The vision the patient has of the healthcare environment is one of recovery and healing. Whether in the clinical setting, or at home under supervision, the assumption is that entering a place that is replete with clinicians, medical devices, monitors and medicine is a safe space – a place for healing.
It would never occur to that patient that the same environment might include dangers like possible injury or a serious new infection. The existence of these dangers needs to be made aware to clinicians, patients, device manufacturers, policymakers and researchers.
To help assuage risks that have crept into the clinical and home health settings, ECRI has spearheaded the cause of creating a safer healthcare environment. The organization has been involved in this pursuit for more than 50 years.
Every year, ECRI evaluates and publishes this important information. As the organization’s website states: “Our Top 10 Health Technology Hazards report is a key resource for several reasons. First and foremost, it consolidates critical information about the most pressing technological risks that could jeopardize patient safety. With the integration of advanced technologies – ranging from artificial intelligence and telemedicine to sophisticated medical devices – the potential for hazards has grown significantly.”
The hazards identified for 2025 include AI-enabled health technologies, unmet technology support needs for home care patients, vulnerable technology vendors and cybersecurity threats, substandard or fraudulent medical devices and supplies and fire risk in areas where supplemental oxygen is in use.
The remaining hazards include dangerously low default alarm limits on anesthesia units, mishandled temporary holds on medication orders, infection risks and tripping hazards from poorly managed infusion lines, skin injuries from medical adhesion products and incomplete investigations of infusion system incidents.
The emergence of AI, and its increasing use in healthcare, has introduced new concerns and highlighted several shortcomings in the technology in other utilizations.
The increasing role of home health care has also introduced new concerns.
In response to the hazards identified by ECRI, the best thing that healthcare systems, hospitals and other providers can do is to take the information, formulate action steps and remedy those hazards.
How does ECRI evaluate and what does it consider for its annual hazards list?
“Our annual Health Technology Hazards report is intended to be a tool that others can use to join in ECRI’s effort to reduce preventable harm in all healthcare settings across the globe. Since the focus is on preventing future harm, we developed a topic-selection process that is predictive, not retrospective,” explains Rob Schluth, principal project engineer I, device safety with ECRI.
Schluth says that topic selection is not simply a math exercise, where they tally the number of reports of incidents that occurred in the past.
“Rather, ECRI’s experts examine safety signals from a range of sources, then use their technological and clinical judgment to identify the technology risks that need attention now to prevent future incidents,” he says.
Schluth says that, to be sure, incident reports play a major role.
“Staff 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 and the Institute for Safe Medication Practices PSO; and they review reports in FDA’s MAUDE database and from other sources,” he says.
But incident reports are only one component. ECRI’s team identifies potential topics based on the insights they gain through the unique combination of activities they perform every day, like investigating incidents, testing medical devices on-site or in ECRI’s lab, observing and assessing hospital workflows and practices, assessing clinical evidence in the literature, reviewing hospital inventories, and speaking with clinicians, clinical engineers, technology managers, purchasing staff, health systems administrators, regulators, device manufacturers and distributors.
Suggested topics are then judged according to criteria that includes “severity, frequency, breadth, insidiousness and public profile.”
“Any one of these factors could warrant including a topic in the report. For example, a hazard that is unlikely to cause severe harm, but that happens frequently – impacting many patients and stressing facility resources – may warrant a spot on the list,” Schluth says.
In addition to the hazards discussed below, ECRI has identified fires associated with the delivery of supplemental oxygen as a hazard requiring more scrutiny. The organization has found that more attention is needed when oxygen is used outside the OR. This includes the home setting. They suggest healthcare facilities educate staff about the “fire triangle.”
The organization suggests to biomeds that “Where possible, annually verify that air-oxygen blenders are accurately delivering the set oxygen concentration.”
ECRI has also identified incidents where “inappropriate default alarm limits caused dangerous conditions to go undetected.” To HTM, the recommendation is: “Ensure that all anesthesia unit default alarm limits are set according to hospital and anesthesia department policy.”
Another hazard identified is mishandled temporary holds on medication orders. “Failure to hold a medication when indicated, or neglecting to either restart or discontinue a held medication as circumstances require, can lead to patient harm.”
