Category Sterilization

Point 74: President’s Corner – Brian Skellie

Brian Skellie headshot at 2014 APP conference by April BerardiBrian Skellie
APP President

Technology for infection prevention:

Why the introduction of more technological advances help to reduce cross contamination risks

The benefits of thousands of years of advancements in infection control are applied and built upon daily: a brief history of sterilization.

Chamberland’s Autoclave (1880), the first steam sterilizer patterned after Papin’s digester (1680), the first pressure cooker.

Asepsis is the most effective technological advancement for a purposeful reduction of microbes to an irreducible minimum. This begins with policy and training, and follows through with checklists, review, and reminders for implementation.

Primum non nocere = above all else we should do no harm.

Antonj van Leeuwenhoek’s microscope (1683)
Antonj van Leeuwenhoek’s microscope (1683)

Physics was the first step in decontamination, using thermal energy: fire and the effects of the sun. Advances have been made in E-beam and radiation, both ionizing and non-ionizing, for sterilization. As a result, new equipment and supplies are now available providing an almost infinite sterilization shelf life. Part of what was found useful from the sun, apart from drying, was the power of short wavelength ultraviolet light to disrupt the DNA of cells. This has been harnessed for disinfection of exposed environmental surfaces, air, and water, but this form of sterilization is not appropriate for initial piercing jewelry. Further study of properties of the sun have resulted in functional plasma etching and cleaning processes and H2O2 gas plasma sterilization. At some point, gadgets for disinfection of procedure rooms such as UV-C robots and hydrogen peroxide (H2O2) vapor foggers may have an application in scale for our trade.

Joseph Lister’s antiseptic sprayer (1867)
Joseph Lister’s antiseptic sprayer (1867)

Chemistry was the next big step in the fight against preventable iatrogenic infection with germicides, from chlorine solutions and carbolic acid to EO gas. Recognizing the potential for stopping infection transmission during procedures by thoroughly cleaning the worker’s hands and the subject site with a germicidal product was an enormous step that has become part of our established thinking. Materials themselves can be used to leverage the natural properties of copper (Cu+) and silver (Ag) that make touch and transfer surfaces inhospitable to microbes, and other embedded compounds have been developed for similar purposes. Some even work with nanotech surface treatments.

Instrument cleaning technology is constantly improving on the basic two fronts of physical action and chemical reaction. Advancements in products safe for the worker and environmentally friendly have brought forth alkaline or enzymatic detergent, or peracetic acid options.

surgical tools from the late 1800s
outmoded surgical equipment from the late 1800s

Consumables have long been a source of worker and client protection and potential oversight. Gloves and other Personal Protective Equipment (PPE) do create a barrier when used correctly, but do not take the place of adequate hand hygiene and application of asepsis. For further protection against exposure to environmental hazards, wearable vapor detectors can be used to alert the worker of chemical hazards from cleaning and disinfecting products. Essential detectors for sterilization or cleaning parameters should be used for validation of each process. Test Soils with protein detection for washing instruments, even manual cleaning should be tested, and Chemical and regular Biological Indicators for sterilization loads.

Cleaning appliances have made validation tests easier and more repeatable, with the availability of small automated instrument washers and medical and dental ultrasonic cleaners. Our last line of defense against cross contamination comes from our environmental air quality, which can be improved with air cleaners equipped with HEPA filtration and UV, thermal or plasma disinfection, and floor scrubbers to vacuum up the dust, wash and dry the floor automatically and robotically.

The health and safety of our clientele and personnel depend on adequate sterilization and disinfection. The advancements listed have changed the way we do our jobs and protect ourselves from risk. As we look towards the future it is impossible to know the impact further technological advancements will have, but they will undoubtedly continue to change how we practice our trade.

Point 73: A Parent’s Guide to Safe Piercing for Children’s Ears

Child's ear piercing performed by Becky Dill at Cold Steel Piercing Photo by Danielle Greenwood
Child’s ear piercing performed by Becky Dill at Cold Steel Piercing
Photo by Danielle Greenwood

Proper technique, sterility, piercing placement, aftercare, jewelry material, and style are among the many important factors that go into a successful piercing. First, let’s look at the technique itself. Piercing guns use pressure to force a pointed object, the jewelry, through the skin. While these mechanisms may seem like a quick, easy, and convenient way of creating holes, they can have major drawbacks in terms of tissue damage, inappropriate jewelry designs, and sterility. These concerns have been documented in medical literature over the years and provide proof of these concerns.

