2014 top 10 hazards executive brief

8/12/2019 2014 Top 10 Hazards Executive Brief

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TOP 10 HEALTHTECHNOLOGYHAZARDS FOR 2014

Adapted from Volume 42Issue 11

November 2013



guidance ARTICLE

1 Adapted from: Health Devices November 2013 www.ecri.org/2014hazards ©2013 ECRI Institute

ECRI Institute encourages the dissemination of the registration hyperlink to access a download of this report, but prohibits the d irect dissemination, posting, or republishing of this work, without prior written permission.

Ensuring the safe use of health technology requiresidentifying possible sources of danger or dif ficultyinvolving medical devices and systems and tak-ing steps to minimize the likelihood that adverseevents will occur. With the vast array of technolo-gies in use at a modern healthcare facility, however,deciding where to commit limited resources is

a continual challenge. We intend this list to be astarting point for patient safety discussions and forsetting health technology safety priorities.

About This List

This Top 10 list of health technology hazards, devel-oped each year by ECRI Institute’s Health DevicesGroup, highlights the technology safety topics that

we believe warrant particular attention for the com-ing year. Some are hazards that we see occurring

with regularity. Some are problems that we believe will become more prevalent, given the way technol-ogy is evolving. And some are well-known risks thatperiodically warrant renewed attention.

But all the items on the list represent problemsthat can be avoided or risks that can be minimizedthrough the careful management of technologies.For each hazard we describe the risk-mitigationstrategies that are currently available, making thislist a practical tool for identifying high-impact stepsyou can take to improve patient care at your facility.

We present here our list for 2014. Additionaldetails about each topic—including our recom-mendations for addressing each hazard and a list ofadditional resources—are available in the November2013 issue of Health Devices.

Criteria for Inclusion

ECRI Institute routinely addresses model-specificdesign, use, and maintenance issues through our

TOP 10 HEALTH TECHNOLOGYHAZARDS FOR 2014THIS ABRIDGED VERSION OF ECRI INSTITUTE’S ANNUAL TOP 10 LIST OF HEALTH TECHNOLOGY HAZ-

ARDS IS PROVIDED AS A COURTESY OF ECRI INSTITUTE. A MORE COMPREHENSIVE DISCUSSION OF

EACH HAZARD, ADDITIONAL RECOMMENDATIONS FOR MINIMIZING THE RISKS, AND A LIST OF USEFUL

RESOURCES FOR MORE INFORMATION ABOUT EACH TOPIC ARE PROVIDED IN THE FULL ARTICLE, PUB-

LISHED IN THE NOVEMBER 2013 ISSUE OF HEALTH DEVICES.

THE LIST FOR 2014

1. Alarm hazards

2. Infusion pump medication errors

3. CT radiation exposures in pediatric patients

4. Data integrity failures in EHRs and otherhealth IT systems

5. Occupational radiation hazards in hybridORs

6. Inadequate reprocessing of endoscopesand surgical instruments

7. Neglecting change management fornetworked devices and systems

8. Risks to pediatric patients from “adult”technologies

9. Robotic surgery complications due toinsufficient training

10. Retained devices and unretrieved fragments



©2013 ECRI Institute Adapted from: Health Devices November 2013 www.ecri.org/2014hazards

ECRI Institute encourages the dissemination of the registration hyperlink to access a download of this report, but prohibits the direct dissemination, posting, or republishing of this work, without prior written permissi

technology evaluation, problem reporting, acci-dent investigation, and alerting services. For this

Top 10 list, we focus only on what we call generichazards—problems that result from the risks inher-ent to the use of certain types or combinations ofmedical technologies.

When nominating topics for consideration,ECRI Institute staff—engineers, scientists, nurses,

physicians, and other patient safety analysts—drawon the resources built up through the organization’s45-year history analyzing healthcare technologies,as well as their own expertise and insight gainedthrough examining health-technology-relatedproblem reports, evaluating medical devices andsystems, investigating incidents, observing andassessing hospital operations and practices, review-ing the literature, and speaking with healthcareprofessionals and device suppliers. Staff then voteon the nominated hazards, weighing factors such asthe 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 conse-quences likely to spread to affect a great numberof people, either within one facility or acrossmany facilities?

Insidiousness. Is the problem dif ficult to rec-ognize? Could the problem lead to a cascade

of downstream errors before it is identified orcorrected?

Profile. Is the hazard likely to receive significantpublicity? Has it been reported in the media, andis an affected hospital likely to receive negativeattention? Has the hazard become a focus ofregulatory bodies or accrediting agencies?

