EXECUTIVE BRIEF

Top 10 HealthTechnology
Hazards for2018
A Report from Health Devices

yearsEXECUTIVE BRIEF

Top 10 HealthTechnology
Hazards for2018
A Report from Health Devices

yearsTop 10 Health Technology
Hazards for 2018
Executive Brief
ECRI Institute is providing this abridged version of its 2018 Top 10 list of health technology hazards as a free public
service to inform healthcare facilities about important safety issues involving the use of medical devices and systems.
The full report—including detailed problem descriptions and ECRI Institute’s step-by-step recommendations for addressing
the hazards—is available to members of certain ECRI Institute programs through their membership web pages.

The List for 2018
1. Ransomware and Other Cybersecurity Threats to Healthcare Delivery Can Endanger Patients
2. Endoscope Reprocessing Failures Continue to Expose Patients to Infection Risk
3. Mattresses and Covers May Be Infected by Body Fluids and Microbiological Contaminants
4. Missed Alarms May Result from Inappropriately Configured Secondary Notification Devices and Systems
5. Improper Cleaning May Cause Device Malfunctions, Equipment Failures, and Potential for Patient Injury
6. Unholstered Electrosurgical Active Electrodes Can Lead to Patient Burns
7. Inadequate Use of Digital Imaging Tools May Lead to Unnecessary Radiation Exposure
8. Workarounds Can Negate the Safety Advantages of Bar-Coded Medication Administration Systems
9. Flaws in Medical Device Networking Can Lead to Delayed or Inappropriate Care
10. Slow Adoption of Safer Enteral Feeding Connectors Leaves Patients at Risk

The Purpose of the List
The safe use of health technology—from beds and stretchers to large, complex imaging systems—requires identifying
possible sources of danger or difficulty with those technologies and taking steps to minimize the likelihood that adverse
events will occur. This list will help healthcare facilities do that.
Produced each year by ECRI Institute’s Health Devices Group, the Top 10 Health Technology Hazards list identifies
the potential sources of danger that we believe warrant the greatest attention for the coming year. The list does notenumerate the most frequently reported problems or the ones associated with the most severe consequences—although
we do consider such information in our analysis. Rather, the list reflects our judgment about which risks should receive
priority now.
All the items on our list represent problems that can be avoided or risks that can be minimized through the carefulmanagement of technologies. With the additional content provided in the full report, the list serves as a tool that
healthcare facilities can use to efficiently and effectively manage the risks.

©2017 ECRI Institute. Executive Brief: Top 10 Health Technology Hazards for 20182

Members can access the full report online. ECRI Institute encourages the dissemination of the registration hyperlink, www.ecri.org/2018hazards,
to access a download of this Executive Brief, but prohibits the direct dissemination, posting, or republishing of this work, without prior permission.

How Topics Are Selected
This list focuses on what we call generic hazards—problems that result from the risks
inherent to the use of certain types or combinations of medical technologies. It does
not discuss risks or problems that pertain to specific models or suppliers.
ECRI Institute engineers, scientists, clinicians, and other patient safety analysts
nominate topics for consideration based on their own expertise and insightgained through:▪▪ Investigating incidents▪▪ Testing medical devices▪▪ Observing operations and assessing hospital practices▪▪ Reviewing the literature▪▪ Speaking with clinicians, clinical engineers, technology managers, purchasing
staff, health systems administrators, and device suppliers
Staff also consider the thousands of health-technology-related problem reports that
we receive through our Problem Reporting Network and through data that participating
facilities share with our patient safety organization, ECRI Institute PSO.
After the topic nomination phase, professionals from ECRI Institute’s many program
areas, as well as members of some of our external advisory committees, review these
topics and select their top 10. We use this feedback to produce the final list, weighing
factors such as the following:▪▪ Severity. What is the likelihood that the hazard could cause serious injury
or death?
▪▪ Frequency. How likely is the hazard? Does it occur often?
▪▪ Breadth. If the hazard occurs, are the consequences likely to spread to affect agreat number of people, either within one facility or across many facilities?
▪▪ Insidiousness. Is the problem difficult to recognize? Could the problem lead to acascade of downstream errors before it is identified or corrected?
▪▪ Profile. Is the hazard likely to receive significant publicity? Has it been reported in
the media, and is an affected hospital likely to receive negative attention? Has thehazard become a focus of regulatory bodies or accrediting agencies?
▪▪ Preventability. Can actions be taken now to prevent the problem or at least
minimize the risks? Would raising awareness of the hazard help reduce future
occurrences?
All the topics we select for the list must, to some degree, be preventable. But any oneof the other criteria can, on its own, warrant including a topic on the list. We encourage
readers to examine these same factors when judging the criticality of these and otherhazards at their own facilities.
Not all hazards on the list will apply at all healthcare facilities. Also note that theexclusion of a topic that was included on a previous year’s list should not be interpreted
to mean that the topic no longer deserves attention. Most of these hazards persist,and hospitals should continue working toward minimizing them. Rather, our experts
determined that the topics listed here should receive greater attention in 2018.

