760-1411 Operation Standards; Records

1. RECORDS

a. The holder of a body art establishment permit shall maintain proper records of body art procedures that have been administered and/or jewelry that has been installed for each patron.

b. A record of each patron shall be prepared prior to any body art procedure being performed.  In the case where multiple visits are necessary to complete the body art procedure, the original or first record may be subsequently noted with the date of the visit and the progress of the procedure appropriately described until its completion. The patrons record shall include the patron's name and signature, address, age, if applicable, manner of verification of identity and age, the date of the procedure, the design of the tattoo, its location on the patron's body, the type of jewelry applied, location of the piercing on the patron's body, or similar information for other types of approved body art and the name of the body artist who performed the work.  The patron record may also be used as a consent form for the application of a body art procedure. This record must include the "Consent for body art procedures" in appendix D of this article. Prior to any piercing procedure, the body artist must also provide the patron with a copy of "Healing Periods for Body Piercings" in Appendix E of this article.

c. The records shall be entered in ink, on paper, which is kept in an organized file, notebook or folder that is kept solely for this purpose. These records shall be available during the course of an inspection for examination by the Commissioner's representative and shall be preserved for at least two (2) years from the date of the most recent body art procedure recorder in the establishment.

d. Before performing the body art procedure, there shall be a discussion with the patron on the risks of the procedure and the possible health complications, which shall be noted in the record.

It is reasonable to make a record of body art procedures, but some leeway is needed for situations that have to balance privacy. Does a middle-aged client have a right to withhold age if obviously an adult? What about their address? What is so important that we must get that information? It has been a custom to honor some requests that have never been a problem but considered a client's right. For example, we are often requested not to make copies or take pictures of a custom design. We surrendering all drawings and agree not to do that design again. This has always been considered a client's right. What compelling health reason is there?

A larger question: is a body art itself also a matter of privacy. It has always been the tradition to agree to a client's request of privacy.  So what is essential that we cannot proceed and how much would we just like to have? Can we give some of it up?  Because this issue may require legal advice it may be enough just to require a "record" and leave it to the discretion of how much information the shop wants or needs to maintain.

Leaving the privacy issue, this section also illustrates the need for a look at the approach to regulating. .

Point c. requires the records be in ink, on paper, in an organized file, or folder, that is kept solely for that purpose. The purpose is to have records readily accessible for the Department. Contrast this with how OSHA approaches similar record keeping. Here they are considering where to keep the Exposure Control Plan in a facility so that it is readily accessible.

"The 'location' of the plan may also be adapted to the circumstances of each particular workplace provided that the employee can access a copy of the plan at the workplace, during the work shift. For example, if the plan is maintained on a computer, access to the computer or hardcopy must be available to the employee." Summary and Explanation OSHA (c)(1)(iii)OP CIT.

It is the accessibility of the records that is important, not how they are stored, on paper or on a computer. Employers are left to determine the best record keeping for their situation as long as those records are accessible when needed. This is performance-base regulating. The performance is getting the records.  This presupposes the existence of records to get, not that they must be in ink. OSHA states "...it does not wish to take away from the flexibility of the performance approach to compliance...while not dictating the specific form of the documentation." Therefore the standard reads Paragraph (c)(1)(iii) "Each employer shall assure that a copy of the Plan is accessible to employees." OpCit.
The Dept has to create the space to permit a professional community to arise. It needs to consider a performance-based change in regulating body arts.

Point d. the risks of the procedure and the possible health complications requires a re-direction of emphasis and the whole truth, that the risks are minor and it is not expected that they would result in health complications.  "Risk" and "possible" are both improperly used and confused.  What needs to be added, more importantly, is not the procedure that causes health complications but the clients are the cause of health complications. More emphasis should be on explaining this to clients instead of focusing the attention on the procedure.