Preventability. Can actions be taken now to pre-

vent the problem or at least minimize the risks? Would raising awareness of the hazard helpreduce future occurrences?

Any of these criteria can warrant including atopic on the list—although all selected hazardsmust, to some degree, be preventable; that is, mea-sures must exist that healthcare facilities can take toreduce the risks.

For More Information

To access the full article, for questions about ECRIInstitute’s annual list of technology hazards, orfor information about membership, contact ECRI

Institute by telephone at (610) 825-6000, ext. 5891;by e-mail at [email protected]; or by fax at(610) 834-1275.

Also see the box on page 13 to learn more aboutECRI Institute’s products and services and to findout how you can access our online self-assessmenttool for gauging your facility’s risks of experiencingthe hazard on this list.





11. larm Hazards Alarm HazardsMedical device alarms can make the differencebetween timely, life-saving interventions andserious injury or death. Physiologic monitors,

ventilators, infusion pumps and many otherdevices generate clinical alarms to help care-givers keep patients safe.

However, it is possible to have too muchof a good thing. Excessive numbers ofalarms—particularly alarms for conditionsthat aren’t clinically significant or that couldbe prevented from occurring in the firstplace—can lead to alarm fatigue, and ulti-mately patient harm. That is:

Caregivers can become overwhelmed,unable to respond to all alarms or to dis-tinguish among simultaneously sounding

alarms. They can become distracted, with alarms

diverting their attention from other impor-tant patient care activities.

They can become desensitized, possi-bly missing an important alarm becausetoo many previous alarms proved to beinsignificant.

Beyond alarm fatigue, patients could be putat risk if an alarm does not activate when itshould, if the alarm signal is not successfullycommunicated to staff or does not include suf-ficient information about the alarm condition,

or if the caregiver who receives the alarm sig-nal is unable to respond or is unfamiliar withthe proper response protocol. In short, any

circumstance that results in the failure of staff(1) to be informed of a valid alarm conditionin a timely manner or (2) to take appropriateaction in response to the alarm can be consid-ered a clinical alarm hazard.

In an April 2013 Sentinel Event Alert,the Joint Commission cited 98 alarm-relatedevents over a three-and-a-half-year period,

with 80 of those events resulting in deathand 13 in permanent loss of function (www.jointcommission.org/sea_issue_50/). In

June, the organization announced that alarmmanagement would be established as aNational Patient Safety Goal, with certainprovisions taking effect during 2014.

Addressing clinical alarm hazards requiresa comprehensive alarm management programinvolving stakeholders from throughout theorganization. Goals for the program shouldinclude (1) minimizing the number of clini-cally insignificant or avoidable alarms so thatthe conditions that truly require attention canbetter be recognized and (2) optimizing alarmnotification and response protocols so thatthe patient receives the appropriate care at thetime it’s needed.

For more information

ECRI Institute offers a free-access Alarm Safety Resource Site: https://www.ecri.org/Forms/Pages/Alarm_Safety_Resource.aspx.

Additional resources can be purchasedfrom ECRI Institute; these include:

The Health Devices alarmmanagement series—a collectionof articles to help healthcarefacilities develop realistically

implementable strategies to reduceclinical alarm hazards.*

A recording of ECRI Institute’sweb conference “Answering theCall to Alarm Safety: GettingReady for Joint Commission’sNational Patient Safety Goal”; fordetails, see: https://www.ecri.org/Conferences/AudioConferences/Pages/Alarm_Safety.aspx.*

ECRI Institute’s Alarm ManagementStarter Kit—a suite of tools foraddressing the Joint Commission’sNational Patient Safety Goal onalarm management (available withpurchase of the web conferencedescribed above).*

Customized, on-site assistance is avail-able through ECRI Institute’s AlarmManagement Safety Review service.Our Applied Solutions Group canidentify your alarm system vulner-abilities and provide realistic, imple-mentable strategies to help improvealarm management at your facility.

* Free to members of the Health Devices System,Health Devices Gold, and SELECTplus programs.





22. Infusion Pump Medication ErrorsInfusion Pump Medication ErrorsInfusion pumps are invaluable to healthcare,delivering specified doses of fluids and medi-cation directly into a patient’s bloodstream

over an extended period of time. However,these devices also represent a large technol-ogy management burden: A hospital may havehundreds or even thousands of these devicesin its inventory, and device failures—or fail-ures to use the devices properly—are notuncommon and can cause significant patientharm. Patients can be highly sensitive to theamount of medication or fluid they receivefrom infusion pumps, and some medicationsare life-sustaining—or life-threatening ifadministered incorrectly.

