ECRI Blog

Sepsis is the body's overwhelming response to infection and can lead to tissue damage, organ failure, and death. According to the Centers for Disease Control and Prevention, anyone can get an infection, and any infection can lead to sepsis, including bacterial infections such as Staphylococcus aureus and Escherichia coli, as well as viral infections such as COVID-19 or influenza. 

According to the Sepsis Alliance, more than 1.7 million adult Americans develop sepsis each year, and approximately 30% of those diagnosed with severe sepsis do not survive. Among survivors, up to half develop postsepsis syndrome, leading to a shortened life expectancy, impaired cognitive function, and diminished quality of life. Yet it is estimated that 35% of adult Americans have never heard of sepsis. 

Recall management remains challenging for healthcare providers, as the number of hazard alerts involving medical devices, pharmaceuticals, and other products continues to increase. From cybersecurity vulnerabilities involving complex medical technologies, to sterility issues with various consumables, to shortages across the industry, managing product recalls and corrections becomes more complex every year. 

An analysis of 2022 data from the ECRI Alerts Workflow system, which facilitates efficient recall and technology risk management for medical equipment, supplies, and pharmaceuticals, highlights the scale of the challenge that providers are facing:

The mental health of children is currently in crisis. According to an investigation reported in 2021 in JAMA Pediatrics, one in four children globally is experiencing elevated depressive symptoms and one in five is experiencing elevated anxiety. In the United States in 2020, anxiety diagnoses for children aged 3 to 17 years increased 29% and depression diagnoses increased 27% compared with 2016, according to a 2022 investigation in JAMA Pediatrics. This equates to 5.6 million children with anxiety and 2.7 million with depression—numbers that are far too high.

Pediatric mental health was already a concern during the 2010s, but the COVID-19 pandemic exacerbated an expanding crisis as children who were experiencing the mounting pressures of social media, increasing gun violence, and other stressors now had to cope with social isolation, disruption to education and other daily activities, and fear and uncertainty surrounding the novel virus. 

ECRI highlighted the pediatric mental health crisis as its number one item in its Top 10 Patient Safety Concerns for 2023.  

Caring for this population’s mental health needs to begin long before these children present to emergency rooms for psychiatric treatment or suicide attempts. While some solutions to the current crisis may fall outside the pediatric primary care office, steps can be taken to protect our youngest and most vulnerable population. 

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
    

Changes in the supply chain, or supply chain disruptions, can happen at any time, but the COVID-19 pandemic set off a domino-effect series of shortages and delays that impacted financial, reputation, and clinical outcomes.

ECRI included supply chain disruptions in its annual list of Top Patient Safety Concerns in 2021, and again in 2022. And while 2023 may bring some improvements, challenges remain.

Healthcare leaders will continue to grapple with supply chain challenges that effect patient safety, healthcare quality, financial standing, and emergency preparedness. In fact, supply chain problems may be compounded by additional medical issues such as RSV and a rampant flu, as well as geopolitical and economic factors, such as war, inflation, spend limits, and staff shortages.

Together these factors slow the supply chain, delaying needed goods, services, and transportation. 

Recently, 3M™ issued an urgent, voluntary recall of select models and lots of 3M™ Steri-Drape™ Surgical Drapes distributed between October 29, 2021, and August 25, 2022.

How is the drape used?

The Steri-Drape is made from clear polyethylene plastic with a matte finish, which includes an adhesive strip. It is used as a surgical drape for patients during procedures. This drape is intended to absorb liquids with no strike-through to decrease the risk of microbial migration, and function as a barrier to skin.

The effected products include: 3M™ Steri-Drape™ Surgical Drapes, Catalog Numbers 1000, 1000NS, 1000NSD, 1010, 1010NS, 1010NSD, 1020, 1020NS, 1021, 1021NS, 1030, 1030NS, 1033, 1060, 1060NS, 1061, 1061NS, and 1071.

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.