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Protecting Patient Safety Appropriate Training and Supervision for Cosmetic and Laser Medical Procedures Cindy L. Lamerson, M.D. Board Certified Dermatologist Private Practice, Reno, NV Member, NSBME Associate Professor of Medicine, UNSOM Protecting Patient Safety Protecting Patient Safety Appropriate Training and Supervision Appropriate Training and Supervision for Cosmetic and Laser Medical for Cosmetic and Laser Medical Procedures Procedures Cindy L. Cindy L. Lamerson Lamerson , M.D. , M.D. Board Certified Dermatologist Board Certified Dermatologist Private Practice, Reno, NV Private Practice, Reno, NV Member, NSBME Member, NSBME Associate Professor of Medicine, UNSOM Associate Professor of Medicine, UNSOM

Protecting Patient Safety - Nevada Legislature · Florida medispa using intense pulsed-light. Patient treated by cosmetologist. Nurse owned spa but was not on-site. Laser sunspot

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Page 1: Protecting Patient Safety - Nevada Legislature · Florida medispa using intense pulsed-light. Patient treated by cosmetologist. Nurse owned spa but was not on-site. Laser sunspot

Protecting Patient SafetyAppropriate Training and Supervision

for Cosmetic and Laser Medical Procedures

Cindy L. Lamerson, M.D.Board Certified Dermatologist

Private Practice, Reno, NVMember, NSBME

Associate Professor of Medicine, UNSOM

Protecting Patient SafetyProtecting Patient SafetyAppropriate Training and Supervision Appropriate Training and Supervision

for Cosmetic and Laser Medical for Cosmetic and Laser Medical ProceduresProcedures

Cindy L. Cindy L. LamersonLamerson, M.D., M.D.Board Certified DermatologistBoard Certified Dermatologist

Private Practice, Reno, NVPrivate Practice, Reno, NVMember, NSBMEMember, NSBME

Associate Professor of Medicine, UNSOMAssociate Professor of Medicine, UNSOM

avorderbruggen
New Stamp
Page 2: Protecting Patient Safety - Nevada Legislature · Florida medispa using intense pulsed-light. Patient treated by cosmetologist. Nurse owned spa but was not on-site. Laser sunspot

“NON-INVASIVE” COSMETIC MEDICAL PROCEDURES UP 700% SINCE 1997

““NONNON--INVASIVEINVASIVE”” COSMETIC MEDICAL COSMETIC MEDICAL PROCEDURES UP 700% SINCE 1997PROCEDURES UP 700% SINCE 1997

Over 11 million cosmetic medical procedures performed in 2006, of those, 9.1 million procedures considered “minimally invasive:”

Top 5:Botox®Chemical peelsLaser Hair Removal & Other Laser ProceduresMicrodermabrasionHyaluronic acid fillers

Over 11 million cosmetic medical Over 11 million cosmetic medical procedures performed in 2006, of those, procedures performed in 2006, of those, 9.1 million procedures considered 9.1 million procedures considered ““minimally invasive:minimally invasive:””

Top 5:Top 5:BotoxBotox®®Chemical peelsChemical peelsLaser Hair Removal & Other Laser ProceduresLaser Hair Removal & Other Laser ProceduresMicrodermabrasionMicrodermabrasionHyaluronic acid fillersHyaluronic acid fillers

Source: “Having a Little Work Done at the Mall,” New York Times, January 13, 2008Source: Source: ““Having a Little Work Done at the Mall,Having a Little Work Done at the Mall,”” New York Times, January 13, 2008New York Times, January 13, 2008

Page 3: Protecting Patient Safety - Nevada Legislature · Florida medispa using intense pulsed-light. Patient treated by cosmetologist. Nurse owned spa but was not on-site. Laser sunspot

AVAILABILITY OF COSMETIC MEDICAL PROCEDURES IN NON-

TRADITIONAL MEDICAL SETTINGS IS ON THE RISE

AVAILABILITY OF COSMETIC AVAILABILITY OF COSMETIC MEDICAL PROCEDURES IN NONMEDICAL PROCEDURES IN NON--

TRADITIONAL MEDICAL SETTINGS IS TRADITIONAL MEDICAL SETTINGS IS ON THE RISEON THE RISE

“In the past three years, the number of medical spas has more than tripled to about 1,500, according to estimates from the International Medical Spa Association. “

