Statim unwrapped sterilization is safely practiced worldwide by professional body piercers.
Outside the practice of medicine, jewelers are using the Statim for steam sterilization for ear and body piercing. The new, cleaned jewelry and other items needed for the procedure are selected for the customer and sterilized unwrapped in the Statim along with a class V or better chemical indicator. Records of the program type, contents and indicator results are kept with client information. Regular biological testing is performed by a third party, and or in house incubation.
The removable sterilization chamber itself provides for aseptic transport to the procedure area. The cassette chamber is opened immediately prior to use, and contents are removed with sterile gloves or an aseptic non touch technique.
To maintain asepsis, we are required to keep sterilized instruments in a sealed container until use. FDA and ISO refers to this a sterile barrier system. The Statim sterilization cassette is designed to perform as a reusable sterile barrier system for safe aseptic transport to the point of use for immediate use, without packaging waste.
The processed contents of the cassette chamber remain sterile indefinitely while engaged in the system.
The Statim can also be used to sterilize and dry hollow and porous loads of instruments and jewelry in packages using the wrapped program for preservation, as with any other autoclave designed for such wrapped loads.
Since 2007 EN ISO 11607 “Devices that are sterilised after being completely sealed or enclosed in at least the primary packaging” is harmonized with the medical device directives in Europe. It consists of 2 parts:
Sterilebarrier.org
- EN ISO 11607-1:2006 Packaging for terminally sterilized medical devices – Part 1: – Requirements for materials, sterile barrier systems and packaging systems
- .EN ISO 11607-2:2006 Packaging for terminally sterilized medical devices – Part 2: -Validation requirements for forming, sealing and assembly processes.
In this standard four key terms are defined. Sterile barrier system is defined as “the minimum packaging configuration that provides a microbial barrier and allows aseptic presentation of the product unit at the point of use”.
Sterilebarrier.org
FDA guidance on sterile barrier systems:
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=37006
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=32839
Approved by Association of Professional Piercers for use as a general purpose sterilizer for both unwrapped and wrapped loads.
Approved by NEHA Body Art Model Code
OCT 2019 section 9:
9.6 After being cleaned, all reusable instruments used for body art must be sterilized by one of the below methods:
- Contained in sterilization packaging and subsequently sterilized, with the date and cycle number noted on packaging or indicator strips (see Section 8.3).
- This information must match up with the sterilization log
- All sterilization packaging must have a color-changing chemical indicator.
- Unwrapped and subsequently sterilized, stored, and sterilized again immediately prior to use.
Afterward, sterilized tools must be stored in a cabinet, drawer, or tightly covered container reserved for the storage of sterilized instruments.
9.7 An autoclave, ultrasonic, and sterilization room or sterilization area is not be required if the body art establishment uses only presterilized disposable instruments, presterilized body art materials, and presterilized supplies.
9.8 All instruments used for body art procedures must remain stored a) in sterile packages and marked with the cycle number until just prior to a body art procedure or b) cleanly in containers and ready for sterilization immediately prior to the procedure.