chemistry

Optim 1 results in Environmental Surface Cleaning Investigation

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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 … Read more

FDA Antiseptic sterility report

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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?

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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 USA by ANSI. ASTM makes recommendations to ANSI. ANSI has typically voted in accordance with the recommendations of the ASTM.

ASTM F04 and ISO TC 150 have merged to facilitate the flow of information.

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.

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Titanium body jewelry

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Titanium!

What Titanium materials are best for body jewelry? My articles at https://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

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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.

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