By Alyx Arnett

A March 2025 report from the Department of Veterans Affairs Office of Inspector General (OIG) has found that staff at the Carl Vinson VA Medical Center in Dublin, Georgia, reprocessed and used surgical instruments with visible damage, despite policies prohibiting such practices. 

The report was prompted in part by a spring 2024 incident in which surgical tools with visible damage—including staining and pitting—were discovered in a rectal tray that had already been used during a patient procedure. While it remains unclear whether the nonconforming instruments were used on the patient, the entire tray had been reprocessed and returned to use, and staff failed to remove the visibly damaged tools prior to the procedure, according to the report. According to VA policy, if one item in a surgical tray is contaminated or nonconforming, the entire tray is considered compromised.

The event occurred after a prior inspection in 2022 had identified similar issues at the facility and after VA leaders had agreed to implement corrective actions.

During the latest inspection, OIG staff found additional nonconforming instruments in randomly selected surgical trays and determined that reprocessing and using visibly damaged tools was an ongoing practice at the facility. According to the report, both current and former Sterile Processing Services (SPS) chiefs allowed the practice, citing factors such as pressure to deliver complete trays, unclear responsibility for instrument replacement, and what one leader described as “staff complacency.”

Training Delays and Policy Noncompliance

As part of its review of the rectal tray incident, the OIG assessed how facility leaders responded after the damaged instruments were discovered in spring 2024. According to the report, the chief of SPS conducted refresher training for sterile processing staff and posted visual reminders in the work area. However, operating room staff did not initially receive similar training, despite internal documentation noting the need for “more rigid inspection” of surgical equipment.

When asked why this training was delayed, the operating room nurse manager cited limited staff time and expressed concern about leadership deprioritizing essential safety efforts, according to the report. The OIG described the lack of timely training as inconsistent with expectations and a missed opportunity to prevent continued use of damaged instruments.

Preventive Maintenance Program Missing Until 2024

Inspectors also found that the facility had failed to implement a preventive maintenance program for surgical instruments, despite a 2016 VA policy requiring one. The program, which involves routine sharpening, repair, and replacement, was only put in place in May 2024 after years of leadership turnover, according to the report.

During initial servicing under the new contract, more than 800 surgical instruments were identified as “beyond repair,” including four from the same rectal tray involved in the spring 2024 incident.

Incomplete Fixes from Prior Oversight

The March 2025 inspection also assessed the facility’s progress on recommendations issued in an earlier March 2024 OIG report. Key corrective actions remained incomplete:

• CensiTrac, an electronic instrument tracking system, had not been fully implemented. OIG found missing documentation, unmarked instruments, and discrepancies between instrument trays and count sheets.
• The CensiTrac coordinator, responsible for overseeing the system and instrument marking, had longstanding performance issues that were not formally addressed by supervisors.
• A room meant for training and meetings continued to be used for meals and breaks, raising contamination concerns. Despite verbal claims of repurposing, inspectors observed food and drink in the room during their visit.

The report cites high leadership turnover as a major contributor to the continued deficiencies. The SPS chief position changed hands four times from early 2022 to late 2023. At the time of inspection, all members of the executive leadership team were serving in acting roles, according to the report. Separately, the VISN chief sterile processing officer noted poor communication and unfilled critical positions within the SPS department.

Recommendations and Response

The OIG made five new recommendations:

1. Ensure proper identification and removal of nonconforming instruments.
2. Provide training for operating room staff on recognizing nonconforming tools.
3. Review whether any patients may have been affected by the approximately 800 nonconforming surgical instruments.
4. Evaluate whether administrative actions are warranted for staff involved in the deficiencies.
5. Strengthen oversight of corrective actions and ensure long-term compliance.

Leaders from both the Carl Vinson VA Medical Center and the VA Southeast Network—which oversees the facility—concurred with the recommendations and submitted action plans. The OIG stated it will continue monitoring until all corrective measures are complete.

In a statement to 24×7, a representative from the Carl Vinson VA Medical Center says the facility is working to address the issues outlined in the OIG reports: “VA is under new leadership and is committed to solving the kinds of problems highlighted in these two OIG reports, which resulted from inspections in 2022 and 2024. The Carl Vinson VA Medical Center and VA Southeast Regional Network are well on their way to addressing all the recommendations in the reports.”

