CHAD S. ZWERLING, MD ANNETTE G WALKER, RN NORMAN R GOLDSTEIN, MD

MICROPIGME ..........

ST ATE OF THE ART ~ "

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CHARLES S. ZWERLING, MD ANNE11E C. \V.~LKER! RN

NORMAN E GOLDSTEIN, MD

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BOOK& . CQVl~R DESIGN 1 (11111 /)ellllis. 1I111lr/) Oil .Prot/milo".\'

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T A

C 0 B L E N T E

Dedication Vll Foreword ix

o F N T S

Preface xi Acknowledgelnents Xlll

SECTION I: An Introduction To Dermatechnology I. Introduction 3

2. History of Tattooing 7 3. Instrumentation - De. cription and Development 17

4. FDA and State Regulations 31

SECTION II: Preprocedural Considerations 5. Psychological Considerations 51 6. Practical Clinical Anatorny 57 7. Morphology 69 8. Photography 83 9. Patient Selection R9 J O. Clinical Evaluation 05 J 1. Preprocedural Consideration 105 12. Artistic Technique: CLIMB III

SECTION III: l\'lethodology 13. Anesthesia 123 14. Role of the Assistant 147 15. Blepharopigmentation Techniques 151 J 6. Brow Pi gmentation Technique 163 17. Li P Pigmentation Techniques L 65 18. Breast Areolar Pigmentation J 69 19. Advanced DermalpigmentL1tion Techniques 175

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SECTION IV: Post-Procedural Considerations 20. Management 181 ~ I. Compl ications of Tattooing 185 ')') Pigmenls 199 23. State of the Alt 209 24. Quality Assurance 21l

APPENDICES I. Sample Forms 223 II. List of Micropigmenlation Organization.

and Experts 228 JJ L. Talloos 011 Famolls People 232 IV. References by Chapter 234 V. Glossary of Cosmetic Products 245 VI. Marketing Considerations 248

INDEX

DEDICATION

AJiectionale/y dedicated to our spouses - Jean, Ramsay and George; for !!rei r patience and support.

And to our children - T(fjlJl1Y. Alexis. and Patrick . .fohn Gnd Cal, for the tillle that we should have spen.t H:ith you.

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F o R E w o R D The lise of permanent eye enhancement by illlradermal pigmentation was

first introduced in J 984 as a new technology in the field of ophthalmology. Over the past 9 years the field or dermalpigmeruation has expanded and embraced other medical specialists and health care practitioners. At the time of publication of the first book on this subject. MicropigmelllCition. there were maTlY areas of speculaLion for the potential lise of this procedure beyond the field of ophtha:Jrnology: nipple reconstrudion. burn treatment, vitiligo and scar-cover-up are only a few examples of now well-established uses for dermal-pigmentation.

Since the technology and information has changed at such a rapid pace from the first book':> publication. it is imperative to review all the accumulated data fur appropriated presentation to (he medical community. With this properly processed information, rational judgements can be made on the worth and place of the procedure, and so that consumers can educate themselves in the h~lsic and advanced applications of this rnicropigrncntation. Many proce-dures have foundered because or a lack of well-organized and documented ~ource m:l!crial.

Micro/1igmentalioll. Slale-of-/he-A ,., has tackleu Ihis enormous task from the scientific, aeiithetic. and practical approaches. Thi.~ book has gathered all the available information accumulated lve)' the past decade and also potential new techniques. uses. and indications for micropigmemation.

ix

p R E F A c E Many medical practitioners may view this book and subject with

immediate disdain. Sinct.: lllicropigmcnwtion hm. developed directly from tallooing, rhere are certain connotations that tend to taint this new field. Thl' image of an uHc!c.\n lil lloo parlor located in the p(lorer sections of a large cily may cpme to one ' s mind. The presence of gross taUoo designs on the human body is often associated with this scenario: huwever. rnicropigrnentation represents the impl:llltation of inert pigment granules in a clean, sterile atmosphere hy a truined praditioncr for the purpo.,e of a natural-appearing cosmetic enhancement. Just as today's general surgeons had thci r origins from the old barber-~urgeons anJ untrained journeymen or medieva l times, the lllicl"opigmcfllalion practitioner can trace his heritage to the tattO(1 artist. We feel a debt of gratitud.:: to the taltoo artist for helping us to reinvent the wheel. as sn often occurs in medicine. It i for this renson of historica l perspect ive thal. we have a

PREFACE

from our colleague:-- so that we may impro e and refine our knowledge of

micropigme ntati~)n. We hope that this book will serve as a springboard for future endeavors by

other colleagues in order to expand this new field of medicine. We have endeavored to review medical principles and ethics thaI will assist the new and experienced praclitioner. Wi! hope this information will diminish unnecessary complications that may be due to a lack of knowledge.

xii

Charll:'s S. ZwerlinR Anl1ette C. Walker Norman F. Coldsleill

ACKNOWLEDGEMENTS

SPECIAL CONTKlBUTORS

George P. Walker Ill. M.D., QualilY Assurance Bernard Schulman. M.D .. Psychological Considerations L. Will iam Luria. M.D .. Breast Pigmentat ion Frank H. Christensen, M.D., friend and previous co-author of

M1CROPIGM I:'NTA nON

In the preparation of this medical textbook. . a true cooperative effort was necessary. We wish to thank all the companies for t.heir time and information. We are especially grald 'ul 10 Frank Christensen. M.D .. for his friendship. original guidance and co-authorship in t.he preparation of the first book Micropigmenfllfioll . Much of his in:ight and thoughts persist into this new textbo(,k. Furthermore we appreciate the special written contributions of L. William Luria. M.D. , GeNge P. Walker Ill , M.D .. and Bernard Schulman, M.D.

Dr. Goldstein would like to !.hank in particular the Stat.e Health Department Director)., State Att()rncy~, the Illany classic tattoo artists and cosmetic tattoo artists who have ass isted with the national survey of 1993.

In panicular a special thank you 1.0 Pnli Pavlik for her contribution in the section on history of tattooing. to Su~an Preston of the A. Mason Blodgett and As:-.ot:i atcs of San Francisco. Rose Marie Beauchemin of Mount Laurel. New Jersey, and Tanya Noland of Little Rock, Arkansas.

Mahalo (thank you) to the Honolulu Medical Library. Lyle and Judy Tuttle. the Tattoo Art Museum. and the World of Tattoos CoHection in Hawai i for their generou:-. contrioutions.

And finally, his staff for t.heir invaluable assistnl1ce with our phone ca ll s, faxes and mai l surveys. A special "mahalo" lO Lois Chinen. Miyo Deal. Anna English. Arlene Floyd. Ali ce: Greer. Lana Llzaro, Chris Mackler. Cristina Simon. Merle Stelscr and his execut ive assistant. Russ Sowers.

An nette Walker wishes to acknowkdp: the late Helen Sheldon who cOlllributed much to the fi eld and Ihe advancement of Ihis book. Her deep appreciation to Arretla Dubose ancl Irma Dial. ['or the loving care of her children during the writing of the hook. A special thank you to Samantha Caruthers. Marcia Cohen, Norma Stadmil ler. Cathy BuKaty. Pati Pavlik . Kathleen Sligar, Con nie Bernabucci. Dr. Paul Manson. Phylli s Azman . CANP. RN. Dr. Benjamin Johnson, Slephen Kahn ESQ .. allll Christy and Michael Van Wagcncn for all their support and advancement of rhe field or rn icropiglTJcntalion.

A ~pec i:.ll thank you to Darlene Templetol} for her ne ver-ending belief :tnd belp in the preparation of this book.. her loya lty. ;md dedication to the field .

Finall y. to her hu~band. Dr. Genrgc P. Walker III fo r hi s enduring love and support. Thank. YOLI for hi~ belief in ,md c lI1~lant encouragement of this project.

xiii

ACKNOWLEDGEMENTS

Dr. Zwerling would like to e~pecially thank his wife Jean S. Zwcrling, R.N. ror her preparation of the chapter on the Rol' of the Ao.;sislanl. her original stimulation 10 write this :;econd book. and for all her love and support. To hi~ Siaff for all their valuable help in typing and preparation of the manuscript. running errands, and help with the compuler: Anne Howell. Sadie Futrell, Tracy Rosner. Cyndi Wilford, and Sue Strunk.

In nduilioll a special thank you 10 Tifrany A. Zwerling for her two orig inal line art pictures as well as our previ IU~ illuslratOr David L. Newman.

His special th:mks to Kristanne Matzek at the American Institute of Permanent Color Technology for her guidance and resources; and. lO Susan Guziek. BSN , for sharing h..::r excellent photographs and providing helpful

references. We wish to thank the contribution of Dnrryl Stephens or Ihe Mm'inc

In!>ul'ance Company for his assistance in our chaplcr on risk management. We owe a great deal of

Section One An Introduction

to Dermatechnology

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c H A p T E R 1

Introduction

Dermalpigmentation. commonly known a~ t;{lIooing, has been present for centur ies in our cultures for the purpose of body adornment. The implanting of pigments. colors. and/or dyes illtraderma.lly results in permanent alteration of Ii 'sue to gain a cosmetic .:flecr. The pigmentation effect is obtained by a procedure in \vhich minute, metabolically inert pigment granules are mechanically placed beneath the epidermis. When the procedure uti lizes microscopes or magnifying lOll pes, the appropriate term is micropigmcntation.

The intent of this book is to serve as t.he updated clinical reference guide to instruct. orient and !,erve as an historical reminder for the physician. nurse. and practitioner who wishes to hccome familiar with the prm:edure of permanent cosmetic application. This new technique has mushroomed in popularity over the pa:t ten years with the advent of the nurse practitioner and trained cosmetologi.st as new providers for this procedure. The introduction of new instrumentation and pigments by select manufacturers and the growing popularity or nurses ucveloping interest in this exciting new procedure was the stimulus to updut.e this textbook. The book will serve as a historical perspective and an orientation to the in~trument or other body parts will be awkward ami pt;rhaps even lime-consuming. After a rev,.' patients. the initial hurdles will be overcome and contldence gained.