Due to the dull nature of the jewelry used in piercing guns, more damage is caused to the tissue when compared to piercings done with quality piercing needles. The effects are similar to a blunt force trauma including significant pain, swelling, scarring, and an increased potential for complications. The gun then pinches the back of the jewelry in place snugly against the skin, allowing no way for the new wound to breathe and heal properly. The customer is often told to turn the jewelry, which only further pushes growing bacteria into the wound, increasing the risk of infection and delaying the healing process considerably.

Additionally, it has not been documented how often piercing guns malfunction. Some operators report that the earring adapter that holds the jewelry often will not release the earring, requiring its removal with pliers. These pliers, which contact contaminated jewelry immediately after it has passed through the client’s tissue, may be reused on multiple customers without full sterilization. Few, if any, gun piercing establishments possess the expensive sterilization equipment necessary for such a process. Occasionally the intense pressure and speed of the gun’s spring-loaded mechanism is not sufficient to force the blunt jewelry through the flesh. In these cases, the earring stud may become lodged part way through the client’s ear. The gun operator, who may not be trained to deal with this possibility, has two options. S/he can remove the jewelry and repierce the ear, risking contamination of the gun and surrounding environment by blood flow from the original wound. Alternately, the operator can attempt to manually force the stud through the client’s flesh, causing excessive trauma to the client and risking a needlestick-type injury for the operator.

Diagram showing the differences in the "cutting edge" of ear piercing studs used in piercing guns. The bottom silhouette is a single use hollow needle.
Diagram showing the differences in the “cutting edge” of ear piercing studs used in piercing guns. The bottom silhouette is a single use hollow needle. Reference: Ear piercing techniques and their effect on cartilage, a histologic study

There may also be a greater likelihood of more serious complications when cartilage or structural tissue such as noses are pierced using a piercing gun. This type of tissue (cartilage) has less blood supply than earlobe tissue and therefore a correspondingly longer healing time; this means that infection in this area can be more likely and more destructive.

Another common concern is sterilization and asepsis. Any kind of procedure which involves contact with blood or bodily fluids requires strict adherence to crosscontamination prevention.

As is now well known, the hepatitis virus can live for extended periods of time on inanimate surfaces, and could be harbored within a reusable piercing gun for several weeks or more. Hepatitis and common staph infections, which could be found on such surfaces, constitute a serious public health threat if they are introduced into even one reusable piercing gun. Considering the dozens of clients whose initial piercings may have direct contact with a single gun in one day, this is a cause for serious concern. Babies, young children, and others with immature or compromised immune systems may be at a higher risk.

Some will argue that the piercing gun never comes in contact directly with a customer’s skin, or is sterilized or disposed of after a single use. This might be true, but the gun operator’s hands do—if they touch the customer’s skin and then touch the gun, the gun is now contaminated. When the gun drives the stud through the flesh— whether or not the skin starts to bleed – there is no way of knowing whether or not tiny particles of blood have been dispersed into the air contaminating everything around it. Piercing guns are usually made with plastic and cannot be adequately cleaned and sterilized for reuse. A quick wipe with an antiseptic pad is not effective in removing disease-carrying blood. Although many manufacturers now make disposable options, these do not negate concerns regarding possible damage to tissue, jewlery quality, or inadequate staff training.

The Association of Professional Piercers does not support the use of piercing guns because the reusable versions can’t be sterilized using APP approved equipment, such as an autoclave. Without proper sterilization, the risk of spreading diseases such as Hepatitis and staph infections increase.

The Bottom Line: Professional piercers use a more modern approach to piercing that’s less traumatic, cleaner, and more likely to result in a smooth healing process.

The Point Issue 73 - Professionals dont use piercing guns

Point 73: Children’s Ear Piercing – Kendra Jane B

Kendra Jane BerndtThe Point Issue 73 - Professionals dont use piercing guns
April Thomas
Julie Taylor

Most of us receive at least one phone a week— sometimes even a day—from a concerned parent wanting to know the best option to pierce their child’s lobes. We are frequently seeing that the safe piercing message is reaching the masses. However, we are still seeing many piercings done with piercing guns. Whether it is because they are unable to find the information in the places they are visiting or because they are intimidated to visit their local tattoo or piercing studio to have their questions answered, parents are using less than favorable methods to pierce their children’s lobes. Perhaps they are leery of taking their six or seven year old daughter or son into said studio because of things that have nothing to do with piercing, such as the music, a worry of profanity or inappropriate behaviour, etc.

