Parliamentary forum's report on laser eye surgery is published

[Rebecca Petris]

The much-awaited report by the Parliamentary forum, which was formed earlier this year to review the safety of laser eye surgery and make recommendations as to regulatory changes, has been released. I will post again with a link when the report itself is available online. (Incidentally, I testified before this panel back in June particularly about the need for clinical results, complications and side effects to be tracked and audited.)

[Rebecca Petris]

Here is the press release (part 1 of 2 - it doesn't all fit in a single post)

PRESS RELEASE
14 DECEMBER 2004


MAKING THE UK THE SAFEST PLACE IN THE WORLD TO HAVE LASER EYE SURGERY


Over 100,000 laser eye procedures are carried out annually in the UK. Concerns have been raised about advertising practices, standards of safety and regulation, and training of ophthalmologists and optometrists.

A group of concerned MPs came together in January 2004 to form an All Party Parliamentary Panel of Enquiry to look into the safety of eye laser surgery in the UK. The Panel consists of

- Frank COOK MP (Lab)
- The Hon Gwyneth DUNWOODY MP (Lab)
- Professor Dr. Ian GIBSON MP (Lab
- Dr. Richard TAYLOR MP (Ind)

The Panel of Enquiry is self-selected and evidence was requested and submitted on a voluntary basis. Nevertheless, the Panel believes it has exposed failings in the present system that requires immediate action. These failures relate to elective laser eye surgery that does not fall within the NHS.

The All Party Parliamentary Panel of Enquiry Report, To Make the UK the Safest Place in the World to have Laser Eye Surgery, sets out recommendations for urgent implementation.

This Report recommends stricter standards of regulation for refractive surgery. The Royal College of Ophthalmologists in conjunction with the College of Optometrists should develop these new standards. Lack of specialist training in refractive surgery is another key area of concern. The Report sets out a list of actions that address ‘current gaps’ in training and continuing education.

There is a clear need for the Healthcare Commission to be given training and resources to properly regulate and monitor the industry. This agency must be able to apply serious and meaningful sanctions where Clinics or surgeons fail to comply with new standards.

We hope this Report adds to the work of The National Institute for Clinical Excellence (NICE), and will assist the government in the work that needs to be done.

A summary of recommendations is listed below. To access the full Report, please e-mail lisaterhaar@btinternet.com and you will receive the full Report as an email attachment by return.


Advertising

- Advertisements must include warnings on possible negative elements such as night vision complications.
- The Royal College of Ophthalmologists must set out control and guidelines that include the Internet.
- All text or promotional materials promoting laser eye surgery, including the Internet, should comply with these guidelines.


Patient Counselling

- RCOphth must provide comprehensive, user-friendly written materials that are targeted to potential patients.
- Information materials should be made available for dissemination by GPs, optometrists and ophthalmologists.
- These materials should provide standard details about:
- Patient selection
- Pros and cons of each technique presented in a properly balanced manner
- Risk and benefit assessment of two eyes at once versus one at a time
- Clear differentiation between the terms ‘enhancement’ and complication
- Overall outcome statistics
- Individual surgeon’s qualifications, experience and outcomes
- Outcomes from individual clinics
- No incentives must be offered to patients to encourage them to sign up immediately for surgery or to staff to encourage them to enrol patients.
- There must be clarity about payment of co-management and follow-up monitoring fees to optometrists.

Patient consent forms
- The RCOphth in collaboration with COptom, Medical Defence Union and Medical Protection Society must agree and provide a template for a universal consent form.
- Patients must have access to counselling and a full explanation of the procedure and treatment.
- A process must be set out that ensures patients confirm their understanding and comprehension of the procedure.
- The Panel recommends a latent period of three days between counselling and signature of the consent form
- The Panel recommends a latent period of seven days between signature of the consent form and surgery.

Surgeon Suitability and Qualifications

- The RCOphth must set out stricter guidelines regulating clinical practice. These guidelines to be monitored and policed by the Healthcare Commission.
- The NICE guidelines to be published soon may be suitable for the Healthcare Commission to use as a standard.
- Sanctions must be set where Clinics flaunt these guidelines.
- Each clinic must have a Consultant with specialist knowledge, training and experience in cornea and refractive techniques.
- He or she must take ultimate responsibility for patients similar to the current system operating in the NHS (where NHS doctors in training report to a Consultant).
- All laser eye surgeons to be listed on a RCOphth sub speciality list.

Training

1. Ophthalmologists

- All surgeons to be suitably trained to an agreed standard. This training to be RCOphth ‘approved’ and certified by a RCOphth training board.
- Clinics and manufacturers must collaborate with the RCOphth to set up and implement an UK-wide training programme for ophthalmologists.
- The College must approve individual clinic and manufacturer system-based training.