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3

C HAP T E R

The micropigmelltati(J1l

procedure of the eyelids will

ellhancethe o~'erall appearance of the patiellt, by giving definitioll

and c%r to the lid contours in the

same way aframe delineates all oil

painting.

Within a . hon span of lime, the proceumc will become rOlltine and can be added [() the other procedures within the co!)metic practice. As with any new procedure. familiari ty comes with practice and repetition. A complete and thorough knowledge of the anatomy is im perat iv.:: before beginning any cosmetic procedure. In addition to the acqui~il i oll of the technical ski ll s, a practical knowlet.lge of patient p:-ychology and cos metology wi ll further aid the prac-titioner in obtaining bettcr results. Facial morphology. lid st.ructure. patient psychology, and co. metic enhancement techniques are equally important to obtain the desired results for the patient. Although the technique is easily maste red and becomes repetitive. it must be applied to the inuividual as a cUSll>mized application. The practilioner should initially approach this technique slowly and

devote time to the understanding of how all fact.ors interrelate and affect the overall result. This can be obtai ned only by approaching each patient individually. ,Although the mastery of the techniques for implanting the pigments is easy, the artistic understanding of facial morphology and cosmetology is complex and can be gai ned only with experience. This texl wi ll focus on those factors thut are con~idered nitica l ill obtaining the aesthetic result that both patieaL and practit ioner desi re. The anatomy and physiology of the eyelids and ot her areas app li cable for de rm aJ pi gmenttll io n must be 1I11(Jer~(()ou before attempting the procedure. This is a simp le outgrowth for the experienced physician and nurse, but wi ll require more diligence for cosmetologists and tattooists. After reading this textbook. all health care providers should be well cH:quainted with the information neces5ary to allow them to become comfortable with micropigrnentation.

Certain prerequisites are necessary to sllccessfully undertake micropig.mentatioll procedures. First. the procedure requi res a steady hand wi th little or no tremor motion. BecHu),c the placement of the pigment is pe rmanent. inappropriate placement of the pigmem wi ll

lead to an undesirable eflet: t. The bcst way to avoid thi , unnecc. sa ry problem is to place the pigment correctly in the begin ning. This require. concentration and a stcady hand . Second , because the procedure often requ ires assi:-ted vii>ua l magnifica tion. experience of familiarity with magnifying hillocu lar loures is helpful. There are many l(lupes currently available on the markct, and a recommended loupe power from two to a maximum of six is recomlllt:nded. Thiru, th.:: practitioner should have good binocular visio n with full (h:PLh perception . Even though a monocular practitioner cou ld probably perform this procedure safely, the practitioner with binocu lar vision has the advantage of s imultaneou~ perception of both eyes of the patient duri ng th~ procedure , and thus can ascertain the ~ymmetry and color intensi ty of tile pigment.

Good patiC lll selection i,' vital for a satisfactory result. It ha~ been our experience that there is a ~eglTlcnt of the population that will b~ wil li ng and ~\ccepting of th is procedure. It is COrnmllf1 sense to choose thc~e motivated pa tients ror Illicropigmentation rather than rho~e who are not truly motivated and need ('()axing. Never tr y to create all atmosphere or need for the

lNTRODUCT

unmotivated or unsure patienl. The ideal patient i:- one who has confidence and self-assurance. Such patients are highly motivated toward the benefits and positive results that the prm;edure will add to their lifestyle.

After the patient has been selected and feels confiden1 about undergoing the proccuurc, it is imponant that the patient and practitioner have a disclIssion regarding the realistic expectations. The patient needs to remember that micropigmcnlation doc). not correct other abnormalities !>uch as skill wrinkling. Time spent with the patient discussing other areas of skin. adnexal. and/or lid characteristics will lead to better patient satisfaction. The micropigmentation procedure of dle eyel ids will enhance the overall appearance of the patient , by giving definition and color to the lid contours in the same way a frame delineates an oil painting. Like the oil painting. the eyelids arc not anatomically changed. but rather demarcated and enhanced. If the patient desires further plastic corrective procctlures or facial reconstruction changes. these should be discussed prior to undertaking micropigmentation. and in most casel> the dermalpigmenlation l>hould be the tinal procedure.

The practitioner is both technician and anist. One needs to read about cosmetology and speak to professionals in the beauty field in order to get a better appreciation of what women and men do to improve their appearance. It is important for (he practitioner to learn about different beauty aids such as mascara, eyeliner. skin foundation. and eye shadow and to understand the needs of the patients and (he complexities of co') metology. Through thorough mastery of the tc(hnique and compre-hension of beauty aids. the practitioner will become truly successful in performing micropigmentalion procedures of the human body. Finally, with this procedure the practitioner gaills a scn:-.c of accomplishment that transcends t.he traditional technical aspects of cosmetic procedures. In rnanyinstances, for the first time, the health care provider will feel the sense of accomplishment as an anist.

o N

5

c H A p T E R

History of Tattooing

Pictorial se lf-adornment has a long hisrory. The earliest evidence of tattooing dates to the Ice Age, or more than 8000 BC These early bodily adornments were probably used to imitate the color of animals. have some mystical Of religiou s purpose , or possibly camoull age. though there i . no clear evidence fOf thes e su pp os itions . Modern tattooing is an extension of the primiti ve custom of painting the body . Examples of body paint include lhe red ochre found in prehi storic burial s ites; blue woad, llsed by the ancient Britons: koh l. used in Asia to enhance the beauty of the eyes; henna. used on fingernails in rh e Middle East: and, o f co ur se , the war painls of the American Indian tribes. The giant co metic industry today mi ght wel l be considered a modification of primitive "war paint" customs. Early cfucie tattoo need les made of bone, and bow ls that held pigment (usuallv soot) have been found in caves and rock stJata in France, Portuga l. Romania. and Scandinavia.

Egyptian Illummies, some as old as -lOOO years. di~play tattoos on womcn bUl not men . These ta\laos were placed on da ncing girls. concubinc~. and womcn singers. and ul-ually depicted the symbol of Res. the goddcs who protected these women.

7

CHAPTER 2

However, men were tattooed in Libya. Male mummies with symbols of sun worship on their skins were found in the tomb of Seti l (I DO BC).

In very early Greece, men were tattooed as a sign of nobility or proof of bravery. Later. when that custom declined, taBOOS in Greece were limited 10 slaves and criminals.

There is no evidence or rallooing among Hebrews even before the Mosaic Law, which forbade it. There is a scarcity of tattoos Oil Jews. even nonreligious Jew, . today.

From the ancient Middle East, t.he practice of taltooing spread to Southern Asia. By 2000 BC, it was practiced by the Shans (Eastern Burma), then the Burmese and Indians, and probably extended to the Is.lands of Lbe South Pacific. There is some controversy concerning the origin of tattooing in the South Pacific . One explanation is that tattooing came from China via Formosa. the Phillippines, and the East Indies. In China, there is evidence thal tatLOoing was. done as early as 1000 Be. The custom continued until the Chou Dynasty (300 -100 BC), primarily in the barbaric tribes of the North. and usually only for branding criminals. A second theory of the origin of South Pacific tattoos is that the practice came later. about 450 BC. from the Scmites of Arabia. A third explanation is that the practice of tattooing carne from South America wilh sailors along the Kon-Tiki route to Polynesia and New Zealand. The fourth. less scientific but definitely more romantic explanation i that it was brought to the islands of the South P:l(:iric by the Goddess of Tattooing. who sang the virtues of the arl as :.he ~wam from Fiji . The theme of her song was that it was proper that

HISTORY o F TATTOOING

women be rattooed. but not men. Somehow the message became confused, and it carne about that men were tallooed instead or women.

It has been well documented that the Jnca~, Mayas, and Aztecs were tattooing themselves long before the Christian era. Daniels, Post, and Amlelagoi> described mummified skin and published photographs of two taHooed hands, one from Ancon. Peru (AD 900-1450), and the other (date unknown) from elsewhere on the coust. They a!. 0 reviewed the histology of mummy skin and could clearly identify black tattoo pigment , presumed to be carbon, melanin, carotene, and ac id rnucopolysaccharides.

The Ainus were u nomadic people who traveled across Asia t.o Siberia lind Japan. Ainu tattoos were originully of a religious nature. The Ainu settled on the Island of Hokaido in Northern Japan. Some contemporary Ainu women have their chins and upper lips tattooed with all imitation of hair or lip accentuation for sexual attractiveness (black or blue-black lipstick). By the time of the Roman Era, the Britons, Iberians, Gauls, Goths, Teutons, PiClS , and Scots were practicing the art of tattooing.

"When the Roman Legions finally conquered the Britons and pushed northward into Scotland, they met with the un-yielding opposition of the original lhcrianinhahilants, now pushed buck by their carlier Celtic conquerors into the High-lands of Central, Northern and Northeastern Scotland. The name -Pict' used by these people is actually a Roman o ne meaning 'painted men ' lind referred to their practice of tattooi ng themsel ves with woad, a blue dye derived from a nat.ive plant. They also colored their entire bodies hlue before battle with dye as they. like the Celts , o[tcn went into battle naked. And while wc think of them a~ being ' hlue Pic IS: the Romans abo r

CHAPTER 2

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Early Romans considered tatoo barbaric. Later, a few Roman ' had an intere!>l in the art of tallooing, but only for a limited time. When Julius Caesar raided Britain in 55 and 54 BC, he found lhe Britons with animal tattoos. It is believed that the name " Briton" is derived from a Breton word meaning "paint-ed in various colors." Early Christians u. ed small tattoo. slIch as the sign of the eros , a lamb, a fish, or the letter "X" or ''IN'' to identify them-selves, just as members of present-day Mexican Ameri-can gangs and clubs often sport the "Pachuco Mark" between the thumb and index finger.

