ECRI Blog

In the modern healthcare environment, healthcare workers often experience job-related fatigue, which can have a negative effect on patient and staff safety and well-being. In addition, worker fatigue is associated with lost workdays, an increase in occupational injuries (e.g., needlesticks), liability issues, and increased turnover. 

Healthcare organizations must address the effects of fatigue on healthcare workers and, whenever possible, reduce duty hours to allow workers more recovery time. However, even the best schedules and optimal staffing cannot eliminate the circadian disruption associated with night work and long hours. Healthcare organizations should implement fatigue management strategies as part of their system-wide efforts to increase patient safety and reduce medical errors. A good fatigue management plan should address the following: 

• Education and training on the effects of fatigue 
• Strategies to increase alertness and mitigate fatigue 
• Opportunities to identify and treat any medical conditions that may affect alertness or fatigue, such as sleep disorders 
• Scheduling policies 
• Adverse event, medical error, and occupational injury investigations 

Healthcare organizations may also wish to consider developing a fatigue risk management system—data-driven sets of management practices for identifying and managing fatigue-related safety risks—as a subset of their overall safety management system. ​ 

Additional resources that may be helpful include the following: 

A member recently asked about liabilities associated with the utilization of data from nonprescription consumer wearable devices that track various health statuses (e.g., heart rate, blood pressure, activity levels, glucose levels). In our response we discuss the potential risks of utilizing such data and provide information and resources to consider.

The wearable medical device market is rapidly expanding—Deloitte Global predicts that nearly 440 million consumer health and wellness wearable devices will ship worldwide by 2024, and around one-third of individuals own one. However, laws and regulations regarding their use remain unclear. While some physicians support their use as a way to encourage patients to track lifestyle habits that contribute to overall healthcare, others are concerned about associated risks. Many nonprescription commercial wearable devices available to the public are not approved or regulated by the U.S. Food and Drug Administration (FDA), and all have varying degrees of accuracy, usability, privacy protections, and interoperability with existing healthcare technology (e.g., electronic health records, remote patient monitoring systems prescribed by providers). Research on the predictive quality of wearables for health outcomes is also lacking. A 2018 JAMIA literature review found only eight studies of at least moderate quality that supported a significant association between data from wearables and the tracked outcome.

Each year, ECRI publishes a list of top patient safety concerns to call attention to safety risks that need to be addressed to keep patients and staff safe. Concerns on this year’s list are heavily influenced by the top concern on our 2022 list – staffing shortages. Staffing shortages continue to plague healthcare and are contributing to challenges related to the pediatric mental health crisis, violence against healthcare staff, mismatches between assignments and competencies, and missed care treatment.

The number-one concern on this year’s list recognized that children and youth are facing a mental health crisis that has been growing for years. Rates of anxiety and depression in those 17 and younger increased by nearly 30% in 2020 compared with 2016 (American Academy of Pediatrics). The number of emergency department visits for adolescent suicide attempts increased by 39% in winter of 2021 compared with winter 2019, per the Centers for Disease Control and Prevention. 
The topics are selected based on a wide scope of data, including scientific literature, patient safety events or concerns reported to or investigated by ECRI, client research requests and queries, and other internal and external data sources. The top 10 patient safety concerns for 2023 are:

1. The pediatric mental health crisis
2. Physical and verbal violence against healthcare staff
3. Clinician needs in times of uncertainty surrounding maternal-fetal medicine
4. Impact on clinicians expected to work outside their scope of practice and competencies
5. Delayed identification and treatment of sepsis
6. Consequences of poor care coordination for patients with complex medical conditions
7. Risks of not looking beyond the “five rights” to achieve medication safety
8. Medication errors resulting from inaccurate patient medication lists
9. Accidental administration of neuromuscular blocking agents
10. Preventable harm due to omitted care or treatment
    

In today's healthcare environment, payers are under increasing pressure to make new and updated medical policy determinations as quickly and cost-effectively as possible.

Health technology assessments (HTAs) can provide a synthesis of the relevant evidence-based clinical literature to enable payers to make informed decisions about whether or not to cover a new medical technology. In this article, we'll explore the importance of HTAs for payers in developing strong, defensible coverage decisions.

What is a health technology assessment?

A HTA is a systematic evaluation of a technology's efficacy, safety, and cost-effectiveness. There are various HTA methods, but all HTAs share a common goal: to provide a fair and objective evaluation of a technology's benefits and risks based on the published clinical literature. This information can be used to help policymakers, clinicians, and healthcare leadersmake informed decisions about whether or not to adopt a new technology. 

We noted with great interest the study by Loeb et al., published in the December 2022 issue of Annals of Internal Medicine, as well as a helpful commentary and various reactions to the findings. In this commentary, we discuss the notion of a “non-inferiority” trial and address several concerns.

What are non-inferiority trials?