To minimize the risk of use errors, werecommend that healthcare facilities dedicateresources to regular training and assessment,both for routine users and incoming staff, sothat all users receive adequate instruction andkeep their skills fresh. And when purchasingnew pumps, we recommend that facilitiesconsider usability issues and involve frontlinestaff in the device evaluation process. Thesemeasures are particularly relevant in light of therecent changes to the infusion pump market,

which have resulted in several popular models

of pumps becoming unavailable because ofregulatory actions or manufacturer marketingdecisions. Such changes may lead healthcare

facilities to switch to unfamiliar brands. Another important consideration is to rec-

ognize the limits of safety technologies. Manypumps today are equipped with onboarddrug libraries that trigger alert limit warningsfor gross misprogrammings. Such “smart”technologies do a good (not perfect) job ofhelping to get the dose correct. This requires,however, that appropriate drug libraries aredeveloped (and maintained) and that staff usethe available safeguards appropriately. In addi-tion, these technologies don’t help preventerrors such as administering an order to the

wrong patient or selecting the wrong drug.

Infusion pump integration—that is, con-necting the servers for the infusion pumps

with other information systems—can provideadditional protections, such as helping verifythat both the right patient and the right drughave been selected. Thus, we recommendthat healthcare facilities begin (or continue)to implement infusion pump integration withrelevant information systems.


Additional resources can be purchasefrom ECRI Institute; these include:

Numerous Health Devices Evaluations and Guidance Articleas well as product alerts, oninfusion technologies.*

A recording of ECRI Institute’sweb conference “Building a SafeFramework for Integrated InfusionPumps”; for details, see: https://www.ecri.org/Conferences/

AudioConferences/Pages/Integrated-Infusion-Pumps.aspx.*

ECRI Institute PSO’s Deep Dive:Medication Safety, published inDecember 2011; for purchasedetails, see: https://eshop.ecri.orgp-142-pso-deep-dive-medicationsafety-events.aspx.**

* Free to members of the Health Devices SystemHealth Devices Gold, and SELECTplus program** Free to ECRI Institute PSO memberorganizations.





33. CT Radiation Exposures inCT Radiation Exposures inPediatric PatientsPediatric Patients

Computed tomography (CT) systems have

proven to be a valuable tool for diagnosingserious injuries and illnesses. However, thisdiagnostic imaging technology is not withoutrisk—especially to pediatric patients, who areinherently more sensitive to the effects of ion-izing radiation than are adults.

While the risk has always been hard toquantify, newly published empirical studiesadd to the evidence that exposure to ionizingradiation from diagnostic imaging at a youngage can increase a person’s risk of developingcancer later in life. As a result, efforts shouldbe made to minimize a child’s exposure to

high doses of ionizing radiation.Practices that can place children needlessly

at risk include the inappropriate use of anytechnology that uses ionizing radiation, as wellas the failure to properly control the radia-tion dose during such procedures—whichcan occur, for example, if an adult protocol isused for pediatric patients. However, CT scansare of particular concern because they delivera comparatively high dose of radiation and are

widely used.

To minimize a child’s exposure to highdoses of ionizing radiation, healthcare provid-

ers can take actions such as the following: Using safer diagnostic options when

appropriate. When time is not of the

essence and the patient’s condition does

not specifically necessitate a CT scan,clinicians should consider lower-dosealternatives like x-rays, or technologieslike magnetic resonance imaging (MRI) orultrasound, which don’t use ionizing radia-tion. (A radiologist should be consulted todetermine the best option.)

Avoiding repeat scanning. If a patient hasalready been scanned at another institu-tion, the facility can try to obtain the exist-ing images from the previous scan, ratherthan conducting a repeat scan.

Following the ALARA principle. That is,

using a dose that is “as low as reasonablyachievable” to acquire the desired diag-nostic information during any imagingprocedure that uses ionizing radiation. Inparticular, healthcare providers should cus-tomize scanning protocols to the needs ofpediatric patients—that is, recognize thatsettings designed for adults are not appro-priate for children.


Additional resources can be purchasedfrom ECRI Institute; these includenumerous Health Devices guidancedocuments related to CT and radiation

safety.*

Customized, on-site assistance isavailable through ECRI Institute’s CTRadiation Dose Safety Review service.Our Applied Solutions Group canevaluate your facility’s CT service andrecommend measures to help youminimize the risks.