When Emperor CorlSlan-tine established Christianity as the Empirc's religion in AD 325, he forbade facial tattooing because it di 'figured the human body. made in Gou" image. In AD 787, Pope Hadrian I banned all forms of tallooing. "Ye shall not makc any cUllings in your flesh for the dead, nor print any marks upon you." (Leviticus XIX:28)

At about the same lime us Constantine was banning facial tattoos, Eskimo women were tattooing themselves. A

mummy of Olle ~uch E.-kimo woman was found on St. Lawrence island. Alaska, in the Bering Strait 40 miles from Russia and 130 miles frolll the Alaskan mainland in 1972. The 1600-year -old tattoos on one arm were clearly evident, but infrared photography was required to delineate the Laltoo. on the other. A. unique tattooing technique, limited tor many years to Alaska. was (kscribed in 1928: "Some of the 51. Lawrence Island Eskimo women and girls have beautifully executed tatroo marh, These are made freehand although sometimes an out li ne is traced before the tattooing takes place. The pigment is made from the soot of seal oi l lamps. which is taken

H S TOR Y o F TATTOOING

from the bottom of tea kettles or similar containers used to boil meat and other fm)d over the open name. The soot is mixed with urine, often that of an older woman. and is applied with s teel needles. Two methods of tallooing arc practiced. One method is to draw a string of sinew or other thread through the eye of the needle. The thread is then soaked thoroughly in the liquid p.igment anu drawn through the skin as the needle is inserted and pushed just under the skin for a distance of about a thirty-second of an inch when the point is again pierced through the skin. A small space is left without tattooing before the process is ug'din repeat.ed. The other method is LO prick the skin with the needle which is dipped in the pigment each time." (Geist, 1928)

Cabeza de Vaca, 1530, and Captain John Smith, 1593, recorded tauoos on natives ill the Gulf of Mexico and in Virginia and Florida. Captain Cook wrote .in his diary, called "First Voyage, 1976," "Both sexes paint their bodies, Tattow. as it is called in their language. This is done by inlaying the Color of black under the skins in such a manner as to be in-delible ." Cook's sailors were in tri gued by the Polynesian tattoos and startcd the almost universal fascination with tattoos by sailors, soldiers and other military personnel of all countries ever since. The word "talloo" actually came into the English language because of Captain Cook. It is interesting rhat the only other Polynesian word that became cOrt'ent in languages other than those of the South Sea Islands wa" "taboo:' from the Tongan .. tabu." a word often used in connection with orders to ban tattooing. The word "tattoo" is a variation of " tattow," "tatau." and 'tattaw." all forms of " Ia." thc Polynesian word ror striking or knocking. In the act of tattooing, Polynesians u 'c a piece of wood to strike a piece of bone or shell with many points on it. carrying the pigment to be driven into the ~kin.

Tattooing flourished in Japan in the 17th Century. it had been re-instated in the 13th Century, after having been abolished for 200 years. Its use was largely confined to the branding of criminals, a punishment that replaced former harsh sentences like t.he loss of a nosc. or an ear. The greater thc number of cOllvictions. the lIlorc tattoos showed on the ri-minal'~ skin.

The late J 8th Century marked the beginning of tallooing as a true art all over Japan. with awards given for the bcst dcsigns of' tattoos. Individual s frequently bequeathed their tattooed skins. Some of these h

C HAP T E R ~

11

HISTORY o F TATTOOING

has been from lhe experiences and experiments of Lanoo masters over the last century lllat we have developed the current micropigmenLation.

Modern tattooing can be dated LO 1880, when Samuel 0 ' Rei lIy designed Ihe first electric tartoo machine in New Yor.k. It was later patented in Great Britain in 1891 by his cousin, Tom Reilly, Tattoo machines used today by tattoo arti sts arc very similar to the original O' Reilly uoit, with some ingenious modifications and artistic embellishments. Many of these modern tattoo machines may be seen in lhe Talloo Art Museum in Sun Francisco or at the World of Tattoos exhibit in Honolulu.

All of the rnicropigmentation instruments now available on the market are in one way. shape or form derivalives of the original O'Reilly instrument. A standard tattoo instrument has the abi lity to change ils frequency from less than 30 cycles per second to over 120 cycles per second. Reciprocating and rolary tattooing machines represent the basic lype~ . Of these two types, the double coil reciprocating machine is the conventional type most used by tattoo artii>L .

According to Pati Pavlik, the Standard American Style of tattoo presently consis'ts of a sol id black outline with a body of color. The proression underwent an important transilion in approximately 1968 when tattoo artists began adopting basic art techniques in lhe application of tattooing . Con-sequently, tattoo art transcended its previoll s single dimension style 10 a multidimensional arl form.

A true pioneer in taUoo recip-ro

CHAPTER 2

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torian.Mr. TUllie also aCIS as a consultant on reconstructive pigmentation (0 doctors specializing in breast reconstruction at Stanford University.

Joe Kaplan has been a major inf1uence in intlddermal cosmetics for the last twenty years. His work with physicians helped legitimize cosmelic and reconstructive taltooing within the medical community. His impact on the industry comi.llucs through his tattoo tudio and supply businesse, in Mt. Vernon and his collaborations with plastic surgeons such as Dr. Schoen bach. Chief of Plastic Surgery at OUf Lady of Mercy Hospital in the Bronx.

Jack Rudy was the first tattooist to introduce the single needle finc line technique. This use of single needle was crucial (0 adapting to the array of situations and circumstances.

By the late 1970s, a greater number of women established them, elves within (he mainstream of tattoo art. Mary Jane Haake. Winonna Martin, Shelia May and Pari Pavlik are all tradilionally trained tUlloO artisls who began offering intradermal makeup and reconstructive pigmentation.

Although they were unaware of each mher's venture into intradennal cosmetics and reconstruction , they all shared a basic parallelism in development: an c1':pertise in classical tattooing and an appreciation of cosmclOlogy with a view toward facial morphology and the disciplines of makeup artistry.

From the standpoint of relatively modern medical applications, the use of tattooing can first be traced to Dr. Pauley who. in 1853, used a form of tattooing to treal "congenital purple plaques" and other various lesions of the skin. In 1848, Cordier had used tattooing as a means of treatment for nevi, and Schuh, in 1858, had the idea of first using skin tattooing in transplanted tissue in the practice of cheiloplasty. Twenty-one years Jarer, in 1879, Dc Wicker began using India ink in tattooing corneas for the cosmetic improvement of unsighlly glaucoma') or comeaI scar . . In 1911. Kolle was the first 10 use tattooing of a reddish pigment to change the contours of scarred lips with the vermilion border. He al 0 performed work in the area of scar revisions as well. In the late 1920's and mid '30s, Knapp. Duggan, and Nanavati began using various metals such as gold and platinum chloride to improve corneal scarring and give the illusion of normal-appearing iris.

In the 19405. Moestin. Mauclaire, Duformentel. and PUSSQt are generally given credit as the fiJ" t group of doctors to introduce the u e of tattooing in general surgery. Also in Ihe I 940s, due to the landmark work of Conway. Hante, Brown. Cannon and McDowell, tattooing was performed in permanent pigment injections in skin grafts and tlaps, as was inlraderrnal injection of tattooing for treatment of capillary hemangiomas.

In the 1960s. Dr. Crowell Beard described in the literature the use of eyelash tattooing with a hypodermic needle anti syringe using a brown pigment as an alternative to eyelash grafting. In 1984. Dr. Gio)'a Angres published his now famous landmark article on the U$e of eyelash tattooing to create an eyeliner and/or eyelash enhancement effect for cosmelic purposes. Dr. Angres was the first medical doctor to tlevelop his own machine and pigments for the specilic purpose of this c:yelincr procedure.

During the slimmer of 1986. the first textbook. MICRO-PIGMENTA TlON. wa. written by Drs. Zwcrling, Chri , tcn:en , and

HISTORY o F TATTOOING

Goldstein. This book provided a foundation of knowledge of the field, served as a reference guide, and created the basis of acceptable technical accuracy for this emerging field .

In 1987 the Permaderm Corporation developed and expanded dcnnalpigmentation to cosmetologists and other non-medical people. Due to numerous legal prohlems with the FTC in 1989-90 and training deficiencies, the company was short-lived. However , a number of cosmetoJogi ' ls and estheticians continued to pursue rnicropigmentation procedure.

In 1989 Dr. George and Annette Walker formed a new company named Derrnouilugc. The unique concept of Demlouflage was to creare an allied approach to dccmalpigmentatkll1 with the emergence of the nurse as an alternative practjtioner to the field. Moreover, with the creative and investigational ability of Annette Walker and other nurse pioneers, new uses of delmalpigmentation were discovered and utilized for patients. Now reconstructive applications for bum victims, vitiligo, scars, and portwine stains were available based on the new techniques and research by Mrs. Walker and others. DennouOage Clinic~. Incorporated. have graduated and trained over 1250 nurses and over 400 technicians in 4 I states, Canada. PUCliO Rico and Mexico.

[n 1992 The American Institute of Permanent Color Technology was formed. This new company offers jts members various training programs around the United States as well a ' educational seminar~ in which leading authorities in the field of pemlanent makeup participate. The company's main purpose i .. to serve as an educational fOTum for the procedure as well as a means of interdisciplinary communication with Lhe field among the physicians, nurses. cosmetologists. and tattooists .

15

c H A p T E

Instrumentation: Description and Development

R

AI publicalion time or the tirst book on rnic:ropigmemation, there wcre a towl of seven legitimate companies that produced micro~ pigmcntation products, offered educational courses, and/or provided practitioner assistance. Since that time, a number of companies have undergone significant reorganization. Several of the previous companies are no longer in business and, therefore, there arc no $lIppor\ service~ for their equipment. It is imperative (hat the pructitioner is a"'lure of these changes so that fUflIrc purchases of obsolete products are made with good di cretion.

There were a number of companies thal had manufactured micro-pigmentation machine.;: CoopcrVision (Natural Eyes), Perm

CHAPTER 3

/8

provid ing educ atiol1. tral n I ng. and research in the tip pi icati on and development of the field of micropigrnentation.

From a historical perspeclive, the Walkers identified a neet! to bridge the gap between the non-medical (cosmetologist') and tattooist) and the rnet!ically-trained pbysicians and surgeons. They believed that tbe nurse represented a viable alternative to this dilemma. Ultimately. nurses have become the largest grOllp of praclitioners in the micropigmentuliol1 markel. Nurses have provided the means of instilling quality issues of appropliate health care in the industry. Because of the acceptance of the nurse by both thc medical field and the cosmetic fiel.d, there has been an increased desi.re for unification within tbe field of rnicropigrnentation.

