Since 2011, more than 100,000 surgical stapler complications and malfunctions have resulted in 412 deaths, 11,181 serious injuries and 98,404 malfunctions, according to the U.S. Food and Drug Administration.
These risks of patient harm led the ECRI Institute to name surgical stapler misuse as the top health technology hazard for patients in 2020. During the past two decades, the organization has investigated 75 stapler accidents, including several fatalities, and published 42 safety alerts.
“Injuries and deaths from the misuse of surgical staplers are substantial and preventable,” Marcus Schabacker, M.D., president and CEO of the ECRI Institute, said in its annual report on top tech hazards. “We want hospitals and other medical institutions to be in a better position to take necessary actions to protect patients from harm.”
ECRI’s latest guidance is intended to help stapler users avoid many of the common errors that can lead to patient harm. The organization identified nine other hazards including one that clinicians have complained about for years—the constant beeping and buzzing from electronic health record (EHR) portals, nurse calls, smartphones and patient care devices.
While the problem of alarm overload in healthcare is well known, industry stakeholders need to recognize notification burden as well, the ECRI Institute said. The combination of alarms, alerts and notifications from all sources, not just from a single medical device, is forcing clinicians 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 ECRI Institute said, ranking this hazard sixth on the list.
"A global approach that considers all these sources is needed to prevent the kind of cognitive overload that can distract or desensitize clinicians or prompt them to use improper notification settings, all of which can lead to missed notifications and patient harm," the organization said
ECRI ranked unproven surgical robotic procedures as the fifth top technology hazard, noting that the risks to patients may not be known for years. Surgical robotic systems are used to assist surgeons in performing a wide—and continually expanding—range of minimally invasive procedures.
But these uses can also lead to injury or unexpected complications and the potential for poorer long-term outcomes, ECRI said. Robotic systems have limitations—they may not provide tactile feedback on forces exerted on tissue, for example—and adverse events do occur. In a 2019 Safety Communication, the FDA noted the potential for late-developing complications associated with surgical robot use for certain cancer-related surgeries.
As more care shifts to ambulatory and home care settings, the organization also identified new cybersecurity risks related to the use of remote patient monitoring and other connected home health care devices. These networked devices come with the same security risks as hospital devices—a security issue that interrupts the transfer of data to the healthcare provider, for example, could lead to misdiagnosis or a delay in care.
The use of home treatment for kidney disease patients is growing rapidly, but this raises concern, the ECRI Institute said. The Trump administration recently unveiled efforts to transform kidney care including expanding access to in-home dialysis for kidney disease care.
The risks associated with a central venous catheter (CVC) can be particularly dangerous in the home setting as family members or other caregivers may be ill-equipped to manage the risks or to respond when a CVC problem occurs, the ECRI Institute said.
“What used to be hospital problems are now concerns in ambulatory and home care settings,” Schabacker said. “As healthcare shifts outside the hospital, ECRI remains committed to building awareness about technology hazards to keep patients safe.”
ECRI's top 10 list included several common problems such as proper sterilization of equipment and medication timing errors in EHRs:
- Point-of-care ultrasound: Speed of adoption has outpaced policies and practices that could prevent misuse or misdiagnosis. Patient safety concerns include the technology not being used when warranted, misdiagnoses, inappropriate use of the modality and overreliance on point-of-care ultrasound when a more comprehensive exam by an imaging specialist is indicated.
- Sterile processing errors in medical/dental offices: Failure to consistently and effectively sterilize contaminated items can lead to patient infections.
- Missing implant data and MRIs: Information about patient implants is often scattered throughout various information systems or records of patient encounters if it is captured at all. Being unaware of a patient’s implant information can put patients in danger and delay MRI scans.
- Medication timing errors in EHRs: Critical medications can be delayed if the order generated from the EHR does not match the dose administration time intended by the prescriber.
- Loose nuts and bolts in devices: Failure to maintain nuts and bolts on medical equipment can lead to catastrophic accidents, harming patients, clinicians or bystanders.