44. Data Integrity Failures in EHRsData Integrity Failures in EHRsand Other Health IT Systemsand Other Health IT Systems

The adoption of electronic health records

(EHRs) in U.S. hospitals has more than tripledfrom 2009 through 2012. This increase canbe attributed to the quality and safety benefitsthat EHRs are expected to offer compared

with their paper-based predecessors, as well asthe financial incentives (and penalties) definedin the Health Information Technology forEconomic and Clinical Health (HITECH)

Act.* As the role of EHRs and other IT-based systems in patient care increases, theintegrity of the data within (and passedamong) those systems becomes an increas-ingly critical patient safety concern.

When designed and implemented well, anEHR or other IT-based system will providecomplete, current, and accurate informationabout the patient and the patient’s care so thatthe clinician can make appropriate treatmentdecisions. The presence of incorrect datain such systems, however, can lead to incor-rect treatment, potentially resulting in patientharm. And reports illustrate myriad ways thatthe integrity of the data in an EHR or otherhealth IT system can be compromised. Con-tributing factors include:

patient/data association errors—that is,one patient’s data from a medical device

or system mistakenly being associated with

another patient’s record; missing data or delayed data delivery;

clock synchronization errors;

inappropriate use of default values;

use of dual work flows (paper andelectronic);

copying and pasting of older informationinto a new report; and

basic data-entry errors (which can bepropagated much further than would haveoccurred with paper-based systems).

Key steps in safeguarding the integrity of

electronic patient data include assessing theclinical work flow to understand how the datais (or will be) used by frontline staff; testingthe system and the associated interfaces (pref-erably in a simulated setting) to verify thatthe system is functioning as intended; provid-ing suf ficient user training and support; andestablishing a mechanism for users to reportproblems as they are discovered.

* From Farzad Mostashari’s Testimony before the Subcom-mittee on Oversight and Investigations Committee onEnergy and Commerce, U.S. House of Representatives.2013 Mar 21 [cited 2013 Oct 1]; see http://docs.house.gov/meetings/IF/IF02/20130321/100544/HHRG-113-IF02- Wstate-MostashariF-20130321-SD002.pdf.



Numerous Health Devices articleson health IT and interoperabilitytopics.*

ECRI Institute PSO’s Deep Dive:Health Information Technology,published in January 2013; forpurchase details, see: https://eshop.ecri.org/p-140-pso-deep-dive-health-information-technology.aspx.**

Customized, on-site assistance is avaable through ECRI Institute’s Readines

Assessment for Exchange of HealthInformation service. Our AppliedSolutions Group can help you identifygaps that could affect the exchange ohealth information within your organization and with outside groups.






55. Occupational Radiation HazardsOccupational Radiation Hazardsin Hybrid ORsin Hybrid ORs

The implementation of hybrid ORs is a

growing trend in healthcare facilities. Theseoperating suites bring advanced imagingcapabilities into the surgical environment viabuilt-in, full-scale angiography systems, whichcan be used to guide complex minimally inva-sive procedures that may need to transition toopen procedures.

However, as these angiography systems areintroduced into the OR, so too are the radia-tion exposure risks associated with the use ofionizing radiation. Patient exposure hazardsare of course a concern. But perhaps lessobvious are the risks to OR staff.

Personnel in radiology departments andcatheterization labs, where imaging deviceshave a long history, are generally well versedin the occupational risks associated with ion-izing radiation and well educated in the safetyprecautions that must be taken. Outside thosemore controlled environments, however, theknowledge of the risks and the experiencein executing precautions may be lacking—asituation that could lead to unnecessary radia-tion exposures to those clinicians working in ahybrid OR on a daily basis.

If a hybrid OR is to be implemented,

healthcare facilities must have in place a radia-

tion protection program that provides staff

with the knowledge and technology they needto minimize occupational radiation exposuresin this unique environment:

The first step in any radiation protectionprogram is training. An appropriate train-ing program will address the specific needsof staff who may not have extensive expe-rience with imaging technologies.

The second step is shielding. Lead apronsare the first line of defense for all staff

working in the vicinity of the equip-ment. Shielding can also be provided byadditional lead barriers, such as those

suspended from the ceiling. In either case,such protections are effective only if theyare actually used.

The third step is monitoring. Effectivemonitoring requires that radiation moni-toring badges be properly worn, main-tained, and reviewed. (These badges trackclinician exposure to radiation by provid-ing a cumulative radiation dose reading

when the badge is later analyzed.) To aug-ment the use of traditional badges, facili-ties may also choose to institute the use ofelectronic badges that provide real-timereadings of the dose rate.


