ECRI 2023 Top 10 Hazards Executive Brief
ECRI 2023 Top 10 Hazards Executive Brief
ECRI 2023 Top 10 Hazards Executive Brief
Top 10 Health
Technology
Hazards for 2023
Expert Insights from ECRI’s Device Evaluation Program
EXECUTIVE BRIEF
www.ecri.org
Top 10 Health Technology Executive Brief
Hazards for 2023 ECRI is providing this Executive Brief describing its 2023 Top 10 list of health technology
hazards to inform the healthcare community about key safety issues involving the use of
medical devices and systems.
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Top 10 Health Technology Hazards for 2023
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Top 10 Health Technology Hazards for 2023
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Gaps in Recalls for At-Home Medical Devices
Cause Patient Confusion and Harm
to always hang the bag, not lay it flat (to keep any remaining
air at the top of the bag); and to prevent the bag from being amounts of air introduced in this
compressed completely flat by the IPI.
location can be fatal.
— That the surgeon should activate the ESU’s active electrode patient or clinician burns or other injuries.
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. Electrosurgical units can cause
unintended burns if operators do not
fully understand the risks.
telemetry monitoring as a safety net for patients who do not have monitor the right patient populations) and regularly assessing
cardiac issues. each patient’s need for continued telemetry monitoring.
1. Gaps in Recalls for At-Home Medical Devices Cause Patient — 2022 Nov 3: Datascope/Getinge—LINEAR intra-aortic balloon catheters: balloon
Confusion and Harm volume may be incorrectly labeled. Accession No. A39828.
Helping patients with recalled Philips CPAP devices used in home [webinar — 2022 Nov 3: Teleflex—Iso-Gard filter S products: may split or detach during use
recording]. 2022 Jun 24. [FDA Class I]. Accession No. A39636 01.
Medtronic—HeartWare ventricular assist device systems: welding defect — 2022 Nov 11: BD—SafetyGlide shielding hypodermic needles (one lot): may be
in internal pump may cause pump malfunction [update] [MHRA FSN difficult to administer medication [ECRI Exclusive Hazard Report]. Accession
2022/005/012/611/003]. ECRI Alerts 2022 Aug 4. Accession No. A39103 04. (To locate No. H0808.
additional alerts related to this product, search ECRI Alerts using the search term — 2022 Nov 14: BD—Insyte Autoguard catheters (one lot): may have surface
“HeartWare Ventricular Assist Device Systems.”) irregularities and roughness [ECRI Exclusive Hazard Report]. Accession No. H0809.
— 2022 Nov 18: Baxter—SUB-Q-SET subcutaneous infusion sets: needle may not be
2. Growing Number of Defective Single-Use Medical Devices Puts beveled [ECRI Exclusive Hazard Report]. Accession No. H08011.
Patients at Risk
Hospital Consumables and Supplies. A page describing ECRI’s Supply Guide program, 3. Inappropriate Use of Automated Dispensing Cabinet Overrides Can
including the Utilization Analytics module and Functional Equivalents service. Result in Medication Errors
Investigating overinfusions—award-winning joint effort by Lower Mainland Device Evaluation Resources:
Biomedical Engineering and Vancouver Coastal Health has a global impact. Device — Pharmacy Technology and Medication Management: The Essentials. This web
Evaluation 2020 Nov 11. page features a collection of Device Evaluation resources on technologies
Supply chain shortfalls pose risks to patient care. Hazard #2—2022 top 10 health used to manage medication preparation, storage, compounding, packaging,
technology hazards. Device Evaluation 2022 Jan 12. and dispensing.
The following examples from ECRI Alerts illustrate the types of problems that occur, — Medication distribution approaches and technologies. Device Evaluation 2018
as well as the ubiquity of such reports; the examples are a sampling from just one Oct 3.
four-week period near the end of 2022: ISMP Resources—The following resources are publicly available from the Institute for
— 2022 Oct 20: Cardinal Health—Vistec x-ray detectable sponges: may be frayed Safe Medication Practices (ISMP), an ECRI affiliate:
[ECRI Exclusive Hazard Report]. Accession No. H0804. — Best practice 16. In: Targeted medication safety best practices for hospitals. 2022.