-Wall Street Journal, “Medspa Boom Has Become a Bust for Some,” Nov. 21, 2006

““In the past three years, the number of In the past three years, the number of medical spas has more than tripled to medical spas has more than tripled to about 1,500, according to estimates from about 1,500, according to estimates from the International Medical Spa the International Medical Spa Association. Association. ““

--Wall Street JournalWall Street Journal, , ““Medspa Boom Has Medspa Boom Has Become a Bust for Some,Become a Bust for Some,”” Nov. 21, 2006Nov. 21, 2006

Page 4: Protecting Patient Safety - Nevada Legislature · Florida medispa using intense pulsed-light. Patient treated by cosmetologist. Nurse owned spa but was not on-site. Laser sunspot

LAWS, REGULATIONS AND DEFINITIONS IN STATE MEDICAL

ACTS HAVE NOT KEPT UP WITH NEW PROCEDURES AND TECHNOLOGY

LAWS, REGULATIONS AND LAWS, REGULATIONS AND DEFINITIONS IN STATE MEDICAL DEFINITIONS IN STATE MEDICAL

ACTS HAVE NOT KEPT UP WITH NEW ACTS HAVE NOT KEPT UP WITH NEW PROCEDURES AND TECHNOLOGYPROCEDURES AND TECHNOLOGY

More than 20 states have no laws addressing whether or not laser medical procedures can be delegated, to whom and under what circumstancesEven fewer states have laws relating to cosmetic injectables and chemical peelsMany states have no definition of the practice of medicine which encompasses cosmetic medical procedures

More than 20 states have no laws More than 20 states have no laws addressing whether or not laser medical addressing whether or not laser medical procedures can be delegated, to whom procedures can be delegated, to whom and under what circumstancesand under what circumstancesEven fewer states have laws relating to Even fewer states have laws relating to cosmetic injectables and chemical peelscosmetic injectables and chemical peelsMany states have no definition of the Many states have no definition of the practice of medicine which encompasses practice of medicine which encompasses cosmetic medical procedurescosmetic medical procedures

Page 5: Protecting Patient Safety - Nevada Legislature · Florida medispa using intense pulsed-light. Patient treated by cosmetologist. Nurse owned spa but was not on-site. Laser sunspot

BUT THAT IS CHANGING. AT LEAST 15 STATES ARE CURRENTLY IN THE

PROCESS OF AMENDING OR CREATING NEW LAWS RELATING TO THIS ISSUE

BUT THAT IS CHANGING. AT LEAST 15 BUT THAT IS CHANGING. AT LEAST 15 STATES ARE CURRENTLY IN THE STATES ARE CURRENTLY IN THE

PROCESS OF AMENDING OR CREATING PROCESS OF AMENDING OR CREATING NEW LAWS RELATING TO THIS ISSUENEW LAWS RELATING TO THIS ISSUE

There are several provisions under which legal issues relating to laser medical procedures can fall. These include but are not limited to:Definition of the practice of medicineDefinition of physician supervisionFalse and deceptive advertisingCorporate practice of medicineMaintenance of medical recordsPatient assessment requirements Facility license requirements for medspasLimit to number of remote facilitiesSale of medical devices

There are several provisions under which legal issues There are several provisions under which legal issues relating to laser medical procedures can fall. These relating to laser medical procedures can fall. These include but are not limited to:include but are not limited to:Definition of the practice of medicineDefinition of the practice of medicineDefinition of physician supervisionDefinition of physician supervisionFalse and deceptive advertisingFalse and deceptive advertisingCorporate practice of medicineCorporate practice of medicineMaintenance of medical recordsMaintenance of medical recordsPatient assessment requirements Patient assessment requirements Facility license requirements for medspasFacility license requirements for medspasLimit to number of remote facilitiesLimit to number of remote facilitiesSale of medical devicesSale of medical devices