ECRI Institute’s infographic “HybridOperating Rooms: With a Focus OnEndovascular Hybrid ORs” is available,

with registration, from: https://www.ecri.org/Forms/Pages/Hybrid-Operat-ing-Rooms.aspx.

Customized, on-site assistance is avail-able through ECRI Institute’s MedicalRadiation Safety Review service. Our

Applied Solutions Group can assessyour medical radiation services withthe goal of reducing the likelihood ofharm due to unnecessary and exces-sive radiation.





66. Inadequate Reprocessing ofInadequate Reprocessing ofEndoscopes and SurgicalEndoscopes and SurgicalInstrumentsInstruments

Every day, healthcare facilities clean anddisinfect (or sterilize) thousands of reus-able surgical instruments and devices so thatthey can be used for subsequent procedures.

When performed properly, this reprocessingremoves residue and potentially infectiousmaterials (e.g., tissue, body fluids) and disin-fects or sterilizes the instrument so that it canbe safely used on the next patient.

When reprocessing is not performed prop-erly, however, patient cross-contaminationis possible, potentially leading to the trans-

mission of infectious agents and the spreadof diseases such as hepatitis C, HIV, andtuberculosis.

Discussions of reprocessing failures fre-quently center on flexible endoscopes, devicesthat can be guided through narrow windingroutes, such as the digestive tract, respiratorytract, and blood vessels, to allow physicians to

view and access internal body structures lessinvasively than would otherwise be possible.Because flexible endoscopes are complexdevices with narrow, hard-to-clean chan-nels, they can be particularly challenging todecontaminate.

However, endoscopes are not the onlydevices subject to reprocessing failures.

Incidents reported to ECRI Institute PSOdescribe other instruments and devices (e.g.,arthroscopy shoulder cannulas, surgical instru-ment trays) that were used, or were presentedfor use, despite still being contaminated withpotentially infectious biological matter.

Successful reprocessing of any devicerequires consistent adherence to a multistepprocedure. Failure to properly perform anystep, including some necessary manual tasks,could compromise the integrity of the processand lead to significant patient harm. Further,

incidents involving improperly reprocessedinstruments can damage an organization’sreputation, reduce patient satisfaction, promptreview by accrediting agencies, and lead tocitations and fines from regulatory bodies orlawsuits from patients.

Consistent, effective reprocessing ofendoscopes and other instruments requiresthat appropriate reprocessing protocols bedeveloped, documented, and followed forall relevant instrument models in a facility’sinventory. Staff need to be trained in theseprotocols, and they need adequate space,equipment, and instructional materials, as wellas suf ficient time to perform the procedurecorrectly.



The Health Devices Guidance Article “Clear Channels:

Ensuring Effective EndoscopeReprocessing.”*

ECRI Institute PSO’s article “SterilProcessing Department’s Role inPatient Safety.”**






77. Neglecting Change ManagementNeglecting Change Managementfor Networked Devices andfor Networked Devices andSystemsSystems

The growing interrelationship betweenmedical technology and IT offers significantbenefits. However, one underappreciatedconsequence of system interoperability is thatupdates, upgrades, or modifications made toone device or system can have unintendedeffects on other connected devices or systems.

ECRI Institute is aware of incidents in which planned and proactive changes to onedevice or system—relating, for example, toupgrading software and systems, improving

wireless networks, or addressing cybersecu-

rity threats—have adversely affected othernetworked medical devices and systems.For example:

A facility-wide PC operating systemupgrade caused the loss of remote-displaycapability for a hospital’s fetal monitoringdevices.

Moving a facility’s obstetrical data manage-ment system server off-site led to prob-lems displaying fetal monitor data at thenurses’ station.

An EHR software upgrade resulted inchanges to certain radiology reports, caus-

ing fields for the date and time of the studyto drop from the legal record.

To prevent such downstream effects,alterations to a network or system must beperformed in a controlled manner and withthe full knowledge of the personnel whomanage or use the connected systems. Initia-tives that once may have been considered “ITprojects” must instead be viewed as “clinicalprojects that require IT expertise.” Softwareupgrades, security patches, server modifica-tions, changes to or replacement of networkhardware, and other system changes canadversely affect patient care if not imple-

mented in a way that accommodates both ITand medical technology needs. Unfortunately,change management—a structured approachfor completing such alterations—appears tobe an underutilized practice.

Appropriate change management policiesand procedures, as outlined in the recommen-dations in the full article, can help minimizethe risks. Just as important, however, is tocultivate an environment in which IT, clinicalengineering, and nursing/medical personnel(1) are aware of how their work affects otheroperations, patient care, and work processes— particularly clinical work processes—and (2)

are able to work together to prevent IT-relatedchanges from adversely affecting networkedmedical devices and systems.