2. Optometrists

- The College should set up background training to provide detailed educational information on refractive surgery and make it widely available.
- Courses should emphasise suitable patients.

3. GPs

- Lecture sessions on refractive surgery should be offered to Local GP groups.
- These Lectures should include a comprehensive explanation of the different options available (PRK Lasek and Lasik), suitability of patients and complication rates.

Identifying the Unsuitable patient

- It is vital that the procedures for accepting suitable patients be standardised and clarified. Only patients who meet defined criteria should be routinely treated.
- Safe operating parameters should be set. Only prescriptions between a range of + 3 to – 8 should be routinely operated on. 90% of eyes have a prescription of less than - 3.75.
- Clarification must be provided to patients where adverse conditions and syndromes that could lead to complications increase the risks associated with laser eye surgery.
- Candidates with significant mental health or emotional problems should be identified by practitioners and critically assessed for their suitability for this surgery.

Regulation

1. Clinics

- The Healthcare Commission must take on the role of regulator to police the industry.
- All clinics in the UK providing laser eye surgery must carry out annual audits for success rates, surgical complications and infection rates. These statistics should be published annually and must be made available to The Healthcare Commission.
- Complications of laser eye surgery referred to NHS Clinics for treatment must be recorded and sent to the Healthcare Commission to be added to the complication rates for the referring clinic.
- The Healthcare Commission should issue an annual licence to practice to clinics and individual surgeons. This must follow proper inspection of premises; verification of surgeons’ registration on the RCOphth Refractive Surgery List; acceptability of published data on outcomes and complication rates; confirming CME compliance; and regular safety checks on the laser device.
- The Healthcare Commission must have the power and authority to enforce the new regulations. Clinics or surgeons who fail to comply with the agreed standards should be removed from the RCOphth Refractive Surgery List.
- These extra responsibilities will stretch the current level of training and resources in the Healthcare Commission. Training and adequate resources must be set in place.
- The Panel recommends the payment of an annual licence fee to the Healthcare Commission to cover the costs involved in regulating and policing the industry.

2. Devices

- The Healthcare Commission should be responsible for annual follow-up checks for laser safety, approved by Medicines and Healthcare Products Regulatory Agency (MHRA).
- Failure to comply must lead to the revocation of the licence.

3. Surgeons

- All surgeons practising laser eye surgery should be RCOphth approved.
- The RCOphth should set out and require a programme of Continuing Medical Education (CME) for refractive surgery.
- The number of procedures conducted by an individual surgeon should be monitored and published by the Healthcare Commission on an annual basis, including complication and enhancement rates.
- Adverse incidents should be recorded and reported to the Ophthalmic Surveillance Unit, including system factors and failures.
- A senior clinician (Consultant surgeon) must be appointed at each clinic who is ultimately responsible for outcomes and patient care.
- Clinics and individual surgeons should be subject to an annual fee to the RCOphth for annual auditing and external monitoring of their practice.

4. Optometrists

Recommendations for the Royal College of Ophthalmologists and College of Optometrists

- The COptom should set up relevant training programmes in refractive surgery for optometrists in collaboration with the RCOphth.

[Rebecca Petris]

Press release part 2 of 2

Patient Follow-up

- The RCOphth must set out transparent guidelines of surgeon responsibility and the practice of co-management and payment of fees to optometrists in conjunction with the General Optic Council (GOC).
- The Healthcare Commission must monitor and assess compliance to these transparent guidelines in conjunction with the GOC.
- Surgeons should be mandated to undertake a one and two year follow up on all patients.
- Clearer definition of complications and the difference between ‘enhancement’ and complication must be set out.
- Guidelines describing mechanisms for dealing with complications must be included in the patient counselling information.
- Laser clinics should be subject to a levy to provide a protection fund for patients who suffer complications. The NHS would be able to draw on these levies where necessary in private cases.
- Clinics would be able to negotiate an annual ‘no claims’ refund where there have been no referrals to the NHS.
- Clinics should be obliged to provide an annual audit and publication of complications, outcomes and adverse incidents for submission to the Healthcare Commission.
- Clinics and surgeons should also be obliged to report adverse incidents to the RCOphth.
- The Ophthalmic Surveillance Unit should undertake a 3-year review and provide a publicly available quality rating of clinics.

[Gretchen]

Yessssss!! (and thanks for your testimony).

Hope these are implemented before the powerful "We're Making a Boatload of Money Off Lasik" lobby gets its hands on it.

Also hope the US follows the UK's example. (I know. . . yeah, right. Here, eye surgery continues to be the equivalent of a contractor saying, "We built you a house, but, uh, we didn't use any nails.")