Page 6: Protecting Patient Safety - Nevada Legislature · Florida medispa using intense pulsed-light. Patient treated by cosmetologist. Nurse owned spa but was not on-site. Laser sunspot

AMERICAN SOCIETY FOR DERMATOLOGIC SURGERY (ASDS)

PATIENT SAFETY SURVEY

AMERICAN SOCIETY FOR AMERICAN SOCIETY FOR DERMATOLOGIC SURGERY (ASDS) DERMATOLOGIC SURGERY (ASDS)

PATIENT SAFETY SURVEYPATIENT SAFETY SURVEYA survey of physicians showed that in the past year:

65% of respondents treated complications caused by a non-physician

92% of respondents treated patients with skin cancer, some of which resulted in patient mortality, which was either overlooked or misdiagnosed by a non-physician.

A survey of physicians showed that in the A survey of physicians showed that in the past year: past year:

65% of respondents treated 65% of respondents treated complications caused by a complications caused by a nonnon--physicianphysician

92% of respondents treated 92% of respondents treated patients with skin cancer, patients with skin cancer, some of which resulted in some of which resulted in patient mortality, which was patient mortality, which was either overlooked or either overlooked or misdiagnosed by a nonmisdiagnosed by a non--physician. physician.

Page 7: Protecting Patient Safety - Nevada Legislature · Florida medispa using intense pulsed-light. Patient treated by cosmetologist. Nurse owned spa but was not on-site. Laser sunspot

The top three complications included:

Burns and scarring from laser hair removalMisdiagnosis of skin cancerBurns and scarring from chemical peels

The top three complications included:The top three complications included:

Burns and scarring from laser hair removalBurns and scarring from laser hair removalMisdiagnosis of skin cancerMisdiagnosis of skin cancerBurns and scarring from chemical peelsBurns and scarring from chemical peels

ASDS PATIENT SAFETY SURVEYASDS PATIENT SAFETY SURVEYASDS PATIENT SAFETY SURVEY

Page 8: Protecting Patient Safety - Nevada Legislature · Florida medispa using intense pulsed-light. Patient treated by cosmetologist. Nurse owned spa but was not on-site. Laser sunspot

TRAINING ON THE USE OF THE LASERS THEMSELVES IS LEAST

IMPORTANT TO LASER SAFETY….

TRAINING ON THE USE OF THE TRAINING ON THE USE OF THE LASERS THEMSELVES IS LEAST LASERS THEMSELVES IS LEAST

IMPORTANT TO LASER SAFETYIMPORTANT TO LASER SAFETY……..

“It is a truism in cutaneous laser therapy that firing a laser handpiece may be the least important portion of the treatment; it is everything but the actual treatment, including patient selection, parameter selection, and recognition and management of undesirable outcomes, that requires judgment and training.”

““It is a truism in cutaneous laser therapy It is a truism in cutaneous laser therapy that firing a laser handpiece may be the that firing a laser handpiece may be the least important portion of the treatment; it least important portion of the treatment; it is everything but the actual treatment, is everything but the actual treatment, including patient selection, parameter including patient selection, parameter selection, and recognition and selection, and recognition and management of undesirable outcomes, management of undesirable outcomes, that requires judgment and training.that requires judgment and training.””

From “Use of Cutaneous Lasers and Light Sources: Appropriate Training and Delegation” Alam, M.; Dover, J.S.; Arndt, K.A.; Skin Therapy Lett. 2007;12(5):5-9.

From From ““Use of Cutaneous Lasers and Light Sources: Appropriate Training Use of Cutaneous Lasers and Light Sources: Appropriate Training and Delegationand Delegation”” Alam, M.; Alam, M.; Dover, J.S.; Arndt, K.A.; Dover, J.S.; Arndt, K.A.; Skin Therapy Lett. Skin Therapy Lett. 2007;12(5):52007;12(5):5--9.9.