For Members Only:
Log in to Accessthe Full Report andSolutions Kit
This Executive Brief helps raiseawareness of critical healthtechnology hazards—a key step inpatient safety efforts. The next steps
involve taking action to prevent the
problems from occurring. The 2018
Top 10 Health Technology Hazards
Solutions Kit—available online tomembers of certain ECRI Instituteprograms—will help with that effort.
The Solutions Kit provides acomprehensive discussion of each
topic, actionable recommendations
for minimizing the risks of harm, andlists of useful resources for more
information about each topic. Log
in to your membership web page toaccess this valuable content.
For information aboutbecoming a member, contact
clientservices@ecri.org or call
+1 (610) 825-6000, ext. 5891.

©2017 ECRI Institute. Executive Brief: Top 10 Health Technology Hazards for 2018
Members can access the full report online. ECRI Institute encourages the dissemination of the registration hyperlink, www.ecri.org/2018hazards,
to access a download of this Executive Brief, but prohibits the direct dissemination, posting, or republishing of this work, without prior permission.

3

Ransomware
and OtherCybersecurity
Threats to
Healthcare Delivery
Can Endanger PatientsRansomware and other types of malicious software programs (malware) can disrupt healthcaredelivery operations, hindering the delivery of care and putting patients at risk.

1

These programs infiltrate a network, propagate through connected devices and systems, andencrypt data, disabling user access, software, and IT assets. Multiple variants of ransomware andother malware have infected healthcare facilities and other organizations throughout the world.
In a healthcare environment, a malware attack can significantly impact care delivery byrendering health IT systems unusable, by preventing access to patient data and records, andby affecting the functionality of networked medical devices. Further, such attacks can disable
third-party services, disrupt the supply chain for drugs and supplies, and affect building andinfrastructure systems.
Such disruptions can lead to canceled procedures and altered workflows (e.g., reverting topaper records). They can also damage equipment and systems, expose sensitive data, and force
closures of entire care units. Ultimately, they can compromise or delay patient care, leading topatient harm.
Safeguarding against malware attacks requires a proactive approach involving senior
management, clinical engineering, IT, and other individuals throughout the organization. ¡©2017 ECRI Institute. Executive Brief: Top 10 Health Technology Hazards for 20184

Members can access the full report online. ECRI Institute encourages the dissemination of the registration hyperlink, www.ecri.org/2018hazards,
to access a download of this Executive Brief, but prohibits the direct dissemination, posting, or republishing of this work, without prior permission.

