I’ll be an educator and participant at BMXnet
This October for World Standards Day 2013.
standards
Stylets and needle safety
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.
OSHA regulations:
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:
Puncture resistant;
1910.1030(d)(2)(viii)(B)
Labeled or color-coded in accordance with this standard;
1910.1030(d)(2)(viii)(C)
Leakproof on the sides and bottom; and
1910.1030(d)(2)(viii)(D)
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
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.
APP Conference soon!
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
FDA guidance on sterilizers
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.
Processing Devices
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.
Returning jewelry(explants) to clients
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]
https://brnskll.com/shares/flash-faq/
Statim misconceptions
Did you read confusing STATIM information in the old APP Procedure Manual? (prior to 2013 edition)
STATIM in the old APP Procedure Manual
In the current 2013 edition of the APP Procedure Manual, I helped correct the previously confusing references to Statim autoclaves.
The current 2013 version of the guidelines refer to the Statim and the acceptable use of unwrapped sterilization methods.
Quotes from the 2013 APP procedure manual:
Sterilization Methods:
Benchtop Sterilization
- Steam under pressure (saturated steam/steam autoclave): 220-270 kpa pressure at 132° Centigrade (270° Fahrenheit) for 3-40 minutes depending on cycle.
- Steam autoclave process types
- Steam flush-pressure pulse (type S):
“Another design in steam sterilization is a steam flush-pressure pulsing process, which removes air rapidly by repeatedly alternating a steam flush and a pressure pulse above atmospheric pressure. Air is rapidly removed from the load as with the prevacuum sterilizer, but air leaks do not affect this process because the steam in the sterilizing chamber is always above atmospheric pressure. Typical sterilization temperatures and times are 132°C to 135°C with 3 to 4 minutes exposure time for porous loads and instruments.” The Statim is an example of a type S steam flush pressure pulse autoclave, which is acceptable for sterilization.
Aseptic Field
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:
Titanium standards: why not G23?
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.