Factors that the ECRI Institute considers in developing the medical technology hazard list include severity of risk, frequency of harm, difficulty of recognizing problems, and preventability.
Surgical staplers are the top medical technology hazard for 2020, according to the ECRI Institute.
Twenty years after publication of the Institute of Medicine's landmark report To Err is Human: Building a Safer Health System, patient safety remains a significant concern for the healthcare sector. The Institute of Medicine report estimated 98,000 Americans were dying annually due to medical errors. Estimates of annual patient deaths due to medical errors have since risen steadily to 440,000 lives, which make medical errors the country's third-leading cause of death.
Earlier this year, the U.S. Food and Drug Administration published an analysis of more than 109,000 adverse stapler incidents from 2011 to 2018, including 412 deaths and 11,181 serious injuries.
"Injuries and deaths from the misuse of surgical staplers are substantial and preventable. We want hospitals and other medical institutions to be in a better position to take necessary actions to protect patients from harm," Marcus Schabacker, MD, PhD, president and CEO of the Plymouth Meeting, Pennsylvania-based ECRI Institute said this week in a prepared statement.
The following is the ECRI Institute's Top 10 list of medical technology hazards for 2020.
1. Surgical staplers:
"Consequences of a staple line failing or staples being misapplied can be fatal. Patients have experienced intraoperative hemorrhaging, tissue damage, unexpected postoperative bleeding, failed anastomoses, and other forms of harm," an ECRI Institute executive report released this week says.
Most surgical stapler adverse incidents are linked to human error such as picking an incorrect staple size and clamping on tissue that is too thick or too thin, the executive report says. ECRI Institute's recommendations for safe use of surgical staplers include hands-on practice with specific staplers that are used in healthcare settings.
2. Point-of-care ultrasound:
"A lack of oversight regarding the use of point-of-care ultrasound (POCUS)—including when to use it and how to use it—may place patients at risk and facilities in jeopardy," the executive report says.
Although POCUS has been established as a valuable technology for diagnosis and guiding interventional procedures, safeguards are insufficient at many healthcare facilities, the executive report says. "Safeguards for ensuring that POCUS users have the requisite training, experience, and skill have not kept pace with the speed of adoption."
Recommendations for POCUS safety include user training and credentialing, exam documentation, and data archiving.
3. Infection risks from sterile processing:
"Insufficient attention to sterilization processes in medical offices, dental offices, and some other ambulatory care settings can expose patients to contaminated instruments, implants, or other critical items," the executive report says.
Physician practice offices and dental offices are high-risk locations because they often do not have the sterilization resources found in hospitals, the executive report says. Recommendations to improve sterile processing in these settings include designating a qualified staff member to support infection prevention and control practices.
4. Hemodialysis risks with central venous catheters in the home health setting:
"Many hemodialysis patients receive treatment through a central venous catheter (CVC) well beyond the period when transition to another form of vascular access is recommended. And the U.S. federal government recently announced a push to increase the use of home treatment for kidney disease patients," the executive report says.
CVCs are often placed through the jugular vein and can result in severe adverse events such as infection, clotting, and disastrous blood loss if there is a disconnection. "Family members or other caregivers may be ill-equipped to manage the risks or to respond when a CVC problem occurs. The possibility that an increasing number of patients with CVCs might receive hemodialysis in the home raises concerns," the executive report says.
5. Surgical robotic procedures:
"While the use of surgical robots in innovative ways or for new procedures can help advance clinical practice, such uses can also lead to injury or unexpected complications and the potential for poorer long-term outcomes," the executive report says.
Although robots have benefits during surgical procedures such as improved dexterity and tremor reduction, they have drawbacks, including limited tactile feedback for forces exerted on tissue, the executive report says. Recommendations for safe use of surgical robots in new procedures include training, credentialing, and privileging operating room staff in the new applications.
6. Alarm, alert, and notification overload:
"More than ever before, clinicians have to divide their attention between direct patient care tasks and responding to prompts from medical devices and health IT systems. As the number of devices that generate alarms, alerts, and other notifications increases, so too does the risk that the clinician will become overwhelmed, creating the potential for a clinically significant event to go unaddressed," the executive report says.
Recommendations to address alert overload include decreasing overall notification burden and helping clinical staff to develop critical thinking skills to ease cognitive overload.
7. Cybersecurity risks in the home health setting:
"Remote patient monitoring technologies are increasingly being used for at-home monitoring to help clinicians identify deteriorating patients before they require hospitalization. As network-connected medical technologies such as these move into the home, cybersecurity policies and practices that address the unique challenges involved must be instituted," the executive report says.
8. Missing implant data for MRI scan patients:
"Patients presenting for magnetic resonance imaging (MRI) studies must be screened for implanted devices to avoid harm. Some implants can heat, move, or malfunction when exposed to an MRI system’s magnetic field. Thus, MRI staff must identify and follow any contraindications or conditions for safe scanning prescribed by the implant manufacturer," the executive report says.
Recommendations include creating implant lists in patients' electronic medical records.
9. Medication errors from dose timing discrepancies in electronic medical records:
"Missed or delayed medication doses can result from discrepancies between the dose administration time intended by the prescriber and the time specified within the automatically generated worklist viewed by the nurse," the executive report says.
10. Loose nuts and bolts in medical devices:
"The nuts, bolts, and screws that hold together medical device components can loosen over time with routine use. Failure to repair or replace loose or missing mechanical fasteners can lead to severe consequences: Devices can tip, fall, collapse, or shift during use—any of which could lead to patient, staff, or bystander injury or death," the executive report says.
Christopher Cheney is the senior clinical care editor at HealthLeaders.
Surgical staplers top the hazard list. From 2011 to 2018, there were more than 109,000 adverse stapler incidents, according to the Food and Drug Administration.
Point of care ultrasound is second on the hazard list because the ability to use the technology safely has not kept pace with its adoption.
Sterile processing risks are highest in physician and dental offices because they lack the sterilization resources found in hospitals.