1

Failure to consistently and effectively reprocess flexible endoscopes—that is, failure to clean anddisinfect or sterilize the instruments between uses—can lead to the spread of deadly infections.
Studies highlighting the challenges of this process, along with continuing reports of patient
exposures to contaminated instruments, underscore why this topic remains a critical concern.
(We have included some version of this topic in eight of the 10 previous editions of our list.)
Areas that require particular attention include:▪▪ The cleaning step, which is largely manual and technique-dependent. If biologic debris andother foreign material is not cleaned from the endoscope first, residual soil can harden,
making subsequent disinfection ineffective.
▪▪ Instrument storage after reprocessing. Moisture trapped in the channels of an endoscope canpromote the proliferation of any microbes not eradicated by reprocessing.
To achieve more reliable and effective endoscope reprocessing, ECRI Institute recommends that
healthcare facilities: (1) establish processes for assessing the quality of the cleaning step—for
example, through magnification-aided visual inspections and the use of biochemical testing—and2(2) implement measures to dry endoscope channels after reprocessing. Additional, detailed
recommendations are presented in our complete report. ¡Endoscope
Reprocessing
Failures Continue
to Expose Patients toInfection Risk
©2017 ECRI Institute. Executive Brief: Top 10 Health Technology Hazards for 2018
Members can access the full report online. ECRI Institute encourages the dissemination of the registration hyperlink, www.ecri.org/2018hazards,
to access a download of this Executive Brief, but prohibits the direct dissemination, posting, or republishing of this work, without prior permission.

5

Mattresses
and Covers
May Be Infectedby Body Fluids
and MicrobiologicalContaminants3

Bed and stretcher mattresses can remain contaminated after cleaning, putting patientsand staff at risk of exposure to body fluids or microbiological contaminants. Reported incidents
include patients lying on an apparently clean bed or stretcher when blood from a previous patient
oozed out of the support surface onto the patient.
A bed or stretcher’s support surface consists of a mattress along with a mattress cover thatprevents the ingress of body fluids and other contaminants into the mattress. The mattress coveris cleaned and disinfected between patients, but the mattress is not. Hence, if the integrity of amattress cover is compromised, the mattress underneath can become contaminated and remain
so for subsequent patients.
To safeguard against this hazard, companies that sell or rent mattress covers must recommend
cleaning and disinfecting materials and procedures that will successfully remove the likely
contaminants without compromising the cover’s integrity (i.e., creating weak spots that could
allow leaks). Unfortunately, this is not always the case.
For their part, healthcare facilities should use appropriate materials and procedures for cleaningand disinfecting mattress covers and should regularly inspect mattresses and mattress covers forsigns of damage or contamination. ¡©2017 ECRI Institute. Executive Brief: Top 10 Health Technology Hazards for 20186

Members can access the full report online. ECRI Institute encourages the dissemination of the registration hyperlink, www.ecri.org/2018hazards,
to access a download of this Executive Brief, but prohibits the direct dissemination, posting, or republishing of this work, without prior permission.

Secondary alarm notification systems are software solutions that send alarms and otherrelevant alerts from a medical device or IT system to a clinician’s smartphone or othercommunication device. The systems are intended to facilitate timely notification of theappropriate clinician, but configuration or management problems with the systems themselves
can lead to alarm delivery delays or failures.
Delayed or failed delivery of a critical alarm or alert can lead to missed alarm conditions, delayedcare, and avoidable patient harm.
Incidents that have been reported include:▪▪ Alarm delivery delays and failures when a system became overloaded. The cause: Alarms
were needlessly being broadcast to all users within a care unit.
▪▪ Dropouts and alarm delivery failures after installation of an antivirus software update. The
cause: The update was incompatible with the secondary alarm notification system.
▪▪ Phones freezing or shutting down when the user switched between software applications.
The cause: Conflicts between the secondary alarm notification system and other smartphone
applications (e.g., text messaging, voice communications).

4

Avoiding such problems requires care during system configuration, verification and validation
during implementation, and assessments of system integrity periodically during use. ¡Missed Alarms
May Result from
Inappropriately
Configured Secondary
Notification Devices
and Systems©2017 ECRI Institute. Executive Brief: Top 10 Health Technology Hazards for 2018
Members can access the full report online. ECRI Institute encourages the dissemination of the registration hyperlink, www.ecri.org/2018hazards,
to access a download of this Executive Brief, but prohibits the direct dissemination, posting, or republishing of this work, without prior permission.

