Duties and responsibilities
Working with medical equipment — Reducing the risks
Originally published March 2012
From simple lighting to technologically-advanced medical devices and surgical instruments, medical equipment is integral to the delivery of quality patient care. Although the potential for adverse events related to equipment malfunction or failure exists, such incidents can be difficult to predict or prevent.
A CMPA review of medico-legal cases arising from equipment problems encountered during medical and surgical procedures between 2005 and 2011 identified 200 cases, of which 174 were closed. The majority of problems occurred in the operating room (OR) or labour and delivery room, although incidents in out-of-hospital specialty clinics (e.g. cosmetic surgery and laser clinics) and physicians' offices were also prevalent. Medico-legal difficulties crossed a broad range of physician groups. Other healthcare professionals (e.g. nurses, technicians), healthcare facilities, and equipment manufacturers were also key players. Legal actions comprised 80% of the closed medico-legal cases. Of interest, 59% of these legal actions were settled, compared with 32% for the overall CMPA experience during the same time period.
In the cases analyzed, 3 predominant equipment-related issues were identified:
- equipment malfunctions and failures
- wrong application, improper use, or unapproved use of equipment during a procedure or during medication delivery by physicians and other healthcare professionals
- new equipment issues, including training and supervision deficiencies
Many equipment issues that had an impact on patient care were beyond the control of the physician, whereas others were due to operator performance. At times, these issues coexisted within the same case. Mechanical issues and faulty equipment were often determined to be the responsibility of the healthcare facility or manufacturer. In contrast, physicians and other healthcare professionals were often held accountable for the wrong application or improper use of equipment.
Regardless of the causes, patient injury resulting from equipment-related misadventures was a recurrent theme. Burns, lacerations, and perforations were the most prevalent injuries.
A sampling of the diverse equipment issues identified in the cases reviewed, as well as illustrative cases, are presented here.
Sample of equipment issues related to organizational factors
The responsibility for equipment care and maintenance varies according to the location of care. For example, in a trial case involving a hospital's failure to calibrate equipment on a regular basis, the judge concluded equipment maintenance was the hospital's responsibility. A peer expert in this case further maintained that the physician's role would centre on the functioning of the equipment during the procedure. However, in clinics or private office settings, the onus for equipment maintenance might shift to the clinic owner or the physician.
Equipment deficiencies during a procedure or during medication delivery
- breakage of surgical instruments (e.g. needles, scalpel blades)
- malfunctioning equipment or equipment failure (e.g. misfiring of a stapler; malfunction of a patient controlled analgesia [PCA] pump)
- detachment of equipment (e.g. ureteric stone basket)
- defective equipment (e.g. rupture of a catheter balloon)
- lack of optimal equipment (e.g. lack of appropriate syringes)
- improper set-up or monitoring of equipment by others (e.g. incorrect settings on phototherapy, laser and lithotripsy machines)
- failure of the healthcare facility to follow the equipment manufacturer's recommendations for maintenance, cleaning, calibration, and replacement
- not reporting equipment malfunction to the appropriate personnel for follow-up and testing
- incorrect training information
- inadequate communication of manufacturer equipment recalls
- pager system failure
Sample of issues related to equipment operator performance
Inappropriate use of equipment
- use of equipment for non-indicated purposes (e.g. inappropriate laser for tattoo removal; use of latex gloves for a patient with a known latex allergy)
- incorrect use of equipment (e.g. misapplication of forceps during delivery)
- incorrect equipment assembly
- failure to check or readjust machine settings prior to a procedure (e.g. laser machine settings)
- failure to use equipment safeguards (e.g. failing to activate properly functioning alarms on an anaesthesia monitor)
- failure to maintain sterile precautions
- continuing a procedure once an equipment problem was evident (technical difficulties with the camera lighting supply during a laparoscopic procedure)
- failure to check equipment for completeness at the end of a procedure (e.g. detachment of a ureteric stone basket)
New equipment issues
- lack of familiarity with new equipment or equipment an individual has not used before
- failure to adjust the treatment parameters for new equipment (e.g. former cautery settings inappropriate for new cautery equipment)
- inadequate supervision of inexperienced physicians and other healthcare professionals
Other equipment issues
- lack of documentation of the level of supervision or direction provided by a physician to clinic or office employees using equipment for technical procedures
In these cases the medical experts may have commented on other aspects of the physicians' care, but only opinions related to equipment are provided here.
