World Standards Day at BMXnet

I am teaching Biomaterials standards for body art at the BMXnet conference in Essen, Germany this month for World Standards Day, the celebration of the birth of ISO October 14th, 1946. ASTM International will participate in the U.S. celebration of World Standards  Day, sponsored by the American National Standards Institute (ANSI) on Oct. 13 in Washington, D.C. This year’s … Read more

Questionable jewelry project

Have you seen any body jewelry that made you wonder whether or not it was safe to wear?
Please add any manufacturer to this list who makes body jewelry that does not seem to meet appropriate safety standards. Our work group is collecting a list of examples for body jewelry review. You can email pictures, too. Your comments will be used in our ongoing project to help inform the public and improve body jewelry quality worldwide.

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Working with a STATIM autoclave

Practical information about your STATIM sterilizer

Statim G4 & Classic 2000, 5000, 7000, & 900 (Stattoo)

These details and suggested practices should help you better understand and streamline your workflow for Body Artists

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Statim misconceptions

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

STATIM in the old APP Procedure Manual

Get the 2013 APP procedure manual
Get the 2013 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

 

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: 

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Anodizing Titanium and Niobium Body Jewelry

Sign up for the workshop with Brian Skellie

APP ConferenceOnline Anodizing is Awesome!”

Previously Presented at BMXnet, UKAPP, APP, LBP, 2º Congresso Educativo para Perfuradores Corporais da América do Sul – ATPB 2013 & more events

1) What is Anodizing?

Anodizing is a process where a coating is built up on the surface of certain metals (titanium, niobium, tantalum, aluminum, magnesium and zinc) by heating, with chemicals, or by electricity. In the case of titanium, the coating that is built up is a layer of titanium dioxide. Titanium dioxide, which is also known as titanium oxide, occurs naturally on the surface of titanium. Anodizing the surface of titanium can be done by the use of heat but the results are not easily controlled. The most common method is to form an oxide layer on the surface with the use of electricity. The way that this is done is with a variable power supply in which an electrode is connected to the positive side (anode), and one to the negative side (cathode).  Both are then submerged into a mildly conductive solution, thus completing the electrical circuit. The piece that is to be anodized is connected to the positive side, and that is why the process is called “anodizing”.

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Nonconforming Imported Titanium

Ti: what can slip by undetected

Ti: what can slip by undetected*En Español*

Some of my colleagues have already learned of this from my biomaterials presentations at APP 2010 and BMXnet conferences. This reflects upon imported jewelry, and the situations that can arise when quality controls are not normalized. So far, most of the response I get from US distributors of medical titanium alloys is for ELI material they only use domestic melts.

I’ve been talking with fellow ASTM committee members about international sourcing for F136 Ti in particular. They all only use domestic melts for ELI material from Perryman, ATI and Fort Wayne Metals for example . Therefore when companies in China or elsewhere want to make jewelry from F136 they either have to buy from a US or EU source that has a distributor in their area, eg Taiwan, or buy from an local mill melt, that quite possibly won’t meet FDA, BSI, ISO etc.

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