7

Improper
Cleaning May
Cause Device
Malfunctions,
Equipment Failures,
and Potential for
Patient Injury

5

Exposing medical devices and other equipment to incompatible cleaning agents or
unapproved cleaning methods can result in:▪▪ Premature deterioration of a device’s nonmetallic parts, which can lead to the often
imperceptible weakening and ultimate breakage of the parts, as well as other associateddamage or malfunctions▪▪ Failure of device electronics or power supplies, resulting from component damage or
fluid intrusion▪▪ Adverse effects from residual surface debris or cleaning residue
All of these occurrences can lead to device performance and safety issues, such as equipment
failure, power supply interruptions, excessive and often incorrect alarms, or unexpected motion or
device operation.
In addition to having significant financial implications, device malfunctions and premature
equipment failures can lead to patient or staff injury or compromised patient care.
The need to stock and use multiple cleaning products, along with the requirement to familiarize
staff with device-specific cleaning methods, is a significant burden for hospitals. Nevertheless, therisk of harm to patients and staff, and the often substantial costs to replace damaged devices,
outweighs the challenge of implementing safe and correct cleaning. ¡©2017 ECRI Institute. Executive Brief: Top 10 Health Technology Hazards for 20188

Members can access the full report online. ECRI Institute encourages the dissemination of the registration hyperlink, www.ecri.org/2018hazards,
to access a download of this Executive Brief, but prohibits the direct dissemination, posting, or republishing of this work, without prior permission.

Electrosurgical unit (ESU) active-electrode pencils that are not safely holstered between
activations can lead to burns or fires if the ESU is inadvertently activated.
Instances of injury or damage have occurred when OR staff placed the active-electrode pencil on,or near, the patient between activations, rather than placing it in a nonconductive safety holster.
With the electrode tip exposed in this manner, a burn or fire could occur if the ESU is inadvertently
activated—for example, if a staff member leans on the pencil or steps on the ESU footswitch.
For decades, ECRI Institute has received reports of, investigated, and published guidance on
burns, arcing, and fires due to inadvertent activation of ESU pencils that were not placed in anonconductive safety holster. Unfortunately, incidents continue to occur.
Proper and consistent use of the safety holsters that are typically supplied with active-electrodepencils can prevent such incidents. And as ECRI Institute’s PriceGuide data shows, the added
costs associated with holster use are minimal. ¡6Unholstered
Electrosurgical
Active Electrodes
Can Lead toPatient Burns©2017 ECRI Institute. Executive Brief: Top 10 Health Technology Hazards for 2018
Members can access the full report online. ECRI Institute encourages the dissemination of the registration hyperlink, www.ecri.org/2018hazards,
to access a download of this Executive Brief, but prohibits the direct dissemination, posting, or republishing of this work, without prior permission.

9

Inadequate
Use of Digital
Imaging Tools May
Lead to Unnecessary
Radiation Exposure

7

Digital imaging tools that can help reduce and control radiation dose are often not used totheir full advantage.
Imaging technologies that use ionizing radiation—computed tomography (CT), angiography,
nuclear medicine, and others—play a vital role in modern medicine, but have inherent risks
that must be managed. Exposure to high doses of ionizing radiation, whether from individual
exposures or from the cumulative effect of multiple exposures, can increase a patient’s long-termrisk of developing cancer. And excessively high doses during an individual procedure can causeradiation burns.
Digital imaging inherently provides the means and tools for users to reduce or control theamount of radiation by enabling image manipulation during procedures and allowing tracking ofradiation dose.
However, such measures cannot protect patients and staff from unnecessary radiation
exposures—and thereby help reduce the long-term risks—if users are not proficient with the tools
at their disposal and do not use those tools when circumstances warrant.
Imaging departments and facilities need to investigate dose-control strategies and provide users
with the training and support they need to gain confidence using newer tools and techniques. ¡©2017 ECRI Institute. Executive Brief: Top 10 Health Technology Hazards for 201810

Members can access the full report online. ECRI Institute encourages the dissemination of the registration hyperlink, www.ecri.org/2018hazards,
to access a download of this Executive Brief, but prohibits the direct dissemination, posting, or republishing of this work, without prior permission.