Numerous Health Devices articles on health IT, medicaland information technologyconvergence, and interoperabilitytopics.*

ECRI Institute PSO’s Deep Dive:Health Information Technology,published in January 2013; forpurchase details, see: https://eshop.ecri.org/p-140-pso-deep-dive-health-information-technology.aspx.**

The Risk Management Reporter article “Risk Managers’ 10

Strategies for Health IT Success”;freely available for a limitedtime at: https://www.ecri.org/EmailResources/PSRQ/RMRep0613-HIT.pdf.

* Free to members of the Health Devices System,Health Devices Gold, and SELECTplus programs.** Free to ECRI Institute PSO memberorganizations.





88. Risks to Pediatric Patients fromRisks to Pediatric Patients from“ dult” Technologies“Adult” Technologies

Healthcare technologies are often developed

with the needs of adult patients in mind,leaving clinicians with little choice but to relyon “adult” technologies in the diagnosis andtreatment of pediatric patients. But due totheir smaller size and ongoing physiologicchanges, children may suffer adverse effects

when subjected to adult-oriented healthcaretechniques.

The following are just a few examples ofhow the care of pediatric patients can be com-promised when applying “adult” healthcaretechnologies:

Exposure to ionizing radiation, such as

that used in CT and x-ray imaging, hasbeen associated with an increased cancerrisk. Because children are still developing,they are especially susceptible to long-termdamage from such exposures. Using adultscanning techniques on pediatric patientscan compound this problem, exposingchildren to an unnecessarily large “adult”dose and potentially exposing regions ofthe body outside the area of interest. Wecover this topic as hazard number 3 in thisyear’s list.

A healthcare facility’s EHR may not beconfigured to optimally support the careof children. For example, the system may

not facilitate the recording and review of

important pediatric-specific data, such as vaccinations.

Medication dosing errors can be particu-larly harmful to children because of thepatient’s small size. This susceptibility toharm, coupled with the use of technolo-gies that aren’t optimized for pediatricpatients, can lead to tragic results. Evena device as simple as a scale can contrib-ute to significant harm: scales that report

weights in both kilograms and pounds havecontributed to errors in which the incor-rect figure was used for weight-based dosecalculations (e.g., the pounds value hadbeen mistakenly recorded in the EHR asthe kilogram value).

Whenever possible, healthcare providersshould use pediatric-specific technologies,rather than using adult-oriented technologyoff-label or employing workarounds. Unfor-tunately, pediatric-specific devices can be slowto reach the market because of the small num-bers of patients available to study, the devices’high-risk nature, and high development costs.

Thus, healthcare providers are often put inthe position of having to use a technologydesigned for adults to diagnose or treat condi-

tions in children. Healthcare personnel mustexercise particular care when this is necessary.





99. Robotic Surgery ComplicationsRobotic Surgery Complicationsdue to Insufficient Trainingdue to Insufficient Training

Robot-assisted surgery involves the use of

robotic arms that are fully controlled by themovements of a surgeon, who is located at acontrol console several feet from the patient.

The past decade has seen a rise in the imple-mentation of such systems to replace opensurgery and traditional minimally invasive sur-gery (MIS) techniques for certain procedures.

The past year, however, has seen a rise inthe number of media reports that are criti-cal of robot-assisted surgery. Some of thereports, which describe complications thatindividual patients have experienced, sug-gest that robotic systems are being used for

a greater number of cases or for additionalkinds of procedures without adequate con-sideration of the surgical team’s proficiencyin using the system for the proceduresperformed.

These reports don’t speak to the ef ficacyof robot-assisted surgery: The articles donot meet the standards of evidence-basedresearch studies, and proponents of these sys-tems can point to many successful outcomes.However, the reports do draw attention to thecritical need for appropriate training, detailedcredentialing, and ongoing surgical team com-petency assessments to minimize patient risk.

Initial training provided by the device sup-

plier can help users become familiar with thesystem, but it does not teach trainees how toperform specific surgical procedures. Thus,it is up to the hospital to verify that surgicalstaff have the necessary procedure-specificskills. For this to happen, surgeons and staff

will need to complete a multifaceted, detailedtraining program to develop proficiency andexpertise with a multipurpose robotic surgerysystem. The program should require that aspecified number of proctored surgeries beperformed, and successful completion of theprogram should lead to credentialing withinthe hospital/system. Consideration must also

be given to how the surgical team will main-tain its competency with the system over time.

