HRMR January 2015


TECH HAZARDS 17


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


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


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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. n To


obtain includes a copy of the more detailed full report, which recommendations, visit https://www.ecri.org/Pages/2015-Hazards.aspx


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