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Quality Manager formerly known as abaqis®

Mitigate risk and elevate your quality of care. Improving both clinical and business outcomes starts with a smarter, more integrated approach to regulatory training, continuing education and quality management.

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HSTMs Partners Addressing Top Health Technology Hazards blog image

HealthStream Partners Addressing Top Healthcare Technology Hazards

March 20th, 2023
March 20th, 2023

Founded as Emergency Care Research Institute, ERCI, is committed to scientific research that promotes meaningful improvements in patient care and safety. Their goal is to reduce preventable patient harm. ECRI provides information on hazards and deficiencies in medical devices each year and releases a list of the top ten technology hazards in order that healthcare leaders can focus on how to address these issues.

Our premier partner network has resources to help ensure that healthcare organizations and providers are aware of these hazards and offers some strategies to help mitigate the dangers to patients and staff. We will focus on two pressing issues of the ten hazards identified in the ECRI report.

Common Misconceptions About Electrosurgery Can Lead to Serious Burns

Electrosurgery units (ESUs) are useful to surgeons in cutting and coagulating tissue at the site of application. While ESUs have been in use in the OR for decades, they can cause fires and burns if operators do not understand the risks associated with their use. Most of the fires are caused when the ESU is improperly activated in an oxygen-rich environment. There are some common misconceptions that contribute to this risk:

  • Using multiple ESUs simultaneously on one patient presents no added risk. In reality, burn risks can increase exponentially when multiple ESUs are used.
  • The surgeon should activate the ESU’s active electrode before its tip is in contact with the patient. In fact, doing so causes a high voltage to develop in the ESU circuit, increasing the likelihood of patient or clinician injury.
  • The return electrode pad can never be safely applied over an orthopedic metal implant, tattoo, or piercing—an assumption that may prompt users to place the return electrode over a less safe part of the anatomy (e.g., a bony prominence). In fact, ECRI’s laboratory testing indicates that placing the return electrode over metal objects embedded in simulated surgical tissue does not heat or burn the surrounding tissue during ESU activation. (Note, however, that placement of the return electrode over a pacemaker or other electronic implant generally should be avoided.)

An incomplete understanding of the risks associated with any of the components involved in the electrosurgical circuit can lead to patient or clinician burns or other injuries.

Underreporting Device-Related Issues May Result in Recurrences of Those Issues

Continuing to use broken or malfunctioning equipment can result in patient harm. Providers sometimes skip reporting malfunctioning devices because they are simply too busy or are unfamiliar with the reporting protocols. However, continuing to use defective equipment can waste clinicians time and potentially result in patient harm.

The Safe Medical Devices Act (SMDA) requires that organizations report adverse events such as injury or death caused by faulty medical devices. The act covers equipment, supplies, and instruments. Some events need to be reported only to the device manufacturer while others need to be reported to the Food and Drug Administration (FDA.) Healthcare organizations need to remove barriers to reporting and educate employees about when reporting is required and how to go about reporting an issue. There are penalties for failing to report these events.

Compliance with SMDA requirements is essential to creating a safety culture, so it is important that staff have resources to help them better understand these issues. Our library from Home Care Pulse includes a review of SMDA requirements, guidance on removing the device from service, and identifying and reporting device-related issues.

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