Currently, no widely recognized require-ments exist for robotic surgery training andcredentialing programs, so hospitals will needto make their own decisions. In the full ar ticle,

we present recommendations that are basedon the experiences of well-established roboticsurgery programs to help hospitals that needto develop a program.



The Health Devices Guidance Article “Da Vinci Decisions:Factors to Consider Before MovingForward with Robotic Surgery.”*

A recording of ECRI Institute’s

web conference “The SurgicalRobot Invasion: Training andSafety,” as well as training andcredentialing guides shared by theweb conference participants; fordetails, see: https://www.ecri.org/Conferences/AudioConferences/Pages/Surgical-Robots.aspx.*






1010. Retained Devices andRetained Devices andUnretrieved Fragments Unretrieved Fragments

The unintended retention of a surgical item

in a patient after surgery or after an inter- ventional diagnostic procedure is the kind ofmedical error that can largely be prevented.But events that shouldn’t happen sometimesdo. For example:

In the last four years alone, ECRIInstitute’s Accident and ForensicInvestigation Group has investigated nineretained surgical item (RSI) incidents.

A 2012 analysis of the PennsylvaniaPatient Safety Reporting System data-base showed that healthcare facilities inthe commonwealth reported 452 events

involving RSIs in 2011—one-third ofthose events reportedly caused patientharm (http://patientsafetyauthority.org/

ADVISORIES/AdvisoryLibrary/2012/Sep;9(3)/Pages/106.aspx).

In October 2013, the Joint Commissionissued a Sentinel Event Alert on the unin-tended retention of foreign objects, notingthat 772 such incidents were reported toits Sentinel Event Database from 2005 to2012, including 16 that resulted in death.

These reports have prompted us to againinclude the topic on our list. (It last appeared

on our list for 2010.) In addition to being apatient safety concern, RSIs are classified bythe Centers for Medicare & Medicaid Services

(CMS) as a hospital-acquired condition; thus,

CMS withholds payment for the treatment ofthis condition.

Reports of surgical items unintentionallyleft inside patients following surgery or aninterventional diagnostic procedure typicallyinvolve one of the following:

A retained device, in which an entire device(including soft goods like a surgical spongeor towel) is unknowingly left behind.

Unretrieved device fragments, in which aportion of a device (e.g., catheter tip, for-ceps jaw) breaks away and remains insidethe patient. (Clinicians may be aware that

a device fragment has been left in thepatient, but decide that the fragment’s loca-tion within the anatomy makes retrievaltoo risky.)

Risks to the patient can include prolongedor additional surgery, as would occur when anRSI is discovered and its removal is deemedappropriate, or future complications, somepotentially serious, as could occur when anRSI leads to infection or causes damage to thesurrounding tissue.

Visually inspecting devices before and afteruse and adhering to accepted surgical count

procedures are key measures for preventingRSI incidents.



The Health Devices Evaluation“Radio-Frequency Surgical SpongDetection.”*

ECRI Institute PSO Patient SafetyE-lerts on retained foreign objectsduring robotic surgery (2012 May31) and retained guidewires (201

Aug 31).**

The Risk Management Reporter article “The Case of the MissingSponge: Practice Variation Is theCulprit.”***

* Free to members of the Health Devices SystemHealth Devices Gold, and SELECTplus program** Free to ECRI Institute PSO memberorganizations.*** Free to members of the Healthcare RiskControl program.





KEY SAFETY RESOURCES FROM ECRI INSTITUTE

ECRI Institute is an independent, nonprofit organization that research-es the best approaches to improving the safety, quality, and cost-effectiveness of patient care. Our unbiased, evidence-based healthcareresearch, information, and advice helps healthcare organizations:

Assess and address patient safety, quality, and risk managementchallenges

Select the safest, most effective medical devices, procedures, anddrugs

Procure healthcare technology in the most cost-effective manner

Develop evidence-based health coverage policies

Align capital investments with strategic technology needs

Following are a few of the products and services we offer to helphealthcare organizations address the kinds of health technologyhazards described in this report.

Online Hazard Self-Assessment Tool

As a complement to this report, ECRI Institute has developed an on-line Health Technology Hazard Self-Assessment Tool to help health-care facilities gauge their risks of experiencing any of the hazardson the list. The Self-Assessment Tool enables users to invite multipleindividuals and departments to respond to a short survey on any ofthe hazard topics; once the surveys are completed, the tool generatesa report rating your level of risk for each hazard (from low to high)and identifying specific practices that could help reduce your risk.