Page 9: Protecting Patient Safety - Nevada Legislature · Florida medispa using intense pulsed-light. Patient treated by cosmetologist. Nurse owned spa but was not on-site. Laser sunspot

RESULTS FROM A STUDY ON COSMETIC MEDICAL PROCEDURE

COMPLICATIONS

RESULTS FROM A STUDY ON RESULTS FROM A STUDY ON COSMETIC MEDICAL PROCEDURE COSMETIC MEDICAL PROCEDURE

COMPLICATIONSCOMPLICATIONS

82% of all complications occurred in facilities that had no direct (on-site) physician supervisionOf these, 57% were in facilities with a “medical director” with limited training in dermatologic procedures and light-based therapyOf all the complications, 78% occurred in non-traditional medical facilities, such as free standing medical spas and laser centers in shopping malls

82% of all complications occurred in facilities that 82% of all complications occurred in facilities that had no direct (onhad no direct (on--site) physician supervisionsite) physician supervisionOf these, 57% were in facilities with a Of these, 57% were in facilities with a ““medical medical directordirector”” with limited training in dermatologic with limited training in dermatologic procedures and lightprocedures and light--based therapybased therapyOf all the complications, 78% occurred in nonOf all the complications, 78% occurred in non--traditional medical facilities, such as free traditional medical facilities, such as free standing medical spas and laser centers in standing medical spas and laser centers in shopping mallsshopping malls

From “Complications from Laser Procedures Performed by Non-Physicians” by Vic A. Narurkar, MD,, Skin & Aging 2005;13(9):70-71.

From From ““Complications from Laser Procedures Performed by NonComplications from Laser Procedures Performed by Non--PhysiciansPhysicians”” by Vic A. Narurkar, MD,, by Vic A. Narurkar, MD,, Skin Skin & Aging & Aging 2005;13(9):702005;13(9):70--71.71.

Page 10: Protecting Patient Safety - Nevada Legislature · Florida medispa using intense pulsed-light. Patient treated by cosmetologist. Nurse owned spa but was not on-site. Laser sunspot

“In the spa environment or in a poorly supervised laser practice, the pressure to ‘convert’ all consultations into treatments may result in poor patient selection, which in turn may dramatically increase the rate of adverse events.”“Incentives for non-physician providers to maximize revenue generation in a spa or thinly supervised setting can increase the risk of adverse events by:– hurrying preoperative evaluation and laser

treatment.– encouraging the treatment of patients who

may be poor laser candidates.”

““In the spa environment or in a poorly supervised In the spa environment or in a poorly supervised laser practice, the pressure to laser practice, the pressure to ‘‘convertconvert’’ all all consultations into treatments may result in poor consultations into treatments may result in poor patient selection, which in turn may dramatically patient selection, which in turn may dramatically increase the rate of adverse events.increase the rate of adverse events.””““Incentives for nonIncentives for non--physician providers to physician providers to maximize revenue generation in a spa or thinly maximize revenue generation in a spa or thinly supervised setting can increase the risk of supervised setting can increase the risk of adverse events by:adverse events by:–– hurrying preoperative evaluation and laser hurrying preoperative evaluation and laser

treatment.treatment.–– encouraging the treatment of patients who encouraging the treatment of patients who

may be poor laser candidates.may be poor laser candidates.””From “Use of Cutaneous Lasers and Light Sources: Appropriate Training and Delegation” by Alam, M.;

Dover, J.S.; Arndt, K.A.; Skin Therapy Lett. 2007;12(5):5-9.From From ““Use of Cutaneous Lasers and Light Sources: Appropriate Training Use of Cutaneous Lasers and Light Sources: Appropriate Training and Delegationand Delegation”” by Alam, M.; by Alam, M.;

Dover, J.S.; Arndt, K.A.; Dover, J.S.; Arndt, K.A.; Skin Therapy Lett. Skin Therapy Lett. 2007;12(5):52007;12(5):5--9.9.

PATIENT OR POTENTIAL LASER CLIENT?

PATIENT OR POTENTIAL LASER PATIENT OR POTENTIAL LASER CLIENT?CLIENT?