The additional requirement that this discussion which shall be noted in the record. is a good idea for liability protection, but not reason that the noting be part of the Article.

 e. Consent

(1) Minors are prohibited from being tattooed (NY Penal Law 260.21). No one can give consent fro the application for application of a tattoo to a minor, NY Penal Law 260.21.
 (2) Pursuant to Suffolk County Local Law 4-1997, body piercing of a minor is prohibited. However, the prohibition of body piercing may be waived as prescribed by Suffolk County Local Law 4-1997.
 (3) Prior to the performance of any body art procedure, the patron must sign the consent form provided in Appendix D of this article.
 (4) For any minor receiving a body piercing, a parent or legal guardian must also sign the consent form in Appendix D of this article.

f. No body art procedures shall be performed upon a person who appears incoherent, or appears to be under the influence of drugs or alcohol.

2. Tattooing Procedures.

            a. There shall be printed Aftercare instructions, as approved by the Department and consistent with Appendix A of this Article, given to each patron or customer on the care of the skin to prevent infection and proper, safe healing after Tattooing. The printed material shall include information for the patron to consult a personal physician immediately, who, in turn, may immediately notify the Suffolk County Department of Health Services, or advise the patient to do so, should an infection become evident.

This section is the most important in the Article and should be cleaned up.  It should read something like: Each client shall be given printed Aftercare Instructions consistent with modern wound healing techniques. A sample of these instructions is available in Appendix A and must include the warning "If you suspect an infection get medical attention right away." 

The way it is written is frightening as if it were Ebola and the physician must immediately notify the Department of a local easily treated skin infection.  And if it is that important why the: or advise the patient to do so.

Further, Appendix A is not medically accepted wound healing technique, but ritual practices that can delay healing and promote infection.

b. A copy of such printed Aftercare instructions shall be posted in a conspicuous place in the workroom, clearly visible to the person being tattooed.

This is a good idea as a suggestion to emphasize aftercare but aftercare usually goes without incident even when not perfect. There are no dire consequences when aftercare is not perfectly followed. Delay of healing by a few hours or day does not expose the client to unacceptable dangers by that delay and does not need a large sign that can be clearly read while being tattooed. (What would be the sense of it being "visible" if it could not be read?)  If any place it should be in an area where the client can concentrate on it, certainly not in the chair.

c. When necessary to shave the area to be tattooed, only single-use, sterilized, disposable safety razors shall be used.

The "sterile" specification is objectionable. It has never been a problem to shave with disposable single-use non-sterile razors.  

Point c. also illustrates clearly the lack of a performance-based approach because it specifies one method of hair removal excluding all others. It should not be part of the Article. How barbershops handle the straight razors might be relevant.

d. Before placing the design on the patron's skin, the body artist shall treat the area with an EPA approved or hospital grade germicidal solution, which shall be applied with sterile cotton or sterile gauze. Only petroleum jelly (petrolatum) or sterile dressings shall be applied to the area to be tattooed and only from single-use, collapsible metal or plastic tubes. The application may be spread by the use of sterile gauze, but not directly with the fingers.

Several comments need to be considered.
1.) Because EPA approved or hospital grade germicidal solution is particularly exact and consistently applied, also specified in 760-1410(3) and in 760-1411(5)(A) it is not accidental insertion but a lack of knowledge of the subject at hand. The Environmental Protection Agency (EPA) approves hard surface disinfectants not intended for human use on the skin. The Food and Drug Administration (FDA) evaluates things that go on the skin: antiseptics.
2.) Again, performance-based wording would be better, and don't forget washing. The area of skin should be washed and then disinfected with an appropriate antiseptic before performing the procedure.

3.) The restrictive applied with sterile cotton or sterile gauze is not the only way to apply antiseptics to the skin, nor do the wipes have to be sterile. The petroleum is not sterile.

4.) It is a long and safe tradition to use jars of A&D removing amounts of ointment with sterile tongue depressors. There is no evidence that this procedure has caused the spread of disease.
5.) No reason is given to specify "petroleum jelly" as the only ointment allowed.
6.) Gauze is not a good method of removing not applying ointment.

7.) A gloved finger or hand is used to move ointment around but it is unheard of to use plain fingers. This is not a method used and should not be pointedly prohibited as if it were a known and used method.

e. The use of single-use tissue and hectographic stencils shall be required for applying a tattoo outline to the skin. Multi-use stencils shall be prohibited. If drawn free hand, non-toxic markers or other devices as approved by the Department shall be used.