Bar-coded medication administration (BCMA) systems help clinicians verify at the point of carethat the medications to be administered match provider orders. Used correctly, these systems
can prevent dangerous medication errors. Used incorrectly, BCMA’s safety advantages can becompletely negated.
Improper practices include administering medications before using the bar-code scanner,
scanning patient bar codes from a list of stickers on a clipboard instead of from the patient
wristband, and preparing medications for more than one patient at a time.
Circumstances that may prompt staff to resort to such workarounds or other unsafe
practices include:▪▪ The system being configured in such a way that it does not support safe clinician workflow▪▪ Staff not understanding how a BCMA system can improve patient safety▪▪ Devices and systems being difficult to use, functioning unreliably, or not being
well maintained
Maximizing the safety benefits of BCMA requires minimizing the circumstances that can leadto improper use. To do this, give careful thought to system implementation, verify that staff

8

understand the importance of performing the multistep workflow correctly, and maintain thesystem so that all the component devices and systems function properly. ¡Workarounds Can
Negate the Safety
Advantages of
Bar-Coded Medication
Administration Systems©2017 ECRI Institute. Executive Brief: Top 10 Health Technology Hazards for 2018
Members can access the full report online. ECRI Institute encourages the dissemination of the registration hyperlink, www.ecri.org/2018hazards,
to access a download of this Executive Brief, but prohibits the direct dissemination, posting, or republishing of this work, without prior permission.

11

Flaws in
Medical Device
Networking Can
Lead to Delayed or
Inappropriate Care

9

Inattention to best practices for implementing networked medical devices and information

systems can lead to incorrect or incomplete data transfers and other data communication errors.
Such errors can delay diagnosis or treatment or prompt a misdiagnosis, affecting patient safety.
Examples include:▪▪ Lab results being delivered from a laboratory information system (LIS) to the electronic healthrecord (EHR) with reference ranges but no lab values, leading to a delay in patient diagnosis
and treatment▪▪ Only partial information being forwarded from a ventilator to the physiologic patient monitor
to which it was networked, leading to a delay in patient care and the potential to causesignificant patient harm▪▪ Data from a fetal monitor not being correctly displayed on the workstation at thenurse’s station, creating the potential for delayed response to a critical change in thepatient’s condition
With more and more medical devices and information systems being connected throughhardwired or wireless networks, it has become increasingly important for healthcare facilities toassess, approve, and implement changes to these networked medical devices and information
systems in a controlled manner. ¡©2017 ECRI Institute. Executive Brief: Top 10 Health Technology Hazards for 201812

Members can access the full report online. ECRI Institute encourages the dissemination of the registration hyperlink, www.ecri.org/2018hazards,
to access a download of this Executive Brief, but prohibits the direct dissemination, posting, or republishing of this work, without prior permission.

Enteral feeding tubing can be inadvertently connected to patient lines intended for otherpurposes, sometimes with fatal consequences.
In one deadly incident, enteral nutrition was delivered into a patient’s lungs when feedingtubing was misconnected to a ventilator suction catheter. In another, nutrition was delivered
through an IV line directly into the bloodstream of a pregnant woman; neither the woman nor the
fetus survived.
Severe incidents such as these are rare. However, enteral tubing misconnections with thepotential to cause severe harm do occur (and are likely underreported).
A newly available, standards-based connector design for enteral feeding systems—known by its
trademarked name, ENFit—can help prevent such misconnections. These new enteral connectors
fit only with each other, not with other connector types.
To date, healthcare facilities have been slow to adopt enteral devices with ENFit connectors,
primarily due to concerns over the availability of components bearing the new connectors.
However, this situation has improved, and a successful transition is now possible. ECRI Institute10and other organizations recommend that healthcare providers throughout the world transition toenteral devices with ENFit connectors as soon as practicable. ¡Slow Adoptionof Safer
Enteral Feeding
Connectors Leaves
Patients at Risk
©2017 ECRI Institute. Executive Brief: Top 10 Health Technology Hazards for 2018
Members can access the full report online. ECRI Institute encourages the dissemination of the registration hyperlink, www.ecri.org/2018hazards,
to access a download of this Executive Brief, but prohibits the direct dissemination, posting, or republishing of this work, without prior permission.

