HC Deb 04 February 2004 vol 417 cc873-80

Motion made, and Question proposed, That this House do now adjourn.—[Margaret Moran.]

7 pm

Dr. Ashok Kumar (Middlesbrough, South and Cleveland, East)

I thank you, Mr. Speaker, for granting me this debate. My own interest in the safety of laser eye surgery began about a year ago, when I read some reports in national newspapers on the matter. Since then, I have followed the subject with great interest; in fact, I even tabled some questions in the House on it. Recent advances in laser technology mean that both long-sightedness and short-sightedness can be treated, and in many cases corrected, through laser eye surgery. Seventy-seven corrective laser eye surgery establishments are currently registered with the National Care Standards Commission. According to aHealth Which? report of February last year, some 100,000 people a year in the UK undergo laser eye surgery.

I want to comment on the history and popularity of laser eye surgery, and then to highlight my three main concerns about the safety and reliability of this service. First, on customer care, there is a need for development and extension of the consumer protection regime, and for the provision of detailed information about the potential risks and complications of surgery. Secondly, in terms of the qualifications of practitioners, there is a need for standardised training requirements for surgeons performing laser eye surgery procedures. My third concern relates to clinical audit and best practice, and the need for regulatory bodies to identify best practice, and to create standard regulations for the entire industry, including minimum standards of pre-care and post-care.

Laser eye surgery was developed by the ophthalmologist Dr. Steven Trokel in 1987, and first used on a patient in Germany in 1988. The first laser eye treatment clinic using Dr. Trokel's laser was founded by US-based investors in Toronto in 1989. Following the success of the US operation, the first UK clinic was opened at Clatterbridge hospital, in Wirral, in January 1991. It grew into a string of clinics now known as Ultralase, one of Britain's foremost laser eye treatment providers. Ultralase and other, smaller companies—along with Boots, Optimax and Maxivision—are believed to perform some 100,000 treatments a year in the UK.

The declining cost of laser eye surgery reflects increased demand and competition within the sector, and demonstrates its popularity. But that is matched by increasing concern among patients and clinicians alike about the resulting side effects and vision damage. Laser eye surgery, a relatively new form of elective surgery, is seen by many as a cosmetic procedure, but the changes made during it are irreversible and can lead to side effects ranging from dry eyes to worsened vision. Nevertheless, an increasing number of people, rather than wear glasses or contact lenses for the rest of their lives, are opting to spend money on a one-off surgical procedure that, in the majority of cases, eliminates the need for glasses or lenses.

There are those for whom refractive surgery is a godsend, freeing them from a lifetime's myopia with one quick, fairly pain-free and relatively cheap procedure, but my concern is that there is currently no adequate means of assessing the quality of the treatment available. If it is true that you get what you pay for, we may note that the range of fees payable for the surgery varies from £495 per eye for Lasek treatment at Optimax, through to £1,650 per eye for Wavefront LASIK at Laservision. In fact, the cost can be as much as £2,000 per eye, as reported by the Discovery Health channel last year when it investigated this topic. That is quite a range.

What exactly is it that people are paying for? What are the basic requirements, and what are the added extras? It is worth mentioning that there are vast differences in the regulations for cosmetic surgery and for laser eye surgery. Since April 2002, minimum standards for cosmetic surgery have been applied by the N CSC, which also vets cosmetic surgeons who generate regular complaints. In May 2002, the Department of Health provided additional reassurance by announcing proposals to require cosmetic surgeons to be medically qualified and to have attended a postgraduate course before being allowed to operate.

Where does that leave laser eye surgery? Surprisingly, the regulations covering the sector do not appear to be as stringent as those covering more traditional cosmetic procedures. I would be interested to hear the Minister's comments on why t hat is.

Negligence claims involving laser eye surgery against doctors belonging to the Medical Defence Union have more than doubled in the past six years. The Medical Defence Union is the largest insurer for UK doctors. It believes that, while some of the claims were for faulty surgery, many more centred on patients' unrealistic expectations about what could be achieved. Recent figures released by the union show that claims over laser eye surgery have increased by 166 per cent. in six years and now account for a third of all ophthalmology claims. The MDI. T has increased its subscription rates for laser eye surgeons and advised them on how to minimise the risk of a claim.