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Related Read:

Summary: ECRI’s 2025 report names AI-enabled health technologies as the top healthcare hazard, citing risks like bias, false results, and safety concerns, while urging careful integration alongside other critical challenges such as home care support gaps, cybersecurity threats, and medical device safety.

Key Takeaways

• AI Risks in Healthcare: Artificial intelligence tops ECRI’s 2025 hazards list, with concerns about patient safety risks, bias, and false results that can disproportionately affect marginalized communities.
• Broader Technology Hazards: ECRI identifies additional risks, including unmet technology support for home care, cybersecurity vulnerabilities, and issues with medical devices and supplies.
• Call for Proactive Measures: ECRI emphasizes the need for healthcare stakeholders to critically evaluate AI integration and adopt strategies to mitigate risks outlined in its Top 10 Health Technology Hazards report.

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Artificial intelligence, now integral to healthcare, leads ECRI’s 2025 list of top health technology risks. While AI promises improved efficiency and outcomes, ECRI warns of significant patient safety risks if not carefully managed. Originally focused on medical imaging, AI now spans diagnostics, documentation, and scheduling. Even unregulated applications in ancillary systems can significantly impact patient care, ECRI emphasizes.

The Downside of AI

“The promise of artificial intelligence’s capabilities must not distract us from its risks or its ability to harm patients and providers,” says Marcus Schabacker, MD, PhD, president and CEO of ECRI. “Balancing innovation in AI with privacy and safety will be one of the most difficult, and most defining, endeavors of modern medicine.”

ECRI experts say AI systems can produce false or misleading results, or “hallucinations,” and the quality of their output can vary across different patient populations. AI models can perpetuate any bias built into them, posing significant risks for underrepresented and historically marginalized communities.

“AI is only as good as the data it is given and the guardrails that govern its use,” says Schabacker. “Healthcare stakeholders at all levels must think critically about the integration of AI, as they would with any new technology.”

The Top 10 Health Technology Hazards

Rounding out the list are technology hazards identified in home care and acute care settings, information security applications, and the medical device supply chain. ECRI’s Top 10 Health Technology Hazards for 2025, in rank order, are:

1. Risks with AI-enabled health technologies
2. Unmet technology support needs for home care patients
3. Vulnerable technology vendors and cybersecurity threats
4. Substandard or fraudulent medical devices and supplies
5. Fire risk from supplemental oxygen
6. Dangerously low default alarm limits on anesthesia units
7. Mishandled temporary holds on medication orders
8. Poorly managed infusion lines
9. Harmful medical adhesive products
10. Incomplete investigations of infusion system incidents

The full Top 10 Health Technology Hazards report, accessible to ECRI members, provides detailed steps that organizations and industry can proactively take to reduce risk and improve patient safety. An executive brief version is available for complimentary download at this link: Top 10 Health Technology Hazards for 2025 Executive Brief.

ECRI will host a live webcast about the top 10 hazards, open to the public, on December 5 at noon ET. A panel of medical device and healthcare safety experts will discuss the hazards’ consequences for patient safety, clinician efficiency, and operational effectiveness, plus strategies for mitigating these risks. Register for the webcast at this link: Top 10 Health Technology Hazards for 2025.

Key Takeaways:

• CMS Initiative: ECRI applauds CMS’s introduction of the Patient Safety Structural Measure, which aims to improve safety practices in healthcare by encouraging a systems-based approach.
• Call for Cultural Change: ECRI emphasizes the need for healthcare institutions to reassess safety protocols and commit to a culture of continuous learning and improvement, driven by the new CMS measure.

ECRI has expressed support for the Centers for Medicare and Medicaid Services (CMS) following the approval of a new Patient Safety Structural Measure as part of the hospital quality reporting program update.

Measure’s Impact on Healthcare Safety

The measure is part of an ongoing effort to prioritize patient and workforce safety across healthcare institutions. By introducing a standardized framework, the measure encourages hospitals to adopt a systems-based approach that could lead to substantial improvements in safety practices.

Preventable medical errors are responsible for an estimated 100,000 deaths annually in the United States, according to ECRI, highlighting a critical issue within the healthcare industry.

Statements from ECRI

In a statement from ECRI president and CEO Dr. Marcus Schabacker, he said that there has been growing concern that the industry has become alarmingly complacent regarding avoidable fatalities and adverse events that jeopardize patient safety. The root cause of most of these adverse events is often systemic failures, which are challenging to address effectively when safety hazards are tackled in isolated, reactive ways.

