President’s Corner The Point 69

As President of the Association of Professional Piercers, I have a regular editorial column in The Point magazine. Issue 69 editorial Some of the most fundamental ideas about piercing are those that are most intriguing and still relevant to question. What materials are available now to make jewelry for initial healing and prolonged wear in the … Read morePresident’s Corner The Point 69

Somatic Piercing

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.

FDA Antiseptic sterility report

Sterility of Antiseptic Products:

FDA Investigates, Deliberates on Potential Recommendations

(Infection Control Today, PDF)
FDA investigates Antiseptics Sterility and potential recommendations_Page_01

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.

Safe steel for body jewelry?

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:

Neither are surgical implant materials. These are engineering specifications.
*AISI and SAE do not establish standards for biocompatibility.

me+.lMore 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.

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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.

Read moreSafe steel for body jewelry?

Stylets and needle safety

A quick sketch from a number of years ago
A quick sketch from a number of years ago

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.

1910.1030(d)(2)(vii)

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.

1910.1030(d)(2)(vii)(A)

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.

1910.1030(d)(2)(vii)(B)

Such bending, recapping or needle removal must be accomplished through the use of a mechanical device or a one-handed technique.

1910.1030(d)(2)(viii)

Immediately or as soon as possible after use, contaminated reusable sharps shall be placed in appropriate containers until properly reprocessed. These containers shall be:

1910.1030(d)(2)(viii)(A)

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 gauze 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

  1. Make 18g wire 3.5” for 14 gauge cannulae
  2. Get IS Needles to make prototypes for other sizes 18 gauge to 4 gauge
  3. Video and photograph to document
  4. 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

Demonstration:

  1. Stylet wire in place, prepared for a piercing.
  2. 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.
  3. Now blunted, the jewelry insertion is safer, and the connection is sturdy without need for a taper.
  4. 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 moreAPP Conference soon!

Pronouncing an open tone towards other forms of modification

I've been a member now since 1996
I’ve been a member now since 1996

Here is some progress to be proud of:

The Association of Professional Piercers is an international non-profit organization dedicated to the dissemination of vital health and safety information about body piercing to piercers, health care professionals, legislators, and the general public. Socially and legislatively, body piercing is situated within the greater body modification community. As a result, we recognize that our role extends beyond the discipline of body piercing. Our position on body art practices such as tattooing, cosmetic tattooing, branding, scarification, suspension, and other forms of body modification is as follows:

Read morePronouncing an open tone towards other forms of modification

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.

Read moreProcessing Devices

Effects of Non-Condensable Gases (NCGs) on Steam Sterilisation Processes

Read the full textEffects of Non Condensable Gases on Sterilization

Summary:

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.

REVIEW

395 CENTRAL SERVICE Volume 13 2005

ZENTRAL STERILISATION

Effects of Non-Condensable Gases (NCGs) on Steam Sterilisation Processes

U. Kaiser

Keywords

  • steam sterilisation process
  • non-condensable gases (NCGs)
  • process challenge device (PCD)

Introduction

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.

Read moreEffects of Non-Condensable Gases (NCGs) on Steam Sterilisation Processes

Disposable wrap

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.

Read moreDisposable wrap

Returning explants to patients

Do not buy or sell used body jewelry brnskll dot com

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.

[NOTEFlashing is an outdated term for sterilizing items unwrapped for immediate use]

Read moreReturning explants to patients

Working with a STATIM autoclave

Practical information about your STATIM sterilizer

Statim G4 & Classic 2000, 5000, 7000, & 900 (Stattoo)

These details and suggested practices should help you better understand and streamline your workflow

Contents

Read moreWorking with a STATIM autoclave

Medical Device Regulation: US or EU

Food, Drug and Cosmetic Act In the States, medical devices are regulated by the Food, Drug and Cosmetic Act. Then called the Food and Drug Act, it was the first piece of legislation to result from investigative journalism, namely a novel titled “The Jungle” by Upton Sinclair. Sinclair described the filthy conditions of pre-WWI Chicago stockyards … Read moreMedical Device Regulation: US or EU