The purpose here is to prohibit the use of re-useable plastic stencils and toxic markers.

1.) There are no such things as "hectographic" stencils though we get the meaning. The current method is to use duplicator stencil masters composed of Carnauba wax and crystalline violet. One manufacturer sells "Hectograph" pencils, which seems to be a trade name not a description of the process that is promoted to write on paper which then can be transferred to the skin.

None of this has ever been shown to be harmful.
2.) Use of stencils, plastic or otherwise, should not be prohibited if sanitary and can be disinfected between uses. "Cutting" stencils was during a time of limited designs, a laborious task assigned to shop workers whenever possible and abandoned in modern times because of the demand for individualized tattoos, not copies.

3.) The approved by the Department pops up again and should be dropped. The Department is unable to approve drawing devices other than to read the labels. These are not sterile either applied to the skin

f. Any skin or mucosa to receive a body art procedure shall be free of rash or any visible infection.

This is probably too restrictive of skin conditions to look for, but not being medically trained I can only guess that it should be more inclusive, such as: visible abnormal skin condition.

3. Dyes or Pigments

a. In preparing non-toxic dyes or pigments to be used by a body artist, only non-toxic, sterile material shall be used. Single-use or individual portions of dyes or pigments in clean, sterilized containers or single-use containers must be used for each patron.

1.) Though dyes are not used in tattoo because they are water soluble there is reason to expand the title to cover the entire contents of the ink formulation, not just the coloring agent. Though dyes currently have no use in tattoo that situation could change. Some new ink concepts are being developed by Harvard Professor Rox Anderson. Regulations must allow for technological improvements.

2.) The clause In preparing non-toxic dyes or pigments to be used by a body artist is confusing. This points to the formulator, preparer or manufacture of the ink.  If this is the intention it is not possible to formulate using sterile materials though it is possible to sterilize ink.

3.) Non-toxic is vague without reference to any standard or degree of non-toxicity. This needs more study before being included.

4.) It is only this year that "sterile" ink has been introduced as an option to inks not claimed to be sterile.  Unless it can be demonstrated that non-sterile inks contribute to disease this should be dropped from the standard. It is also only this year that individual portions have been manufactured. It has never been a problem, and until proof is offered that it does pose a threat it should not be included.

5.) Ink cups have never been sterile and have never been pointed to as a contributing agent in contamination.  There is not justification offered for this.

b. After tattooing, the remaining unused dye or pigment in the single-use or individual containers must be discarded.

c. All inks, dyes, pigments, needles, body art instruments and equipment for performing body art procedures shall be specifically manufactured for that purpose and shall be used according to the manufacturer's instructions.  When available, the inks, dyes and pigments for body art procedures must comply with applicable U. S. Food and Drug Administration regulations. The mixing of approved inks, dyes or pigments and/or their dilution with sterile water or alcohol using aseptic procedures is acceptable if in conformance with applicable U. S. Food & Drug Administration regulations when available.

This restrictive expression "shall be specifically manufactured for that purpose" discourages the development of technology. There is no compelling reason to prohibit using new and novel techniques and tools not specifically manufactured for body art. The use of tools and techniques in ways other than intended by the manufacturer has provided significant improvements in life and this industry and should not be prohibited by the Article. For example, most all the tools used for piercing were made for dentistry, not intended for body arts. The very needles we used were entomology needles not tattoo needles.  In the 1980's we had a hard time getting a sterilizer, suppliers in Suffolk County refused to sell them to us.

The last sentence

The mixing of approved inks, dyes or pigments and/or their dilution with sterile water or alcohol using aseptic procedures is acceptable if in conformance with applicable U. S. Food & Drug Administration regulations when available

1.) According to the presentation of the FDA Science Forum on April 19, 2006 the mixing of anything with the ink is adulteration. This provision itself is in violation of FDA rules.  

2.) The body artist must prove the ink or the mixing conforms to FDA regulations.  Even the Department could not do this.  To require this of body artists is unreal.

d. Patrons shall be provided printed warning of the potential physical reactions from the use of certain dyes (when available) in a form acceptable to the Department.

