Medicolegal Aspects of Dermatological Surgery
Dermatologists wishing to offer surgical services to patients should first ensure that they have had proper instruction and are sufficiently experienced and competent to perform surgical procedures.
The purpose of a negligence claim is to provide compensation for an individual injured by another’s negligence. The plaintiff must show that:
- The defendant owed him a duty of care
- The defendant was in breach of that duty, e.g. was careless
- The harm the victim complains of was as a result of inadequate standard of care.
A medical practitioner owes his patient a duty of care. The standard the Law demands is the standard of a reasonably skilled and experienced Doctor claiming to have and exercising a particular skill.
Adequate pre-operative assessment of the lesion and the patient’s suitability for surgery are essential. The size, site and nature of the lesion must be considered. Particular care must be given to the characteristics of the skin and the anatomy at the site of the lesion. Great caution is needed in the axilla, femoral triangle, neck, particularly the posterior triangle, where the spinal accessory nerve lies, the wrist and the hand.
Pulsatile lesions should be avoided. A lesion lying in the region of the nerve may be a neurofibroma. Superficially situated nerves or arteries are vulnerable and great are must be taken to avoid them.
The cosmetic outcome of surgery is important and practitioners should consider whether they have adequate specialist knowledge to achieve a good result. This is particularly important when assessing a facial lesion.
The patient’s past history, general health, medication and allergies must be known and considered.
A medical practitioner must have valid consent to treat a patient. To be valid, consent must be freely given, specific, must cover what is to be done and must be based on an understanding of the implications and nature of the treatment.
A doctor has a duty to explain to the patient, in language the patient can understand, the nature, purpose and material risks of the proposed procedure and alternative forms of management. The patient must be capable of understanding the explanation given. If he is incapable, informed consent cannot be obtained. Where a patient has been given insufficient information, the doctor may be found to have been in breach of his duty and liable to the patient if damage results.
Oral consent is not usually appropriate for major procedures. If only oral consent is obtained, an entry should be made in the clinical notes confirming that consent has been given, together with details of any warning given to the patient, such as the possibility of visible scars or the risk of keloid formation.
Written consent provides documentary evidence that consent has been obtained. Written consent is recommended for all procedures requiring a general anaesthetic, or operations other than minor ones performed under local or regional anaesthesia, for major invasive procedures, such as endoscopies and biopsies, etc., and for potentially hazardous investigative techniques. In the case of parents of children under sixteen or adults who are known to be litigious, written consent may also be advisable for even a minor procedure.
Consent should be obtained by a medical practitioner, not a nurse, who is familiar with the details and risks of the proposed operation or investigation.
If an operation carries with it a material risk which the surgeon has expressly mentioned to the patient, it is prudent to record this fact in the clinical notes and in the correspondence with the patient’s GP. Doctors should mention material risks to patients. Material risks are defined as those to which a reasonable doctor believes a person in the patient’s position would be likely to attach significance.
Before giving consent, the patient must understand the alternatives available to him. He should understand what to expect at the operation and post-operatively, including possible complications. He should be warned to expect a scar, particularly if the surgery is for cosmetic reasons.
Equipment and Drugs
Surgery should be performed in a properly equipped adequately lit room. A surgeon should be familiar with the surgical equipment he proposes to use. Surgical equipment must be sterile and adequately maintained.
The Consumer Protection Act, 1987, requires a producer to ensure that a product is up to standard and fit for the intended purpose. A product will include any pharmaceutical preparation given to a patient or any equipment used in treatment. The supplier of a product has a responsibility to identify the producer when any damage is caused by a defect in the product. If that cannot be done, then the liability rests with the supplier. Doctors become suppliers when they dispense any product to a patient, such as, for example, suturing material or local anaesthetic. To avoid strict liability, the doctor must know the name of the supplier and/or the name of the producer. A record of the name of the product, the batch name and the doctor’s supplier must be maintained, and the record annotated to show the dates between which each batch was used. These records must be kept for eleven years and are essential if, in the event of a product being in some way faulty, strict liability is to be passed on to the producer.
If a doctor alters a product, he may become a producer; for example, if he mixes drugs prior to injection, or alters a piece of equipment for personal preference, such as bending a needle. It may be a defence if these changes accord with the original producer’s instructions and guidelines.
If a patient suffers damage from the use of a piece of equipment in the course of treatment, liability may rest with the producer or supplier. However, the producer may escape strict liability if it can be shown that the equipment was not maintained or calibrated or used in accordance with his instructions.
The Act enforces a strict liability, so, if the product is defective and the consumer’s health is damaged, the producer is liable. It is not necessary to prove negligence.
A reliable procedure should be adopted for identifying patients in order to ensure that the correct patient receives the correct operation. Abbreviations and assumptions should be avoided. Late changes in theatre lists are undesirable.
An account should always be made of the swabs and packs, instruments and needles used by the surgeon and the assistants during an operation, however minor or superficial. Before completing an operation the surgeon should ascertain that all swabs and packs have been accounted for. Changes in personnel during the course of an operation are undesirable.
Authorities on minor surgery now recommend that every excised lesion is sent for histology to identify the occasional surprise malignancy.
Specimen containers should be labelled carefully and a request form completed. Practitioners should check that a histological report has been received and that the appropriate follow-up is arranged.
In the unlikely event of a mishap, The Medical Defence Union recommend that the patient or patient’s representative is told the facts without speculation or comment on the actions of others. The courtesy of a sincere and honest explanation and where appropriate an apology as well is owed to a patient under these circumstances. Arrangements should be set in hand to rectify the damage expeditiously.
A member of the Medical Secretariat of The Medical Defence Union is always available to advise members if difficulties occur.
The brief notes above are not exhaustive. Further information is provided in the following booklets, available from The Medical Defence Union:
- Consent to Treatment
- Product Liability
- Medico-Legal Aspects of Minor Surgery
Theatre Safeguards (produced by the three defence societies in conjunction with The Royal College of Nursing and The National Association of Theatre Nurses).