Page 11: Protecting Patient Safety - Nevada Legislature · Florida medispa using intense pulsed-light. Patient treated by cosmetologist. Nurse owned spa but was not on-site. Laser sunspot

Patient seen by nurse without physician examination, for “pigmentation spots” on right cheekReceived 3 treatments with Q-switch YAG laserPatient seen 11 months later by Dermatologist with subcutaneous massBx diagnosis: “Amelanotic melanoma, locally metastatic”

Patient seen by nurse without Patient seen by nurse without physician examination, for physician examination, for ““pigmentation spotspigmentation spots”” on right on right cheekcheekReceived 3 treatments with QReceived 3 treatments with Q--switch YAG laserswitch YAG laserPatient seen 11 months later Patient seen 11 months later by Dermatologist with by Dermatologist with subcutaneous masssubcutaneous massBx diagnosis: Bx diagnosis: ““Amelanotic Amelanotic melanoma, locally metastaticmelanoma, locally metastatic””

INAPPROPRIATE DIAGNOSIS/MISSED CANCER DIAGNOSIS

INAPPROPRIATE DIAGNOSIS/MISSED INAPPROPRIATE DIAGNOSIS/MISSED CANCER DIAGNOSISCANCER DIAGNOSIS

Page 12: Protecting Patient Safety - Nevada Legislature · Florida medispa using intense pulsed-light. Patient treated by cosmetologist. Nurse owned spa but was not on-site. Laser sunspot

Laser sunspot removal at a Florida medispausing intense pulsed-light.Patient treated by cosmetologist. Nurse owned spa but was not on-site.

Laser sunspot Laser sunspot removal at a removal at a Florida Florida medispamedispausing intense using intense pulsedpulsed--light.light.Patient treated by Patient treated by cosmetologist. cosmetologist. Nurse owned spa Nurse owned spa but was not onbut was not on--site.site.

UNTRAINED, UNSUPERVISED PRACTITIONER

UNTRAINED, UNSUPERVISED UNTRAINED, UNSUPERVISED PRACTITIONERPRACTITIONER

Page 13: Protecting Patient Safety - Nevada Legislature · Florida medispa using intense pulsed-light. Patient treated by cosmetologist. Nurse owned spa but was not on-site. Laser sunspot

Laser Hair Removal by a non-physician in a CA mall medispa at a setting too high for African American skin.

Patient is currently suing spa.

Laser Hair Removal by Laser Hair Removal by a nona non--physician in a physician in a CA mall CA mall medispamedispa at at a setting too high a setting too high for African for African American skin.American skin.

Patient is currently Patient is currently suing spa.suing spa.

INCORRECT DEVICE/SETTING FOR SKIN TYPE

INCORRECT DEVICE/SETTING FOR INCORRECT DEVICE/SETTING FOR SKIN TYPESKIN TYPE

Page 14: Protecting Patient Safety - Nevada Legislature · Florida medispa using intense pulsed-light. Patient treated by cosmetologist. Nurse owned spa but was not on-site. Laser sunspot

Resulting from the use of a laser by a non-physician for hair removalResulting from the use of a laser by a nonResulting from the use of a laser by a non--physician for hair removalphysician for hair removal

HYPERPIGMENTATION, HYPOPIGMENTATION & SCARRING

HYPERPIGMENTATION, HYPERPIGMENTATION, HYPOPIGMENTATION & SCARRINGHYPOPIGMENTATION & SCARRING

Page 15: Protecting Patient Safety - Nevada Legislature · Florida medispa using intense pulsed-light. Patient treated by cosmetologist. Nurse owned spa but was not on-site. Laser sunspot

BURNS FROM LASER HAIR REMOVALBURNS FROM LASER HAIR REMOVALBURNS FROM LASER HAIR REMOVAL

Page 16: Protecting Patient Safety - Nevada Legislature · Florida medispa using intense pulsed-light. Patient treated by cosmetologist. Nurse owned spa but was not on-site. Laser sunspot

PULSED LIGHT WITHOUT COOLING, DIRECT APPLICATION ON SKIN

PULSED LIGHT WITHOUT COOLING, DIRECT APPLICATION ON SKIN

Page 17: Protecting Patient Safety - Nevada Legislature · Florida medispa using intense pulsed-light. Patient treated by cosmetologist. Nurse owned spa but was not on-site. Laser sunspot