13

ECRI Institute Resources for Addressing the Hazards
Members of certain ECRI Institute programs canaccess resources such as the following to learn
more about the topics included on this year’s list:
1. Ransomware and Other Cybersecurity Threats
Cybersecurity: The Essentials—This web page features acollection of Health Devices resources on the topic.
Cybersecurity: understanding key terms and concepts.
Health Devices 2016 Sep 14.
11 questions about IEC 80001-1. Health Devices 2017
Aug 23.
Fostering CE/IT/InfoSec collaboration for better medical
device implementation. Health Devices 2017 Sep
20.
Getting the most out of the MDS2 form. Health Devices2017 Aug 23.
Networked medical devices—get the answers youneed for safe, secure acquisition and use. HealthDevices 2016 Sep 14.
Ransomware attacks: how to protect your medical device
systems. Health Devices 2017 Jun 29.
Software management gaps put patients, and patientdata, at risk. Hazard #6—top 10 health technology
hazards for 2017. Health Devices 2016 Nov 4.
Vulnerability scanning of medical devices: avoiding thepitfalls. Health Devices 2017 Aug 23.

2. Endoscope Reprocessing
ECRI Institute has included the potential for crosscontamination from reusable medical devices andinstruments in several previous editions of our Top 10
Hazards list:—— The online cumulative subject index for theTop 10 Health Technology Hazards provides acomplete listing.
—— See, in particular: Inadequate cleaning offlexible endoscopes before disinfection canspread deadly pathogens. Hazard #1—top 10
health technology hazards for 2016. HealthDevices 2015 Nov 7.

3. Mattress and Mattress Cover Contamination
Bed and stretcher support surfaces (mattresses
and mattress covers): risks of microbiologicalcontamination and fluid ingress [ECRI Exclusive
Hazard Report]. Health Devices Alerts 2017 Sep 28(Accession No. H0398).

Damaged or worn bed and stretcher mattress covers
may allow fluid ingress. Health Devices Alerts 2014
Sep 11 (Accession No. H0237).
Disinfectant concentrations for EPA’s list of products
effective against Clostridium difficile. HealthDevices 2017 May 10.
Disinfectant concentrations for EPA’s list of products
effective against Mycobacterium tuberculosis,
human HIV-1, and hepatitis B virus. Health Devices2017 May 10.
Reducing the risks of fluid ingress and microbiologicalcontamination in bed and stretcher support
surfaces. Health Devices 2017 May 10.

4. Secondary Alarm Notification Systems
Alarm Management: The Essentials—This page
contains our complete collection of Health Devices
guidance, tools, and other resources for improving
clinical alarm safety.
Alarm middleware vendor roundtable: cutting throughthe confusion [Health Devices web conference].
2015 Apr 29.
Evaluation background: ancillary alarm notification
systems. Health Devices 2016 Dec 22.
Inappropriately configured ancillary alarm notification
systems may result in missing critical alarms.
Health Devices Alerts 2014 Nov 20 (Accession No.
H0242).
Using third-party software for alarm notification: risks
and recommendations. Health Devices 2017 Feb 1.

5. Improper Cleaning and Device Failures
Guidance from Health Devices:—— Device failures caused by cleaning products
and practices. Hazard #10—top 10 healthtechnology hazards for 2017. Health Devices
2016 Nov 4.
—— How improper cleaning can damage medical
equipment. Health Devices 2017 Aug 16.
Also: Cleaning/Disinfectant Wipe Compatibility(customizable chart, Microsoft Word).
Incident reports published in Health Devices Alerts(January 2016 through September 2017):—— Baxter—SIGMA Spectrum infusion pumps:
improper battery contact may cause infusion
to cease, potentially resulting in patient harm
[ECRI Exclusive Hazard Report]. Health Devices
Alerts 2017 Sep 27 (Accession No. H0399).

©2017 ECRI Institute. Executive Brief: Top 10 Health Technology Hazards for 201814

Members can access the full report online. ECRI Institute encourages the dissemination of the registration hyperlink, www.ecri.org/2018hazards,
to access a download of this Executive Brief, but prohibits the direct dissemination, posting, or republishing of this work, without prior permission.