When a patient receives an adhesive wound cover or tape to affix an IV line, they assume that there will be no harm resulting from that adhesive product. ECRI has found that some can result in “medical-adhesive-related skin injuries.” The organization provides advice to clinical staff on this issue.
Also, when an infusion system incident occurs, ECRI has found that “Organizations that lack the expertise or resources to conduct a thorough investigation of such incidents will be poorly positioned to prevent future, potentially fatal infusion-related medication errors or other incidents.”
The organization offers its Incident Management and Investigation (IMI) Plan as a resource for recommendations.
Slow Roll AI
AI can be a revolutionary technology in healthcare, yet it still retains some flaws that limit unreserved use. It still depends on the quality of the data it is fed along with an absence of personal biases. Much like the term “garbage in, garbage out” which originated at IBM during the 1960s, AI depends on good input. There are also times AI strays from accurate information and can be prone to “hallucinations.”
“’Garbage in garbage out’ still stands today. Although, in AI it is more about ‘did I use a good training/validation data set?’ AI has spread to different areas of healthcare. Currently there are more than 1,000 AI applications cleared by the FDA. While a lot of those applications are speeding up processes or running in the background – like with image reconstruction AI-based algorithms – some of those are detecting and labeling abnormalities and assisting healthcare professionals in diagnosing patients. Human intervention should always be required in the diagnostic process, with AI used just as an assisting application wherein a clinician provides the final diagnosis,” says Francisco Rodríguez-Campos, MSc., Ph.D., MRSO (MRSC), principal project officer I: medical imaging, device safety at ECRI.
He says that any application of AI in health care should be monitored.
“While AI is promising that it ‘works’ on its own, we do need to monitor its performance over time and look for hallucinations in its predictions. AI is also being used in non-clinical areas of hospitals administrative processes – like in patient scheduling, prescription refilling, and appointment reminder bots – and even in health technology management departments (to create maintenance procedures, and verification checklists, for example). Those applications do not follow an FDA clearance process. Nevertheless, they can end up impacting patient care. Such applications also need to be monitored and included in the healthcare institution’s inventory of AI applications,” Rodríguez-Campos says.
Healthcare in the Home Setting
Trends are seen throughout U.S. culture and healthcare is no exception. Technology, along with an aging population, has increased the utilization of home healthcare. Removing healthcare from the more controlled clinical setting comes with challenges.
“The delivery of healthcare outside of traditional settings can present technology management challenges. One key step for monitoring devices in the home environment is to maintain up-to-date databases of device allocations, including recipients’ contact information. This will also help with communicating any recall and alert notices for the at-home devices,” says Priyanka Shah, MS, principal project engineer I, device safety, ECRI.
She says that devices such as ventilators, dialysis machines and infusion pumps traditionally have been used in acute care settings under clinical supervision but increasingly are being used in the home.
“For the 2025 edition of our report, we focused on the inappropriate setup and management of such devices when used in that environment, since inattention to these steps can lead to patient harm,” Shah says.
“For example, venous needle dislodgments during dialysis can result from tripping, snagging, or pulling on bloodlines, posing higher risks in home settings. Similarly, ventilator alarms may fail to sound or go unheard due to ambient noise, improper device configuration, or lack of end-user training, leading to harm or fatalities. Harm or hospitalization can also occur from improper programming of the infusion pumps or by forgetting to remove the cap from the infusion line,” Shah adds.
She says that proper device use and operation is supported by minimizing setup burden, providing users with clear instructions for setup, use, and troubleshooting, and sharing contact details for clinical and vendor support.
“Evaluating device usability before deployment and offering concise education and training to patients and caregivers further support safety and reduce the potential for risks,” Shah says.
Vulnerabilities Through Third-Party Vendors
While health care systems take measures to employ cybersecurity measures to protect patient data and access to medical equipment, many rely on external third-party providers to take similar measures, without knowing for certain. As ECRI points out, “Essential tools ranging from scheduling and billing services to electronic health records and other clinical systems are frequently provided by third-party vendors.”