Dr. Christine Tompkins of the MDU is on the record as saying: Patients need to understand what the risks are. And they need to think about whether or not the benefits they think they will get from the procedure actually outweigh the risks, in order to decide whether they want to go ahead with it. In very rare case complications can lead to corneal ectasia, where fluid pressure builds up on the eye, and patients can need a corneal transplant to correct the condition. Other complications, although deemed "minor" by clinics, occur "relatively frequently", according to a recent review by the American Academy of Ophthalmology. Patients can experience dry eyes or night vision problems that can affect the ability to drive or work in the evening or in dim light.

My first concern is about customer care and access to information. The guidelines make it clear that there should be information available about the possible negative effects of laser eye surgery, but it is for the clinic to determine whether this means blinding the patient with science through a list of technical outcomes or, alternatively, reassuring them that mishaps are so rare that they do not need to worry.

The Health Which? Report last February catalogued a range of complaints from those who have experienced negative effects following laser eye surgery. Some were temporary, but in other cases long-term effects were cited. The report said: Patients shouldn't be taken in by the claims about the safety and success rates of laser eye surgery. Whilst most do benefit from laser eye surgery, nobody knows the real number who have disastrous or disappointing results although we do know that litigation is increasing. Complication and success rates vary from clinic to clinic and surgeon to surgeon". He continued: Patients need more honesty about so-called minor complications and the fact that many who have surgery still need glasses or lenses. He concluded: We'd also like all companies to publish their complication rates and results and have them independently audited so that patients can make an informed choice. My second concern is the qualification of practitioners. Early last year, I tabled I written question about the qualifications required for laser eye surgery practitioners and the clinical assessment and audit of such procedures, and I received an answer on 28 April 2003. The then Minister, my hon. Friend the Member for Tottenham (Mr. Lammy), informed me that such establishments must register with the National Care Standards Commission and are required to comply with the private and voluntary health care regulations. He stated: Regulation 42(1) requires that the registered person has in place a professional protocol drawn up by a trained and experienced medical practitioner or dentist from the relevant discipline in which treatment is to be provided…The vast majority of laser eye surgery takes place in private practice. The Department of Health does not collect information about such procedures by individual surgeons."—[Official Report, 28 April 2003; Vol. 404, c. 275W.] That answer is worrying on two counts. First, as the regulations stand at the moment, they require not the person conducting the procedure but the clinical director for the registered clinic to be qualified in, in this case, refractive eye surgery, which means that in practice the patient, who might naturally assume that the person responsible for changing the shape and size of their cornea using pulses of high-frequency light is qualified, may be operated on by a general practitioner or similar. Indeed, after speaking to the Royal College of Ophthalmology and the NCSC, it is unclear what standards of qualification exist for laser eye surgeons and what constitutes a competent and experienced surgeon.

Dr. Sherry Williams of the Medical Protection Society told me that because refractive surgery is not conducted in the NHS, no training is available through the NHS. It is therefore left to the industry to determine that each individual clinic sets its own standards, and that is not immediately apparent to patients seeking service in the industry.

There are no specific regulations in refractive surgery, and the only legal requirement for doctors performing laser surgery is that they are registered with the General Medical Council. Any doctor currently employed by a refractive surgery chain can operate after a laser surgery course of just a few days. I find the suggestion that surgeons operating in the private sector should not be bound by the same degree of clinical assessment and audit as those within the NHS worrying, and in that I am not alone.

The public minutes of the NCSC board meeting last June state: The issue of laser eye surgery was raised, following increased public concern and recent press reports, and it was suggested that the regulation of these should be highlighted to the Commission for Healthcare Audit and Inspection. I know that CHAI will become responsible for the sector in April this year, but I am still unaware of any efforts to address my specific concerns. Having researched the issue, there is general agreement among interested parties, which include NCSC inspectors, the RCO and the laser eye industry, that more detailed basic regulation would be welcome, as long as it is not too prohibitive or prescriptive. This agreement is particularly true in the light of the decreasing cost and increasing popularity of refractive eye surgery procedures.

One inspector told me that in the inspectors' opinion the regulations and guidelines that they were required to use during their inspection of laser eye surgery clinics were loose, woolly and open to interpretation. Given that all inspectors for the NCSC are clinicians of one sort or another, to my mind that is not a statement to be ignored. I come to best practice. I do not want to be seen as too critical of a new and innovative area of medical practice that is a great credit to those who developed it. I admire the spirit of innovation in laser eye surgery.

While researching the subject, I have become aware that there are those who exemplify the best practice, which I feel needs to be rolled out across the sector. Ultralase—whose chairman, Christopher Neave, is also chief executive of the relatively new industry body, the Eye Laser Association—is one of the larger independent health care providers in the laser eye surgery sector. It does not simply operate within company standards, which appear to be more severe than those required at the statutory level at present. Indeed, during a recent meeting I was most impressed to note that certain changes that I recommended are to be added to its guidance as a direct result of our meeting.