Occasionally a client has an allergic reaction to ink: an area swells up. It has been treated with shots of cortisone and other methods. Treated or not the area recedes in a few months or even a year. It has also been reported that an allergy to an ink has been known to break out years after the tattoo. There has not been sufficient study available to the tattoo community that would help us direct clients to acceptable treatment regimens. A warning should be given that some people are allergic to some ink, and although bothersome, perhaps itchy and of great distress to the client does not seem to be a health threat. The FDA has reiterated their position that it is up to clients to avoid being tattooed with inks that cause them to have an allergic reaction.

4. Sterilizing and Care of Tattoo Needles and Equipment.

a. A set of individual, single-use, sterilized needles shall be used by a tattoo artist for each new patron. An adequate number of sterilized needles shall be on hand to supply peak demands.

1.) The word "set" is confusing because it is never used in tattoo to refer to tattoo needles. A question might arise "Does that mean we can't use just one needle?" and "What does a set consist of?"  There is no need for the word at all.  Single-use, sterilized needles... is exactly correct and not confusing.
2.) Only new single-use sterilized needles shall be used on a customer. That is clear. If more explanation seems to be needed, then the explanations of the Article can emphasize intent.
3.) The Article's including stocking levels makes good business sense and show that the Department believes tattooists will not keep an adequate supply on hand and will use dirty needles. The Department's view is very disappointing.  The second sentence should be deleted.

b. Sterilization shall be accomplished by holding needles in an acceptable steam autoclave for no less than 20 minutes at no less than 15 pounds pressure at a temperature of no less than 250 degrees Fahrenheit or 121 degrees Celsius or other methods as approved by the Department.

The most usual method of in-house sterilization is by steam. With improvements in technology new methods and sterilizers are available. For example, new autoclaves are currently available that utilize higher temperatures and decreased time, and though dry heat is not the most appropriate it is an effective method of sterilization.  A performance-based approach might word this point something like: In-house sterilization shall be appropriate for the item and reach a Sterility Assurance Level of 10 to the minus 6.
"Acceptable" steam sterilizer and methods "approved" by the Department are thrown in to exercise hands-on control of every aspect of body art activity and should be removed. The Department must begin to foster a climate of professionalism, not treat body artists as children.

c. All sets of needles shall be placed in chemically treated sealed bags that indicate, by color change, sterilization has occurred.

A performance-based rule might read something like this: When sterilized in-house, needles, tubes and grips will be sterilized in pouches designed for that purpose.

d. No rusty, defective or faulty needles shall be used for tattooing.

This should be removed because by definition "needles" used for tattoo would exclude rusty, defective or faulty needles. This sentence is insulting.

e. Unused, Sterilized needles shall remain in sealed sterilized bags until needed and stored in such a manner to prevent contamination.

Unused Sterilized needles tubes and grips will be kept in their sealed sterilization bags until used and handled and stored to insure the integrity of the bag.

f. Upon conclusion of the use of a set of tattoo needles on a patron by a body artist, and if the needle stems are going to be reused, the used needle & stem unit is to be first sterilized, then the needles shall be removed from the needle stem and placed immediately into an acceptable sharps container for storage until final disposal from the premises.

This point violates a caveat of infection control procedures: handling of contaminated items must be kept to an absolute minimum.

This point violates OSHA regulations.

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.
Exception: (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.

Exception procedure: (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)(4)(iii)(A)(1)
Contaminated sharps shall be discarded immediately or as soon as feasible in containers that are...closable...puncture resistant...leak proof...color-coded...
1910.1030(d)(4)(iii)(A)(2)
During use, containers for contaminated sharps shall be:
(d)(4)(iii)(A)(2)(i)
Easily accessible to personnel and located as close as is feasible to the immediate area where sharps are used...

Point f. should read something like: All contaminated needles must be discarded immediately or as soon as possible in "sharps" containers located as close as is feasible to the immediate area where sharps are used. The word "must" is crucial because it means there are no exceptions.

g. All needle tubes are to be of the shallow open-end type and must be sterilized in accordance with approved methods prior to use. Sterilized needle tubes shall be stored in such a manner as to prevent contamination.

