Optim 1 results in Environmental Surface Cleaning Investigation

Dental Advisor and Dr John Molinari: Environmental Surface Cleaning Investigation Are your surfaces really clean? Dr John Molinari tests alcohol and QUAT surface cleaners, as well as OPTIM 1: One-Step Cleaner & Intermediate Disinfectant.OPTIM 1 was the only disinfectant wipe to successfully clean and remove proteins with a single application. Buy direct from Brian‘s Statim.us … Read moreOptim 1 results in Environmental Surface Cleaning Investigation

FDA Antiseptic sterility report

Sterility of Antiseptic Products:

FDA Investigates, Deliberates on Potential Recommendations

(Infection Control Today, PDF)
FDA investigates Antiseptics Sterility and potential recommendations_Page_01

In light of a number of high-profile recalls of contaminated alcohol prep products in the last several years, the Food and Drug Administration (FDA) is currently weighing whether or not to require sterility of patient skin prep products, specifically items such as alcohol prep pads used for injections, but it is not ruling out other surgical prep products.

On Dec. 12, 2012, the FDA held a hearing to receive expert testimony and public comment on how to address microbial contamination of these patient preoperative skin preparation drug products. It is a step in the ongoing investigational process that the agency is undertaking to determine issues related to sterility impacted by manufacturing processes.

An FDA spokesperson says that the panel members and FDA’s working group have received the submissions from the hearing and have been deliberating. FDA’s working group will be ready to make new recommendations in the coming months. The spokesperson adds that FDA’s working group has been soliciting clinician feedback from the FDA’s federal partners and other public health organizations, and that the agency will be ready to make new recommendations in the coming months.

Currently, patient preoperative skin preparations are not required to be sterile, since bacteria can contaminate these products at the time of manufacture or during product use. But because contaminated patient preoperative skin preparations have been associated with clinical infections and adverse outcomes, the FDA is exploring certain scientific and product-use issues related to patient preoperative skin preparations.

Patient preoperative skin preparations are over-the-counter (OTC) topical antiseptic drug products used to reduce the number of bacteria on the skin prior to medical procedures or injections. Although they are marketed predominantly to healthcare facilities, the use of these products extends beyond the healthcare facility setting.

Safe steel for body jewelry?

 

A forum participant asked:

please discuss 316l and implant grade 316lvm grade stainless steel

They added a link to an essay titled
Body Jewelry Materials. Understanding Implant Grade Surgical Steel

The easy answer:

Neither are surgical implant materials. These are engineering specifications.
*AISI and SAE do not establish standards for biocompatibility.

me+.lMore detail: ASTM ? ANSI ? ISO

One thing to know is that ISO and ASTM are both international organizations for standards, but ISO is restricted to members of national standards bodies such as ANSI. Individuals or companies cannot become ISO members.

ASTM members are comprised of representatives of both government and stakeholders in related business, such as me. I joined ASTM in the mid 1990’s to represent the needs and learn more about the responsibilities of the body piercing business, and have been able to attend conferences, contribute my research based evaluations and vote for standards that affect us as body artists.

ISO voting is done for the US by ANSI. ASTM makes recommendations to ANSI. ANSI has typically voted in accordance with the recommendations of the ASTM.

The 2013 update that my ASTM F04.12 committee just voted to approve for the most common steel alloy for surgical implant is also most the commonly used for body jewelry, F138.

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ASTM F138-13a specifies chemical, mechanical and metallurgical refinements for 316 series steel alloys for surgical implant. It doesn’t really matter if the material is 316L, 316LVM, etc. The material is only acceptable for body jewelry when specified for human surgical implant and validated for this purpose to a peer reviewed scientific standard such as ASTM or ISO provides. AISI/SAE

As an aside: I don’t personally use steel alloy jewelry for initial piercings. I prefer pure unalloyed metals or simpler alloys with a greater margin of safety and less reactivity in the body.

Read moreSafe steel for body jewelry?

Titanium body jewelry

Titanium!

What Titanium materials are best for body jewelry? My articles at http://jewelry.piercing.org/ and https://brnskll.com/shares/titanium-standards-why-not-g23/ explain that the two most effective Titanium standards are alloyed ASTM F136 and pure ASTM F67, the most common being the former as it is stronger, harder and easier to polish. Both are used for permanent surgical implants.

Sharpies for labeling

Can we label sterilization packages with a Sharpie brand marker?

Question

Our staff used to label all of our cardiovascular sets and supplies with a red Sharpie brand permanent marker and we would use a black Sharpie for all other items. This provided a quick and easy method to visually identify these special critical items. The labeling was restricted to the autoclave tape on the outside of wrapped packages and the film side of peel pouches.

Read moreSharpies for labeling

OPTIM 33TB protocol

OPTIM 33 TB is a One-Step Cleaner Disinfectant with no hazardous ingredients.

For the modern body artist, OPTIM offers a number of advantages for cleaning and thorough and safe disinfection in one minute for:

  • Temperature sensitive Body jewelry materials for healed piercings
    Such as wood, horn, stone, bone, certain polymers
    Break the chain of infection for MRSA, VRE, HCV, HBV, HIV, Mycobacteria and other pathogens for non-critical items that can not withstand the heat of an autoclave.
  • Tattoo machine frames, coils, springs, clip cords
  • Mayo trays and other work surfaces
  • Exam tables, massage tables, tattoo chairs
  • Display cases
  • Furniture in your waiting area including fabric covered items.
  • Suspension rigs and equipment

Read moreOPTIM 33TB protocol

Learn about piercing bumps

Have you noticed some sort of raised bump at the exit point of your piercing?

This could be due to a number of sources of irritation or infection that can result in overgrowth of scar tissue when the healing process is disrupted. There may be a single, simple solution though it commonly may take a combination of protective measures to help this turn out well.

Read moreLearn about piercing bumps

Rubber Gloves: “Born” – and Now Banished – At Johns Hopkins – 01/14/2008

old laytex glove

William Stewart Halsted, The Johns Hopkins Hospital’s first surgeon in chief, is widely credited as the first to develop and introduce rubber surgical gloves in the United States. That was in 1894, five years after the institution opened.

Now, in an effort to make medical care safer for patients and health care workers, The Johns Hopkins Hospital has become the first major medical institution to become “latex safe” by ending all use of latex gloves and almost all medical latex products.

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 moreWorld Standards Day at BMXnet

Anodizing Titanium and Niobium Body Jewelry

Sign up for the workshop with Brian Skellie

APP Conference / Online Anodizing is Awesome!”

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

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.

Read moreAnodizing Titanium and Niobium Body Jewelry

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.

Read moreNonconforming Imported Titanium

Skin antiseptics for piercing preparation

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.

Read moreSkin antiseptics for piercing preparation