The NCSC, the RCO and the laser eye surgery industry have all expressed, to differing degrees, interest in creating a set of standards for the benefit of patient safety.

In conclusion, I should like to say that as patients' knowledge of their rights grows, so do their expectations and demands. After recent high-profile debates about the competence and clinical auditing of surgeons and other health care professionals in the public sector, I believe that it is important that we extend our gaze to the private sector as well.

I do not want to unduly criticise private health practitioners. In fact, the Eye Laser Association agrees with me that there are distinct benefits in recognising the best practice of some practitioners and requiring others to bring themselves up to scratch. Just one example is that of pre-care assessment. Ultralase reports that about 25 per cent. of people are ineligible for laser eye surgery due to certain medical conditions, and recommends that any clinic operating should not have a turn away rate significantly lower than 25 per cent. It also refuses to conduct surgery on the same day as a patient is assessed. I am led to believe that the RCO is drafting guidelines requiring a cooling-off period between assessment and treatment of patients, but this is not currently mandatory.

Similarly, different clinics offer different after-care advice and treatment. As long as the consumer has no indication what the recommended minimum information and treatment are, and as long as the industry has no requirement to provide that minimum, but simply to provide some, it will continue to be the consumer, if anyone, who suffers.

I look forward to hearing from my hon. Friend what steps are being taken to address my three concerns. I ask her to use the powers available to her under section 130(1) of the Health and Social Care (Community Health and Standards) Act 2003 to direct the Commission for Healthcare Audit and Inspection to investigate the need for closer scrutiny of the laser eye sector.

7.18 pm
The Parliamentary Under-Secretary of State for Health (Miss Melanie Johnson)

First, I congratulate my hon. Friend the Member for Middlesbrough, South and Cleveland, East (Dr. Kumar) on securing today's debate. He has already demonstrated his interest in this important subject, and I emphasise that the Government share that interest.

My hon. Friend will know that the NHS does not routinely provide laser eye surgery to correct refractive errors. The Government's view is that spectacles or contact lenses can usually correct refractory errors in a safe and cost-effective way.

The majority of laser eye surgery, therefore, takes place in private hospitals, and there appears to be a growth in the number of occasions on which this procedure is undertaken.It is, of course, important that service standards are clear and that those standards provide patients who choose to have laser eye surgery with the necessary assurance that the procedure is being carried out safely and appropriately.

I am aware of information received from the Eye Laser Association that states that more than 100,000 laser eye procedures are carried out in the United Kingdom each year. Indeed, it informs us that laser eye surgery is the single most performed surgical procedure world-wide and that the number of procedures undertaken has run into millions.

Patient safety and quality assurance are the cornerstones of the new regulatory system for independent health care. Nevertheless, the Government are aware that people have concerns about laser eye surgery. That has been clear in Parliament, from questions from Members and early-day motions, as well as from news items that the media have carried. One of the concerns has been that the practice is not properly regulated. I hope to reassure my hon. Friend on that.

The debate gives me an opportunity to speak more widely about what the Government have done to improve the regulation of care provided by health establishments in the independent sector overall. As my hon. Friend said, the Care Standards Act 2000 established the National Care Standards Commission as an independent regulator and sector watchdog for social and independent health care services in England. The commission began operating in April 2002. The aim of the Act was to modernise the regulatory system and to protect vulnerable people in society by introducing, for the first time. consistent national minimum standards for providers of social and independent health care in England. The commission's main aim is to drive up the quality of services and improve the level of protection for vulnerable people.

The commission registers, inspects and regulates health and social care providers against regulations and national minimum standards set by the Government. In applying the standards, the commission looks for evidence that the facilities, resources, policies, work force, services and activities offered by providers lead to positive outcomes and experience for service users. The regulations and standards to which providers of services are required to adhere are stringent and service user-oriented. Providers are subject to annual inspections by the commission, which requires providers of laser eye surgery to keep records of each surgical procedure undertaken, including accidents or adverse incidents. It also requires independent hospitals where laser eye surgery takes place to submit annual figures to it showing the number of complaints made and the action taken in response to them.The NCSC currently has 77 corrective laser eve surgery establishments registered, with a further 18 applications pending. It has had to take no enforcement action on clinical issues against any of those establishments.