Derrnouilagc has assumed this enonl1()Us task of educating nurse ' and answering to Lhe numerOUl> nursing boards across the coulIlry regarding nurse practice issues. Annette Walker has travelled the ollntryextensively addressing these nursing boards and convincing them of the legitimacy of this procedure. Many states. due to her sole efforts. have now establishet! nurse practice acts that have approved of micropigmenturion a: an acceptable procedure.

The success or Annette Walker and Dermouflagc Clinics. Inc . in gaining recogni.tion and acceptance of micH1pigmentalion by nursing boards has been the primary stimulus ['or the re-cmergence of micro-pigmentation in the 19~Os.

Derrnouflage continues to provide quality education in basic and advanced micropigmel1lrtlion tcchniqucs. Specialty courses and research llpportllnitics are available through the company ' s eXlensive referral network. The graduates of the Dcrmouflage courses qualify for the only A-ratcd liability insurance available (as rated by Standard and Poor's) through Marine Insurance.

Derrnouflage Clinics. Inc. provides a large variety of iroll oxide pigments, meeting color recommendations for cosmetics by the FDA. The glycerol-based pigmcl1ls are packaged in sterile containers and meet the requirements of 6 micron or greater pigment granule size to inhibit po~tprocedural migration. The company distributes autoclaves and manufactures a slate-o['-Ule-an, inexpensive. ergol11atically contoured derm-table equipped with a stainless steel mayo stand and non-heat producing magnifying lamp. The company produces and distributes a cost-effective implanter with sterile disposable batTels and probes available.

The company provide~ training. certification. cOlllinuing education. and materials in the application of permanellt micropigrnentarion of the skin Cor cosmetic and ci1mouJlaging of disfigured areas such as in the corrccLive coloration of scars due to burns. wounds. etc .. vitiligo. alopecia. nirthrnarks. plastic surgical reconstruction. etc. Includes such cosmetic application ' as permanent eyeliner. eyebrows. and lip coloration. and corrective coloration Ille'burcs ror a:.ymmetrical racial rcatllrc~ . Currem resc:arch and ernerging applications include correction of hypertrophied scars and scar c()ntracturc~. especially racial . by the Dermnuflage techniques. Courses available for graduate~ include ba;;ic. advanced. and cuntinuing educatil.lI1.

For a complete listing. or all available products. services. and educational courscs. the reader can cal! 205-543-27M~ ror further i nrormation.

NSTRUMENTATION

Permark

Tile Enhancer system was introduced in 1985 by Dr. Michael Palipa, an ophthalmic plastic surgeon, practicing in West Palm Beach. Florida. This comp;my still provides very active invo lvenlcnt in the micro -pigmentation field today .

The Enhancer's pigmenting pen is straight, like a conventional writing pen. In addition to its ergomatic shape. the straight pen provides maximum visibility of the reciprocating needle cnd~ . This safety design is extremely important in ensuring the proper location for pigment introduction. For additional visibilit.y , the cone is beveled, permitting practitioners to see the needle location before it leaves the cone and enters the skin.

The pen-shaped handpiece provides the surgeon with a choice of performing the eyelid enhancement either facing the patient or from overhead. The pen utilizes five different need le sizes and operates at a ~pccd range up to 9000 reciprocations per minute with a low noise facl()r. To ensure that the needle exi ts the cone in the same exact depth for each penetration. the needle is directly connected to the reciprocating shaft. This prevents any movement or notation of the needle in the cone. The patented pcn has a calibrated dep th gauge which permits needle penetration selection from [Amm to 2.0111m.

S 60 0..

CJ)

'0 50 Z ..!!.. N :r:

40 ~ 0 z w ::> a 30 w cr: lJ...

Z 0

~ 20 cr: OJ :>

10

Instruments

2 3 4 5

SPEED SETTING (on knob)

Maximum 66 Cycle

6

Graph demonstrates the relationship of handpiece vibration to speed settings. Values shown are approximate. (Courtesy of Vision Concepts .)

------ ---- - - ------ - - - - --

7

19

CHAPTER 3

20

Presently there are two basic model. of the Enhancer system: the Enhancer II and the MicroENHANCER.

The Enhancer 11 is an Underwriter Laboratory (lJ/L) approved unit thm can function as a micropigmemation device as well as a dermabrader handpiece. A unique printed circuit board provides maximum . peed control, and all speeds are controlled by the practitioner with a linearly accelerating root pedal. Low speeds are ideal for individual dOL pbcement with maximulll safety and control. High speeds arc smoothly and easily attained, ami are used for completing the eyelid pigmentation and in other tissue pigmenting procedures. In case of foolswirch failure. a unique backup system in the power pack permits manual control of the needle speeds by l\1eans of a rheostat.

A prccision high-torquc motor permits arraumatic penetration of the skin by thc rcciprocating needles . At the same time. the lightweight. powerful motor permits penetration of scarred and grafted tissues for pigmenting. This is especially important in skin grafts. breast reconstructions, and trauma cases requiring pigment enhancement. The motor requires no maintenance or lubrication, and is guaranteed for the life of the cqu ipment.

The MkroENHANCER was introduced in the fall of 1992 as a micropigmcntation device only. Utilizing the same patented handpiece as the Enhanpeed of 6000 rpm allows for all micropigmentation type procedures. Micropigmenration Devices lnc ., the manufacturer and distributor of the Pcm1Urk Enhancer System supports its equipment with a full line of gamma radiated, heat sealed pigments and necdles as well as a customer service department.

Micropigmentation Devices Jnc. under the Permark brand eurrel1lly supplies 37 colors of gamma radiated pigments in reusable container. The colors range from flesh tones. nipple areolar shades, eyebrow and eyeliner colors. lip tones, and skin toner" ' mixers of whi te, yellow. brown, and red .

The base pigment is an iron oxide compound. suspended in a mixture of glycerol and alcohol. The company maintain stricL quality control of tbe product and has full product liability insurance. The only disclaimer is if a practitioner mixes or lIses the Permark pigment in conjunction with non-insured products by other suppliers. Each pigment package has an expiration date. The company has a policy of Tcstcrilizution wirhout charge for any pigment that is returned unopened within one year from the e.\piration dalc. All colors are stockc:d and can be shipped within 24 hours.

Currently Pc:rmark runs training seminars in the use of their equipment only. This six hour in-service training program is taught at various locations around the counrr)'. A cerriticate i~ awarded at the completion of the course.

For additional information, color charls, seminar schedules, and product lilerature contact Micropigmcntation Devices Inc., 450 Raritan CenLel Drive, Edison, ~cw Jersey 08X37 or call 8002825228 or in New Jersey 9082253700.

----------------------------------------------------------

NSTRUMENTATTON

Alcon (NatllralEyes)

Originally, the CooperVision Company, in association with Dr. Giora Angres, developed a prototype Natural Eyes unit thal function plin1

CHAPTER 3

22

operating range of 6,000 to 16,000 pulses per minute (100-270 Hz). The maximum speed of the machine is 16,000 pulses per millllle with a nominal needle excursion of 1.25 mm. The tip assembly is a disposable three-pronged 27 gauge needle, bonded together in the shape of a pyramid. Viewed from above. the needle points are like an equidistant triangle. The needles protrude out or the nose cone for a distance that can vary from 1.5 111m to 2 mm. Optimal pigment placement is approximately 1 mm to 1.2 I11JTl into the skin. Actual needle tip penetration is then controlled by the surgeon.

Console. The console includes all the wiring and powering connections to which the handpiece is attached. The console con.'isls of a pulse rate display unit. which is a solid state analogue panel meter. This depicts the pulse ratc percent thaI represents the natural DC voltage applied to the motor drive handpiece. The maximum pulse rate slide adjust control sets the maximum voltage for a pul.se rate that can be delivered to lhe handpiece via the f'ootswitch. The main power switch is a simple onloff butto!) Ihal applies voltage 10 the machine from an external wall unil. The handpiece connector is a chrome-finished connector used to connect Ule handpiece cord to the front of rhe macbine. In the rear of the machine the chrome-finished connector is used ro connect the foots witch cord to the console ullit..

Foot..

NSTRUMENTATION

pouch; (3) thread the assembly tightly into the handpiece head withoul the use or tools; (4) press the needle tip or cover firmly againsl a hard. sterile surt'ace in order to "scat the needle". (Listen for an audihle click. which ensures engagement. Also the praclitioner shou ld note the removal of a small piece of metal from the posterior portion or the head unit. which usually guarantees a proper connection.): (5) remove the protective metal cover from the tip: (6) hold the drive unit, rolate the motor base, and observe a 1.2 mm nominal needle ex.cursion (recently. U1C company has stated it is not unu~ual to have a 1.5 mll1 to even 2 m111 needle excursion). The recommended procedure at this timc is not to press the cone to the skin surface while performing the proceJure. To reseat the needle, (1) reinstall protcctive cover, press against a hard. sterile surface. and listen again for an audible click, which ensures engagement. rr problems pers is \' the practitioner is usually advised to see the troubleshooting section in the operator's manu

CHAPTER 3

2-1

The dimensions of the machine arc 3 3/4 inches by 8 1/3 inches by 9 inches. Tht! power requirements are 115 volts pills or minus 10% at 0.25 amps. The leakage facrm is less than 100 microamps.

Starting from the number one power selling on the power control unit, the Accents single needle handpiece cxtends only slightly from the needle guide. thereby creating the illusion thai the needle is nOI in mOlion. Gradually adjusting tht! power conlrol to the higher settings of 3,4. or 5 will cause the needle to extend to its proper extension, as wcll as providing 1'01' appropriate penetration of the skin (depending on the skin lype). Settings of 6.7. and 8 arc thc mo:-t widely used. as they prove to be the most suitable for average skin tissues. It is important to nOle that the AcceJ1ls handpiece was designed so that the needle will not eXLend pasL the predetermined length of (l060 +/- O'()IO inches (or 1.5 +/- 0.25 mm). regardless of what sClting is used. Placing the power unit setting at 9 or 10 will not increase pcrfonnancc. but will only increase t.he vibmtion of the unit. Dioptics does nOt re(;Ommend using settings of 9 or 10 unless penetration i, not obtainable at a lower power setting.