HERPES SIMPLEX INFECTION POST LP1064 LASER FOR HAIR REDUCTIONHERPES SIMPLEXHERPES SIMPLEX INFECTION POST INFECTION POST

LP1064 LASER FOR HAIR REDUCTIONLP1064 LASER FOR HAIR REDUCTION

Page 18: Protecting Patient Safety - Nevada Legislature · Florida medispa using intense pulsed-light. Patient treated by cosmetologist. Nurse owned spa but was not on-site. Laser sunspot

22-year-old Shiri Berg – hair removal treatment at a “Day Spa” in North Carolina. Applied lidocaine cream from her waist to her ankles and wrapped her legs in plastic wrapPatient suffered heart failure and brain damage and died of lidocaine toxicityOff-site physician “medical director” did not examine patients, take their medical histories, or write individual prescriptions for the anesthetic gelPhysician lost his license for 6 months

22-year-old Shiri Berg – hair removal treatment at a “Day Spa” in North Carolina. Applied lidocaine cream from her waist to her ankles and wrapped her legs in plastic wrapPatient suffered heart failure and brain damage and died of lidocaine toxicityOff-site physician “medical director” did not examine patients, take their medical histories, or write individual prescriptions for the anesthetic gelPhysician lost his license for 6 months

FATAL REACTIONSFATAL REACTIONSFATAL REACTIONS

Page 19: Protecting Patient Safety - Nevada Legislature · Florida medispa using intense pulsed-light. Patient treated by cosmetologist. Nurse owned spa but was not on-site. Laser sunspot

AMERICAN SOCIETY FOR DERMATOLOGIC SURGERY POSITION

AMERICAN SOCIETY FOR AMERICAN SOCIETY FOR DERMATOLOGIC SURGERY POSITIONDERMATOLOGIC SURGERY POSITION

Non-physicians:Are not trained to diagnose skin diseases like skin cancer.Are not fully trained to comprehensively evaluate the causes, types and symptoms of skin conditions related to aging and sun-damage. Are ill-equipped to treat these skin disorders without direct medical supervision.This can lead to inaccurate treatment and the potential for harm.

NonNon--physicians:physicians:Are not trained to diagnose skin diseases like Are not trained to diagnose skin diseases like skin cancer.skin cancer.Are not fully trained to comprehensively Are not fully trained to comprehensively evaluate the causes, types and symptoms of evaluate the causes, types and symptoms of skin conditions related to aging and sunskin conditions related to aging and sun--damage. damage. Are illAre ill--equipped to treat these skin disorders equipped to treat these skin disorders without direct medical supervision.without direct medical supervision.This can lead to inaccurate treatment and the This can lead to inaccurate treatment and the potential for harm.potential for harm.

Page 20: Protecting Patient Safety - Nevada Legislature · Florida medispa using intense pulsed-light. Patient treated by cosmetologist. Nurse owned spa but was not on-site. Laser sunspot

• Under appropriate circumstances, certain cosmetic medical procedures can be delegated.

• However, only trained and licensed medical staff with direct, on-site supervision by a physician should perform these procedures.

• On-site physician supervision ensures the necessary responsiveness to questions and a greater likelihood that complications will be avoided.

•• Under appropriate circumstances, certain Under appropriate circumstances, certain cosmetic medical procedures can be delegated. cosmetic medical procedures can be delegated.

•• However, only trained and licensed medical However, only trained and licensed medical staff with direct, onstaff with direct, on--site supervision by a site supervision by a physician should perform these procedures. physician should perform these procedures.

•• OnOn--site physician supervision ensures the site physician supervision ensures the necessary responsiveness to questions and a necessary responsiveness to questions and a greater likelihood that complications will be greater likelihood that complications will be avoided.avoided.