— 2022 Oct 20: Medtronic—HeartWare ventricular assist device systems: may [Access requires free registration.]
exhibit a delay or failure to restart; manufacturer develops alternative pump start — ISMP guidelines for the safe use of automated dispensing cabinets. 2019 Feb 7.
algorithm [update]. Accession No. A36178 04. [Access requires free registration.]
— 2022 Oct 24: GlaxoSmithKline—BOOSTRIX DPT booster vaccine: syringes may be — Over-the-top risky: overuse of ADC overrides, removal of drugs without an order,
cracked. Accession No. A39763. and use of non-profiled cabinets. 2019 Oct 24.
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Top 10 Health Technology Hazards for 2023
— Safety enhancements every hospital must consider in wake of another tragic 6. Inflatable Pressure Infusers Can Deliver Fatal Air Emboli from IV
neuromuscular blocker event. 2019 Jan 17. Solution Bags
Inflatable pressure infusers may infuse residual air from IV solution bags
4. Undetected Venous Needle Dislodgement or Access-Bloodline resulting in air emboli [ECRI Exclusive Hazard Report]. ECRI Alerts 2022 Apr 1.
Separation during Hemodialysis Can Lead to Death Accession No. H0706.
Hemodialysis risks with central venous catheters—will the home dialysis push
A case study describing this hazard is included in: ECRI. Healthcare Incident
increase the dangers? Hazard #4—2020 top 10 health technology hazards. Device
Management and Investigation Course, Module 4. 2022. (Purchase required;
Evaluation 2019 Sep 26.
learn more at: https://www.ecri.org/healthcare-incident-management-
Hemodialysis venous catheter components may disengage during routine use, investigation-course.)
quickly causing patient harm or death [ECRI Exclusive Hazard Report]. ECRI
Alerts 2019 Jul 11. Accession No. H0526. 7. Confusion Surrounding Ventilator Cleaning and Disinfection
Undetected venous line needle dislodgment during hemodialysis. Device
Requirements Can Lead to Cross-Contamination
Evaluation 1998 Nov;27(11):404-5. Respiratory Assistance Technologies: The Essentials. This web page features a
collection of Device Evaluation resources on ventilators and other respiratory
Undetected venous needle dislodgment or access-bloodline separation during
assistance technologies.
hemodialysis can lead to death [ECRI Exclusive Hazard Report]. ECRI Alerts 2022 Mar
31. Accession No. H0758. Safe cleaning and disinfection of ventilators: ECRI’s recommendations. Device
Evaluation 2021 Oct 6.
5. Failure to Manage Cybersecurity Risks Associated with Cloud-
Based Clinical Systems Can Result in Care Disruptions 8. Common Misconceptions about Electrosurgery Can Lead to
Cybersecurity: The Essentials. This web page features a collection of Device
Serious Burns
Evaluation resources on cybersecurity topics. Electrosurgery: The Essentials. This web page features a collection of Device
Evaluation resources on electrosurgical topics.
Choosing cloud services for point-of-care ultrasound: what you need to
consider. Device Evaluation 2019 Nov 27. ECRI Institute provides 3 keys to safe return electrode use during monopolar
radiofrequency ablation [ECRI Exclusive Hazard Report]. ECRI Alerts 2015 Sep 29.
Cybersecurity attacks can disrupt healthcare delivery, impacting patient safety.
Accession No. H0248.
Hazard #1—2022 top 10 health technology hazards. Device Evaluation 2022 Jan 12.
Evaluation background: active laparoscopic electrode shielding systems. Device
Evaluation 2020 Oct 7.
General risks and protective measures during laparoscopic monopolar
electrosurgery. Device Evaluation 2016 Oct 14.
