EMTALA (Emergency Medical Treatment and Active Labor Act)
This federal law governs how patients are treated in emergency rooms, and imposes duties on ophthalmologists who serve on-call to hospitals.
EMTALA provides information on the basic obligations hospitals and physicians have under EMTALA.
Unapproved Devices
Ophthalmologists are privy to various treatment alternatives, many of which are tested and employed by their peers around the world long before they are approved for use here in the U.S. Before deciding whether or not to use the newest device available, physicians would be well advised to evaluate the patient safety and professional liability risks.
See OMIC’s checklist Risk Analysis of Unapproved Devices below.
Unapproved Devices
See OMIC’s article below.
When FDA Leaves Doctors To Their Own Devices
Off-label Drugs and Devices
Sample Language For Off-label Consent. Physicians are well-advised to obtain informed consent for off-label devices or drugs.
See OMIC’s sample consent language to incorporate into consent forms as needed.
Off-Label Sample Consent Language
See list of articles and forms about the use of off-label and unapproved drugs and devices below.
Medicolegal Implications of Using Off-label Drugs and Devices
Informed Consent and Elective Procedures
Liability Issues Associated with PRK and the Excimer Laser
When FDA Leaves Doctors to Their Own Devices
Checklist for risk analysis of unapproved devices
Suggested Informed Consent Clauses for Documenting Off-Label PRK
Dilating Drops: Patient Safety and Liability Risks
Dilating drops are used on countless patients daily during diagnostic examinations and surgical procedures. They are essential in order to obtain an adequate view of the retina and fundus. Indeed, failure to perform a thorough examination of the eye could lead to significant patient harm such as delay in diagnosis or failure to diagnose, as well as surgical complications due to poor visibility.
See OMIC’s risk management recommendation guide below.
Dilating Drops
Dilating DropsDiscuss Potential Side Effects of Eye Drops
Information Regarding Dilating Eye Drops (for the patient)
Making Your Office Safe
Case Study – Patient Slip and Fall Following Dilation
Wrong Site/Wrong IOL (AAO)
OMIC would like to call your attention to the important work being done by various organizations to prevent wrong site surgery and wrong IOL placement. Refer to the links below:
The American Academy of Ophthalmology- AAO.org
The ASORN( American Society of Ophthalmic Registered Nurses)- ASORN.org
The Joint commission on Accrditation of Health (JCAHO)- JCAHO.org
Universal Protocol for Eliminating Wrong Site, Wrong Procedure, and Wrong Patient Surgery http://www.jointcommission.org/standards_information/up.aspx
