The document summarizes optometry laws and regulations in Florida, including:
1) What constitutes a complete eye exam according to state law, including required tests and documentation.
2) The minimum equipment an optometrist must have to perform exams, including an ophthalmoscope, tonometer, retinoscope, and phoropter.
3) Additional equipment that certified optometrists must have to provide advanced care, such as a Goldmann tonometer and fundus camera.
4) Guidelines around supportive staff duties, advertising, continuing education requirements, and other typical regulatory violations.
Keratometer is an ophthalmic instruments and has a very important role in optometry field specially for IOL power calculation, Contact lens fitting, to rule out corneal pathology and its progression ie Keratoconus, PMCD.
Troubleshooting bifocals and Market Availability in Nepal
Bifocals in Anisometropia
Prismatic Effect in Bifocal
Bifocal Prescription
Bifocals in High Astigmatism
In this Presentation we learn about :-
1.What is Subjective Refraction.
2.Why we should relax the accommodation.
3.Outlines of Subjective Refraction.
4.Different Techniques or Instruments.
5.Determining Near Addition.
6.The Final Prescription.
7.References.
Pediatric Ophthalmic dispensing in different visual problemsRaju Kaiti
Pediatric dispensing, introduction, different from adult dispensing, frame selection, lens selection, special case fitting, Do's and Dont's, Measurements, Down's syndrome, albinism, aphakia, strabismus, syndromes
Keratometer is an ophthalmic instruments and has a very important role in optometry field specially for IOL power calculation, Contact lens fitting, to rule out corneal pathology and its progression ie Keratoconus, PMCD.
Troubleshooting bifocals and Market Availability in Nepal
Bifocals in Anisometropia
Prismatic Effect in Bifocal
Bifocal Prescription
Bifocals in High Astigmatism
In this Presentation we learn about :-
1.What is Subjective Refraction.
2.Why we should relax the accommodation.
3.Outlines of Subjective Refraction.
4.Different Techniques or Instruments.
5.Determining Near Addition.
6.The Final Prescription.
7.References.
Pediatric Ophthalmic dispensing in different visual problemsRaju Kaiti
Pediatric dispensing, introduction, different from adult dispensing, frame selection, lens selection, special case fitting, Do's and Dont's, Measurements, Down's syndrome, albinism, aphakia, strabismus, syndromes
Optometry and Orthoptics (Laws and Acts)Maryam Fida
Optometry is a health care profession that involves examining the eyes and applicable visual systems for defects or abnormalities as well as the correction of refractive error with glasses or contact lenses and treatment of eye diseases.
Definition of optometry and optometrist
The World Council of Optometry, World Health Organization and about 75 optometry organisations from over 40 countries have all over the world adopted the following definition, to be used to describe optometry and optometrist.
Optometry is a healthcare profession that is autonomous, educated, and regulated (licensed/registered).
Optometrists are the primary healthcare practitioners of the eye and visual system who provide comprehensive eye and vision care, which includes refraction and dispensing, detection/diagnosis and management of disease in the eye, and the rehabilitation of conditions of the visual system.
Competencies
• refractive error,
• ocular disease management,
• medical therapeutics,
• binocular vision,
• sports vision,
• vision therapy,
• contact lenses
Laws of optometry
Currently, optometrists can…
1. Prescribe Schedule II (hydrocodone products only), III, IV, and V narcotics (including oral antivirals, oral steroids, etc)
2. Order imaging, such as MRIs, CT scans, and x-rays
3. Remove foreign bodies
4. Perform post-operative care after 90 days with referral from a physician
5. Treat glaucoma with topicals and orals
6. Treat anterior uveitis
7. Perform dilation and irrigation
8. Perform scraping, debridement, or removal of corneal epithelium
9. Deliver injections limited to anaphylaxis
Optometrists cannot…
1. Perform surgical procedures (Any procedure that involves mechanical or laser means to cut, alter, or infiltrate human tissue is included here. This restriction includes refractive surgery, any laser procedure, or chalazia removal/eyelid or conjunctival cyst lancing procedures, to name a few) (Colorado is one of a few states with verbage to explicitly exclude surgery-most statutes maintain that the license to practice optometry does not include the right to practice medicine)
2. Deliver injectables, except for in the case of anaphylaxis
3. Treat posterior uveitis
4. Prescribe Schedule I or II narcotics
Acts of optometry
1. Health Professions Procedural Code
The Health Professions Procedural Code shall be deemed to be part of this Act.