Within this article, we have presented similar information in two forms. The first is intended for an audience with a more complete understanding of piercing industry jargon and intricacies. The second presentation has been simplified with our clients in mind. Our intention was to provide something that you are able to print and send home. You can choose which presentation is most appropriate for your target audience. Either way, we encourage you to share the link to this article and repost on every site that questions the safest way to pierce children’s ears.

What is the APP’s position on ear piercing guns?
It is the position of the Association of Professional Piercers that only sterile disposable equipment is suitable for body piercing, and that only materials which are certified as safe for internal implant should be placed inside a fresh or unhealed piercing. We consider any procedure that places vulnerable tissue in contact with either non-sterile equipment or jewelry that is not considered medically safe for long-term internal wear to be unsafe. Such procedures place the health of recipients at an unacceptable risk. For this reason, APP Members may not use reusable ear piercing guns for any type of piercing procedure.

Reusable ear piercing guns can put clients in direct contact with the blood and bodily fluids of previous clients.
Although they can become contaminated with bloodborne pathogens dozens of times in one day, ear piercing guns are often not sanitized in a medically recognized way. Plastic ear piercing guns cannot be autoclave sterilized and may not be sufficiently cleaned between use on multiple clients. Even if the antiseptic wipes used were able to kill all pathogens on contact, simply wiping the external surfaces of the gun with isopropyl alcohol or other antiseptics does not kill pathogens within the working parts of the gun. Blood from one client can become aerosolized, becoming airborne in microscopic particles, and contaminate the inside components of the gun. The next client’s tissue and jewelry may come into contact with these contaminated surfaces. This creates the possibility of transmitting bloodborne disease-causing microorganisms through such ear piercing, as many medical studies report.

The Point Issue 73 - childrens ear piercing Frankie PistoneAs is now well known, the Hepatitis virus can live for extended periods of time on inanimate surfaces, and could be harbored within a piercing gun for several weeks or more. Hepatitis and common staph infections, which could be found on such surfaces, constitute a serious public health threat if they are introduced into even one reusable piercing gun. Considering the dozens of clients whose initial piercings may have direct contact with a single gun in one day, this is a cause for serious concern. Babies, young children, and others with immature or compromised immune systems may be at higher risk.

Additionally, it has not been documented how often piercing guns malfunction. Some operators report that the earring adapter that holds the jewelry will often not release the earring, requiring its removal with pliers. These pliers, which contact contaminated jewelry immediately after it has passed through the client’s tissue, may be reused on multiple customers without full sterilization. Few, if any, gun piercing establishments possess the expensive sterilization equipment (steam autoclave or chemclave) necessary for such a process.

Piercing guns can cause significant tissue damage.
Though slightly pointy in appearance, most ear piercing studs are quite dull. Therefore, these instruments use excessive pressure over a larger surface area in order to force the metal shaft through the skin. The effect on the body is more like a crush injury than a piercing and causes similar tissue damage. Medically, this is referred to as “blunt force trauma.” At the least, it can result in significant pain and swelling for the client, but it also has the potential to cause scarring and increased incidence of auricular chondritis, a severe tissue disfigurement.

Occasionally the intense pressure and speed of the gun’s spring-loaded mechanism is not sufficient to force the blunt jewelry through the flesh. In these cases, the earring stud may become lodged part way through the client’s ear. The gun operator, who may not be trained to deal with this possibility, has two options. S/he can remove the jewelry and repierce the ear, risking contamination of the gun and surrounding environment with blood flow from the original wound. Alternately, the operator can attempt to manually force the stud through the client’s flesh, causing excessive trauma to the client and risking a needlestick-type injury for the operator. How often such gun malfunction occurs has not been documented by manufacturers, but some gun operators report that it is frequent.