Dioptics took into

NSTRUMENTATION

needle extraction of 1. 9 mm rnayirnplanl pigment in the orbicularis muscle uncVor tar. liS plate. Because this ha:, been shown to increase the potential for hematoma and pigment migration, it is quile important to operate the handpiece wilh the bevel open. In the past few year~ Accents has offered additional needle configurations: seven needle dimension ( 28 gauge! .015" with maximum neetlle extension of 0 to 2.Smm+f- .25I11m): three needle dimension (2)) guage! .0 IS" with needle extension of 0 to 1.5mm+/-. 25 mill ): and, a three needlt: dimension (26 gauge/ .018" with maximum needle extension of 0 to 2.5lT\1l\+!-.25I1lm).

The handpiece is tapered down from the final third of the unit to rhe tip, thus increasing the visibility of the needle tip. The grainlike texture of the handpiece is easier to grip. The needle guide, made of a plastic, maintains more pigment per series of dots than its metal predecessor.

The company recommends thal if any tlefccts are discovered while testing the handpiece, thc unit should be repackagetl in ils entirety and returned to Dioptics. A replacement pack will be sent immediately.

Warning. The company cautions that the Accents handpiece is a disposable. single-usc instrument and (;unnot be reused. There are two specific reasons why reuse is cOlltraindi(;ated. First , the handpiece and especially the needle and guide , contain moving parts. This makes cleaning and subsequent sterilizing extremely difficult since pigments from a prior case can remain insitle the needle guide. This warning is consistent with hospital accreditalion policy regarding reu~e of disposables. Secondly, as the handpiece utilized a needle to penetrate the skin 10 a very specific depth. a dull (reused) needle may not penetrate 1.0 the propcr depth, resulting in a less effective procedurt:' , and implantation of pigment in thc epidermis. Reu. e of disposables (both pigment and handpieccs) may also affect liability insurance exposure in the event of any legal proceedings by patients.

Table 3 I: PigmcllI Mixtures and Mlichinc Design Features

Titanium Backup Needle Type D;sposab:e Autcmabc Pigment Iron Oxide Dioxide

Man~1actw2r Vanab~ Variable Power Single, H~ndp!eCIJ & Pigment Colors Pigfl'.en( Pigment (Pri)ojuct Name) Spetd Thrust Supply MultIlJ'e Se:nipermlnent RfSe~;OIr A\'2I~bIe Avai'abIf Avai~bie

Alcon Yes No No YES No Yes Yes Ves Nu INa1Ura!:I~i

:1!cpt!CS ~o Yes Yes Yes Yes No Yes Yes Yes [Actenls)

VlSlCn Cw:rPIS Yes )'~s v. .. , Yes Yes Yes Yes YdS Yes iGlamour EifSI

AJiler. ~o Yes riO YeS NQ ~{} YES Yes Yes I Penna! lie)

Derrmutloge Yes No rIo Y15 Yes No Yes Yes Yes

Cosmetyr.e flo Yas lID Yes Yes ~1C No No No iDSL5())))

Permark Yes No '110 Yes YES No Yes Its Yes \Ennarn:er)

Concep; inc. N(j No ~~o Yes Yes Yes Yes Yes Yes ilasnj"e!}

-------- - - - - ----- - -- --- --- -- - - -

~mell! Pigment MixtlJre Mixture Containing Handpiece

Con!ammQ7~ Ethyl Compatability Isopropyl A!Gchol Yidh Other Akllnol &G!'iWlIl ~ines

Yes tfu Uo

~,o Yes Yes

No Yes Yes

IJo YeS Ves

No Yes T"II

No No No

flo Yas NQ

~.o Yes No

25

C H A P TE R 3

26

For further information, the r~ader may write to Dioptics M edica l Products, Accents Di vision. 15550 Roc.kficld Boulevard, Suite C, Irvine. California 92718. The phone number is 805-541-0811.

Lasting Impressions

Lasting Imprcssions I is a rnedical-csthctician manufacturer and distributor of micropigmcl1tation products and services. Its founder, Darlene and Richard Story have committed their company to a five-point approach:

1. Improve pigment quality, selection and sizes: All the company' , pigments are manufactured from FDA approved products under sterile condit ions with pigment granular size at 6 microns. The company u es 44 different Microcolors and the shades come in 4 sizes l5cc, 2cc, and 0.5cc vials and a 0.5cc tester vial.

2. Create a color mixing system: The compa ny created a patent-pending mixing sy tem for its 44 base color set. This system all ows the practitioner the flexibility for cus tom color preparation.

3. Establish a consultant" support group: The company provides the practitioner with appropriate physician, nurse, and technologL ts referrals within the micropigmcnLation field.

4. Estahlish a Lrainiog program: The company is establishing its own training program to assist the novice practitioner in proper training and certifjl:tltion within the field.

5. Integrate estheticians with the medical field: Wilh the increasing use of physicians and nurses relying on eSLheticians to assist and even perfonn various pennanent makeup procedures. La. ting Impressions I is committed in helping the estheticians integrate into the medical field.

For further inrormation contact Darlene or Richard Story a t 237 Liberty Road, Englewood, New Jersey 0763 1. Phone toll free 800-377-40li8. In New J ersey call 201-87l-7388 and FAX 201-871-4942.

VlSion Concepts (Glnmour Eyes)

Vision Concepts, Inc. developed a new system for micropigmenwtion known as Glamour Eyes in 1984 and had the following features: reusahle handpiece, separate disposable needles, reasonable price, separate pigments, and complete backup circuitry for the machine. The Vision Concepts system consist.ed of a handpiece. power unit. and footswitch. The company had designated the LOtal system as the GLE 100 System.

Ha nd piece. The handpiece wa~ it semipermanent, linear solenoid clevice:! thaI wa!> guaranteed ror 90 days. The handpiece conriguration was straight, allowing for a better surgical field of view while reducing hand ratigue. and was compatible with the Dioptics console. The handpiece was unique with its relillahlc reservoir that automatically fed the pigment to the

INSTRUMENTATION

needle, thus eliminating the need for const ::J

~ '0.

U) "0

"0 en :u ::J c: Q) ,9' en Q) 2 3: 'E

:J:

Number 01 Cases a.. ..c: a Q)

U) t- o.. a :0 Original Cost of Performed to Q) Q) CL

'" :0 :0 7' E en Cost of Disposables Recoup Investment a "" OJ ..::.: "0 CL Company Machine per Case (Allow $500/Case) ' ~ '~ 0> en '" "" '" Q) 5 :> :> co 2:

Alcon $6.000 $60. '15 Y N N 3 N "Natural Eyes"

Diopllcs $2 .500 $150 8 t~ Y Y 1 Y "Accents" 3

Permark 53,500 $65 8 Y N N 1 N 3

Vision Concepts 51 .850 S71. 7 Y Y Y 1 N "Glamour Eyes" 3

Alltek 51 .250 $36. 6 N Y N N "Permline"

Dermoufiage $ 450 $40. 2 Y N N 1 Y 3

Cosmedyne 51 ,500 $115. 5 N Y Y Y

.... '0 ~ Q)

'" Q) a: c: Q)

E 0> 0:: .~ ~ Compatibility E with Other 0 :; Machines

CHAPTER 3

28

To our knowledge the company is no longer in business. Buyer should beware of any old equipment purchases since there appears to be no one servicing this equipment today.

Alltek (PerrtUIline)

Pennaline eyeliner system is another microsurgical devicc for applying permanent lashliner. This system was produced by the AlltekCompany and included a solid state power unit, semidisposable handpiece, sterile tips and pigments. Unfortunately. this company is no longer in bu iness. The fonowing information is of historical significance only and could be helpful in the even! that a practitioner may wish to buy a used unit.

Power Unit. The console or power unit for the Permaline system is US made, microprocessor controlled circuitry with a digital display readout. The unit is 9 inches long, 6 inches wide, [Uld 2 inches high. With the digital readout sYSlel11. the company stated, the results are exacting and repeatable.

Handpiece. The Alitek system handpiece is reusable and consi'ls of one pre,cision moving part. The system is designed to function with similar singleneedle systems such as the Dioptics-Accents machine system. According to the company. the handpiece can be used for over 50 procedures before a replacement is necessary.

Needle Assem bly. The company offers a disposable needle assembly to be used in conjunction with the multiuse handpiece. The stainle's 'leet needle is fine-gauged and manufactured to exacLing toleran

INSTRUMENTATION

Eye-lite Inc. (EL2000)

The EL :WOO by Eye-Lite, Inc. was a new instrument in the market-place. Again this company represents another casualty in the instru-mentation companies of the late 1980s. The company i~ out of husiness. In tlc~igning the EL 2000, Eye-Lite had taken special care to ensure that the surgeon had the facility , during the procedure, to alter the depth of penetration of the needle. the speed of the needle, and the pulsatility of the needle. It i ' fclt with these three features. greater control is afforded the surgeon and thus a safer and more even application of the pigment can be achieved.

Speed. The range of cannula speed in the EL 2000 can be varied by the surgeon from approx imately 1000 cpm (0 2000 Cplll. This range allows fast penetration and even pigment application while keeping the needle speed at a safe controlled rate.

Penetration Depth. Due to variances in eyelid thickness from patient to patient and the angle at which different surgeons hold t.he handpiece, EL 2000 corporales the facility of manually adjusting the protrusion or the needle beyond the needle guard. By simply turning the nose cone of the handpiece ill a clockwise direction , the penetration depth of the needle can be increa~cd from 0.6 111m up to 1.5 mm. This adjustment can be done during the procedure. even with the machine running.

Pulse Rate. Another feature unique 10 the EL 2000 is a "burst" or "pulse" mode. With this feature, the surgeon can set the needle speed anywhere within the manufactured range while also ~etting the pulse rate, which bas an approxi mate range from 0.5 seconds to 1.5 seconds. For example, if the pulse rate has been set at it maximum and the speed ha been set at 2000 cpm. the surgeon depresses the foots witch to position j and the needle wi II activate at 2000 eplll per period of 1.5 seconds, then top for 1.5 seconds, and then activate for 1.5 second . etc. If at any time

during the procedure the surgeon wishes to operate in a continuous mode, he simply depresses the footswitch to position 2, and the needle will run continuously at the preset ~peed.