Members of several ECRI Institute programs can access the HealthTechnology Hazard Self-Assessment Tool from their member homepage at www.ecri.org. If you are not a member and would like tolearn more about using the tool, see the contact information below.

Technology Management Services

More in-depth information on a wide range of medical technologyissues is available through programs such as the following:

The Health Devices program is best known for its comparative,brand-name evaluations of medical devices and systems. Basedon extensive laboratory testing, ECRI Institute’s evaluations focuson the safety, performance, efficacy, and human factors design ofspecific medical devices and technologies.

SELECTplus, ECRI Institute’s industry-leading advisory service forsupply chain and materials management professionals, assistswith the safe, cost-effective procurement of capital medicalequipment and health information technologies.

In addition, ECRI Institute’s Applied Solutions Group providescustomized services and on-site assistance to help healthcare facili-ties and health systems address challenges ranging from managingmedical equipment needs for a major construction project to identify-ing and addressing patient safety vulnerabilities.

Patient Safety, Quality, and Risk Management

ECRI Institute also offers a variety of programs designed to meet theneeds of patient safety, quality, and risk management professionals;these include:

ECRI Institute PSO, a component of ECRI Institute dedicatedto collecting and analyzing patient safety information and

sharing lessons learned and best practices, operates under thePatient Safety and Quality Improvement Act. This act createda framework for healthcare providers to share data with PSOs,who in turn can provide analysis and feedback regarding patientsafety matters in a protected legal environment. Additionally,PSOs can collect the information in a standardized format inorder to aggregate the data and learn from it. For informationabout becoming an ECRI Institute PSO member organization,refer to www.ecri.org/pso.

Healthcare Risk Control (HRC) is a membership programproviding access to a wealth of practical resources, includingmore than 300 unbiased, in-depth risk analyses; dozens ofself-assessment tools; more than 500 policies and proceduresthat can be tailored to your needs; ready-to-use education andtraining tools; standards and best practices; and bimonthly andonline newsletters.

To Learn More

This executive briefing of ECRI Institute’s annual Top 10 list of healthtechnology hazards is provided as a courtesy of ECRI Institute. Amore comprehensive discussion of each hazard, additional recom-mendations for minimizing the risks, and a list of useful resources formore information about each topic are provided in the November2013 issue of Health Devices, available for purchase at a discountedrate at https://eshop.ecri.org/p-160-health-devices-journal-novem-ber-2013.aspx.

For more information about this report, the self-assessment tool,or any of our membership programs, contact ECRI Institute by tele-phone at (610) 825-6000, ext. 5891; by e-mail at [email protected]; or by fax at (610) 834-1275. You can also visit us online at

www.ecri.org.



Alarm events are accidents waiting to happen—the result of a perfect

storm in an error-prone system. Patient deaths and other alarm-related

events plague hospitals and make the news. And, they persist on ECRI

Institute’s annual list of Top 10 Health Technology Hazards.

ECRI Institute’s Alarm Management Safety Reviews can help.

Our experienced healthcare consultants come on site to assess yourorganization’s culture, infrastructure, practices, and technology. Our

approach identifies and addresses your patient safety vulnerabilities and

provides implementable alarm management strategies.

Don’t wait for a perfect storm. Take steps now to improve alarm safety.

Visit www.ecri.org/alarmsafety

M S 1 2 0 7 1



UNITED STATES

5200 Butler Pike,Plymouth Meeting, PA19462-1298, USA

Telephone +1 (610) 825-6000Fax +1 (610) 834-1275

EUROPE

Suite 104, 29 Broadwater RoadWelwyn Garden City,

Hertfordshire, AL7 3BQ, UKTelephone +44 (1707) 871 511Fax +44 (1707) 393 138

ASIA PACIFIC

11-3-10, Jalan 3/109F,Danau Business Centre,Taman Danau Desa,

58100 Kuala Lumpur, MalaysiaTelephone +60 3 7988 1919Fax +60 3 7988 1170

MIDDLE EAST

Office No. 1101, 11th Floor, Al Shafar Tower 1, TECOMP.O. Box 128740

Dubai, United Arab EmiratesTelephone +971 4 3638335Fax +971 4 3637364

OBJECTIVES OF THE HEALTH DEVICES

SYSTEM

To improve the effectiveness, safety, and economy of

health services by:

Providing independent, objective judgment for

selecting, purchasing, managing, and using

medical devices, equipment, and systems.

Functioning as an information clearinghouse

for hazards and deficiencies in medical devices.

Encouraging the improvement of medical

devices through an informed marketplace.

2014 top 10 hazards executive brief

Documents