When an effective treatment is expensive or inconvenient, we might consider a reasonable alternative that is cheaper and/or more convenient. How much reduction in effectiveness is acceptable? Research studies can be designed as “non-inferiority” trials that, critically, set a numerical threshold for how much reduced effectiveness one is willing to tolerate in exchange for the known benefits of reduced cost and/or convenience. If the study can rule out the possibility of an effectiveness reduction as large as the numerical threshold, then the cheaper treatment can be deemed “non-inferior.” Ideally, the threshold is not based on one research team’s opinion, but rather on empirical data from those who would experience both the reduced benefits and better cost/harm profile. Even if data-based, the answer is a middle-of-the-road judgment with no objectively correct answer, as different people would set higher or lower thresholds.

This is part two of a two-part blog.

A nurse's aide, when transferring a mother in labor to the delivery room, turned off the infusion pump delivering Pitocin, a drug administered intravenously to accelerate contractions. The aide removed the infusion set from the pump without first closing the manual clamp on the line. A free-flow infusion occurred, and the mother received nearly 35 times the prescribed amount of drug. The infant suffered organ damage and pneumonia and died four days later.

This incident happened in 1991.

A decade earlier, ECRI had warned about the dangers of IV free flow in a 1982 evaluation of infusion controllers. Free-flow, or unrestricted gravity flow, refers to the uncontrolled delivery of an infusion to a patient when a controlled or metered delivery was intended. Depending on the drug being administered, IV free flow can lead to death or serious patient harm. That's why the test criteria for our 1982 evaluation specified that infusion devices should provide safeguards to prevent uncontrolled flow.

Fast-forward to the decade after that incident. By the early 2000s, many infusion pumps included an effective free-flow protection mechanism to guard against this hazard. Today, such mechanisms are a standard safety feature.

But how many patients suffered harm in the meantime?

It's with that question in mind that we issued a challenge to industry within the pages of our Hazards report. The report identifies 10 health technology hazards that ECRI's experts believe warrant priority attention. In ECRI's view, several of the hazards listed could be mitigated—and possibly eliminated—by improved device designs or manufacturing quality processes. We encourage industry to rise to that challenge.

This is part one of a two-part blog.

Reducing preventable harm is at the core of ECRI’s mission, and has been for more than 50 years. Since the publication of the first issue of the Health Devices journal in 1971, ECRI has served as an information clearinghouse for hazards and deficiencies in medical devices. We collect and analyze reports of device-related problems, identify root causes, and develop practical recommendations to prevent future occurrences and prevent harm.

ECRI’s annual Top 10 Health Technology Hazards report is one tool we develop to help members of the healthcare community participate in that mission. The report informs frontline healthcare workers, administrators, clinical engineers, IT professionals, medical device manufacturers, patients, regulatory bodies, and others about device-related hazards, and it empowers them to address those issues to make healthcare safer.

Influenza (flu) is a contagious respiratory illness caused by various viruses. It can cause mild to severe illness, and at times can even lead to death. Flu season started earlier than usual this season, and it has been joined by RSV and ongoing COVID-19 to form the “tridemic.” 

We know that getting the flu vaccine is the best defense against getting the flu; and even if a vaccinated person does contract the flu, the vaccine can significantly reduce symptoms. However not every eligible person is getting vaccinated, especially in communities of color.

The Centers for Disease Control and Prevention (CDC) has reported that inequities in access to the flu vaccine and misinformation about the vaccine can contribute to lower vaccination rates in minority communities.

With a vaccination rate of only 43% during the 2021–2022 flu season, Black, Hispanic, and American Indian/Alaska Native adults were more likely to get the flu and more likely to be hospitalized due to the flu. In fact, when the CDC examined hospitalizations caused by the flu, hospitalization rates were 80 percent higher among Black adults than white adults.

As always, influenza (flu) is in the news this time of year, along with recommendations that all eligible individuals get vaccinated against it. As many as 50% of eligible people typically skip a flu shot, and this year the temptation to skip may be stronger than usual.

After facing COVID-19, some people may be quick to dismiss the relatively much smaller risk posed by the flu, and persisting disinformation around COVID-19 vaccines casts a shadow on other vaccines. Several factors, however, suggest that this year's flu season comes with new risks and the potential for a new public health crisis. 

The tridemic is here—are you ready? By taking steps to understand the tridemic, and the effects it’s having on healthcare, your organization can better prepare for and manage the likely increase in utilization of emergency departments, pediatric practices, and inpatient hospital stays. 

What is the tridemic?

The tridemic is the unofficial name that has been given to the rise in cases of three different illnesses—influenza (the flu), COVID-19, and respiratory syncytial virus (RSV). Flu and RSV cases comprise the majority of circulating illnesses, as COVID numbers have been stable recently.

Alone, each of these illnesses can tax an already strained healthcare system. Together, they have the potential to cripple healthcare infrastructure due to worsening illness severity and sheer number of cases. 

Rising numbers in cases have been reported in Canada and in half of the United States. As the holidays and colder weather quickly approach, and with them a likely increase in indoor celebrations, experts fear that tridemic numbers will continue to rise.