ASDS POSITIONASDS POSITIONASDS POSITION

Page 21: Protecting Patient Safety - Nevada Legislature · Florida medispa using intense pulsed-light. Patient treated by cosmetologist. Nurse owned spa but was not on-site. Laser sunspot

POLICY RECOMMENDATIONS FOR PATIENT SAFETY

POLICY RECOMMENDATIONS FOR POLICY RECOMMENDATIONS FOR PATIENT SAFETYPATIENT SAFETY

Definition of the practice of medicine should include the affectation of living tissue, not just the treatment of illness and disease.Appropriately trained physicians should be on-site and immediately available during the performance of cosmetic medical proceduresMedical records should be keptInitial examination should be done by a physician before first treatment to ensure patient is a good candidate for the procedure and that there are not any pre-existing conditions or contraindications presentFalse and deceptive advertising should be prohibited

Definition of the practice of medicine should Definition of the practice of medicine should include the affectation of living tissue, not just include the affectation of living tissue, not just the treatment of illness and disease.the treatment of illness and disease.Appropriately trained physicians should be onAppropriately trained physicians should be on--site and immediately available during the site and immediately available during the performance of cosmetic medical proceduresperformance of cosmetic medical proceduresMedical records should be keptMedical records should be keptInitial examination should be done by a Initial examination should be done by a physician before first treatment to ensure physician before first treatment to ensure patient is a good candidate for the procedure patient is a good candidate for the procedure and that there are not any preand that there are not any pre--existing existing conditions or contraindications presentconditions or contraindications presentFalse and deceptive advertising should be False and deceptive advertising should be prohibitedprohibited

Page 22: Protecting Patient Safety - Nevada Legislature · Florida medispa using intense pulsed-light. Patient treated by cosmetologist. Nurse owned spa but was not on-site. Laser sunspot

RECOMMENDED LANGUAGE FOR FALSE & MISLEADING ADVERTISING

RECOMMENDED LANGUAGE FOR RECOMMENDED LANGUAGE FOR FALSE & MISLEADING ADVERTISINGFALSE & MISLEADING ADVERTISING

Any advertising for a cosmetic medical procedure should:Identify the physician and surgeon performing or supervising treatmentInclude a statement that the supervising physician or surgeon is board certified or board eligible for an accredited board Identify the particular specialty or subspecialty for which the physician or surgeon has certification.

Any advertising for a cosmetic medical Any advertising for a cosmetic medical procedure should:procedure should:Identify the physician and surgeon Identify the physician and surgeon performing or supervising treatmentperforming or supervising treatmentInclude a statement that the supervising Include a statement that the supervising physician or surgeon is board certified or physician or surgeon is board certified or board eligible for an accredited board board eligible for an accredited board Identify the particular specialty or Identify the particular specialty or subspecialty for which the physician or subspecialty for which the physician or surgeon has certification.surgeon has certification.

Page 23: Protecting Patient Safety - Nevada Legislature · Florida medispa using intense pulsed-light. Patient treated by cosmetologist. Nurse owned spa but was not on-site. Laser sunspot

DEFINITION OF COSMETIC MEDICAL PROCEDURE

DEFINITION OF COSMETIC MEDICAL DEFINITION OF COSMETIC MEDICAL PROCEDUREPROCEDURE

A treatment or procedure that uses a biologic or synthetic material, chemical application, mechanical device, or displaced energy form of any kind if it alters or damages or is capable of altering or damaging living tissue to improve the patient’s appearance or achieve an enhanced aesthetic result.

Such acts or procedures include, for example, the use of all lasers, light sources, microwave energy, chemical application, the injection or insertion of foreign or natural substances, or soft tissue augmentation.

A treatment or procedure that uses a biologic or A treatment or procedure that uses a biologic or synthetic material, chemical application, synthetic material, chemical application, mechanical device, or displaced energy form of mechanical device, or displaced energy form of any kind if it alters or damages or is capable of any kind if it alters or damages or is capable of altering or damaging living tissue to improve altering or damaging living tissue to improve the patientthe patient’’s appearance or achieve an s appearance or achieve an enhanced aesthetic result.enhanced aesthetic result.