When used on structural tissue such as cartilage, more serious complications such as auricular chondritis, shattered cartilage, and excessive scarring are common. Gun piercings can result in the separation of subcutaneous fascia from cartilage tissue, creating spaces in which fluids collect. This can lead to both temporary swelling and permanent lumps of tissue at or near the piercing site. These range from mildly annoying to grossly disfiguring, and some require surgery to correct. Incidence can be minimized by having the piercing performed with a sharp surgical needle, which slides smoothly through the tissue and causes less tissue separation. A trained piercer will also use a post-piercing pressure technique that minimizes hypertrophic scar formation.

Cartilage has less blood flow than lobe tissue and a correspondingly longer healing time. Therefore infections in this area are much more common and can be much more destructive. The use of non-sterile piercing equipment and insufficient aftercare has been associated with increased incidence of auricular chondritis, a severe and disfiguring infection in cartilage tissue. This can result in deformity and collapse of structural ear tissue, requiring antibiotic therapy and extensive reconstructive surgery to correct. Again, medical literature has documented many such cases and is available on request.

The Point Issue 73 - childrens ear piercing - Courtney MaxwellThe length and design of gun studs is inappropriate for healing piercings.
Ear piercing studs are too short for some earlobes and most cartilage. Initially, the pressure of the gun’s mechanism is sufficient to force the pieces to lock over the tissue. However, once they are locked on, the compressed tissue cannot return to its normal state. This constriction causes further irritation. At the least, the diminished air and blood circulation in the compressed tissue can lead to prolonged healing, minor complications, and scarring. More disturbingly, the pressure of such tight jewelry can result in additional swelling and impaction. Both piercers and medical personnel have seen stud gun jewelry completely embedded in ear lobes and cartilage (as well as navels, nostrils and lips), even when pierced “properly” with a gun. This may require the jewelry to be cut out surgically, particularly in cases where one or both sides of the gun stud have disappeared completely beneath the surface of the skin. Such risk is minimal when jewelry is custom fit to the anatomy of the client, and installed with a needle piercing technique which creates less trauma and swelling. Custom fit jewelry should allow sufficient room for swelling and can be downsized to fit snugly on healed tissue.

Jewelry that fits too closely also increases the risk of infection because it does not allow for thorough cleaning. During normal healing, body fluids containing cellular discharge and other products of the healing process are excreted from the piercing. But with inappropriate jewelry, they can become trapped around the fistula. The fluid coagulates, becoming sticky and trapping bacteria against the skin. Unless thoroughly and frequently removed, this becomes an invitation for secondary infection. The design of the “butterfly” clasp of most gun studs can exacerbate this problem. Again, these consequences can be avoided with implant-grade jewelry that is designed for ease of cleaning and long-term wear.

Not all piercing jewelry is safe for prolonged wear.
Most ear piercing studs are not made of materials certified by the FDA, ASTM, or ISO as safe for long term implant in the human body. Even when coated in nontoxic gold plating, materials from underlying alloys can leach into human tissue through corrosion, scratches and surface defects, causing cytotoxicity and allergic reaction. Since manufacturing a durable corrosionand defect-free coating for such studs is extremely difficult, medical literature considers only implant grade steel (ASTM F138) and titanium (ASTM F67 and ASTM F136) to be appropriate for piercing jewelry composition. Studs made of any other materials, including nonimplant grade steel (steel not batch certified as ASTM F138), should not be used, regardless of the presence of surface plating.

Misuse of ear piercing guns is extremely common.
Even though many manufacturers’ instructions and local regulations prohibit it, some gun operators do not stop at piercing only the lobes, and may pierce ear cartilage, nostrils, navels, eyebrows, tongues and other body parts with the ear stud guns. This is absolutely inappropriate and very dangerous.

Although gun piercing establishments usually train their operators, this training is not standardized and may amount to merely viewing a video, reading an instruction booklet, and/or practicing on cosmetic sponges or other employees. Allegations have been made that some establishments do not inform their employees of the serious risks involved in both performing and receiving gun piercings, and do not instruct staff on how to deal with situations such as client medical complications or gun malfunction. Indeed, surveys conducted in jewelry stores, beauty parlors, and mall kiosks in England and the US revealed that many employees had little knowledge of risks or risk management related to their procedure.

