Cover Focus | Apr 2015

Guidelines for Refractive Surgery

The Irish College of Ophthalmologists has issued recommendations as a response to growing concerns over the use of hard-sell tactics in laser vision correction.

A set of voluntary guidelines has been established for refractive surgeons practicing in Ireland. The Irish College of Ophthalmologists (ICO) released the recommendations in February, not only as a reference tool for the public, patients, and health care professionals, but also as a means to assist consumers in making informed decisions regarding refractive surgery.1

Some sources suggest that these guidelines, which provide an overview of what consumers can expect during the entire refractive surgery process—from decision-making preoperatively to patient care postoperatively—were issued as a response to growing concerns over the use of hard-sell tactics in laser vision correction marketing.

“People may be led by the advertising used to think [laser vision correction] is a trivial procedure with minimal complications,” Billy Power, president of the ICO, said in an article published in the Irish Times.2

According to the article, litigation in refractive surgery has increased in Ireland in recent years, with at least 21 lawsuits having been filed by individual consumers against several high-street eye laser clinics since 2008. As a result of the increase, indemnity insurance for refractive surgeons now costs about €97,000 annually—more than two times what it cost 3 years ago.

In addition to the concerns of the ICO and individual ophthalmologists over the increased use of hard-sell tactics and marketing in laser vision correction, there is also worry that patients are not receiving adequate pre- and postoperative care.

“I am amazed at the number of patients who say they never met their eye surgeon before the day of their laser operation,” Mr. Power said in the Irish Times article.2 “You wouldn't do that with an ingrown toenail, and you certainly shouldn't with an operation on your eye.”

In order to address these and other key issues in refractive surgery care, the ICO's guidelines include sections on the consent process and advertising and marketing as well as on clinical governance and facilities. In addition to abiding by the Guide to Professional Conduct and Ethics for Registered Medical Practitioners,3 surgeons must have undergone subspecialty training for refractive surgery, work within the limits of their professional competence, keep their knowledge and skills up to date, be members of at least one relevant professional organization that provides continuing professional development, and maintain competence in order to make appropriate and acceptable decisions regarding patient management.4

Of more serious note, all advertising materials must adhere to the Advertising Standards Authority of Ireland (ASAI)5 and to the Medical Council of Ireland guidelines3 and must be legal, factual, and not misleading. All materials must safeguard patients from unrealistic expectations, should not offer a discount based on a deadline date for booking an appointment, and should not offer surgery as a competition prize or as a package deal (eg, a special price for referring a friend or for two people).

“Accurate, fair, and balanced communication with the patient and the general public is essential,” the guidelines state.3 “Communication through statements, testimonials, photographs, graphics, or other means must not convey false, untrue, deceptive, or misleading information. They must not omit material information without which the communications would be deceptive. … If communications refer to benefits or other attributes of ophthalmic procedures that involve significant risks, realistic assessments of their safety and efficacy must also be included, as well as the availability of alternatives and, where necessary to avoid deception, descriptions and/or assessments of the benefits or other attributes of those alternatives.”

The statement adds, “Information on procedures must not trivialize the seriousness of surgery or minimize the potential risks. Due to increased direct-to-patient advertising, advances in treatment … should not be presented in such a way as to lead to the misconception that surgical procedures are without risk.”

With regard to the consent and postoperative care processes, the ICO guidelines include provisions for informed consent to be given to the patient at least 24 hours in advance of the procedure so that the risks and benefits of the procedure can be discussed. Additionally, patients must be scheduled for an appointment with the operating surgeon prior to surgery, and the procedure should not be carried out any sooner than 24 hours after this meeting. Once surgery has taken place, the guidelines stipulate that it is the responsibility of the surgeon to ensure appropriate postoperative management and that he or she should conduct the first postoperative evaluation of patients.

Although the guidelines are voluntary, the ICO stated that members who do not adhere to them will be refused membership. A full listing of the ICO guidelines may be found at http://eyedoctors.ie/medium/files/ICO_Guides_Refractive_Surgery_Final_(web)-r.pdf.

“A key priority for the ICO is educating the public on the importance of taking care of their eye health,” the organization said in a news release.1 “We are focused on setting the highest standards of eye care in Ireland to ensure best outcomes for patients.” n

1. ICO publish guidelines for refractive eye surgery. Irish College of Ophthalmologists website. www.eyedoctors.ie/press-release/February-8-2015/ICO-Publish-Guidelines-for-Refractive-Eye-Surtery/26.html. Accessed March 19, 2015.

2. Cullen P. New rules for eye-laser surgery due hard-sell tactics. Irish Times. www.irishtimes.com/news/health/new-rules-for-eye-laser-surgery-due-hard-sell-tactics-1.2096131. Accessed March 19, 2015.

3. Guide to professional conduct and ethics for registered medical practitioners. Irish Medical Council website. http://www.medicalcouncil.ie/News-and-Publications/Publications/Information-for-Doctors/Guide-to-Professional-Conduct-and-Ethics-for-Registered-Medical-Practitioners.pdf. Accessed March 19, 2015.

4. Guidelines for refractive surgery in Ireland. Irish College of Ophthalmologists website. http://eyedoctors.ie/medium/files/ICO_Guides_Refractive_Surgery_Final_(web)-r.pdf Accessed March 19, 2015.

5. ASAI Code. Advertising Standards Authority of Ireland website. http://www.asai.ie/code.asp. Accessed March 19, 2015.

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