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September 2020: Clinical Claims & Risk Newsletter

Technology Trouble: Preventing Medical Equipment Malfunctions

Mike Walsh, AIC, CPCU

Liability Claims Manager

It is no secret that healthcare providers rely heavily on medical technology to diagnose and treat patients. Because of this dependence, providers must guard against technology mishaps because medical equipment can fail or be used incorrectly with devastating impact. The list of such vital equipment is long and terrifying, including x-ray machines, blood pressure monitoring devices, IV pumps, heart defibrillators and much more.

Medical technology failure or misuse can have many potential causes. Equipment may fail due to a manufacturer’s defect or surpassing its depreciation life by wearing out from a long history of use. User error could be the result of simple negligence or a lack of proper training available to its employee users. Equipment errors can also occur because of a lack of proper maintenance or pre-use testing. For example, the failure to follow a proper schedule to maintain charged batteries in a defibrillator could be responsible for a momentary delay that makes the difference between a patient’s life and death.

These recent claims further illustrate the need to properly maintain essential medical equipment and train employees to use it correctly.

In the first claim, the wrong time on a printout sent from an iSTAT blood analyzer seemed to indicate that a patient’s seriously decreased hemoglobin and hematocrit levels were not addressed in a timely fashion. Significant defense costs were incurred to show the time generated by the equipment was incorrect and facility employees did administer timely treatment.

Another case features an eye surgery clinic technician who failed to maintain and test an A-Scan machine. A patient was then tested using the wrong settings. Based on the erroneous test results, the wrong lens was implanted and a revision procedure needed to correct the inaccuracy. An unfavorable medical review panel opinion resulted in a $50,000 settlement.

Caroline Stegeman, RN, BSN, MJ, ONC, CPHRM, CPSO

Director of Patient Safety

Medical technology can be an incredible asset used to enhance patient safety and the quality of care provided to all patients within a healthcare organization. Unfortunately, many patients have also been harmed due to the high risks associated with these processes.

The Joint Commission (standards of environmental care 02.04.01) recommends implementing these best practices to limit exposures:

  • Maintain a written inventory of all medical equipment.
  • Identify the activities and associated frequencies in writing for maintaining, inspecting and testing all medical equipment on the inventory in accordance with manufacturer recommendations.
  • Monitor and report all incidents in which medical equipment is suspected in or attributed to the death, serious injury or serious illness of any individual as required by the Safe Medical Devices Act of 1990.
  • Perform safety, operational, and functional checks before initial use and after major repairs/upgrades of technology on the medical equipment inventory.
  • Note how the equipment is used, including the seriousness and prevalence of harm during normal use.
  • Record likely consequences of equipment failure or malfunction, including the seriousness of and prevalence of harm.
  • Plan the availability of an alternative or back-up equipment in the event the equipment fails or malfunctions.
  • Provide the incident history of identical or similar equipment.
  • Provide maintenance requirements of the equipment.

Facility medical equipment use and policy considerations should also include:

  • Understanding the use of the equipment upon purchase
  • Considering who will manage technology supplies and inspect the equipment
  • Educating and training staff
  • Providing manufacturer contact information to personnel
  • Ensuring a process for removing and storing improper functioning medical equipment
  • Implementing policies and procedures of recommended best practices and considerations

If you have any questions related to this newsletter, please contact:

Stacie Jenkins, MSN, RN, CPSO
Vice President of Patient Safety & Risk
Caroline Stegeman, RN, BSN, MJ, ONC, CPHRM, CPSO
Director of Patient Safety
Mike Walsh, AIC, CPCU
Liability Claims Manager