Definitions
“College” means the College of Optometrists of Ontario; (“Ordre”)
“Health Professions Procedural Code” means the Health Professions Procedural Code set out in Schedule 2 to the Regulated Health Professions Act, 1991; (“Code des professions de la santé”)
“member” means a member of the College; (“membre”)
“profession” means the profession of optometry; (“profession”).
Assignment on Regulatory Prespectives of Clinical TrialsDeepak Kumar
Assignment on Origin and Principles of International Conference on Harmonization - Good Clinical Practice, (ICH-GCP) guidelines Ethical Committee- Institutional Review Board, Ethical Guidelines for Biomedical Research and Human Participant-Schedule Y, ICMR
“CFDA Registration – Market Access Before Investment” delivered by Tim Lin, T...ulmedical
Due to a large population, increasing middle class and government plans to build tens of thousands of hospitals, there is a lot of demand for high quality medical devices in China. For many foreign medical device manufacturers, the regulatory barriers are still significant obstacles.
The medical device regulation in China is less harmonized and generally unique from other major markets. The primary challenges tend to be: actual testing, drafting standards, language barriers and license parking. These additional requirements create a delay in the registration process.
Foreign manufacturers need to specifically understand the Chinese medical device regulation in advance, and then are able to determine appropriate strategies aimed at successful China market entry.
This is the content for a live webinar, "CFDA Registration, Market Access before Investment...Solving the CFDA Challenge" delivered by UL's Tim Lin. Tim is the Senior Technical Consultant working in the Greater China Region. He majored in public health and medical device engineering, and worked as a reviewer in the Taiwan FDA for high and moderate-risk medical device and clinical trial protocol for over 5 years; and also drafted guidance for industry. He is now responsible for risk management file, usability engineering, software validation and CE MDD technical documentation.
The United States has always been and remains to be the leading place
for the conduct of clinical trials. According to Clinicaltrials.gov, the largest
clinical trials registry, 32% of registered clinical trials were conducted in
the U.S. as of May 2022 (1). Factors such as the availability of qualified
healthcare professionals, high-quality infrastructure and facilities,
cutting-edge research, an efficient regulatory system, and a high
standard of ethics and participant protection make the U.S. the leading
country for clinical trials.
Clinical trials follow extensive preclinical research to test the safety and
efficacy of a new drug, medical device, or biological in humans. They are
usually divided into three phases: phases I, II, and III which are designed
to ascertain safety, pharmacokinetics, efficacy, dosage, and adverse
events. Figure 1 shows the typical route from discovery and preclinical
studies to the post-marketing phase (phase IV).Clinical trials represent the longest and most expensive step in bringing
drugs to the market and have the highest attrition rate, only 10% of drugs
that enter phase I trials are granted marketing approval. Therefore,
clinical trials should be conducted by experts that are
well-versed with all the regulations and guidelines in a particular region to
boost the chances of drug approval.
The United States Food and Drug Administration (US FDA) is the
regulatory body that approves and oversees the conduct of clinical trials
for drugs, medical devices, and biologicals that are intended to be
marketed in the U.S and is touted to have the most stringent standards
for drug approval. The primary role of the FDA is to protect public health
by ensuring that medicinal products and devices are safe and efficacious.
Therefore, it is necessary for sponsors/investigators or contract research
organizations (CRO) that are conducting clinical trials to be familiar with
regulations and guidances that govern the conduct of clinical trials.Conducting a clinical trial in the United States requires a deep understanding of the
regulations and guidelines set by the FDA. It is important to know what is needed for a
successful clinical trial, from selecting an appropriate study site to obtaining informed
consent from participants. Additionally, it is essential to understand the requirements for data
collection and analysis, as well as how to develop an effective protocol. Clinical trial services
in USA can provide guidance on all of these aspects and more, helping you ensure that your
clinical trial meets all necessary standards
In Ontario, Independent Health Facilities (IHF) are licensed by the Ministry of Health. Doctors may have hands-on training to help patients manage illness, and investors may have the capital to acquire a medical facility. But very few people understand the bureaucratic process associated with transferring IHF licenses. Here is a little info n the complex bureaucracy.
For more info: http://medpros.wysework.com/healthcare-services/diagnostic-imaging/
clinical trial start up activities lahar ppt 3.pptx
Optometry Investigators
1. Optometry
Chapter 463
Rules 64B13
Investigational Managers Meeting
August 30, 2006
Fort Lauderdale, FL
Robert M. Easton, Jr., O.D., F.A.A.O.
Optometric Physician
Member, Florida Board of Optometry
2. What constitutes a complete
examination of the eye?
CPT Procedure Codes, Laws, and Rules
92004 New Patient
92014 Established Patient
463.005(c) Minimum procedures
which shall constitute a visual
examination.