ECRI has advocated for a more comprehensive approach. This advocacy is embodied in ECRI’s Total Systems Safety (TSS) framework, which emphasizes redesigning system elements through clinically informed human factor engineering to improve patient and workforce safety on a programmatic level.

“This CMS structural measure could be a catalyst for healthcare institutions to revisit their approach to safety, assess where they stand, and commit to addressing long-standing issues with a heightened level of transparency and urgency,” said Schabacker.

A Call for Action

Schabacker added that the introduction of this structural measure by CMS provides a crucial opportunity for healthcare institutions to reevaluate their safety protocols, confront enduring challenges, and commit to a culture of continuous learning and improvement. This initiative brings safety to the forefront, calling for systemic and cultural changes that foster resilience within healthcare systems.

He commended CMS for taking this bold step and said it stands in solidarity with health systems striving to achieve zero preventable harm in the delivery of patient care.

By Rick Schrenker 

I was recently reminded of my pre-retirement risk management work and how the writings of Henry Petroski and others influenced it. “Things work because they work in a particular configuration, at a particular scale, and in a particular context and culture.”

Design Changes Must Be Analyzed for New Failure Modes

Construction of the Francis Scott Key Bridge commenced the same year as my Baltimore high school commencement: 1972.  I had attended what would today be called a STEM school. In my sophomore year, our class was the first to take a “computer math” course. We did some FORTRAN programming using punch cards. Surely, reader, you remember using them.

“Any design change…can introduce new failure modes or bring into play latent failure modes. Thus, it follows that any design change, no matter how seemingly benign or beneficial, must be analyzed with the objectives of the original design in mind.”

While the design of the Key Bridge did not change over its almost 50 years of service, the type of container ship that caused the collapse of the bridge did not exist when the bridge was conceived. Time will tell how inadequate 20th-century standards-compliant safeguards in the Key Bridge were to deflect and absorb the impact of an out-of-control 21st-century ship.

But what does the Key Bridge disaster have to do with medical technology?

Old Rules Challenge Modern Medical Technology

Consider this: The law that continues to serve as the foundation for the regulation of medical devices in the United States, the Medical Device Amendments to the Food Drug and Cosmetics Act of 1938, dates to 1976..

The age of the Medical Device Amendments is relevant is because devices granted 510k clearance since 1976 must be substantially equivalent to an approved predicate device.The initial set of predicate devices, known as preamendment devices, were commercially available before 1976.

(In my snarkier moments, I’ve been known to argue that if applied to NASA, this would support a claim that a Space Shuttle is substantially equivalent to a Wright Flyer.)

Now consider this observation from a 2006 article in IEEE Computer concerning issues that arose with the simultaneous presence of multiple generations of IT in a healthcare environment.

“… We observe that many clinical systems currently in use were created prior to the recent, dramatic changes in healthcare delivery. Integrated health networks with more complex workflows and a greater need for seamless movement of patient data on demand, anywhere within the network, have for the most part replaced free-standing hospitals, clinics, and group practices. Retrofitting yesterday’s systems to meet today’s needs can only result in a “solution” that falls short … Software engineers have long known that extensive retrofitting causes software to age very rapidly. Considering what we do know about building complex software systems and in the light of these dramatic changes in the industry, it is unfortunate that the prevailing sentiment among healthcare professionals seems to be that legacy information systems, their developers, and their vendors are failing to meet the needs of physicians and hospitals.”

But that was years ago too, right? These kinds of simultaneous old and new mixes of technology no longer occur, right?

Boeing 737 MAX Crashes Linked to Design Changes

Consider the more recent (and mind-bogglingly ongoing) series of consequential failures around Boeing’s 737 MAX. Technically, the 2018 and 2019 fatal crashes tie back to a series of design changes aimed at increasing the efficiency and range of the 737 MAX so Boeing’s products could better compete with those of Airbus. But there is more to the story. For me, the most telling aspect of how Boeing’s corporate culture sacrificed attention to safety was that it successfully lobbied to weaken FAA oversight of design processes, allowing Boeing to self-regulate.

And yet here we are in 2024, reading about yet more Boeing failures.

“It wasn’t that long ago that Boeing’s reputation was that of a staid industrial giant, known for building the safest, most advanced planes in the sky. It helped introduce the world to commercial jet travel.

Pilots and others in the industry, as well as members of the flying public, summed up their confidence in the company with the expression, “If it’s not Boeing, I’m not going.” The company still sells coffee cups and tee shirts with that slogan.”

