations of their leading infection control authorities and local regulatory guidelines / recommendations.  SciCan