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.
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.
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
I strongly suggest that my fellow piercers discontinue the use of any caps applied manually after piercing, especially two handed capping methods, which appear most likely to result in sharps injury.
OSHA considers recapping of needles unacceptable risk unless there are no alternatives. OSHA allows one handed capping, such as spearing the needle tip into a stopper on your work tray, or using a mechanical device such as a tweezer or clamp to apply the cap providing a safe distance from the sharp end. Even using a receiving tube can pose risks if the tube a small diameter or not sufficiently puncture resistant.
When piercing without a clamp, longer needles allow the tube to be held securely far away from the tip once it has passed through the body. I use 3 inch needles for all body piercings so that the sharp end can be cleared far enough from the pierced area and the tube can be secured close to the blunt base without the need to manipulate the sharp end.
The stylet approach is stable, and based on existing self-blunting sharps technology. Provided that the wire is the appropriate size, the sharp is secured and there is not a cutting edge to catch or stick. It will only move back in the needle with a similar level of force that would puncture through a cork or plastic tube. A telescoping metal tube with a reduction to catch the needle could be more secure, and I’m working on a demonstration of that as well.
This is a prototypical demonstration of the concept and a version of it can be made to fit into needles for our industry with a number of locking and blunting variations of the same strong passivated 304 steel as the needles.
Contaminated needles and other contaminated sharps shall not be bent, recapped, or removed except as noted in paragraphs (d)(2)(vii)(A) and (d)(2)(vii)(B) below. Shearing or breaking of contaminated needles is prohibited.
Contaminated needles and other contaminated sharps shall not be bent, recapped or removed unless the employer can demonstrate that no alternative is feasible or that such action is required by a specific medical or dental procedure.
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.
A gravity displacement (class N) steam sterilization process can not reliably remove gases from hollow or porous items, resulting in areas that do not get sterilized, and the failure of the load. They should not be used for body jewelry, needles, tattoo tubes or textiles.
395 CENTRAL SERVICE Volume 13 2005
Effects of Non-Condensable Gases (NCGs) on Steam Sterilisation Processes
steam sterilisation process
non-condensable gases (NCGs)
process challenge device (PCD)
The dangers posed by non-condensable gases (NCGs) in steam sterilisation processes have long been underestimated. Biological indicators, or the best chemical indicators on the market, do not signal the presence of a NCG content of up to 10% in a sterilisation process so long as there is mixing of steam and NCGs in the sterilisation chamber.