1.) Though tubes do not pose the same level of puncture threat as needles they are still contaminated during use and can be included in points a., b., c and e. above. (if d. is deleted).

2.) Specifying the construction of the tubes prohibits many current styles without evidence that only this type is safe to use. There are other styles that are used and there is no evidence that other styles contribute to disease. Point g. is misguided and should be removed.

5. Aftercare of Tattoo.

a. The completed tattoo shall be washed with a piece of sterile gauze or sterile cotton saturated with an EPA approved or hospital grade germicidal solution. It shall be allowed to air dry.

1.) The incorrect germicidal is listed again, as pointed out in 760-1410 and above. The EPA approves hard surface disinfectants for inanimate matter not human skin.

2.) This section needs re-examination in light of modern wound healing techniques by a wound healing expert.  

The purpose of wound cleansing is to remove 'foreign bodies', excess exudate and bacteria from a wound. This is particularly important in infected wounds or those at risk of infection. (1)p239

Exudate is required on the wound surface to maintain phagocyte levels, as well as other wound healing hormones and chemical stimuli. Wound irrigation will remove these and is therefore best avoided. However, it may be necessary to cleanse the surrounding skin to prevent excoriation from excess exudate. This may be achieved by irrigation or wiping AROUND the wound with a wet swab and then a dry swab. This is not always an easy procedure. It is preferable that a dressing should be used which maintains moist wound healing but absorbs excess exudate and does not allow it to leak onto the surrounding skin. In this case cleansing the wound as a separate procedure is NOT necessary. OpCit p.240

b. After drying, anti-bacterial ointment shall be applied from a single-use collapsible metal or plastic tube and the entire area covered with a piece of sterile, non-stick tissue, bandage or gauze fastened to the site with a low-tack tape. Aftercare instructions provided to the client must be consistent with those outlined in Appendix A of this document.

One of the major misconceptions in the treatment of acute wounds is the use of topical agents...Many physicians still use these agents, either out of habit or because most of their patients heal in spite of them. In fact, many antimicrobial agents have been found to inhibit either cell proliferation or migration in vitro. Our practice with regard to all topical agents in acute wound healing is 'Prime, no nociere' (first, do no harm); that is, in the majority of cases we do not use them. Derm. Clinics p635

The choice of dressing must reflect the patient's risk of infection, the management of identified infection, and the risk of cross infection. Infection Control p.240
The two main aims of the dressing must be: To manage this exudate without it either having prolonged contact with the patient's skin and To contain the exudate and prevent strike-through. The strikethrough provides a pathway for the bacteria to the external surface, which may then be transmitted to other areas of the body, or other people...and from exogenous sources back into the wound. P.241

6. Body Piercing, Scarification and Branding procedures

a. Printed aftercare instructions, as approved by the Department and consistent with Appendix A of this article shall be given to each patron or customer on the increased risk of an invasive infection resulting from the piercing of mucus membrane tissue, specifically piercing the navel area, genital area, tongue and nipple. Such printed instructions shall also include information for the patron on the care of the body opening caused by body piercing, scarification or branding as a precaution to prevent infection and to consult a private physician immediately who, in turn, may immediately notify the Suffolk County Department of Health Services or advise the patient to do so should an infection become evident. Information should also be provided with reference to the security or snugness of certain jewelry to prevent ingestion or lodging in body cavities.

1.) This section is specific to body piercing, scarification and branding. One of the points in the first sentence is to compare the "the increased risk of an invasive infection" with piercing without making it clear that wounds of outer layers of skin as seen in tattoos provide less of a threat of systemic infection compared to wounds that expose deeper layers of the skin as seen in piercings. This makes sense but may not be a complete picture. "Invasive" is most likely an incorrect description. The conclusion to draw is that piercing wounds require more aftercare concern than tattoo. This needs more consideration.

2.) ...increased risk of an invasive infection resulting from the piercing of mucus membrane tissue, specifically piercing the navel area, genital area, tongue and nipple. None of the body parts listed, the navel, genital area, tongue and nipple are lined with mucous membranes ... This sentence probably should have ended increased risk of an invasive infection resulting from piercing, (period.) the rest omitted.