Continuing a procedure when an equipment problem was evident
Following instillation of oil into both ears three days prior, a middle-aged woman with bilateral impacted cerumen presented to an ambulatory clinic for earwax removal. Although the practice in the community hospital was to use disposable plastic syringes for ear syringing, no plastic syringe was available. Therefore, the nurse provided a metal syringe to the physician, who was experienced in ear syringing. He noted the metal cap of the syringe did not screw on properly due to rust on the cap and thread lines. However, he concluded the fit was reasonable. During the third irrigation attempt of the left ear, the metal tip of the syringe came off, resulting in a perforation of the tympanic membrane. Despite subsequent surgical repair, the woman was left with a mild sensorineural hearing loss.
The woman initiated a legal action alleging the physician perforated her left ear drum during ear syringing, but later decided not to proceed.
A peer expert was of the opinion that it was not appropriate for the physician to use the metal syringe, as a potential equipment malfunction was evident before the ear syringing. However, he commended the physician for his excellent follow-up care and immediate referral to an otolaryngologist. The expert also maintained that it was the hospital's responsibility to properly maintain the metal syringes. The hospital has since discarded all metal syringes.
Use of a surgical instrument with a known history of malfunction
A 40-year-old woman with lipodystrophy and stage 4 cellulite of the lateral thighs presented to a surgical clinic for liposuction under general anaesthetic. The cosmetic surgeon was aware the handle of the power-assisted liposuction device had a history of problems and had in fact been returned to the manufacturer for servicing on at least 4 occasions. Early in the procedure, the cosmetic surgeon noted the liposuction device was not functioning properly and the handle was becoming warm. To view the power setting on the liposuction unit, he briefly laid down the device with the handle on the paper drape covering the patient's calf. A full-thickness skin burn resulted. The burn eventually healed following appropriate treatment, but the patient was left with a scar.
The patient began legal proceedings. In this specific case, the track record of recurring maintenance problems with the equipment and the failure to take special care in its use was felt to be indefensible. The patient was paid a settlement by the CMPA on behalf of the member.
Managing medico-legal risks
The following risk management considerations are based on the expert opinions in the analyzed cases:
Responsibility and accountability for equipment set up, care, and maintenance varies according to the location of care. For example, in the hospital setting, the organization and healthcare professionals other than the physician are usually responsible for these tasks. However, in clinics or private office settings, the clinic owner or physicians may have responsibility for equipment. Organizations should consider:
- Is there a verification process that the required equipment is available, appropriately sterilized, and functioning, and that the settings are appropriate for the particular case?
- Are the manufacturer's recommendations for equipment maintenance, cleaning, calibration, and replacement followed? Do clear policies and procedures exist for handling equipment concerns and recalls?
- If new equipment is introduced, do healthcare professionals receive appropriate training prior to using it?
Equipment operator factors
Users of equipment should consider:
- Are you familiar with the equipment you are using, and is it appropriate for the procedure?
- If the desired equipment is not available, have you appropriately considered and documented your options and discussed these with the patient?
- If equipment malfunctions or fails during a procedure, do you take and document appropriate measures, including advising the required personnel for maintenance?
- Is all equipment inspected for completeness at the end of the procedure, particularly if the instrument breaks, is disassembled during the procedure, or has the potential to detach?
- When supervising or delegating a procedure involving equipment to a trainee or another healthcare professional, do you consider if the individual has the required knowledge, skills, qualifications, and experience to perform the procedure and to operate the necessary equipment? If necessary, is appropriate supervision available?
Physicians frequently use equipment to assist with diagnosis and treatment. Equipment failure, malfunction, or inappropriate use can result in complaints to medical regulatory authorities (Colleges) or in legal actions. Physicians are encouraged to be familiar with how to appropriately use the equipment in their practices and the potential pitfalls of use.