Playing it safe: ECRI Institute

Playing it safe: ECRI Institute

ECRI Institute’s 2015 Top 10 Health Technology Hazards highlights many perennial problems plus some newer issues. HRMR rounds up its findings.

Healthcare risk managers tend to be keenly aware of the safety hazards present in the hospital environment, yet one particular type of hazard—that related to technology—is constantly evolving but often neglected. With this in mind, ECRI Institute, an independent nonprofit that researches the best approaches to improving patient care, has published its 2015 Top 10 Health Technology Hazards.

“Technology safety can often be overlooked,” says James Keller Jr, vice president, health technology evaluation and safety, ECRI Institute. “Based on our experience, there are serious safety problems that need to be addressed. ECRI Institute recommends that hospitals use our list as a guide to help prioritize their technology-related safety initiatives.”

The 2015 Top 10 Health Technology Hazards report, available for download as a free public service, details a variety of technology hazards that put patients at risk.

For the fourth year in a row, clinical alarm hazards, a Joint Commission National Patient Safety Goal, remains number one on ECRI’s list. This year, the report draws particular attention to alarm configuration practices. ECRI Institute is aware of several deaths and other cases of severe patient harm that may have been prevented with more effective alarm policies and practices.

Recall management, which appears on the list for the first time, points to overwhelmed recall and safety-alert programs as a potential for serious consequences for healthcare facilities and patients. ECRI experts are concerned that existing hospital recall tracking programs are not keeping pace with the growing number of medical device recalls issued each year. The Food and Drug Administration reports that the annual number of medical device recalls nearly doubled between 2003 and 2012, from 604 recalls to 1,190 annually.

To develop the annual list, ECRI Institute’s multidisciplinary staff of engineers, scientists, nurses, physicians, and patient safety analysts drew on the resources of the Institute’s 45-year history, as well as expertise and insight gained through testing and analyzing healthcare technologies. This includes examining health technology-related problem reports from hospitals and health systems worldwide, and reports received through ECRI Institute Patient Safety Organization.

Here is a summary of the report’s main findings and recommendations:


1. Alarm hazards

The report argues that while many strategies for reducing alarm hazards focus on alarm fatigue—whereby staff miss alarms as they are overwhelmed or desensitised by the sheer number of alarms that activate—there are other factors also at play.

“In ECRI Institute’s experience, alarm-related adverse events—which can involve missed alarms or unrecognized alarm conditions—can often be traced to inappropriate alarm configuration practices,” it states. It goes on to give detailed recommendations for establishing a policy describing care area-specific standard alarm configuration practices.

“If a policy already exists, assess the policy for completeness and clinical relevance,” it adds.


2. Data integrity

Incorrect or missing data in electronic health records and other health IT systems is a major problem in healthcare. “What makes this problem so troubling is that the integrity of the data in health IT (HIT) systems can be compromised in a number of ways, and once errors are introduced, they can be difficult to spot and correct,” states the report.

It recommends that before implementing a new system or modifying an existing one, it is important to assess the clinical workflow to understand how the system is (or will be) used by frontline staff, and identify inefficiencies as well as any potential error sources.

The system should be thoroughly tested and staff should be comprehensively trained. A reporting system for HIT-related incidents and near-misses should also be in place.


3. Mix-up of IV lines leading to misadministration of drugs and solutions

The report highlights the risks surrounding the tangle of tubing created when multiple IV infusions need to be administered to a single patient—a common occurrence in healthcare.

“If a medication or IV solution is delivered to the wrong infusion site, or at the wrong rate, the consequences can be severe,” it states. It recommends that for all instances in which multiple IV infusions need to be administered to a single patient, staff should (i) physically trace existing lines from source to site, and verify that the patient connector is attached to the correct administration site; (ii) label each infusion line with the name of the drug or solution being infused; and (iii) make connections without forcing or adapting.


4. Inadequate reprocessing of endoscopes and surgical instruments

When reprocessing is not performed properly, pathogens can be spread to subsequent patients, potentially leading to hospital-acquired infections or the spread of disease.

“One critical reprocessing step—one that is sometimes overlooked or inconsistently performed—is the initial cleaning of the device or instrument at the site of use (eg, in the procedure room). If organic soils and other contaminants are not first removed, successful disinfection or sterilization of the device or instrument may not be possible,” states the report.