“Boeing was once known for safety and engineering. But critics say an emphasis on profits changed that.”

But the point is that this is nothing new.

“Petroski returns time and again to that theme, describing it as ‘… the myopia that can occur in the wake of prolonged and remarkable success…’  Intellectually we know that a safe past does not guarantee a safe future, but Petroski drives the point home by describing how success-fueled hubris took the National Aeronautics and Space Administration (NASA) from the glory years of the Apollo program to and through the failures of Mars satellites and two space shuttle disasters. And it is worth remembering that many of the space program failures were not associated so much with design as with program management.”

Healthcare Delivery Faces High Consequential Risks

Consequential failures of technology happen. Consequential accidents happen. Consequential management decisions happen. And they happen in every safety-critical line of business. The delivery of healthcare is not immune. 

And while failures that occur during the delivery of healthcare rarely, if ever, result in shutting down a harbor that employs thousands or plane crashes that kill hundreds, in total they can be far more consequential. Keep in mind that it was just over 30 years ago that the National Institute of Medicine estimated that somewhere between 44,000 and 98,000 U.S. citizens died annually because of failures in the delivery of care.

Yes, changes have been instituted that have improved safety, some as simple as verifying a patient’s birthdate before starting any caregiving activity. On the other hand, the symbiotic working relationships among healthcare workers in general, and nursing and CE/HTM in particular, are bound to be increasingly stressed by staffing shortages. Certainly, the workload has not lessened, leading to increasing production pressure on everyone involved. And this can increase the likelihood of scenarios that place patients at increased risk.

HTM Faces Increasing Challenges

The CE/HTM world has always had a lot of priorities to juggle, but from my now admittedly at-a-distance perspective it has never been more challenging. Still, we should remember that the profession originated to address patient safety issues associated with technology. There is a lot of technology safety history from which to learn, some very recent. The Key Bridge and Boeing stories are ongoing, and CE/HTM can learn from them, especially since many technology failures are often attributable to management failures.

The warning from Santayana is no less important now than it has ever been: “Those who cannot remember the past are condemned to repeat it.”

Rick Schrenker is a former systems engineering manager for Massachusetts General Hospital. Questions and comments can be directed to 24×7 Magazine chief editor Keri Forsythe-Stephens at editor@24x7mag.com.

References:

1. Petroski, H. Success through Failure—The Paradox of Design Princeton University Press. 2006; 167.
2. Petroski, H. Design Paradigms—Case Histories of Error and Judgment in Engineering Cambridge University Press. 1994. 57.
3. LaPlante P. et al, Healthcare Professionals’ Perceptions of Medical Software and What to Do About It, pp 28 – 29, IEEE Computer, April 2006.
4. Robison P, “Flying Blind – The 737 Tragedy and the Fall of Boeing”, p 117, Anchor Books, 2022.
5. https://www.cnn.com/2024/01/30/business/boeing-history-of-problems/index.html . Last accessed April 11, 2024.
6. Schrenker, R, Learning from Failure: The Teachings of Petroski, Biomedical Instrumentation and Technology, 2007, https://array.aami.org/doi/full/10.2345/0899-8205%282007%2941%5B395%3ALFFTTO%5D2.0.CO%3B2, Last accessed April 11, 2024.
7. Phillips J, et al, Nursing and Patient Safety, PSNet, April 2021, Last accessed April 11, 2024.
8. Holt C, Confronting the BMET Staffing Shortage, 24×7, August 17, 2018. https://24x7mag.com/professional-development/department-management/succession-planning/confronting-bmet-staffing-shortage/, Last accessed April 11, 2024.

Studies show the pandemic disrupted the traditional hands-on, in-person educational experiences of new clinicians, an issue compounded by healthcare workforce shortages. According to ECRI, without sufficient preparation, support, and training throughout the transition into practice, new clinicians may be especially prone to loss of confidence, burnout, and reduced mindfulness around a culture of safety. The convergence of these factors can result in failures to address preventable harm or incidents that cause adverse events for patients, according to ECRI researchers.

Difficulties accessing maternal and perinatal care also made the list, along with the decline of healthcare workers’ wellbeing, and unintended outcomes of adopting new technologies. The Top 10 Patient Safety Concerns report serves as a guide for helping providers and systems reduce risks and improve outcomes for their patients and workforce. ECRI researchers compiled the report by drawing on evidence-based research, data, and expert insights.