System Accessories.The EL 2000 sy~tel11 includes the control console, the footswitch , the instruction manual. and the handpiece.

American Institute Of Permanent Color Technology

The American Institute of Permanent Color Technology specia lizes in educational programs for demographic application, including micro-pigmentation and l11ultitrepannic procedures. The Institute administrates a natural micropigl11entation research program. consisting of seven approved research facilities (nationwide). an "esthetic:> research r"cility in Ohio, and

29

CHAPTER 3

30

an education center in Kentucky. Each facility is responsible for oil-going contributions to the industry. as well as loca l affiliate participation. the Schei bncr Center in Sydncy, Australia. Other affiliate projects include Canada, Mexico and New Zealand (projected 1993).

The AIPCT was created in it joint effort con isting of an '"all -star team" of accompli.shed Derl11a-Techs and medical professionals nationwide. and heraldcd the comi ng together o f the "Macro-Theory" approach to permanent color application. Macro-Theory is a specific combination of ALL variations of pemlanent color application. both "age-old" anc.l "new wave" . Irs purpose is t.o provide the technician witb the most effective appli cati on for each individual situat ion as it occurs, providing an mTay of alternati ve procedures and the proper method of dctcl111ining which is best.

The American Insti tute offers a multitude of specialized programs divided into th ree main categories: (J) Permanent Color Application. (2) Paramedical/Corrective Pcrmanenl Col()f Procedures, and (3) Multi-trep

c H A p T E

FDA and State Regulations

HISTORY

R

The historical evolution of todny's modern drug and cosmetic regulations can be traced to the Federal Food and Drugs Act of 1906 which was created largely by the work of Dr. Harvey W. Wiley in 1906. The essence of the 1906 legislation dealt with the prevention of ales or transportation of adu lterated, misbranded, poisonous or deleterious foods, drugs. medicines and liquors, and the regulation of their traffic through inlerstate commerce. Unfortunately. the act never discussed premarket testing for efficacy and safety. The acl also discussed tl,e tenn "drug" as recognized in the United States Pharmacopoea or national formu lary for internal and external use.

Federal Food , Dr ug a nd Cosmetic Act. or 1938. ft was not until 1938 after numcrous complaints by the public sector that the Federal Food. Drug and Cosmetic Act of 11)38 was passed. Unfortunately. it took a disaster involving diethylene glycocol, a toxic substance mixed i.n the elixir of :"ulfanilamide. in which 100 people lost their lives in 1938, lO prompt the passing of ihe acl. The! t)38 provision defined more clearly the concepts of cosmetics. drugs and foods. The 1

CHAPTER 4

32

Durham-Humphrey Amendments of 1951. The next major addition LO the federal guidelines were the Durham-Humphrey amendments of 1951, !>ometimcs known as the prescription drug amendment. These amendments considered that distribution of drugs was to be done by pharmacies and clarified the nature of prescriptions.

Color Additive Amendment of 1960. Tn order to simplify the product development of color additives, as well as provide scientific data, in 1960 the FDA developed the Color Additive Amendment, which exempts certain chemicals, dyes, and pigments from batch testing. Throughout the decade of the 1960s, various cosmetic and pharmaceutical companies began in-depth scientific analysis of these pigments and provided the FDA with the appropriate data and analysis necessary for their exemption.

Drug Amendments of 1962. As with the sulfanilamide disaster of 1l)38, in 1962 history repeated itself with a thalidomide disaster. Because of this tragic cpi. ode, the Kefauver-Harris drug amendments were added to the previous acts concerning safety, effectiveness, and reliability. as well as standardization of drug names. In add ition. the articles considered factory inspection and effect of state laws. registration of drug establishments, and patielll information (informed consent).

Fair Packaging Act of 1966. In 1966, the Fair Packaging Act was passed in order for consumers to be informed of label statements of the products identified and the quantity of contents a. specilied by law. The purpose of this act was to prevent deception and to offer consumers a means of evaluating and comparing different products.

Medical Device Amendments of 1976. On May 28, 1976. the Federal Food. Drug, and Cosmetic Act was amended again as the "medical device amendmenls of 1976." The act consisted of classification of device intended for human use, performance standards, premarket approval. band devices, and judicial revic,,,' . Tn addition, the Jaw discussed general provisions respecting control of devices intended for human use as well as a classification of the devices themselves.

In the 1970s, numerous publication of cosmetic investig~ltion were published in the Federal Register, and various subcommittees such as the Cosmetic, Toiletry, and Fmgrance Association Subcommittees on Quality Assurance were created. These various studies and agencies have considered the issues of product preservation and antimicrobial and antifungal safety of cosmetics produced in the industry.

In 1976. the Federal Food and Drug Administratioll (FDA) received variolls petitions for the listing of iron oxides as permanent color additives to be used in externally applied cosmetics, including lipstiCKS and those used around the eye. The commissioner evaluateo the clata ancl concluded thaI iron oxides were safe as long as the following criteria were met; (a) that the color additives of the iron oxides consisted or combinations of :"ynthetically prepared iron oxides and was free from admixture with other substances: (b) that the iron oxides would contain no more than three parts per million of arsenic. no more than ten parts per million of lead, and not more than rhre.:: pans per million of mercury: and, (c) that the iron oxides were safe when applied to the areas surrounding the eye as long us their production was con:.iSlcnt with good manufacturing praclices. However. in

---- ----------------------

FDA AND S TAT E REGULAT I ONS

a later amendment known as Titk 21. part 70 concerning color additives, sc

CHAPTER 4

34

imparting color thereto. Color includes black, white, and imermediate grays. Tn the earlier part of 1985, ajoint meeting of the various departments of

the FDA was convened in order to discuss the subject of tattoo colors and tattooing apparatLis. The purpose of this meeting was to determine the enforcement policy regarding human body tallooing. especial.ly in the area of the eye (eyelid tattoo). A general resolution was created that stated the following decisions:

'That the agency policy continue to be that the dyes and pigments used in tattooing are color additives as defined under section 201(T) of the FDC Act and that they are cosmetics.

'That tattooing in the area of the eye is considered to be more of more serious concern than other body areas. The agency policy concerning human body tattooing. generally will remain unchanged from the past policy.

"That the devict! status of the apparatlls used to create a tatloo i: unclear; however, it was concluded that the device authorities would not be applied at this time. After CDRH has responded to any 51 O(K) submission for the use uf such an apparatus. the.y should refer the information to the CFSAN for any appropriate action.

''That the CFSAN will dral't the policy statement of the regulatory status of tattoos with special reference to the eyes. (e.g., colors, dyes, pigments and apparalu , used to create tattoos) for the concurrence by ORA."

The essence of this resolution is that the device status of the micropigment

FDA AND S TAT E REGULATIONS

undergo far more stringent and careful regulation by the FDA than does the cosmetic industry. In essence. a drug company is considered to be guilty and must prove its innocence before a new drug: can be released to the American public, whereas in the cosmetic industry the burden of proof falls on Ihe FDA. The FDA mllst prove that the cosmetic finn's new product can cause potential harm 0 the human being. IIi. rather obviou. that there j,' a vast dillcrcnce in the approach of these regulations between a drug

CHAPT E R 4

36

Current State Laws Pertajning to Tattooing Norman Goldstein, M.D., F.A.C.P.,

Clinical Professor, Medicine John A. Bums School of Medicine, Univer 'ity of Hawaii

State Local 1993 Reply State Statutes Ordinances Pending Remark.~

Alabama No Ahl~ka Nil X Aritona No Leg~lation being consid~red . Arkansas y~> Writren conscnt of parent or guardian

of minor ( I g yrs.). A 6-month appr(o-ticeship under a I icenscd physician or certi fied ~nnanent ani,1 licensed for 3 vrs.

California y~, X No r;gulatillns2

Colormetologist or cnsnJctician or medical doctor. or a l ic~lIsed nur;e under direct u~r\'ision of a medical doclor.

Connecticut Yc, Delaware No f'lorida Yes X Limited to a person liceR:;">! to

practice medicine or dentistry, or by a person under his direclitln.~ Dr. must train technician 2xfyr."

Georgia Yes X Eyeliner prohibited except in con-junction wilh Doc(()r's office. Other tattoos are penniued.

Ha __ aii YI:'\ Regulations first e":lbli 'hed 1949. rc\iscd 198 I. Annual inspection and pennit reqllired. During WW II , 400 people tllttooed daily! Today, 21 licensed tattoo parlors on Oahu_ I 011 Maui. 6 on "Big Island" of Hawaii.

Idaho No Yes X May have local ordinances. lllinllis y.:,1 X No Regulation~~ Indiana yc, ts inducted in license to pmctice

medicine Of osteopathic medicine. Iowa YI!S Yes No cosmetic tattoo regulations ~r

,c at thi, tim~. Kansas :-1n Legi~lalion being considered IApr..

1993) to be done by docUJr only.1 Kenlll,ky No Legislation cnnsidc:red: all rattoo,

must have Registered Nurse prc-~ent at all rillles during tallooing.

Louisiun:1 No X xfainc Yes Tart{)ning of minors ( 18) prohi-

bited. Fine:, $50 1{1 $500 or prison up to 6 months. Prior to 1975 it was ill~eal ro tattoo the Ixxh of a female person. -

Maryland Yc, Cosmetology Board prohibit COi-rnetologilots trom doing cosmetic lattooing in ('oslIIctology sa lons or by liccnseJ co,mclOlogists .

. \iassachuse![

FDA AND S TAT E REGULATIONS

Slate LOC'.tI 1993 Reply Slate Statutes Ordinances I'ending Remarks

Michigan Yes A liCell\cd ~(}smetoJogisl may do cosmetic wltoQing in a licensed cosmetology t:~tnblblunl!nL Other licensees may: ifl'rmittcd in their scope of practlc~ .-

Minncwta No Yes X 51. Paul and Minneapolis Mis~i8Sippi No Miswuri No Yes Local ordinance ' in Springfield and

Waynesville. Montana No Ndmlska No Nevada Yes Yes Cosmetology Boord prohibits tatloo-

ing. No S[al~ liccns.ing for tJuooi ng. but Reno aqd Las Vegas have sirict guidelines:'

New Hampshire Yes New Jersey No New Mexico Nol X l\ew York Nol Yes Banned in New York City boroughs

(Jicpalitis cases Coney L~land 19(1) Buffalo (Eri~ County) & N.Y. Stale considering lleW regulations.