“Healthcare organizations should follow NIST and HIPAA guidance and best practices recommendations. This would include ensuring there are adequate resources and enforced policy requirements to review third-party vendor security prior to contracting, as well as throughout the contract period. Organizations should employ top-down enforcement that advocates for vetting vendor security from a technical and legal perspective in line with their data classification policy as well as their security risk acceptance levels that uphold the regulatory requirements associated with the services enlisted,” ECRI Vice President, Information Security Officer Kallie Smith says.
She says that additionally, testing and assurance of said security mechanisms should be collected and analyzed and avenues for risk acceptance and checkpoints should be put in place that protect the organization and those whose data may be involved in any risk decisions.
Substandard Supplies Entering the System
Just as patents expect safe medical devices and a sterile environment, they also expect that the supplies that they count on during treatment to be of the highest quality. Unfortunately, finding substandard and even counterfeit medical supplies in the care setting is not a new problem.
“For medical devices and supplies, difficulty regulating foreign manufacturing and controlling the quality of products that comprise components or services sourced from multiple entities are large factors. Widely accessible online marketplaces that don’t perform due diligence on the products being sold also create an easy avenue for entry,” says Karen Haberland, senior project officer of device evaluations, ECRI.
She says that a lack of post-market surveillance or end user reporting makes this issue hard to pin down.
“Many clinicians don’t know how or are unwilling to take the time to report device failures, especially when the incident appears relatively minor, so there is little documentation of how widespread the problem is,” Haberland says.
Infusion Line Concerns
Another hazard identified by ECRI and included on the 2025 hazards list is the problem of poorly managed infusion lines that can become a tripping hazard and/or risk infection.
“Maintaining patient infusion lines off floors requires a total systems safety approach with people, securement products, workflows, and facility culture supporting the goal of zero infusion lines on floors. Healthcare facility leadership can provide point-of-care inventory of facility-evaluated infusion line/cord holders, train relevant clinicians how to use these products, and explain why infusion line/cord holders are needed to enhance safety,” says Amanda Sivek, Ph.D., a-IPC, principal project engineer II, device safety, ECRI.
She says that a potential workflow modification for nurse managers and infusion/vascular access specialists is to check patient infusion lines at least once per shift (e.g., during rounds) to ensure that the lines are not on the floor.
HTM’s Important Role
HTM professionals are in a unique role in addressing, mitigating and preventing hazards in the clinical setting and, increasingly, in the home healthcare environment.
“The future of healthcare depends on HTM professionals stepping beyond their traditional roles to become strategic partners in safety. HTM professionals are uniquely positioned in healthcare to contribute to and, at times, lead multidisciplinary teams and partnerships to reduce risks to patients, staff, and others. I think of HTM as the connective tissue between clinical partners and medical technology – the ones who should truly understand both the technical capabilities and the clinical implications of healthcare technology,” says Dustin Telford, consultant, healthcare incident investigation and technology consulting, ECRI.
He says that HTM professionals should contribute actively to healthcare by not only tackling the hazards in ECRI’s Top 10 report but also going beyond and being visionaries who anticipate future challenges, analysts who understand complex systems, and doers who implement practical solutions. Whether their title is biomedical technician, clinical engineer, service engineer, security specialist, or simply “machine doctor,” HTM professionals should be involved in preventing harm before it happens.
Telford suggests that HTM professionals can directly address the hazards listed on the 2025 list by following these steps: By leading technology governance initiatives that ensure safety across the entire life cycle of healthcare technology; fostering partnerships between clinical, technical, and administrative teams to create comprehensive safety solutions; driving systematic approaches to risk identification and mitigation before incidents occur; and building bridges between hospital-based and home-based care technology support.
In addition, he suggests championing safety culture through education, collaboration and proactive risk management, developing standardized processes that balance clinical needs with technical capabilities, guiding technology assessment and implementation to optimize both safety and effectiveness and creating sustainable frameworks for continuous safety improvement.
Telford also suggests that HTM professionals should be engaging stakeholders at all levels to support technology safety initiatives and they should be sharing insights and experiences across the healthcare technology community.
