– Surgical stapler misuse and point-of-care ultrasound tops ECRI Institute’s 2020 health technology hazards list that warrant attention from healthcare leaders.
– Hazards selected are based on a rigorous review of ECRI’s incident investigations, medical device testing, and public and private incident reporting databases.
ECRI Institute identified surgical stapler misuse as the number one health technology hazard in its Top 10 Health Technology Hazards for 2020 report. ECRI Institute’s Top 10 Health Technology Hazards, now in its 13th year, identifies top health technology concerns that warrant attention from healthcare leaders. The hazards selected are based on a rigorous review of ECRI’s incident investigations, medical device testing, and public and private incident reporting databases.
Impact of Surgical Stapler Misuse
Earlier this year, the U.S. Food and Drug Administration published an analysis of 109,997 stapler incidents since 2011, including 412 deaths, 11,181 serious injuries, and 98,404 malfunctions. During the past two decades, ECRI Institute has investigated 75 stapler accidents, including several fatalities, and published 42 safety alerts. ECRI’s latest guidance is intended to help stapler users avoid many of the common errors that can lead to patient harm.
“Injuries and deaths from the misuse of surgical staplers are substantial and preventable,” said Marcus Schabacker, MD, Ph.D., president, and CEO, ECRI Institute. “We want hospitals and other medical institutions to be in a better position to take necessary actions to protect patients from harm.”
The full list of 2020 health technology hazards includes:
1. Surgical stapler misuse—malfunctions and misuse can lead to patient harm.
Surgical staplers are complex devices requiring meticulous techniques to operate. Some models are used just to staple (seal) tissue, while others are designed to both staple and cut. 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.
2. Point-of-care ultrasound—the speed of adoption has outpaced policies and practices that could prevent misuse or misdiagnosis.
POCUS refers to the use of medical ultrasound by the treating clinician at the bedside. It is a powerful tool for diagnosis and for guiding interventional procedures in many clinical environments. POCUS scanners are typically highly portable, comparatively inexpensive, and easy to use—features that have fueled the technology’s rapid and broad adoption throughout medicine.
At many healthcare facilities, however, safeguards for ensuring that POCUS users have the requisite training, experience, and skill have not kept pace with the speed of adoption. The lack of sufficient oversight increases the potential that patients will be adversely affected by problems associated with use, or lack of use, of the technology.
3. Sterile processing errors in medical/dental offices—failure to consistently and effectively sterilize contaminated items can lead to patient infections.
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. As we’ve highlighted in previous editions of our Top 10 Hazards list, failure to consistently and effectively clean and disinfect or sterilize contaminated items before use can expose patients to virulent pathogens.
4. Central venous catheter (CVC) risk in at-home hemodialysis—risks associated with CVCs can be particularly dangerous in the home setting, where family members may be ill-equipped to manage the risks.
For appropriate patients, home hemodialysis can provide many long-term benefits. For patients who receive hemodialysis through a CVC, however, the risks of home dialysis may outweigh the benefits. CVCs are typically placed through the jugular vein (or other large central veins), providing a pathway directly from the outside of the body to the patient’s heart. As a result, the consequences of infection, clotting, disconnection (with a potential for massive blood loss), and air embolism can be severe.
5. Unproven surgical robotic procedures—surgical robots are being used for an expanding range of procedures, sometimes before the risks have been fully assessed.
With their mechanical wrists, surgical robots can offer the surgeon benefits such as improved dexterity, motion scaling, and tremor reduction. However, these systems also have limitations— they may not provide tactile feedback on forces exerted on tissue, for example—and adverse events do occur. In some cases, complications from a robotic procedure may not appear for years. (In a 2019 Safety Communication, FDA noted the potential for late-developing complications associated with surgical robot use for certain cancer-related surgeries.)
6. Alarm, alert, and notification overload—high number of notifications can overwhelm clinicians, creating the potential for a significant event to go unaddressed.
The problem of alarm overload is well known. Just as important to consider, however, is the global notification burden—that is, the combination of alarms, alerts, and notifications from all sources, not just from a single medical device. Patient care devices sound alarms and flash visual indicators. Phones buzz with calls or text notifications. EHR portals display pop-up clinical decision-support alerts. And nurse call systems beep and light up to indicate that a patient needs attention.
7. Connected home healthcare security risks—interruption in the transfer of patient monitoring data from cybersecurity issues can lead to misdiagnosis or delayed care.
As with any networked medical device, connected devices used in the home must be protected against threats that could interrupt the flow of data, alter or degrade the device’s performance, or expose protected health information. A cybersecurity issue that interrupts the transfer of data to the healthcare provider, for example, could lead to misdiagnosis or a delay in care.
Challenges include: the deployment may rely on the patient’s home network, which the provider doesn’t control; physical access to the device is limited, which can complicate troubleshooting and installing updates; and patient compliance can be difficult to sustain, particularly if the patient lacks proficiency using the device or has unwarranted fears about cybersecurity risks.
8. Missing implant data and MRIs—being unaware of a patient’s implant information can put patients in danger and delay MRI scans.
Unfortunately, information about patient implants is often scattered throughout various information systems or records of patient encounters, if it is captured at all. Without a single place within the electronic health record (EHR) to store implant information, care providers have no reliable means for determining the type and location of any implants.
Even screening interviews can be unreliable, as patients may not remember details about implants or may not be in a condition to respond. Direct harm to the patient is possible if a scan is, inappropriately, conducted in the presence of an unidentified implant. Also, the patient’s treatment can be adversely affected if a scan needs to be postponed while care providers search for implant information.
9. 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.
A combination of configuration and usability issues within the electronic health record (EHR) can contribute to such discrepancies. Consider the following scenario: Late in the morning, a physician enters an order for a once-daily medication and assumes that the patient will be given the first dose that morning.
At that facility, however, the default administration time programmed into the EHR for once-daily medications is 8:00 a.m. Because the order was placed later in the morning, the medication for that patient would not appear on the nurse’s worklist until the following morning, unless the prescriber was aware of the default administration time and had specifically changed the time within the order.
10. 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.
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. Additionally, workflow can be impeded, compromising patient care, and devices can sustain significant damage.
Why The Annual List Matters
“What used to be hospital problems are now concerns in ambulatory and home care settings,” said Schabacker. “As healthcare shifts outside the hospital, ECRI remains committed to building awareness about technology hazards to keep patients safe.”