North Carolina Yes X Prohibited under 18 yrs. J;ine up to 'SOO, impnwnment up to 6 mOluhs.

or both. North Dakota No No ,ramtes or I'ule~ to date. Ohio No X Oklahoma Yes Onl)' perillits a .licensed practitioner

of the healing arts, performed in the COlu:e of his practice.

Oregoo No Yes Slat~ laws under Eleelrology Boan:! ~nJing , Ponland has regulations.

Pennsylvania Yes Tm[ooing minor,; prohibited without parent's consent OK yn:..). Fine not to ex,ced $2.500.

Rhode L land y~s Comprehensive regu lations about tauOl) [lI1ists and lattOO parlor

inspections. South Carolina Yes Prohibits all titltO()~ (1966). In 1986.

physicians may perfonn for cosmetic or re.constructive surgery.

South D:JKOla Yes Yes SWtc ,lnd local regulations being considered.

Tennessee Nol X Texas Yes Unlawful to litnO\) any person under

age of 21 yrs. Some cilies and counties ha\e local ordinances.

Utah No Yes X Salll.;(ke County has regulations. Vermont Yes pf(lhibir~d except by a p.:rsOIl IkenseJ

til practice medicine or osteopathy. Virginia No Yt> X Rrg!Jiakd at local lc\'e!s. PCl1nit~

Illedicul JOCftJr>, vdclinuriulls, regis-Icrl."(lliuThC~ 0r 3nv other liecos.:d medical

CHAPTER 4

STATE lAWS AND REGUlATIONS

Tattooing was forbidden by Moses because il was the worship of idol '. The Mosak Law does seem to have been obeyed by most of his followers throughollt the centuries. However, despite biblical injuctions. despite Muhammed's 1 prohihitions (nine references in (he Hadilh pertaining to tattooing), despite decrees by the Roman Emperor Constantine in ca, AD, 300. Pope Hadrian in A.D. 787, Emperor Mcjci in Japan in 1868. Natjonal Laws such as that of the French in 1889. and despite more laws against. or limiting tattoos for reasons of public health. tattooing persists today. Indeed. the number or tattoo artists,. professional and amateur, as weJl as the number of physicians and veterinarians who arc doing tattooing for cosmetic purposes. is increasing at a phenomenal rate . Membership in regional. national and imclllational tattoo clubs i .. also increasing yearly.

CURRENT STATE lAWS PERTAINING TO NURSES

State State Statutes

Alabama No California Yes Colorado Yes Connecticut No District of Columbia No Florida No Georgia Yes Illinois No Indiana Yes Kansas No Kentucky Yes Louisiana No Maryland No Massachusetts Ycs Michigan No New Jersey No New York No North Carolina No Ohio No Oklahoma Yes Pennsylvania No South Carolina Yes Texas No Vcrnwnt .... cs Virginia No

38

Allnette Walkel; R.N.

Nursing Board Rulings

2,3 1.2,3 I 1 1 2,3 I 2,3 4 2,3 I I 2,3 I I J I 1 2,3 I 2,3 I 2,3 I

Remarks

Under dodor's supcrvision

Under doctor's supervision

Doctors only

LEGEND 1 = Independent Conlractor 2. = Advanced Nurse Practice 3 = Standardized Nurse Pracrice 4- = Not Within Legal Scope of

Nursing Practicc

FDA AND S TAT E REGULAT

With the participation of nurses. cosrnelolObrjsts, .lIld cstheticians. the field has more than doubled in the past 3 yeurs.

In 1979. a review of laws and regulations pertaining 10 tattooing was published in the Journal of Dermatological Surgery and Oncology. A fol lowup . urvcy was conducted in May 1985 and published in Micropigmen/(J/io/l ill 1986. These surveys were based on information ob-tained from directo[s of State Health Departments and! or their legal advisors in selected major cities in the United Slales. A 1992 national survey has been completed and is inc luded in this text

Replies were received from 46 states, as well as several cities. Based on this urvey and the 1979 and 1985 reports. 26 states do not. have regulations, or statutes pertaining to tattoos. Several health department directors or attorneys have related that. even though theiT stille. do not have regulations. some cities and ("ounties within the stales do regulate taltooing. Several states, such as fduho.lowa. Missouri, Minnesota. South Dakota, Texas. and Virginia. advise persons engaged in such activities to contact local authorit ics about locaJ ordinances.

States with cities tJlat have local ordinances include: Minl1e~ow (S l. Paul. Minneapolis), Nevada (Reno, Las Vega, ). Oregon (MultnoJTlah. Portland County). Ulah (Salt Lake County), California (Long Beach, Oceanside, San Diego. San Francisco), Maryland (Baltimore). New Jcrsey (Camden), New Mexico (A lbuquerque. Las Cruces, Sante Fe). New York (New York City). Ohio (CincinI1Uli), Virginia (Chesapeake. Hampton. Newporl News. Norfolk , Portsmouth. Virginia Beach). and Washington (Seallie. Tacoma).

CHANGES IN STATE LAWS SINCE THE 1979 AND 1985 SURVEYS

The Arkansa.s Board of Health adopted Rules and Regulations for Talloo Establishments in April 1992. and these were signed into law by Governor Frank White on June 30, 19lr2. Tattoo ~lI1i sL Hre required to be examined and certified. Adequate knowledge of bacteriology and aseptic technique must be proven by examinat ion . A chest x-ray and bloodtest for syphilis must be performed: and. an annual Certificate of I.nspeclion for wttoo shop::. is required. The physical environl1lent and operation standards for taltoo ~hops are specified in the Rules and Regulations. Written consent of a parent O[ guardian is required for tattooing or minors (under age 18).

Since the last survey in 1985, Colorado, Georgia, iowa. Maryland. Michigan. Nevada. Rhode Island. South Carolina and South D:.tk.nta have instituted regulations com:erning tattoos.

New Hampshire. Pennsylvania. and Texas also have State Regulations

o N S

31.,1

CHAPTER 4

perll.11ll1ng to tattooing. At this time, twenty-four states now have statute ' pertaining. to classic andlor cosmetic tatLOoing. M.my of the state health department directors or their legal departmentS have indicated considerable interest in establishing rules and regulations in the ncar future. These include Arizona, Kansas, Kentucky. New York and South Dakota.

Current official information is still pending from AJaska, California, Florida, Georgia. Idaho, Hlinnis, Louisiana, Minnesota, New Mexico, Nonh Carolina, Ohio, Tennessee, Utah, Virginia. West Virginia and Wi consin.

24 STATES HAVE STATUTES PERTAINING TO TAITOOING

Arkansas, California. Colorado, Florida, Georgia , Hawaii , lIlinois, fndiana. Iowa. Maine, Maryland, Massachusetts, Michigan, Nevada, New Hampshire. North C~u'olina, Oklahoma" Pennsylvania. Rhode Island, South Carolina. South Dakota, Texas, Vermont.

TATI'OOING BY PHYSICIANS AND PARA-MEDICAL PERSONNEL

Six states (Georgia. Indiana, Massachusetts, Oklahoma. South Carolina and Vermont) permit tattooing by medical personnel only. Kansas has legislation pending to permit tClLLooing by doctors only. Florida permits tattooing by a person licensed to practice medicine or dentistry. or by a pcr~on under his direction , and the doctor must train the technician two limes a year. Connecticut permits a licensed physician, or technician under the supervision of a physician, to elo tauooing. Tattooing is included in the license. Tattooing is included in the license to practice medicine or osteopathic medicine in Indiana. Interestingly , in 1985, a Monroe County, Indiana Circuit Judge ruled that tattoo artist Kevin Brady was not practicing medicine. but was given permission to tattoo as "un art form". Virginia does not have State regulations but does permit any county, city or town to regulate its tattoo parlors (excluding medical eloctors, veterinarians, registered nurses. and any other licensed medical doctors in performance of their professional duties). Kentucky is considering regulations requiring a registered nurse to be presenr at all times during tattooing. In 1966. South Carolina outlawed tattoos. but in 1986, physicians were permitted for reasons of cosmctic or reconstructive su rgery .

FDA AND S TAT E REGULATIONS

PROHIBITION OF THE TATTOOING OF MINORS

Of rhe states that have rules and regulations prohibiting tattoos, to have specific laws that controllattooing of minors.

Arkansas. Written permission of parent or guardian is required for minors under the age or 18. The wnsent HUlst be kept on file for two years.

Hawaii. Similar pemlission is required for tattooing under the age of 18. Hawaii also prohibits tattooing of any person under the influence of intoxicating substances: ''These substances shall include, but shall not be limited to alcohol, drugs. paints and glues." Hawaii has l.icensed tattoo artists (classic artists and cosmetic artists): 221 are on the island of Oahu.

Maine. Prohibits tattooing of persons under the age of 18, as verified by a drive r' s license, liquor 1.0. card. military LD. card. or other adequate record. Maine further prohibits tattooing for the purpose of removing. camouflaging or altering any blemish. birthmark or scar" by tattoo anists. Prior to 1975. it was legal to tattoo the body of a female person.

New l-hl mpshire. Tattooing of person!> under the age of 18 is prohibited. In March 1985. legislation was passed and signed by the Governor, allowing towns to regulate tattooing facilities.

North Car olina. Prohibits any person or persons from tattooing the arm, limb. or any part of the body of any other person under 18 years of age. This i:- a misdemeanor, punishable by a fine not to exceed $500, imprisonment for not more than six months. or bot.h.

Pen nsylvania. Prohibits Mooing of minors without parental consent. The age of minority is 18, and fines arc not to c.xceed $2,500.

Mjnncsot~l. Does not have state laws pel1aining to tattooing, but in St. Paul. [aIlOOS are prohibited Oil persons under the age of 18 . In Minneapolis. persons under the age of 18 , except in the presence of and with the written pcrmission of the parcnt or legal guardian. are prohibited from being taHoned. Springfield and Waynesville (Fort Leonard Wood) have local ordinances prohibiting tattoos under the age of J 8.