©2023 ECRI. May be disseminated for internal educational purposes solely at the subscribing site.
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Top 10 Health Technology Hazards for 2023
Using electrosurgery on patients with jewelry, body piercings, and tattoos. Device 10. Underreporting Device-Related Issues May Risk Recurrence
Evaluation 2023 Jan 11. Device Evaluation Resources:
Using multiple electrosurgical units on one patient: what to do when you can’t avoid — Don’t lose the evidence—sequestering equipment after an incident. 2014 Mar 5.
it. Device Evaluation 2018 May 30.
— Evidence storage and recovery policies and procedures. 2014 Mar 5.
9. Overuse of Cardiac Telemetry Can Lead to Clinician Cognitive — Investigating overinfusions—award-winning joint effort by Lower Mainland
Overload and Missed Critical Events Biomedical Engineering and Vancouver Coastal Health has a global impact. Device
Device Evaluation Essentials Pages—The following web pages feature a collection of Evaluation 2020 Nov 11.
Device Evaluation resources on the topics and technologies listed: — Overwhelmed recall and safety-alert management programs. Hazard #10—top 10
— Alarm Management: The Essentials health technology hazards for 2015. 2014 Nov 24.
Clinical alarms. Health System Risk Management 2020 Mar 30. — Healthcare Incident Management and Investigation Course. Online course from
ECRI’s Accident and Forensic Investigation Service.
Evaluation background: telemetry systems with integrated displays. Device
Evaluation 2022 Jun 22. ISMP Resources—The following resources are publicly available from the Institute for
Safe Medication Practices (ISMP), an ECRI affiliate:
Improper customization of physiologic monitor alarm settings may result in
missed alarms. Hazard #7—2019 top 10 health technology hazards. Device — Reporting:
Evaluation 2018 Sep 26. Pump up the volume: tips for increasing error reporting and decreasing patient
Improving patient surveillance in telemetry: don’t just rely on the harm. 2021 Aug 26.
monitor. Device Evaluation 2015 Sep 16. Reporting and second-order problem solving can turn short-term fixes into
Inadequate surveillance of monitored patients in a telemetry setting may long-term remedies. 2016 May 19.
put patients at risk. Hazard #4—top 10 health technology hazards for Safety requires a state of mindfulness (part 1). 2014 Jul 31.
2016. Device Evaluation 2015 Nov 7.
Speaking up about patient safety requires an observant questioner and a high
Integrated-display telemetry transmitters: key capabilities that can keep patients index of suspicion. 2019 Oct 10.
safe. Device Evaluation 2022 Apr 20.
Two effective initiatives for C-suite leaders to improve medication safety and
Over-reliance on arrhythmia detection algorithms in physiologic monitoring systems the reliability of outcomes. 2017 Mar 23.
puts patients on telemetry at risk [ECRI Exclusive Hazard Report]. ECRI Alerts 2015
— Culture-Related:
Jun 12. Accession No. H0261.
The differences between human error, at-risk behavior, and reckless behavior
Preventing the overuse of cardiac telemetry monitoring—Christiana Care Health
are key to a Just Culture. 2020 Jun 18.
System’s award-winning project. Device Evaluation 2015 Jan 14.
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Top 10 Health Technology Hazards for 2023
During the pandemic, aspire to identify and prevent medication errors and to
avoid blaming attitudes. 2020 Aug 27.
Jones J, Treiber L, Shabo R, et al. Just Culture, medication error prevention,
and second victim support: a better prescription for preparing nursing students
for practice [white paper]. Kennesaw (GA): WellStar School of Nursing, WellStar
College of Health and Human Services, Kennesaw State University; 2021.
Just Culture, medication error prevention, and second victim support needed in
nursing curriculum. 2021 May 20.
— Other Articles
Telling true stories is an ISMP hallmark. Here’s why you should tell stories,
too…. 2017 Aug 24.
Using information from external errors to signal a “clear and present danger”.
2017 Feb 9.
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