Brian W Skellie – Sharing ideas
What autoclaves are approved to sterilize hollow items by the FDA?
The standards for autoclaves that can process items with lumens are publicly accessible through the FDA site.
Standards are useful, and guidance based on evidence is often even more so.
Scope
This guidance provides recommendations regarding reuse instructions in labeling for reusable medical devices and the validation of the recommended reprocessing process in the instructions. The recommendations are applicable to the three device reprocessing situations below.
An interesting observation on safety issues raised in returning contaminated items such as jewelry to clients, as voiced by this medical professional’s concerns for their patients. It is evident that infection control measures should be carefully considered when previously worn jewelry or other contaminated personal items are to be returned to a customer.
I am an OR nurse and recently started a new job in a prestigious orthopedic hospital. At the request of a surgeon or patient when implants are removed we have been cleaning and flashing them and returning them to the patient in a plastic bag.
[NOTE: Flashing is an outdated term for sterilizing items unwrapped for immediate use]
https://brnskll.com/shares/flash-faq/
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.
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.
Please stop referring to body jewelry materials by overly vague and inappropriate standards. Using the term G23 for body jewelry materials is too superficial, and is not an implant standard.