There are two types of national minimum standard: core standards, which cover general issues that apply to all independent health care providers, and service-specific standards Core standards require a registered establishment to ensure that before an appointment any qualifications relevant to the post are verified, and that the relevant regulatory or licensing body is asked to confirm that the applicant is appropriately registered. Core standards also require employers to make arrangements for staff training and continuing professional development.

Service-specific standards are those developed for a particular sector and a particular service user group. They do not imply that all providers must offer a uniform level of service; instead, they set out a minimum level of service that will guarantee a basic level of care for service users. Of course some establishments already exceed many of the standards, and in doing so have developed excellent levels of service provision. They provide a very high standard of care. The commission is determined to promote innovative good practice where and when it finds it.

The type of laser used in laser eye surgery is a class 4 laser. Its use is regulated by the NCSC, and, as I have said, providers of laser eye surgery are required to he registered with the commission as a licence to trade. The commission maintains specific service standards in respect of the use of class 4 lasers.

The service standards that are specific to class 4 state that all staff using lasers and intense pulsed lights are to have regular, recorded update training, both planned and in reaction to relevant technological and medical developments; and that they use the lasers and intense pulsed light only for treatments for which they have been trained and, where appropriate, hold qualifications. The standards also stipulate that an expert medical practitioner must produce a protocol. That protocol has to be followed and will set out the necessary pre-treatment checks and tests, the manner in which the procedure is to be applied, the acceptable variations in the settings used, and when to abort a treatment. A further standard deals with the protection of people in the controlled area around working lasers.

The standards provide a tool for the commission and providers jointly to improve the quality of services and they are used in conjunction with the Private and Voluntary Health Care (England) Regulations 2001—the legal instrument that governs how independent providers operate. The regulations state that registered providers should ensure that they employ an appropriate level of suitably qualified, skilled and experienced persons and that they should ensure that each person receives appropriate training, supervision and appraisal, and that staff are enabled to obtain further qualifications, where available, appropriate to the work that they perform.

The NCSC board has in the past highlighted the issue of laser eye surgery and recommended that the procedures and practices around it be reviewed in greater depth in the future. Inspections and reviews undertaken by the commission have also discovered that some establishments have fallen short of the required standards; those establishments now have a legal obligation to improve.

As my hon. Friend said, there are no specific qualifications in refractive surgery. A doctor undertaking laser eye surgery must be registered with the General Medical Council. The Royal College of Ophthalmologists recommends that only qualified ophthalmologists should be able to undertake the procedure and that they should have undertaken appropriate additional specialist training. However, all doctors must work within the principles of "good medical practice"—the standards that a doctor must keep to ensure continued registration with the GMC. Those standards state that in providing care you must recognise and work within the limits of your professional competence and be competent when making diagnoses and when giving or arranging treatment".

On present evidence, we believe that the current safeguards are adequate to ensure the safety and well-being of service users, but as evidence on complication rates is gathered and considered we expect—in conjunction with the wider medical profession—to take a view on the continuation of laser eye surgery by those who are not ophthalmologists.

I am also aware that there has been some concern over a reported rise in complaints, which my hon. Friend highlighted, but that is not borne out by the figures—certainly not by the NCSC figures. Since the implementation of the Care Standards Act 2000 in April 2002, the NCSC has received only two official complaints relating to laser eye surgery. One has been resolved to the patient's satisfaction and one is still ongoing and is being reviewed by the commission.

It is right that, in order to minimise risks to service users, the commission continues to keep the position surrounding laser eye surgery under continuous review. If there is a need for the Government to act, we will do so. Nevertheless, as I stated earlier, the NCSC has not felt it necessary to take enforcement action on clinical issues against any such establishments. It is worth pointing out that if a complaint were made against a doctor, the GMC would have to take into account any advice from the Royal College of Ophthalmologists about who should be undertaking the surgery.

On the power of the NCSC, the legislation that it is charged with applying gives far-reaching powers to act in the interest of users and to champion their rights. The commission will use those powers wisely and with discretion to assist service providers to comply with standards wherever possible. It will nevertheless take swift and vigorous action if it finds that the health, safety and well-being of service users are being compromised.

It remains for me to say that the arrangements will continue under the Commission for Healthcare Audit and Inspection, and I am confident that the success of the present arrangements will be continued as the NCSC transfers its responsibilities to CHAI in April this year.

I hope that I have been able to allay some of my hon. Friend's concerns over the provision of laser eye surgery in England. I understand that he is due to meet representatives of the National Care Standards Commission shortly, and I hope that they will be able to allay his concerns still further.

Question put and agreed to.

Adjourned accordingly at half-past Seven o'clock.