Considering that a large proportion of gun operators’ clientele are minors or young adults, it is not surprising that few gun piercing complications are reported to medical personnel. Many clients may have been pierced without the knowledge or consent of parents or guardians who provide healthcare access. Therefore, the majority of the infections, scarring and minor complications may go unreported and untreated. Furthermore, because of the ease of acquiring a gun piercing and the lack of awareness of risk, many consumers fail to associate their negative experiences with the piercing gun itself. They believe that, since it is quicker and easier to acquire a gun piercing than a manicure, gun piercing must be inherently risk-free. Often it is only when complications prove so severe as to require immediate medical attention that the connection is made and gun stud complications get reported to medical personnel.

Despite these pronounced risks associated with gun piercing, most areas allow gun operators to perform piercings without supervision. Recent legislation has begun to prohibit the use of guns on ear cartilage and other non-lobe locations, and the state of New Hampshire has made all non-sterile equipment illegal, but these changes are not yet nationwide. It is our hope that, with accurate and adequate information, consumers and the legislatures will understand and therefore reject the use of gun piercing in the interests of the public health.

References Cited:

Pediatric Emergency Care. 1999 June 15(3): 189-92.
Ear-piercing techniques as a cause of auricular chondritis.
More DR, Seidel JS, Bryan PA.

International Journal of Pediatric Otorhinolaryngology. 1990 March 19(1): 73-6.
Embedded earrings: a complication of the ear-piercing gun.
Muntz HR, Pa-C DJ, Asher BF.

Plastic and Reconstructive Surgery. 2003 February 111(2): 891-7; discussion 898.
Ear reconstruction after auricular chondritis secondary to ear piercing.
Margulis A, Bauer BS, Alizadeh K.

Contact Dermatitis. 1984 Jan; 10(1): 39-41.
Nickel release from ear piercing kits and earrings.
Fischer T, Fregert S, Gruvberger B, Rystedt I.

British Journal of Plastic Surgery. 2002 April 55(3): 194-7.
Piercing the upper ear: a simple infection, a difficult reconstruction.
Cicchetti S, Skillman J, Gault DT.

Scottish Medical Journal. 2001 February 46(1): 9-10.
The risks of ear piercing in children.
Macgregor DM.

American Journal of Infection Control. 2001 August 29(4): 271-4.
Body piercing as a risk factor for viral hepatitis: an integrative research review.
Hayes MO, Harkness GA.

Journal Laryngology and Otology. 2001 July 115(7): 519-21.
Ear deformity in children following high ear-piercing: current practice, consent issues and legislation.
Jervis PN, Clifton NJ, Woolford TJ.

Cutis. 1994 February 53(2): 82.
Embedded earrings.
Cohen HA, Nussinovitch M, Straussberg R.

Scandinavian Journal of Rheumatology. 2001; 30(5): 311.
Does mechanical insult to cartilage trigger relapsing polychondritis?
Alissa H, Kadanoff R, Adams E.

British Journal of Dermatology. 2002 April 146(4): 636-42.
Decrease in nickel sensitization in a Danish schoolgirl population with ears pierced after implementation of a nickel- exposure regulation.
Jensen CS, Lisby S, Baadsgaard O, Volund A, Menne T.

Toxicology In Vitro. 2000 Dec 14(6): 497-504.
Cytotoxicity due to corrosion of ear piercing studs.
Rogero SO, Higa OZ, Saiki M, Correa OV, Costa I.

Journal of the American Medical Association. 1974 March 11; 227(10): 1165.
Ear piercing and hepatitis. Nonsterile instruments for ear piercing and the subsequent onset of viral hepatitis.
Johnson CJ, Anderson H, Spearman J, Madson J.

Journal of the American Medical Association. 1969 March 24; 207(12): 2285.
Hepatitis from ear piercing.
Van Sciver AE.

Journal of the American Medical Association. 291.8 (2004): 981-985.
Outbreak of Pseudomonas aeruginosa infections caused by commercial piercing of upper ear cartilage.
Keene, William E, Amy C Markum, and Mansour Samadpour.

Point #73: President’s Corner – Brian Skellie

Brian Skellie headshot at 2014 APP conference by April BerardiBrian Skellie
APP President

The APP is always going to be a work in progress, since standards are ever changing with new evidence. Lauded among the guiding principles we maintain as safety standards for our membership is the practice of asepsis. We refer to many procedural acts as practice, as they are rarely ever perfect and require a profound theoretical understanding coupled with regular exercise and critical self observation for improvement. Asepsis requires the right combination of cleaning and sterilization with touching and not touching manual, instrumental and environmental surfaces for infection prevention and control (IPC).