64B13-3.007 (2) (a-l) Minimum
Procedures for Vision Analysis
3. Optometry’s Required Eye
Exam
Patient History; medical and ocular, includes patient’s chief complaint
Family History; medical and ocular
Visual Acuity; unaided and aided in each eye
External Examination
Pupillary Examination must document size, direct and consensual response
Visual Field by confrontation using finger counting in each quadrant
Ophthalmoscopy, internal examination; recording c/d ratio, a/v ratio, and
any other abnormalities. A dilated exam is required on all New Patients
Biomicroscopy or Slit Lamp Examination of lids, lashes, conj, cornea, a/c,
iris, lens. Corneal Iris Angle assessment of narrow or wide
Tonometry or pressure of each eye with the time it was taken
Refraction for distance with acuities, and near refraction assessment of
accommodation with acuities
Extra ocular muscle balance assessment by cover test, phorias, stereopsis,
versions
Other tests indicated based upon the patient history or by objective signs
and symptoms discovered during the eye exam
Diagnosis which can be cross referenced to a ICD-9 code
Treatment Plan such as correction, medications, referral, and when to return
4. What Equipment must an Optometrist
have to perform a complete
examination?
463.005 (b) Minimum equipment
which a licensed practitioner shall at
all times possess to engage in the
practice of optometry.
64B13-3.004 (1-8) Minimum
Equipment Requirements
14. Certified Optometrist’s
equipment
64B13-3.011 (4) (c)
3. Goldmann applanation tonometer
4. Static threshold visual field unit
5. Gonioscope
6. Fundus camera
7. Biomicroscope
8. Stereoscopic view of optic nerve using
lenses such as digital high mag, Volk 90,
hruby lens
21. Foreign Body Removal
463.014 (4) Surgery of any kind, including
the use of lasers, is expressly prohibited.
Certified optometrists may remove
superficial foreign bodies. For the
purposes of this subsection, the term
"superficial foreign bodies" means
any foreign matter that is embedded
in the conjunctiva or cornea but which
has not penetrated the globe.
26. Distinction of Duties in the
office
463.002 Definitions 6) "Direct
supervision" means supervision to an
extent that the licensee remains on
the premises while all procedures are
being done and gives final approval
to any procedures performed by an
employee.
27. Distinction of Duties in the
office
463.002 Definitions7) "General
supervision" means the responsible
supervision of supportive personnel by a
licensee who need not be present when
such procedures are performed, but who
assumes legal liability thereof. Except in
cases of emergency, "general supervision"
shall require the easy availability or
physical presence of the licensee for
consultation with and direction of the
supportive personnel.
28. Distinction of Duties in the
office
463.009 Supportive personnel.--No person other than a
licensed practitioner may engage in the practice of
optometry as defined in s. 463.002(5). Except as provided in
this section, under no circumstances shall non-licensed
supportive personnel be delegated diagnosis or treatment
duties; however, such personnel may perform data
gathering, preliminary testing, prescribed visual therapy, and
related duties under the direct supervision of the licensed
practitioner. Non-licensed personnel, who need not be
employees of the licensed practitioner, may perform
ministerial duties, tasks, and functions assigned to them by
and performed under the general supervision of a licensed
practitioner, including obtaining information from consumers
for the purpose of making appointments for the licensed
practitioner. The licensed practitioner shall be responsible for
all delegated acts performed by persons under her or his
direct and general supervision.
29. Typical Optometric Violations
463.007 Renewal of license; continuing
education.-- 3) Unless otherwise provided by
law, the board shall require licensees to
periodically demonstrate their professional
competence, as a condition of renewal of a
license, by completing up to 30 hours of
continuing education during the 2-year period
preceding license renewal. For certified
optometrists, the 30-hour continuing education
requirement shall include 6 or more hours of
approved transcript-quality coursework in ocular
and systemic pharmacology and the diagnosis,
treatment, and management of ocular and
systemic conditions and diseases during the 2-year
period preceding application for license renewal.
30. Typical Optometric Violations
463.016 Grounds for disciplinary
action; action by the board.-
f) Advertising goods or services in a
manner which is fraudulent, false,
deceptive, or misleading in form or
content.
31. Typical Optometric Violations
463.014 Certain acts prohibited.--
(1)(a) No corporation, lay body, organization, or
individual other than a licensed practitioner shall
engage in the practice of optometry through the
means of engaging the services, upon a salary,
commission, or other means or inducement, of
any person licensed to practice optometry in this
state. Nothing in this section shall be deemed to
prohibit the association of a licensed practitioner
with a multidisciplinary group of licensed health
care professionals, the primary objective of which
is the diagnosis and treatment of the human body.