One of the most commonly used materials for body jewelry, the ASTM F136 – Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) has been revised to F136-13 developed by Committee F04.12, ASTM BOS Volume13.01.
The new version changes are in section 9. Special Requirements
Sterility of Antiseptic Products:
FDA Investigates, Deliberates on Potential Recommendations
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.
SSI Prevention: Evidence-Based Practices Replace Lingering “Sacred Cows’ in the OR
This report explores the prevention of surgical site infections (SSIs) within the context of evidence-based practices replacing “sacred cows” in the operating room. It focuses on the critical practice of preoperative hair removal.
When Thomas Paine noted in 1776 that, “A long habit of not thinking a thing wrong, gives it a superficial appearance of being right,” he could not have imagined that he was describing a current tug-of-war that still exists in some operating rooms today.
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:
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.
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
Original article: Researchers Develop Off-Grid Sterilization with Solar Steam.
Copyright 2013 by Virgo Publishing https://www.infectioncontroltoday.com/
Posted on: 07/22/2013
Rice University graduate student Oara Neumann, left, and scientist Naomi Halas are co-authors of a new study about a highly efficient method of turning sunlight into heat. They expect their technology to have an initial impact as an ultra-small-scale system to treat human waste in developing nations without sewer systems or electricity. Photo by Jeff Fitlow/Rice University.
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.
Such bending, recapping or needle removal must be accomplished through the use of a mechanical device or a one-handed technique.
Immediately or as soon as possible after use, contaminated reusable sharps shall be placed in appropriate containers until properly reprocessed. These containers shall be:
Labeled or color-coded in accordance with this standard;
Leakproof on the sides and bottom; and
In accordance with the requirements set forth in paragraph (d)(4)(ii)(E) for reusable sharps.via Bloodborne pathogens. – 1910.1030.
Engineering Sharps Safety Workshop
Wednesday, October 22, 2003
Work practice controls
Demonstrated knowledge of and aptitude for appropriate aseptic techniques, and practices, and legal issues involved is required prior to handling sharp instruments.
Watch the sharp end
Maintain awareness and control of sharp implements at all times
Don’t point sharp things at your self, especially fingers
Aim away from client and piercer
- Example: Eyebrow begins by aiming away from eye towards hairline and away from the scalp and forehead.
- Example: Navel begins by aiming out from the top center of the navel opening, out and away from the stomach.
- Example: Tongue begins underneath the medial sulcus center and out away from upper lip and nose.
- Example: Male urethral piercing begins inside urethra and aim outward between the glans penis perineal seam.
Use nonwoven gauze or SMS to support tissue upon exit
- To decelerate leaving the exit wound and avoid fingers
- To reduce tissue tearing and aiming sharp accidents
Select sharp device of appropriate length
- Three inch sharp instruments (currently lancet pointed cannulae) allow for superior control and aim.
- Use the extra length to keep fingertips away from sharp end.
Use appropriate amount of pressure for gentle penetration and exit
- To reduce pressure is to reduce risk, error, and equipment failure
- Slow down to ensure correct angle of exit
Engineered safety controls
No available devices exist specifically engineered to effectively reduce sharp injury risk both safe and effective to satisfy the requirements of the job.
Possible Ideas to assess
- At least one half inch longer than the needle tube
- Use as pin coupling to aid insertion of internally threaded jewelry
- Friction fit/notch/tab for wire/tube to lock in place
- Make 18g wire 3.5” for 14 gauge cannulae
- Get IS Needles to make prototypes for other sizes 18 gauge to 4 gauge
- Video and photograph to document
- Assess at 10 procedures
Using smaller tubing or wire stock cut to size for the stylets.
- The rod is slightly curved in the middle, to provide enough friction to prevent it from sliding back once advanced.
- For a REALLY tight fit you can bend the wire twice in opposite directions and it will basically LOCK the wire into the needle and not allow it to twist or pull out at all.
- The ends are rounded with a cup burr and polished to avoid injury.
- The tail end can even be tapered or threaded to ensure a transfer with internally threaded jewelry.
- 26/28g fits NeoMetal 18g threadless and most other 18g internally threaded posts
- 20g fits NeoMetal 16g threadless and some other 16g and larger internally threaded posts
- 18g fits 14 and 12g internally threaded posts
- Telescoping tubing better suited for larger bore needles
Transfer pin (TP) connector size and jewelry ga:
- 26ga TP ? 19ga/18ga jewelry
- 22ga TP ? 16ga jewelry
- 20ga TP ? 14ga/12ga jewelry
- 19ga NB ? 14ga/12ga jewelry
- Stylet wire in place, prepared for a piercing.
- Once pierced through, the wire is inserted into the jewelry then advanced flush with the butt of needle, blunting the sharp and maintaining a connection for the jewelry transfer.
- Now blunted, the jewelry insertion is safer, and the connection is sturdy without need for a taper.
- Blunted needle can be disposed of safely in a sharps container immediately, without need to return it to the work surface.
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.
Read the full text: Effects of Non Condensable Gases on Sterilization
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.
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.
Can unused wrapped items be re-sterilized reusing the original wraps?
When unused sterile instrument sets are returned from the OR or patient floors our policy is to re-sterilize the sets. Since these were unopened we inspect the wrap to be sure there are no holes, replace the tapes and labeling and re-sterilize the item.
An interesting observation on safety issues raised in returning contaminated items such as jewelry to clients, as voiced by this medical professional’s concerns for their patients. It is evident that infection control measures should be carefully considered when previously worn jewelry or other contaminated personal items are to be returned to a customer.
Please regard the discussion in the comments below
I am an OR nurse and recently started a new job in a prestigious orthopedic hospital. At the request of a surgeon or patient when implants are removed we have been cleaning and flashing them and returning them to the patient in a plastic bag.
[NOTE: Flashing is an outdated term for sterilizing items unwrapped for immediate use]https://brnskll.com/shares/flash-faq/
Can we label sterilization packages with a Sharpie brand marker?
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.
Whoso would be a man must be a nonconformist. He who would gather immortal palms must not be hindered by the name of goodness, but must explore if it be goodness. Nothing is at last sacred but the integrity of your own mind. Absolve you to yourself, and you shall have the suffrage of the world.
— “Self Reliance,” Ralph Waldo Emerson
You may find this conversation interesting or useful as a colleague if you are on the fence about joining the Association of Professional Piercers.