We apply two types of asepsis to reduce or eliminate infection transmission: medical asepsis which emphasizes protection for the client and their environment is more concerned with cleanliness and prevention of the spread of the clients own organisms to other clients, while surgical asepsis which focuses on sterilization and maintaining sterility for items that will be introduced to a wound or piercing cavity or penetrate the skin, thus preventing the introduction of organisms to the client. Medical asepsis can be referred to as clean technique, and surgical asepsis as sterile technique. A thorough and effective means of surgical asepsis should be implemented for all body art procedures. [CE resource]

Sterile technique is not one set-in-stone method, this is a guideline for establishing your own individual technique.” Nor is it advocating precautions beyond what our sort of minimally invasive ear piercing procedures require for antisepsis and sterility. For those who are curious to learn more about Maximum Sterile Barrier precautions, the CDC HICPAC describes further steps that can be taken for more seriously invasive punctures such as a central venous or arterial catheter. For body artists, an achievable version of surgical asepsis (sterile technique) maintains barriers such as sterile gloves, masks and eye protection, and removes obstacles likely to compromise these barriers such as hanging earrings and necklaces, long hair, rings and watches.

“I think that when you say ‘aseptic technique,’ a lot of people automatically think ‘operating room’ or ‘surgical procedure,’” explains Kathleen Meehan Arias, MS, CIC, president of the Association for Professionals in Infection Control and Epidemiology (APIC) and director of Arias Infection Control Consulting LLC. “That’s rightly so because that is where the bulk of it is. But whenever you are doing anything that bypasses the skin barrier, you should automatically think aseptic technique.” — Applying Aseptic Technique in all Clinical Settings

This outline of technique suggestions comes from the AORN, APIC and CDC standards and recommended practices as well as a number of textbook resources such as Asepsis, the Right Touch. Much of it needs very little interpretation for our purposes. Safety precautions should result in greater control of the procedure, clinical benefits, reduced harm, and limited liability for negligence.

Rationale: There exist standards for prevention of surgical site infection that apply to even minor invasive elective procedures, and piercing falls within this category by definition.

“When implemented, these guidelines should reduce the risk of disease transmission in the piercing environment, from piercee to piercer, and from piercee to piercee. Based on principles of infection control, the document delineates specific guidelines related to protective attire and barrier techniques; handwashing and care of hands; the use and care of sharp instruments and needles; sterilization or disinfection of instruments; cleaning and disinfection of environmental surfaces; disinfection and the decontamination room; single-use disposable items; the handling of previously worn piercing jewelry; disposal of waste materials; and implementation of recommendations.”— Piercing Experience adapted IPC standards from the CDC

My personal observation is that these policies have helped limit risk at my studio. They have been reviewed by legal counsel, qualified bioscientists, medical professionals, and university professors. That said, I’m sure that they could always use more input and adaptation. Body art safety is an ever-evolving field of interest.

One might say there is no single right way to pierce. Many variations are possible with an understanding and application of asepsis. We are an industry in which studios market based on their specialties, and for some that is participation in continuing education, gaining knowledge, and raising standards. Maintaining a positive tone one can show those as strengths without diminishing others. This is crucial to developing the bonds between us as fellow professionals. If you believe something you do has advantages, feel free to share that with your customers in a way that does not end up overly critical of our other colleagues.

2013 APP Procedure ManualIt should be clear that these position statements in support of surgical asepsis are neither contradictory nor accusatory of others currently using APP minimum standards for medical asepsis according to our 2013 revised Procedure Manual. They build upon them as we are all encouraged to do as Members, employing additional precautions and elective limitations based on evidence and strong theoretical rationale. My preference is to demonstrate best practices as an educator instead of the minimums. If we all did no more than what was required, the industry would not be as interesting.

I believe that it is the responsibility of each of us to uphold the values we feel are important, and to continually advance our standards in order to achieve our goals. I do have romantic hopes that over time the industry will move in the direction of pure, validated, ethical materials and practices that are as harmless as possible. A predictable, consistent, safe, simple, and gentle piercing experience is attainable today and can be refined based on these principles and open communication among colleagues. The recommendations that I make in addition to APP minimums result from a continually researched process of elimination and adaptation, and they are freely shared for peer review. Please consider this a formal request for comments.