The Food and Drug Administration (FDA) has specified that there are nearly 1,700 different categories of medical equipment devices. The variety of medical equipment devices is immense and differs drastically from blood pressure monitors, thermometers, pacemakers and heart valves, to medical lasers for dermatology, radiographic and fluoroscopic X-ray machines and therapeutic and diagnostic ultrasound equipment. Despite the fact that these medical equipment devices can vary from simple hand use equipment to highly technological units, they all are intended with the objective of saving or improving lives. Unfortunately, any one of these medical devices can malfunction due to defects or failures that prevent these medical devices from working properly. Also, if this equipment has not been correctly maintained, it can negatively intensify the condition of a patient.
I recently attended a course on medical law and ethics and was informed that negligence “is the failure or omission to perform professional duties to an accepted standard of care, such as a reasonable person would do.” The class also detailed that an unintentional tort “happens when a person has no intentions of injuring a patient.” Health care professionals can be sued for a variety of situations, but most lawsuits are brought forth due to the unintentional tort of negligence. There is the propensity that more than one person or group can be held liable for negligence when a medical equipment device fails to operate properly and injures a patient.
Biomedical engineering departments support medical equipment devices and they do not expect the medical devices they maintain to cause injury. But there is the possibility that medical equipment devices can be inadequately or poorly maintained with substandard quality materials that can inflict injuries to patients. Hospitals and health care providers use medical equipment that is maintained by biomedical engineering departments or service repair companies for medical procedures on patients. They can be held liable if the medical equipment device malfunctions and causes injuries to a patient.
Hospitals can be held liable for medical equipment failure for many different reasons. For example, hospitals can be liable in negligence or medical malpractice if they fail to maintain medical equipment properly. They also can be liable for failure to properly train medical professionals in operating the equipment. If they fail to properly train hospital staff in using medical equipment and that leads to the careless operation or improper use of the equipment, this can cause the hospital to be liable. Health care providers can also be liable for failing to test medical equipment prior to using it on patients. It is normally accepted that the equipment furnished by a hospital for a patient’s use should be operational and safe for the uses and purposes intended under the conditions.
One practical way to avoid and prevent negligence with the use of medical equipment is to have a comprehensive preventive maintenance program and medical equipment operational training when equipment is installed and continual training as staff comes on board.
A recent medical equipment incident of an electrosurgical unit (ESU) that was investigated was used on a patient that underwent a sinus and tonsillectomy procedure. A grounding patient pad had been placed on the patient’s thigh for the possible use of mono-polar current. The surgeon used an uninsulated forceps in bipolar, with a metal suction coagulator and a metal mouth gag. Even though mono-polar current was never used the patient received burns to the internal commissure on both sides of their mouth. The injury was described as very painful, with a lengthy recovery, and plastic surgery was likely. The ESU device was examined with the forceps, the non-insulated body of the entire forceps have radio frequency (RF) applied to them when activated. As a result it was possible to have a patient burn from the side of the handle with direct contact, especially if it occurred over an extended amount of time. This could have also limited the bipolar forceps effectiveness and possibly require more power to effectively coagulate the intended area. With the description provided, it was not possible to determine the exact cause of the burn but there was likely some RF leakage from the side of the forceps during use.
Use of the uninsulated forceps should be limited to areas where no unintended patient contact with the forceps body is likely. The report described all the available bipolar forceps offered by the manufacture and it identified the options for tip type for both the insulated and the non-insulated forceps. The ESU was fully inspected and HF tested, no field corrective action was warranted since no device failure was found and the burn likely occurred due to a use error and additional information and training was recommended for the use of insulated and the non-insulated forceps.
Medical equipment devices are intended to be used in very specific methods and have manufacturer’s instructions for their use. The manufacturers of these medical equipment devices also provide operational training for proper use and maintenance training to properly maintain the equipment. If doctors or other medical professionals do not follow the manufacturer’s instructions for the intended use or ignores warnings concerning the medical device, they may be liable for negligence. They may also be liable if they were aware of potential hazards of the device and they failed to advise the patient of the dangers.
In addition, if the medical equipment device was not being maintained correctly, or if there is an issue with negligence in use of the device, the doctor or other medical professionals may be liable for negligence and a medical malpractice lawsuit will be probable. If the manufacturer of the medical equipment device is at fault for an injury, a product liability claim can be processed rather than a medical malpractice claim. Malpractice claims point blame on a particular entity, product liabilities are more concerned with protecting consumers from dangerous products. The supplier of medical devices that distribute or sell them – such as drug stores or medical supply stores – can also be held liable. A product liability lawsuit may be brought if a defective medical device is sold by the supplier and they may also be a liable party in a lawsuit along with the manufacture.
In conclusion, where a hospital Biomedical Engineering department or service company controls and maintains medical equipment, to the moment a medical professional or physician uses it, it will usually be held liable for unapparent defects in the product. If you provide equipment for use or service and repair medical equipment, you can be liable for negligence for damage or injury that results from servicing the equipment. Therefore, many hospitals and medical businesses are demanding that service repair companies maintain insurance coverage that protects both the service company and the client against these types of incidences. Most standard insurance packages exclude coverage from incidents resulting from the service of medical equipment. The sale of refurbished equipment causing bodily injury, wrong calibrations of medical equipment causing injury or even death, or destruction of equipment as a result of your servicing are examples of events that are not covered by most insurance policies. The appropriate insurance coverage should be acquired for protection against lawsuits due to these events.
Additionally, hospitals, service companies and manufacturers of defective medical products can be held liable for product defects and commonly the plaintiffs will sue the manufacturer, the service company and the hospital. Despite the fact that actions against hospitals for defective products generally allege negligence, lawsuits against the manufacturers of medical equipment devices are usually brought as product liability actions. If a product manufacturer is no longer in business, a plaintiff’s only alternative may be to sue the hospital or service company. A comprehensive preventive maintenance program and making sure service documentation is in order can limit liability. Providing service training to engineers and documenting that they are trained, and ensuring that adequate liability insurance is provided, can prevent or reduce the liability to a patient incident.