Health & Medical

Useful links for further reading on the subjects of instrument processing and sterilization

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For brevity, I suggest that you use all sterile disposable single use items, however if you are to reprocess used instruments:  Classes Come to the APP or the APT conference for classes on the subject Read the notes from one of the recent APP classes https://brnskll.com/shares/statim/ for a thorough description of some options, including accessible … Read more

World Standards Day at BMXnet

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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

Nonconforming Imported Titanium

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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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Skin antiseptics for piercing preparation

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Thoughts on options for skin cleaning prior to body art procedures.

If a product is not labeled for surgical preparation, it really doesn’t matter how good of a hand and body soap or cleanser it is. It would only be a really strong hand wash product, or possibly aftercare for our purposes.

Choose a product that has claims as a “surgical skin preparation” because “scrub” alone is only the first step as cleaning. A two step “scrub then paint” process is appropriate and advised by CDC.  That involves a solvent or detergent scrub to clean followed by the surgical antiseptic to kill microbes to an irreducible minimum level of contamination.

What does the evidence suggest that we use?

I have replaced this two step product in my procedure with a sterile version by Aplicare or Cardinal Health
  • I’ve been using FDA approved skin prep PVP-I, CHG or alcoholic CHG, or alcohol depending on the area, with a preference for sterile products, and keep looking for other safe, appropriate options.
  • For oral preparation, an antiseptic mouthwash containing CPC or dilute H2O2 and friction.

I’m still looking for a universal surgical preparation agent, and have not found anything on the market that is both proven and FDA approved other than PVP-I, CHG based products and alcohol. I don’t want to recommend anything unless it is tested and labeled for the purpose.

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Medical Device Regulation: US or EU

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Food, Drug and Cosmetic Act In the States, medical devices are regulated by the Food, Drug and Cosmetic Act. Then called the Food and Drug Act, it was the first piece of legislation to result from investigative journalism, namely a novel titled “The Jungle” by Upton Sinclair. Sinclair described the filthy conditions of pre-WWI Chicago stockyards … Read more