Risk Management

In-Office Lasers: You Could Get Burned

By E. Randy Craven, MD

Argus, July, 1994

Portable lasers may provide for convenience, but they also mean added legal obligations. Here’s some of the issues:

General Liability Duties

General liability duties increase with personal ownership of laser equipment. General liability refers to incidents not directly related to the care of the patient, e.g., a patient falls over some furniture in the waiting room. Among the general liability duties associated with laser ownership are properly maintaining and managing the equipment and ensuring that office staff are made aware of the hazards of working around the laser. To understand proper use and maintenance, thoroughly review the user’s manual.

Accidental Exposure to Laser Energy

Ophthalmologists must take precautions to prevent accidental exposure of laser energy to the eye and skin from either direct or diffusely reflected laser beams. When operating the laser, close the treatment room door and post a large sign stating “laser in use.” Place protective eyewear outside the door for personnel to put on before entering the room. Wavelength-specific goggles can be purchased through the manufacturer. Some manufacturers recommend door interlocks to automatically disable the laser when the treatment room door is opened.

Window coverings like hospitals use to cover operating room windows during laser procedures may be needed if the laser is located in a ground floor office near an outdoor public walkway.

Proper Maintenance

For continued reliability, follow the manufacturer’s recommended maintenance guidelines and ensure that a trained technician performs scheduled maintenance. Failure to do so may put the ophthalmologist at risk if a claim arises from a laser malfunction. Fortunately, most laser malfunctions are not likely to lead to a patient injury.

A preoperative check list or “flight plan” for double-checking the laser prior to use will help ensure a smooth procedure. The list should include spot size, power setting, pulse duration, wavelength, and proper alignment and delivery of the energy to a test object. Including this protocol in the office manual provides written documentation that a protocol is followed.

Informed Consent

The extent of potential hazards to the patient depends on the type of laser and its therapeutic application. Inform patients of the specific risks associated with a proposed treatment. For example, a trabeculoplasty carries significantly different risks than a panretinal photocoagulation. Common risks associated with lasers are overexposure, underexposure, reflection of the laser to unintended tissue site and thermal damage. Clearly communicate to the patient that any of these can cause major tissue damage, including vision impairment or blindness. Inform patients that, depending on the type of treatment, complications could occur weeks, months or even years later.

One potential informed consent issue is the need to obtain separate consent for multiple laser procedures. While obtaining informed consent each time the ophthalmologist uses the laser is probably not necessary, if the physician anticipates multiple procedures, inform the patient before treatment begins. As with any procedure, provide the patient with progress reports to avoid an unpleasant surprise or disappointment if laser therapy must be repeated.

Another issue concerns “piggybacking” consents, such as assuming that a cataract surgery consent form covers consent for a YAG laser capsulotomy procedure. A laser capsulotomy is a separate identifiable risk; if it is not specifically identified as part of the cataract surgery consent, it needs to be discussed with the patient prior to the YAG procedure. Document this discussion in the patient’s record.

The fact that the ophthalmologist and the patient discussed the potential risks of laser surgery and that the patient understood these risks should be clearly documented in the medical record and on an informed consent form. To request a model consent form addressing the clinical risks of laser surgery, call OMIC’s Risk Management Department, 1-800-562-6642 option 4.