“Through no fault of their own, clinicians who started practicing medicine in the last several years didn’t have the same early experience as those who came before them – before the pandemic laid bare critical weaknesses in our healthcare system,” said Marcus Schabacker, MD, PhD, president and CEO of ECRI. “ECRI’s top patient safety concern is a call to action to set new clinicians up for success through a Total Systems Safety approach and assess and redesign the environments in which clinicians are trained, onboarded, mentored, and supported.”

The top 10 patient safety concerns for 2024 are:

1. Transitioning new clinicians from education to practice
2. Workarounds with barcode medication administration systems
3. Access to maternal and perinatal care
4. Unintended consequences of technology adoption
5. Physical and emotional well-being of healthcare workers
6. Complexity of preventing diagnostic error
7. Equitable care for people with physical and intellectual disabilities
8. Drug, supply, and equipment shortages
9. Misuse of parenteral syringes to administer oral liquid medications
10. Preventing patient falls

ECRI’s experts identify several recommendations for these concerns, especially to better prepare new clinicians for practice, including collaborative partnerships among academic and healthcare institutions, robust transition-to-practice programs with intense preceptorships, and simulation-based education to supplement live hands-on learning.

“Hospitals and health systems that are ECRI members have reported to us they’re very concerned about the current state of how newly trained clinicians are transitioned into practice,” said Dheerendra Kommala, MD, chief medical officer at ECRI. “More research is needed to quantify how this issue impacts patient safety outcomes. In the meantime, early indicators warn us to act now. Investments in this new generation of healthcare professionals will establish a stronger, more resilient workforce for decades to come.”

AdventHealth received the award for launching a Patient Falls Bootcamp that reduced incidents of patients falling by 33% overall, with some hospital units improving as much as 40-50% over the previous year.

Each year in the United States, between 700,000 and 1,000,000 people fall in hospitals, according to the Agency for Healthcare Research and Quality. Many of these falls result in severe harm or even death.

The annual Safety Excellence Award recognizes outstanding patient safety initiatives led by PSOs that partner with ECRI, and members of ECRI and the ISMP PSO. The winning submission was selected based on a blinded panel review of four key criteria: impact, culture of safety, scale, and innovation.

“We applaud AdventHealth Zephyrhills and AdventHealth Dade City hospitals for successfully tackling a perennial issue in healthcare: fall prevention,” says Dheerendra Kommala, MD, chief medical officer, ECRI. “The bootcamp has proven to be a powerful intervention that not only enhanced patient safety, but also helped to foster a sustained culture of patient fall prevention. ECRI is proud to support AdventHealth’s ongoing commitment to excellence in safety and quality.”

The AdventHealth Patient Falls Bootcamp helped frontline hospital staff identify safety hazards, recognize the characteristics of a high-risk patient, and ensure fall risk strategies were in place. The bootcamp included education sessions on the use of gait belts, tips for conversations with patients, and guidance on implementing an early mobility program. AdventHealth credits ECRI’s guidance on high-risk patients, risk assessment questionnaires, and strategies to identify hazards as contributing factors to the program’s success.

“The bootcamp shook up the traditional approach to strategy sessions by incorporating high-energy activities that immersed participants in a new way of thinking,” says Peggy Maguire, the director of risk management for both AdventHealth Zephyrhills and AdventHealth Dade City. “The concept of a bootcamp incorporates intensive training designed to rapidly improve and significantly impact a metric. This award recognizes the cultural transformation that was ignited and sustained across both hospitals as a result.”

The AdventHealth PSO is one of several PSOs that partner with ECRI. The 2023 Safety Excellence Award ceremony was held virtually on November 1, 2023, as part of ECRI and the ISMP PSO’s Annual Meeting.

“Inaccuracies resulting from diverse skin tones in pulse oximeter readings and other medical devices create risks for patients and can delay access to needed treatments and possibly result in poor outcomes,” says ASDSA President Vince Bertucci, MD, FRCPC. “ASDSA members, who are all board certified dermatologists and experts in treating the skin, call on the FDA and other policymakers to address issues of medical device safety in patients of all skin types.”

