As President of the Association of Professional Piercers, I have a regular editorial column in The Point magazine. Issue 73 editorial Please enjoy my article on asepsis in the new issue of The Point by the Association of Professional Piercers
In an organization comprised of exceptional participants who have gladly offered countless hours of work and traveled across the planet to share their ardor for safe body adornment, it is the privilege and great pleasure of the President each year to shine a light upon one who has exemplified our mission. To offer a special award in esteem of the outstanding contributions of this volunteer is equally to recognize the potential we all have to achieve the goals set forth by our Association.
Sir Arthur C. Clarke’s Third Law states: “Any sufficiently advanced technology is indistinguishable from magic.” Had I been at Arthur’s elbow as he wrote those words, I’d have suggested adding: “to the uninformed observer.”
Nick completed his Masters degree at the Ohio State University in Somatic and Cultural Studies in 2002. His final project, “Somatic Piercing: The Art and Ritual of Body Piercing” portrays his experiences in body rituals as well as illuminates other piercers’ views on the matter.
You are a pierced woman, he said, looking into my eyes and smiling. I lifted my head so that I could take a peek: Brian Skellie, my piercer, had successfully stabbed me with a needle so I could wear a silver ring with a hematite stone on my navel.
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.
Neither are surgical implant materials. These are engineering specifications. *AISI and SAE do not establish standards for biocompatibility.
More 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.
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.
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.
My company Piercers.com and I are pleased to sponsor a Statim autoclave for sterilization at this year’s event again! I will be there to educate and to learn, as well as to sell infection control equipment and anodizers. The Statim 2000 G4 is on the way, and the new Optim 33TB Blue version for surface disinfection as well. — at Unperfekthaus for the BMXnet … Read more Sponsorship for BMXnet 2013 infection control
CONFERENCE IS ALMOST UPON US! THE CONFERENCE ADVANCED (ONLINE) REGISTRATION WILL SHUT DOWN AT MIDNIGHT ON MAY 17TH, PST ANY CHANGES TO YOUR REGISTRATION SHOULD BE MADE BEFORE THEN (OR WILL HAVE TO WAIT UNTIL WE ARE ONSITE IN LAS VEGAS) BANQUET DINNER SPONSORED BY INDUSTRIAL STRENGTH BODY JEWELRY; ANATOMETAL, INC.; LEROI, INC.; AND KAOS SOFTWEAR THURSDAY JUNE … Read more APP Conference soon!
Standards are useful, and guidance based on evidence is often even more so.
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.
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.