3.)... Such printed instructions shall also include information for the patron on the care of the body opening caused by body piercing, scarification or branding. Scarification and branding do not create body openings. Body opening should have been omitted.

4.) These seem to be three different aftercare considerations.

5.) Comments were previously made in reference to "private physician" and won't be repeated here though they should be considered here as well.

6.) We are glad to see the security of jewelry addressed. This is a very good innovative addition. An expansion would find it useful to include information on how to remove jewelry. Clients come back saying they tried but don't know how to remove their captive bead ring.

b. A copy of such printed aftercare instructions shall be posted in a conspicuous place in the workroom, clearly visible to the person being pierced. A copy of "Healing Periods for Body Piercing", Appendix E of this Article, must be posted at each body piercing station.

Objections to this have been made elsewhere. One can imagine a workroom now with five sets of instructions on the walls large enough to be read by the clients during the procedures: Tattooing, Piercing, Piercing Times, Scarification and Branding.

c. When necessary to shave the area to be pierced, only single-use, sterilized and disposable safety razors shall be used.

The comments previously made should be considered here also. The rationale for sterile needle use is the knicking of the skin during shaving might contribute to the spread of infection. As long as the razors are single-use should be sufficient.  There is no evidence to suggest otherwise.

d. Ear piercing guns and ear piercing needles are to be used only for piercing ear lobes. The piercing device may not be used to pierce any other part of the body.

1.) Instructions that come with the gun say that the gun can be used for the ear lobe and outer cartilage. This needs further examination.

2.) "Ear piercing needles" should be removed because it is a customs import term used to label cannula needles used for piercing.

e. For all body piercing, a single-use, sterilized disposable surgical piercing needle of the same gauge as the jewelry shall be required.

1.) There is no classification "surgical piercing needle" in the Federal Register of Medical Devices.

2.) The same concern shown with tattoo needles with reference to sterilization and disposal should be applied to piercing needles. They are no less contaminated and do not posed any less of a threat.

3.) There is no evidence to support the requirement that only a needle of the same gauge size must be used. Some piercers have always used slightly larger needles. This practice, since the inception of piercing, should not be prohibited without convincing evidence that it is harmful.

f. Skin shall be marked with a non-toxic marker prior to cleansing with antiseptic. The area being pierced must be free of sores and lesions.

1.) The procedure is washing, then an antiseptic, then the marking, just like tattoo.
2.) The same skin conditions that increase a client's infection risks from tattoo apply to piercing as well.

g. When applied, jewelry should be pushed through the skin following the needle, in the same direction as the piercing.

Whereas the most common method of piercing is as described, the Article is attempting to regulate the actual procedure and method of piercing unrelated to health matters preventing the development and introduction of other and perhaps superior techniques. A European technique uses a catheter and inserts the jewelry from the other end. This must be deleted.

h. Ear lobe piercing is exempt from provisions of the Article, except those provisions dealing with personal hygiene, use of single-use sterile equipment devices, aftercare instructions and jewelry.

This point is now confused.

Is the piercing gun a single-use sterile device?
Does personal hygiene mean a sink at every jewelry counter, a separate room?
General piercing aftercare instructions? Jewelry?
If ear piercing guns are considered a significant threat to the health of the community evidence should be presented or just drop consideration at this time.

i. If the body art procedure area requires covering, it must be done with sterile, non-stick gauze, non-stick bandage or non-stick tissue and fastened to the body with an appropriate, adhesive first-aid type bandaging tape.

1.) This consideration should be handled in the aftercare instructions sections, just like tattoo.
2.) The "first-aid type" inclusion is an obvious reference to masking and scotch tape.
3.) The Article again restricts the options without cause or explanation to exempt other types of bandages.

7. Sterilization of Piercing Jewelry and Needles; Jewelry Requirements

a. An individually bagged sterilized single-use needle and bagged sterilized jewelry shall be used for each piercing.