—— BD CareFusion—Model 8100 Alaris LVP
modules: lower door hinge may crack [ECRI
Exclusive User Experience Network] [Update].
Health Devices Alerts 2016 Dec 1 (Accession
No. S0251 02).
—— Bed and stretcher support surfaces(mattresses and mattress covers): risksof microbiological contamination and fluid
ingress [ECRI Exclusive Hazard Report].
Health Devices Alerts 2017 Sep 28(Accession No. H0398).
—— CareFusion—Model 8100 Alaris infusion
system pump modules: cracked or broken
upper platen hinge may result in drug
overdelivery [ECRI Exclusive Hazard Report].
Health Devices Alerts 2016 May 13(Accession No. H0319).
—— Cook—various products: reprocessing
instructions may be inadequate. HealthDevices Alerts 2017 Jun 6 (Accession No.
A28514 01).
—— Fujifilm—endoscopic ultrasonic probes:
manufacturer updates operation manual
to clarify reprocessing procedure. HealthDevices Alerts 2017 Sep 22 (Accession No.
A29262).
—— Haemonetics—various cell processor andcollection system devices: improper cleaning
may damage pump rollers, potentiallyleading to device malfunction [Update].
Health Devices Alerts 2016 Feb 23(Accession No. A25476 01).
—— Infusion pumps—failure to follow
manufacturers’ recommended cleaning
instructions may cause premature device
failures [ECRI Exclusive Hazard Report].
Health Devices Alerts 2016 Jun 16(Accession No. H0328).
—— Intuitive—da Vinci Surgical Systems: certain
disinfectant wipes may damage instrument
arm plastic components. Health Devices
Alerts 2016 Jan 14 (Accession No. A25621).
—— Intuitive—da Vinci Xi endoscopes:
manufacturer corrects German reprocessing
addendum to address inaccurate statement.
Health Devices Alerts 2017 Apr 6 (Accession
No. A27862).
—— Medical Technology Industries—Model
430 Series MTI Quad examination/
treatment chairs: incorrect cleaning agentsor procedures may damage side controls,potentially causing spontaneous movement[ECRI Exclusive Hazard Report]. HealthDevices Alerts 2017 Jun 29 (Accession No.
H0386).
—— Medtronic—Puritan Bennett 980 ventilators:
exhalation valve flow sensor assembly(EVQ) may cause device instability and/or
inoperative condition [ECRI Exclusive Hazard
Report]. Health Devices Alerts 2017 Oct 12(Accession No. H0400).
—— PENTAX—medical endoscopes: manufacturer
reminds users of proper reprocessing
methods. Health Devices Alerts 2017 Apr 24(Accession No. A27855).
—— Philips—MX40 patient worn monitors:
incorrect cleaning can cause patientmonitoring malfunctions [ECRI Exclusive
Hazard Report]. Health Devices Alerts 2017
Mar 23 (Accession No. H0371).
—— Philips—M4841/51 telemetry transmitters:
batteries may short circuit and overheat.
Health Devices Alerts 2017 Feb 7 (Accession
No. A28028).
—— Philips—various ECG trunk cables: use ofunapproved cleaning agents may damage
plastic shell of connector [ECRI Exclusive
User Experience Network]. Health Devices
Alerts 2016 Nov 23 (Accession No. S0306).
—— Siemens—Artis systems with wirelessfootswitch: liquids may infiltrate gap infootswitch housing, potentially resulting infootswitch failure. Health Devices Alerts
2017 Mar 9 (Accession No. A28208).
—— Stryker—SmartLife large aseptic housings:
failure to use recommended cleaning
practices may cause deterioration; sections
may separate. Health Devices Alerts 2017
Jun 8 (Accession No. A28506 01).
—— Zimmer Biomet—Gender Solutions patellofemoral joint prosthesis milling handpieces:
may be inoperable if preventive maintenanceis not performed in accordance with IFU.
Health Devices Alerts 2016 Dec 5 (Accession
No. A27352).

6. Unholstered ESU Active Electrodes
Burns and fires from electrosurgical active electrodes[hazard update]. Health Devices 1993 AugSep;22(8-9):421-2. (Free-access version; can beshared with nonmembers.)
Burns during electrosurgery. In: Top 10 healthtechnology hazards: are you protecting yourpatients from these high-priority risks? HealthDevices 2007 Nov 1.
Clamping electrosurgical unit electrode cables may
result in burn risk and/or fire [ECRI Exclusive
Hazard Report]. Health Devices Alerts 2016 Jun
24 (Accession No. H0329).
Electrosurgery checklist—Available through ECRI
Institute’s Medical Device Safety Reports
website.

