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.
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.
Immediately or as soon as possible after use, contaminated reusable sharps shall be placed in appropriate containers until properly reprocessed. These containers shall be:
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
Stylet wire
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
Test
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.
What fits?
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
Demonstration:
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.
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
What autoclaves are approved to sterilize hollow items by the FDA?
The standards for autoclaves that can process items with lumens are publicly accessible through the FDA site.
Standards are useful, and guidance based on evidence is often even more so.
Scope
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.
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
Question
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]
The actual procedure surface is referred to as an “aseptic field,” and is a sterilized surface that becomes exposed to air contact only at the beginning of the piercing procedure. The aseptic field used by most piercers is the sterile inside surface of a freshly opened large autoclave or sterile glove package, Statim cassette, rigid sterilization container, or sterilized tray. Once the package is opened, sterile tools, needles, jewelry, and disposables can be dropped onto the inside surface for use. The exterior of sterilized packages such as those containing the jewelry should not touch the aseptic field; the contents should be carefully dispensed onto it.
DISPOSABLE SUPPLIES
To minimize the risk of cross-contamination and to ensure that piercing room procedures are as clean as possible, many components of the tray setup must be disposable. Unless supplies are purchased presterilized* or will be sterilized in an autoclave immediately prior to the procedure, all disposables must be individually packaged in autoclave bags, sterilized, and remain intact in their pouches stored in enclosed, nonporous drawers or containers until use. Disposable materials that must be sterilized include: marking implements, piercing needles, corks or synthetic stoppers, elastic bands, swabs, and gauze.
* This includes only FDA-cleared items that are commercially sterilized according to accepted medical standards. The supplier must make documentation of appropriate sterilization available.
The following is to clarify the inconsistencies in the previous editions:
Please stop referring to body jewelry materials by overly vague and inappropriate standards. Using the term G23 for body jewelry materials is too superficial, and is not an implant standard.