These requirements for piercing and tattoo should mirror each other.  For tattoo it is written a. A set of individual, single-use, sterilized needles shall be used by a tattoo artist for each new patron. An adequate number of sterilized needles shall be on hand to supply peak demands

Better would be: Individually packaged single-use sterile needles and jewelry shall be used for each client. That should be adequate. The jewelry does not have to be bagged separately.  The same objections to certain parts of tattoo apply here as well.

b. Sterilization shall be accomplished by holding needles in an acceptable steam autoclave for no less than 20 minutes at no less than 15 pounds pressure at a temperature of no less than 250 degrees Fahrenheit or 121 degrees Celsius or by any other method approved by the Department.

The same comments as in (4)(b.) above apply here.

c. All sets of needles shall be placed in chemically treated sealed bags that indicate, by color change, sterilization has occurred.

A performance-based rule might read something like this: When sterilized in-house, needles, tubes and grips will be sterilized in pouches designed for that purpose.

d. Unused, Sterilized needles and jewelry shall remain in sealed sterilized bags until needed and stored in such a manner to prevent contamination.

Unused Sterilized needles tubes and jewelry will be kept in their sealed sterilization bags until used and handled and stored to insure the integrity of the bag.

e. Corroded, defective or faulty needles and Jewelry shall not be used for body piercing.

This should be removed because by definition "needles" and jewelry used for piercing must be suitable and therefore exclude Corroded, defective or faulty needles and Jewelry.

f. Upon completion of the piercing, used needles shall be placed immediately into an acceptable sharps container for storage until final disposal from the premises.

This point could use more accurate _expression to reflect relevant comments provided in (4)(f)
and should read something like: All contaminated needles shall be discarded immediately or as soon as possible in "sharps" containers located as close as is feasible to the immediate area where sharps are used.

g. Packages of single-use factory-sterilized needles, jewelry, tubes, clamps and other body art instruments must indicate the process by which sterilization was accomplished, have an indicator that clearly demonstrates successful sterilization and, if there is an expiration date on the package, the contents must not be kept in the body art establishment past such date.

1.) A compelling reason is not offered why naming the particular process, e.g. Gas or Steam, should be the subject of regulation.  Some piercing needles are gas sterilized in very economical packages. It should be enough for small items that the box or outer wrapping contain an assertion to that effect.

2.) It is obvious the Article believes piercers may use stale dated products.  It should be remembered that dating does not mean the item is no longer sterile.

h. Jewelry to be used for a body art procedure must consist only of those materials listed in the definition of jewelry herein.

This provision like others attempts to exhaustively include and exclude the material of jewelry without presenting any evidence and making some blunders. For example, there is no classification "surgical-IMPLANT grade stainless steel, and no "surgical-grade plastic".

It would only be reasonable, without the particular expertise to draw all the distinctions that neither we nor the Board has, to require that the material be considered hypoallergenic and suitable for the purpose. For example, it would not be suitable to insert jewelry containing free nickel, known to cause common nickel allergy, or other type or shape of jewelry, e.g. sharp edges that would delay normally expected healing. Unless they were deep, jagged or sharp "angel hair" cracks and small pitting will not delay or interfere with healing nor harbor bacteria greater than the piercing itself.

8. Care of Multi-use body art instruments for body art and related equipment.

a. All other multi-use equipment and body art instruments used in connection with a body art procedure shall be so designed and of such material as to be durable, non-toxic, corrosion resistant, smooth and easily cleanable. Such equipment and body art instruments shall be stored cleaned and in a protected manner and when necessary be sterilized.

The Department has not exhibited expertise to determine the suitable construction of body art instruments.  Whereas these qualities are desirable, their absence is not excluding which leaves, stored cleaned and in a protected manner and when necessary be sterilized.

b. The following process shall be performed after each use of a multi-use body art instrument used for body art:

(1) The body art instrument shall be cleaned by scrubbing with an appropriate soap or disinfectant solution and warm water, or by procedures that follow the manufacturer's cleaning instructions to remove blood and tissue residue.

This more properly should read something like Re-useable Contaminated body art instruments shall be cleaned and sterilized before re-use. There is no blood or tissue residue.

(2) The body art instrument shall be placed in an ultrasonic cleaner, which shall be operated in accordance with the manufacturer's instructions. A copy of these instructions shall be kept by the body artist(s) in the area of the ultrasonic cleaner for review by the department's representative and the body artists.