©2017 ECRI Institute. Executive Brief: Top 10 Health Technology Hazards for 2018
Members can access the full report online. ECRI Institute encourages the dissemination of the registration hyperlink, www.ecri.org/2018hazards,
to access a download of this Executive Brief, but prohibits the direct dissemination, posting, or republishing of this work, without prior permission.

15

Essentials pages—Web pages featuring collections of
Health Devices resources on the following topics:—— Electrosurgery: The Essentials—— Surgical Fire Prevention: The Essentials
Keeping monopolar electrosurgical forceps from being
activated by mistake. Health Devices 2016 Oct 14.
Preventing and fighting airway fires. Healthcare Risk
Control 2016 May 24.

Fostering CE/IT/InfoSec collaboration for better medical
device implementation. Health Devices 2017 Sep
20.
GE CARESCAPE B850 monitor may fail to convey some
ventilator alarms when equipped with GE compact
airway module. Health Devices Alerts 2012 Apr 12(Accession No. H0168).

Surgical fires. Healthcare Risk Control 2016 Jun 1.

Look who’s talking: a guide to interoperability groups
and resources [guidance article]. Health Devices
2011 Jun;40(6):190-8.

The team approach to surgical fire prevention—part 2of ECRI Institute’s Clinical Guide to Surgical Fire
Prevention. Health Devices 2017 Feb 8.

Networked medical devices—get the answers youneed for safe, secure acquisition and use. HealthDevices 2016 Sep 14.

7. Digital Imaging Tools for Reducing
Radiation Dose

10. Enteral Feeding Misconnections

CT Dose Control: The Essentials—This web page features
a collection of Health Devices resources on dose
control issues, with a focus on CT.

8. Bar-Coded Medication Administration System
Workarounds

Implementing the ENFit initiative for preventing enteraltubing misconnections. Health Devices 2017
Mar 29.
Health Technology Assessment Information Service.
ENFit enteral connectors: avoiding enteral tubing
misconnections [special report]. 2017 Jun 30.

Bar-coded medication administration systems.
Healthcare Risk Control 2012 Sep 1.

9. Medical Device Networking Errors
Biomed-IT collaboration critical to ensuring proper
functioning of medical devices residing on hospital
IT infrastructure. Health Devices Alerts 2013 Jun 6(Accession No. S0241).

©2017 ECRI Institute. Executive Brief: Top 10 Health Technology Hazards for 201816

Members can access the full report online. ECRI Institute encourages the dissemination of the registration hyperlink, www.ecri.org/2018hazards,
to access a download of this Executive Brief, but prohibits the direct dissemination, posting, or republishing of this work, without prior permission.

The faster you respond to product safety
alerts and hazards, the safer your patients
Our Top 10 Health Technology Hazards for 2018 list is just a snapshot of how
we can help you keep patients safe. ECRI Institute has trusted resources tohelp with your medical technology management challenges—including smart
alternatives for recalled devices, and much more.
▪▪ Alerts Tracker® helps you streamline your recall management processby automatically distributing alerts to the appropriate staff within yourorganization.
▪▪ Health Devices System delivers exclusive product evaluations basedon first-hand laboratory testing to help you make informed procurement
decisions suited to your specific needs or budget.
▪▪ ECRI Institute’s Accident Investigation Team is on call to help you whenan accident or serious adverse event occurs in your facility.
Turn to ECRI Institute for objective, evidence-based guidance for your mostcritical medical technology management needs. Explore our memberships andservices at www.ecri.org/technology.

We’re here to help.
Contact us today at (610) 825-6000, ext.
5891, or clientservices@ecri.org.

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Objectives of the Health Devices System
To improve the effectiveness, safety, and economy ofhealth services by: Providing independent, objective judgment for
selecting, purchasing, managing, and using
medical devices, equipment, and systems.
 Functioning as an information clearinghousefor hazards and deficiencies in medical devices.
 Encouraging the improvement of medical
devices through an informed marketplace.

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US HEADQUARTERS
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