Nevad a. Washoe County (Reno) has regulations concerning tattoo parlors. but docs not have a specific age restriction . Clark County (Las Vegas, North Las Vegas, Henderson, and Boulder) prohibit tattooing of persons under the age of 18,

Texas. It is unlawful to tatloo any persons under the age of '21 , but some cities and counties do have local ordinances.

Sout h Dakota. Prohibits tattooing under the age of I H. unle~s the minor' s parents have signed a consent form. Any person who lattoos a minor without paremal consent is guilty of tI Class II misdemeanor. This act and the laws permitting an, municipality in the State of South Dakota to re gulate the practice of tallooing was passed by the 1985 State Legislature. and became effecti ve Jul y I, 1985.

./1

CHAPTER 4

STANDARDS OFTAITOO PARI1JR INSPECTION

Several states, including Arkansas, Colorado, Hawaii, Nevada, Majne Rhode Island. South Dakota and Utah have specific standards for tattoo parlor inspection. Michigan has OSHA (Occupation Safety and Health Administration) rules if an employee-employer relationship exists in the tattoo parlor. The citics of Reno and Las Vegas, Nevada, and Springfield ~U1u Waynesville (Fort Leonard Wood) in Missouri also have inspection regulations. Included in the main regulations isa prohibition relating to tallooing of animals in a taUoo cstablishment used for tattooing human beings.

STATE BOARDS OF NURSING RULES, REGUlATIONS, AND OPINIONS

With the advent or nur~es, allied health practitioners, and cosmetologists performing dennalpigmentation, a number of the various stales' boards of medical examiners, nursing boards, and/or cosmetology boards have hau to address this issue of paralllcdical practices. The various boards and agencies have struggled to ueal with this rapidly growing field. Unfortunately there have been a number of conflicts nnd confusions resulting from the different board interpretatiolls. The opinion. rendered in variolls stales usually have not con ' iuered the ovcran aspects of micropigmentution (the treatment of various di:easc~ and disorders as well as its use for cosmetics and/or body adornment) but rather short tcrm problems. For example. in Michigan in 1989. in response to whether cosmetologists could perform the procedure, the ALlorney General's opinion \Va that beautifying the skin was in the scope of practice of a cosmetologist. In 1992. when nurses were beginning to becomc involved in rnicropigmemation , the Michigan cosmeto.logists attempted to use that legal opinion to prevcnt nurses from performing this procedure. Since other practitioners slich as plastic surgeons and dermatologists also "beautify the skin" . it was argued that this scope of treatment was not in the sole purview or cosmetology. Thl.! Attorney General's Office finally escaped the whole argulllent by stating that their statement was an opinion and nor a law.

In January 1993, the Alfomey General of Colorado made a ruling and law that minopigmentalion is to bt! regulated by the Board of Cosmetology. By our understanding. a practitioner cloe.~ not have to be a cosmetologists but will be regulated by the Board of Cosmctology. No specific rules , policil!s, and/or guidelines have been made available . Htw.:t!ver. all

-- ---- ----------------------------------------------------------

FDA AND S TAT E REGULATIONS

education of mkropigment.ntion is to be provided by cosmetology schools with no outside experts or educators in .. llied fields to be allowed. Physicians and their technicians have been exempted from this ruling.

The Boards of Cosmetology differ from state to state as to whether minopigmemution is deemed within the Board's scope or purview. The reader is urged 10 check with each state's board for precise clarification. We know of instances in which a board has stated that the procedure could not be performed within a licensed salon, but. if within that salon there exists a separate designated arC

CHAPTER 4

44

check with their local boards before beginning any dermalpigmentation type of practice.

Presently the only state to consider micropigmenlation with the scope of legal nurse practice is Kentucky. North Carolina has established an advanced nurse practice act, but has also stated that the procedure i not within the legal scope of practice for a registered nurse. Alabama. Illinois, Ohio. Louisiana, Maryland. Michigan. New Jersey, New York, Pcnnsylvania. Texas. Virginia, Di . trict of Columbia, and Florida have ruled that micropigmentation is "not witJ1in the legal scope of practice of a registered nurse."

California is the only state that has ruled that micropigmentation is a standardized procedure in which a registered nurse performs the procedure under the general superv.ision or direction of a licensed physician. At the September 1991 California Board of Nur. ing. the board concluded that micropigmenLation procedufCs applied as tTeatment of disease, injuric . or defom1ities would be regarded as a medical function beyond lhe usual cope of registered nur. ing practice. The procedures may be performed by a registered nurse in accordance with a standardized plan in an organized healm care system. The California Board and Legislature, in the amendment of Section 2725 of the Nursing Practice Act, recognized thal llursing is a dynamic field, continually evolving to include more sophisticated palient care activities. Furthermore, there exists an overlapping area of functions and procedures between physicians and registered nurses in which either party hu. a clear legal authority to provide functions and procedures for patients. The means designated to authorize such performance by a registered nursc is u St~U1dardized Procedure which is not subject to prior approval by the respective boards of nursing and medicine; however, standardized procedures must be developed according to cel1ain regulatory requirements.

[n Florida, a rec.:ent ruling has stated that tcchnicians mu. t now perform micropigmentation under the direct supervision of a I icensed physician.. Heretofore, technicians were permitted to work independently under general supervision of a physician who was not required to be present on the premises.

A SUMMARY OF THE FEDERAL FOOD, DRUG AND COSMETIC ACT WITH AMENDMENTS

Public Law No. 384, 59th Congress, approved June 30. 1906. For preventing the manufacture , sale. or transportation of adullerated or misbranded or poisol1ous or deleterious foods. drugs. medicines, and liquors, for regUlating traffic.: therein.

Public Law No. 538, 71st Congress, approved July 8. 1930. An act to amelld sct:lion 8 of the act approved June 30, 1906.

F D A AN D S TAT E R E G U LA TI ONS

Public Law. No. 541 , 73rd Congr ess, approved June 22, 1934. An act to amend the act of June 30, 1906 relat ing to seafood.

P ublic Law No. 356, 74th Congress, approved August 27, 1935. To amend section I OA of the Federal Food aod Drugs Act of June 30, 1906, relating to seafood.

Public LAw No. 717, 75th C ong r ess, approved June 25. 1938. Federal Food. Drug and Cosmetic Act.

Public Law No. 151 , 76th Congress, approved Ju ne 23. 1939. To provide for temporary postponement of the operations of certain prov isions of the Federal Food, Drug and Cosmetic Act.

}-'ublic Law No. 366, 77th Congress, as amended, by providing for the certi tication of batches of drugs composed wholly or partly of insu lin.

Public Law. No. 139, 79th Congress, approved July 6 . 1945. To amend the act of .J une 25. 1938, as amended , by providi ng for the certification of batches of drugs composed wholly or partly of any kind of penicillin or derivative thereof.

Public .Law No. 16, 80th Congress, approved March 10, 1947. To amend Lhe ac t of J une 25, 1938, as amended. by pro-vid ing for the certification of batches of drugs composed wholly or partly of any kind of streptomycin, or any derivative thereof.

Public Law No. 749, 80th C ongress, approved June 24, 1948. To amend sections 30 I (K) and 304(A) of the Federal Food. Drug and Cosmetic Act, as amended.

Public Law No. 164, Si s t Congress, approved Ju ly 13, 1949. To amend the act of June 25 , 193X, as amended. by providing (or the ccnilication of batches or drugs composed wholly or partly of any kind of aureomycin, chloramphenicol or bacilracin.

Public Law No. 360, 81 st Congr ess, approved October 18, 1949. To amend secLion SO 1 of the Federal Food. Drug, and Cosmetic Act. as amended.

Public Law No. 215, 82nd Con gress, approved October 25. 1951 . To amend sections 303(C) and 503(B) of the Federal Food. Drug , and Cosmetic Act. as amended.

Publ ic La w No. 201 , 83rd Congress, approved August 5. 1953. To amend sections 502(L) and 507 of the act of Ju ne 25. 1938, ill order to identify the d rug known as aureomycin by its chemical name. chlortetracycline.

Public Law No. 217, 83rd C ongress, approved August 7. 1953. To amend the Federal Food. Drug, and Cosmetic Act. to protecl the public health and welfare by providing certain au thority for factory inspection.

Puhlic Law No. 335, 83rd Congr ess, approved April 15. 1954. To amend sections 40 I and 70 I of the Federal Food. Drug. and Cosmetic Act lO simplify the procedures governing the estab lishment of food standards.

Public Law No. 5 18, tUrd Congress, approved Ju ly 22. 1954. To amt:nd Ihe Federal Food, Drug.. and Cosmetic Act with respect to residue ' of pe~ticidc chemicals in or on raw agricultural commodities.

Public La w No. 672, 84 th Con gress, approved July 9 , 1956. To amend ~cction 402(C) or the Federal Food. Drug. and Cosmetic Act. with respect to the coloring of orange.

45

CHAPTER 4

46

Public Law No. 905, 84th Congress, approved Augu~t I, 1956. To amend sections 40 I and 70 I (E) of the Federal Food, Drug. and Cosmetic Act to s implify the procedures governing t.he prescribing of regulation undcr certai n provisions of such act.

Public Law No. 250. 85th Congress, approved August 31, 1957. To amend section 304(0) of the Federal Food, Drug, and Cosmetic Act, with respect to the disposition of certain imported articles which have been seized or condemned.

Public Law No. 929, 85th Congress, approved September 6, 1958. Food Additives Amendment of 1958.

Public Law No.2, 86th Congress, approved March 17. 1959. To amend the Federal Food. Drug, and Cosmetic Act to permit the temporary listing and certification of citrus No.2 for coloring mature oranges under tolerances found safe by the Secretary of Health, Education and Welfare, to permi t continuance of established coloring practice in the orange industry.

Public Law No. 537, 86th Congrcss, approved June 29, 1960. To amend the Federal Food, Drug, and Cosmetic Act, with respect to label declaration of th e use of pesticide chemical. o n raw agricu ltura l commodities which arc the produce of the soil.

Public Law No. 618, 86th Congress, approved July 12, 1960. Color Additive Amendm