Such acts or procedures include, for example, Such acts or procedures include, for example, the use of all lasers, light sources, microwave the use of all lasers, light sources, microwave energy, chemical application, the injection or energy, chemical application, the injection or insertion of foreign or natural substances, or insertion of foreign or natural substances, or soft tissue augmentation.soft tissue augmentation.

Page 24: Protecting Patient Safety - Nevada Legislature · Florida medispa using intense pulsed-light. Patient treated by cosmetologist. Nurse owned spa but was not on-site. Laser sunspot

Immediate supervision: Physician must be in the same room as the procedure is taking place

Direct supervision: Physician must be on-site and immediately available while the procedure is taking place

General supervision: Physician need not be on-site but must be available for direct communication by telephone

Immediate supervision:Immediate supervision: Physician must be Physician must be in the same room as the procedure is in the same room as the procedure is taking placetaking place

Direct supervision:Direct supervision: Physician must be onPhysician must be on--site and immediately available while the site and immediately available while the procedure is taking placeprocedure is taking place

General supervision:General supervision: Physician need not be Physician need not be onon--site but must be available for direct site but must be available for direct communication by telephone communication by telephone

DEFINITION OF SUPERVISIONDEFINITION OF SUPERVISIONDEFINITION OF SUPERVISION

Page 25: Protecting Patient Safety - Nevada Legislature · Florida medispa using intense pulsed-light. Patient treated by cosmetologist. Nurse owned spa but was not on-site. Laser sunspot

From Louisiana: • Lasers “whether used or applied for

surgical, therapeutic or cosmetic purposes on human beings” constitutes the practice of medicine

• All treatments and procedures must be performed under the licensed physician’s direction and immediate personal supervision—i.e., where the physician is physically present on the premises and immediately available at all times that the non-physician is on duty and retains full responsibility

From LouisianaFrom Louisiana: : •• Lasers Lasers ““whether used or applied for whether used or applied for

surgical, therapeutic or cosmetic surgical, therapeutic or cosmetic purposes on human beingspurposes on human beings”” constitutes constitutes the practice of medicine the practice of medicine

•• All treatments and procedures must be All treatments and procedures must be performed under the licensed physicianperformed under the licensed physician’’s s direction and immediate personal direction and immediate personal supervisionsupervision——i.e., where the physician is i.e., where the physician is physically present on the premises and physically present on the premises and immediately available at all times that the immediately available at all times that the nonnon--physician is on duty and retains full physician is on duty and retains full responsibilityresponsibility

SAMPLE REGULATORY LANGUAGESAMPLE REGULATORY LANGUAGESAMPLE REGULATORY LANGUAGE

Page 26: Protecting Patient Safety - Nevada Legislature · Florida medispa using intense pulsed-light. Patient treated by cosmetologist. Nurse owned spa but was not on-site. Laser sunspot

From Mississippi:The use of laser, pulsed light or similar devices, either for invasive or cosmetic procedures, is considered to be the practice of medicine in the state of MississippiTherefore such use shall be limited to physicians and those directly supervised by physicians, such that a physician is on the premises and would be directly involved in the treatment if required.

From MississippiFrom Mississippi::The use of laser, pulsed light or similar The use of laser, pulsed light or similar devices, either for invasive or cosmetic devices, either for invasive or cosmetic procedures, is considered to be the procedures, is considered to be the practice of medicine in the state of practice of medicine in the state of MississippiMississippiTherefore such use shall be limited to Therefore such use shall be limited to physicians and those directly supervised physicians and those directly supervised by physicians, such that a physician is on by physicians, such that a physician is on the premises and would be directly the premises and would be directly involved in the treatment if required.involved in the treatment if required.

SAMPLE REGULATORY LANGUAGESAMPLE REGULATORY LANGUAGESAMPLE REGULATORY LANGUAGE

Page 27: Protecting Patient Safety - Nevada Legislature · Florida medispa using intense pulsed-light. Patient treated by cosmetologist. Nurse owned spa but was not on-site. Laser sunspot

After all, there’s a reason they’re called

“Medical Spas”

After all, thereAfter all, there’’s a reason s a reason theythey’’re called re called

““MedicalMedical SpasSpas””