It adds that the intricacy of some instruments can add a further layer of complication. It makes a number of recommendations for ensuring reprocessing is done properly, including the provision of adequate space and resourcing for reprocessing, and fostering communication and collaboration between reprocessing personnel and the departments they support.


5. Ventilator disconnections not caught because of mis-set or missed alarms

A complete or partial disconnection at any point along the breathing circuit—the pathway that conveys gases between the ventilator and the patient—could quickly lead to anoxic brain injury and ultimately could be fatal. While ventilators have sensors and alarms to warn caregivers when a disconnection occurs, the report stresses that these must be set to appropriate levels and must be audible in order to be effective.

Its recommendations include (i) developing a policy on setting ventilator low-pressure and low-minute volume alarms to levels that are appropriate for detecting disconnections; (ii) directing respiratory therapists to confirm, during their regular ventilator checks, that all alarms are active; and (iii) assessing whether alarms can be adequately heard in the areas where the ventilator will be used.


6. Patient-handling device use errors and device failures

A diverse range of patient-handling technologies is available to help reduce the risk of staff and patient injury during such activities. However, improper use of these devices, failure to maintain them appropriately, or failures associated with the devices themselves can likewise result in injuries.

The report recommends training caregivers to recognize scenarios that might require the use of patient-handling equipment.

“First, train caregivers to recognize scenarios that might require the use of patient-handling equipment,” it states. “Manually trying to lift, move, or transfer even lightweight patients can be hazardous. Of particular concern are activities that place the caregiver in awkward positions or that require heavy lifting.”


7. ‘Dose creep’: unnoticed variations in diagnostic radiation exposures

Dose creep is a pattern of radiation exposure levels (ie, dose) being increased by clinicians over time in an attempt to achieve better image quality in diagnostic radiography.

“Although it is unlikely to result in immediate harm, it’s an insidious problem that can have long-term consequences and that, over time, can affect many patients,” states the report.

It says the dose creep is in many ways an unintended consequence of switching from film to digital detectors, and stresses the importance of the standardized exposure index (EI) which enables healthcare facilities to track the exposure factors that are used and to identify trends that might indicate variation from the optimal values.


8. Robotic surgery: complications due to insufficient training

“If surgeons, the rest of the surgical team, and associated staff are not sufficiently trained on how to use the robotic surgical system and how to perform a surgery under these unique conditions, adverse events can result,” states the report.

ECRI Institute has investigated several surgical robot-related adverse events in which situations unique to robot-assisted surgery had probably contributed to patient harm.

“The circumstances of robot-assisted surgery dictate that a ‘robot-centric’ approach be used when determining how surgeons and other surgical team members will be trained, how their qualifications will be assessed, and how all associated activities will be conducted—from how decisions are made to perform a procedure robotically to how the equipment is cleaned after the surgery,” states the report.


9. Cybersecurity: insufficient protections for medical devices and systems

“The growing trend toward the networking and connectivity of medical devices is associated with a corresponding increase in the vulnerability of these devices to malware and malicious attacks,” states the report. 

It recommends that clinical engineering, IT, and risk management departments should collaborate on reviewing and, if necessary, updating cybersecurity management policies.

Medical device cybersecurity risks should be proactively assessed, and it is important to keep up with the latest updates and patches for operating systems and anti-malware software. Access to medical devices should be limited by a firewall and log-in access to all medical devices should be audited.

The report also recommends setting up a process for monitoring and reporting cybersecurity threats and events. The need for a cybersecurity risk assessment, reliable cybersecurity safeguards and a mitigation plan in the event of network infiltration and malware infection is also highlighted.


10. Overwhelmed recall and safety alert management programs

The report emphasises that alerts alone cannot protect patients from harm: healthcare facilities must respond appropriately to these alerts to avoid preventable injury. It recommends a review of processes for identifying product safety alerts and recalls, managing their distribution to relevant staff, and documenting corrective actions taken.

The attitude of those at the top of the organization and the designation of alerts management as a critical patient safety activity, are also vital to the success of any program. Also important is a closed-loop process that, in addition to the distribution of alerts, includes confirmation that an alert has been received by a responsible party and documentation of the remediation efforts.

To obtain a copy of the full report, which includes more detailed recommendations, visit:


Risk Management, IT and Data Security, ECRI Institute, 2015 Top 10 Health Technology Hazards, James Keller Jr