The purpose of cleaning is to reduce the bioburden level so that sterilization is achievable. Ultrasonic cleaners dislodge fine particles that can't be reached by hand scrubbing. Because there is no blood or tissue seeping into areas that cannot be reached by hand scrubbing there is no compelling reason to require ultrasonic cleaning.

(3) The body art instrument shall be packed individually in a peel-pack containing either a sterilizer indicator or an internal temperature indicator. It shall then be sterilized.

A more reasonable _expression might be: Re-useable contaminated body art instruments will be sterilized in pouches designed for that purpose, kept in their sealed sterilization bags until used and handled and stored to insure the integrity of the bag.
We understand what "peel-pack" means but this change of name is inconsistent with identifying sterilization bags.
The internal temperature indicator is not an indicator but an integrator.

(4) All multi-use and single-use body art instruments, needles, jewelry autoclaved on-premise must have the date of sterilization and the initials of the person doing the sterilization.  Any such sterilized item not used within 365 days of the processing date is to be opened and its contents re-sterilized.

Any item sterilized on-premise must have etc.. The reason for the signature needs explanation.

c. Sterilizers shall be used, cleaned and maintained according to the manufacturer's instructions. A copy of the procedures recommended by the manufacturer for the operation of the sterilization unit shall be available for inspection by the Department.

The manufacturer's use and maintenance instructions are for reference for the employee. They must be available to the employee if needed. It is not necessary to include "shall be available for inspection by the Department" because they are required to be available to the employee. It should be reworded and changed focus from enforcement to performance.

d. A written record showing the history of the use of the sterilizer in the most recent 36 months shall be kept on the premises. This record will include the type of body art instruments sterilized, the date of the process, duration of time for the sterilization process, the maximum temperature and pressure attained during the process and the name of the person performing the process.

With dated, signed bags and periodic spore testing this extensive record keeping needs compelling justification.

e. The body art establishment shall demonstrate by quarterly spore destruction tests that the sterilizer used is capable of attaining sterilization. The tests shall be verified through an independent laboratory approved by the department. These test records shall be retained in the body art establishment for a period of 3 years. The body art establishment's permit shall not be issued or renewed until the department receives such documentation of the sterilizer's ability to destroy spores.

1.) Sterility Assurances means repeated spore testing consistently produces negative results. A failed spore test means there is no assurance that the items sterilized since the last successful spore test are sterile.  A successful spore test is necessary before the sterilizer can be put back into service. All the items after the last successful test are then re-sterilized.

For this reason it is prudent to test frequently so that few items would be used that could be suspect. A month or less is a minimum. Quarterly is unheard of.

2.) It would contribute to sterility assurance to allow in-house spore testing so that this can be done economically, faster and more often. The ideal situation would be no release into use until the spore test is confirmed. Factory made needles, tubes and supplies are not released without a confirmed spore test for every lot. There is no evidence to suggest that body artists would be falsifying their own records and this should go forward.

f. The ultrasonic cleaner and the sterilizer shall not be located or operated in body art procedure areas or areas frequented by the public.

g. Prior to use, all body art instruments used for body art procedures and jewelry to be used in approved body art procedures are to be sterile and single use. Those body art instruments that are designed for multiple uses must be sterilized in accordance with Sections 760-1410.4b and 760.1410.7b described herein. These sterile body art instruments and jewelry are to be stored in a safe, sanitary, manner and protected from accidental contamination until such time as they are to be used for the body art procedure. All jewelry and body art instruments that are packaged and sterilized in the establishment must be clearly marked with the date of sterilization and the initials of the person monitoring the process. If the package containing the body art instrument has been breached, the expiration date has passed, the "indicator" has not changed to verify a successful sterilization process, or the package is otherwise visibly compromised or contaminated, the body art instrument or jewelry must be repackaged and re-sterilized.

This paragraph is a duplication of paragraph 7601411.8d4, 7g, 8a, 8d

These are personal views and opinions of Wes Wood and do not necessarily represent the views and opinions of Unimax Supply Co Inc.
Copyright 2006