Some of the new ASDSA patient safety recommendations include:

• Creating increased public and physician awareness of the limitations of medical devices, specifically pulse oximetry, of potential erroneous readings in patients with diverse skin tones.
• Providing patients with enhanced instructions for using medical devices where diverse skin tones could be impacted.
• Stating the accepted ranges of values that are normal, borderline, or overly concerning / emergent for medical devices, like pulse oximeters, for patients with all skin types.
• Calling for further research to develop all medical devices, specifically pulse oximetry devices, with all skin types included, and incorporating newer technologies to improve device performance.
• Requiring that the FDA set heightened minimum performance standards for pulse oximeters, to account for patients with diverse skin types.
• Asking that the FDA reclassify and directly regulate over-the-counter pulse oximetry devices, which are currently designated as not for medical use.

To read the full position statement, visit asds.net/Portals/0/PDF/asdsa-position-statement-medical-device-safety.pdf.

• Falls (42%)
• Delay in treatment (6%)
• Unintended retention of foreign object (6%)
• Wrong surgery (6%)
• Suicide (5%)

Failures in communications, teamwork, and consistently following polices were the leading causes for reported sentinel events. Most reported sentinel events occurred in a hospital (88%). Of all the sentinel events, 20% were associated with patient death, 44% with severe temporary harm, and 13% with unexpected additional care/extended stay.

“COVID-19 continued to present challenges to healthcare organizations throughout 2022, and we saw the number of sentinel events increase above pre-pandemic levels,” says Haytham Kaafarani, MD, MPH, FACS, chief patient safety officer and medical director, The Joint Commission. “For each sentinel event, a Joint Commission patient safety specialist worked with the impacted healthcare organization to identify underlying causes and improvement strategies. Our goal is to help prevent these types of adverse events from occurring again.”

The majority of sentinel events (90%) were voluntarily self-reported to The Joint Commission by an accredited or certified healthcare organization. The remaining sentinel events were reported either by patients or their families, or employees of a healthcare organization. 

Reporting of sentinel events to The Joint Commission is a voluntary process, and no conclusions should be drawn about the actual relative frequency of events or trends in events over time. 

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

The potential shutdown will occur without warnings or alarms to alert the user. Once the error occurs, the coiled cord needs to be replaced for the device to work again. The issue may occur in units distributed before July 24, 2017, and affects approximately 2,300 devices.

An unexpected pump shutdown and any interruption to therapy that occurs can lead to unstable blood flow (hemodynamic instability), organ damage and/or death, especially for people who are critically ill and most likely to receive therapy using these devices, according to the FDA.

IABP Device Use

Both IABPs are electromechanical systems used to inflate and deflate intra-aortic balloons. These systems provide temporary support to the left ventricle through counter pulsation. Once the balloon is positioned in the aorta, the pump is set to work in synchrony with the electrocardiogram or arterial pressure waveform to make the balloon inflate and deflate at the right time during the cardiac cycle.

Cardiosave Intra-Aortic Balloon Pumps are indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure in adults.

From June 2019 to August 2022, Datascope/Getinge has reported 44 complaints about damaged coiled cords resulting in unexpected shutdowns. There have been no reports of injuries or deaths related to this issue.

The FDA says it is evaluating published literature that reports elevated levels of formaldehyde, cyclohexanone, and other volatile chemicals (such as human-made chemicals used and produced in manufacturing) from neonatal incubators. Potential sources of these airborne chemicals include materials used to make neonatal incubators as well as natural and human-made sources external to the incubator.

Further reading: Kids on Ventilators at Risk of Eardrum Fluid Buildup

The FDA is working with incubator manufacturers to collect and evaluate data from their products to determine whether these airborne chemicals are released, and if so, the amount of exposure and the potential risks to health from such exposure, if any, for newborns and others (such as health care providers). Currently, the FDA is not aware of any reported adverse events related to the use of neonatal incubators and exposure to these airborne chemicals. 

At this time, the FDA has made several recommendations for healthcare providers and facilities, following its outreach, including: 

• Continue to use neonatal incubators. The FDA recognizes that incubators are critical for infants less than four weeks old who cannot maintain their body temperature.  
• Be aware that the FDA is working with manufacturers to understand the potential for exposure to airborne chemicals (formaldehyde, cyclohexanone, and other volatile chemicals) that may be released from neonatal incubators, potential health risks, and mitigation strategies, if needed.  
• While the FDA further evaluates this issue, as an interim precautionary measure, consider running new neonatal incubators prior to use with patients for a week in a well-ventilated space using clinically relevant conditions for temperature and humidity, as the release of these airborne chemicals may decline over time.