Leveraging Medical Device Data to Address Serious Reportable Events

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Away from the ICU, clinicians may not be able to detect the onset of a serious reportable event because the medical devices monitoring patients are typically only periodically reporting on them instead of constantly surveilling them. Recent advances in medical device integration and data analytics, however, enable clinicians to perform effective monitoring continually in lower acuity care settings. By John Zaleski, PhD, Philips Capsule.

It’s early afternoon in the surgical intensive care unit (SICU), and our census is full. We have several cardiac patients on the schedule today, and Mrs. P. is another who came back from surgery this morning after coronary artery bypass grafting (CABG) for an occluded coronary artery. Mrs. P. is of small build and 80-years-old. We’re monitoring Mrs. P. closely, and she meets the criteria for the rapid post-operative mechanical ventilation weaning protocol. Everything seems to be proceeding normally and, per protocol, mandatory support level is being reduced gradually. The time has come to attempt a spontaneous breathing trial, and Mrs. P. is placed in pressure support mode on the mechanical ventilator. Respiratory Therapy is very busy today managing multiple patients, and both nursing and intensivists are shuttling between patient rooms and the central monitoring stations, per usual.

Then it happens. Subtle at first, but Mrs. P.’s chest tube indicates an increased sign of bleeding, seemingly in concert with an ever-increasing heart rate—she is growing slightly tachycardic and with increased respirations (tachypneic). She may not be tolerating the last reduction very well. She begins to struggle a bit after 10 minutes, when an XTACHY alarm annunciates at the central station. Members of the team arrive in short order to find Mrs. P. breathing rapidly, using accessory muscles, and with chest tube bleeding exceeding 100 CCs/hour—above the limit to remain on the rapid weaning protocol. Showing clear signs of respiratory distress, Mrs. P. is quickly placed back on full ventilatory support, and an assessment proceeds to determine whether she has suffered any injury. A decision is made to monitor Mrs. P. very closely and to guard against any attempt at occlusions or unintentional extubation until her strength returns. Mrs. P. ends up spending an additional (unplanned) three days in SICU, and then is discharged to the step-down unit and, eventually, home to complete her recovery.

The events around Mrs. P’s deterioration and the fatigue associated with her inability to tolerate full spontaneous respiratory support are unfortunate incidents that occur occasionally in the intensive care unit. Co-morbidities and chronic ailments experienced particularly in the elderly can make them more prone to the onset of deterioration difficult to anticipate, save for the likely physiological consequences and interactions of conditions such as chronic obstructive pulmonary disorder (COPD), congestive heart failure (CHF), malignant neoplasms, stroke, coronary artery disease (CAD), and many other conditions.

The National Trial Lawyers, citing 2013 data published in the Journal of Patient Safety, estimated that in excess of 400,000 preventable deaths occur in US hospitals. As defined by the National Quality Forum, these serious reportable events (SREs) are harmful—largely preventable—incidents that happen to patients and staff caused by a variety of reasons ranging from unexpected patient deterioration, clinician errors, criminal acts, and equipment failure.

These devastating incidents also result in hospitals facing civil litigation from patients or families as well as penalties from The Centers for Medicare and Medicaid Services (CMS) under its Hospital-Acquired Condition Reduction Program. Hospitals with total HAC scores in the worst-performing quartile are subject to a 1% payment reduction. In the last fiscal year, 774 hospitals were subject to penalties in the program, Kaiser Health News reported.

Continuous technology-supported monitoring and smarter alerting can remove some of the burden from clinicians.

Some SREs are attributable to errors in patient monitoring. For example, events may be sudden, and response to the patient is delayed. Or the event can occur after slow decompensation that was tracked through bedside monitoring, but for whatever reason, was overlooked by clinicians.

Faced with chronic staffing shortages, clinician burnout and growing patient demand, the risk for such monitoring-related errors escalates. Many leaders, however, are discovering that continuous technology-supported monitoring and smarter alerting can remove some of the burden from clinicians and notify them sooner to prevent the onset of SREs while also improving their experience.

Such tools, many of which can also automate some of the distracting data entry and analysis, free up time for clinicians to apply their soft skills and to consider the needs of the patient, which also aids in SRE prevention and improved diagnosis.

Staffing Challenges Exacerbate Problems

Driven by COVID-19, economic concerns, retirements and other causes, the healthcare industry has lost more than 524,000 workers since February 2020, according to a September 2021 report from the US Bureau of Labor Statistics. The loss of staff has only exacerbated hospitals’ chronic shortages of nurses. In a letter to the US Department of Health and Human Services, the president of the American Nurses Association warned that the “crisis-level human resource shortage of nurses puts our ability to care for patients in jeopardy.”

Other than trying to cover more patients with less staff, the pandemic has also contributed to nurses’ burden in new ways through donning and doffing of personal protective equipment (PPE) to care for patients with the virus who also require specialized care even outside of intensive care units (ICU). This distracted focus can affect nurses’ management of important yet non-contagious conditions.

While nurses may have extra support in these ICUs, which tend to have staff-to-patient ratios approaching 1:1, the medical-surgical and other non-critical care units may not have such a large team assigned to help with monitoring and management. Although patients in lower-acuity departments tend to be lower-risk, SREs are always a concern anywhere and everywhere, especially when patients receive post-surgical opioids. Patients with cardiac, respiratory disease and/or obstructive sleep apnea, for example, are particularly at risk for opioid-induced respiratory depression, according to a study in BMJ Open. A significant portion of patients in both the ICU and non-critical units likely have one or more of those conditions.

Due to workforce shortages and limited financial resources, increasing staff in non-critical care departments is not always feasible.

Other research has shown that nearly 1 in 5 patients transferred from ICUs to general care units experienced an adverse event, with 36% determined to be preventable, according to a study published in Critical Care Medicine. Meanwhile, research published in the Journal of Hospital Medicine found 18% of non-ICU patients with COVID-19 had adverse events and 6% died.

Due to workforce shortages and limited financial resources, increasing staff in non-critical care departments is not always feasible, which increases the risk for the patient, as well as the burden for the clinician who must monitor more patients without backup. Advanced bedside monitoring tools, however, can help these clinicians work more efficiently and productively, even when they are responsible for more patients. More importantly, the tools can enable clinicians to respond earlier and sooner to a potential adverse clinical event.

Continuous Monitoring Is Beneficial in Lower Acuity Environments

Historically, continuous monitoring was performed of necessity in critical care units. But continuous physiologic monitoring in lower acuity settings relative to patient safety and identifying earlier onset of patient decompensation has many benefits for the patient and care providers. Recent advances in medical device integration (MDI) and data analytics technology, however, enable clinicians to perform effective monitoring with fewer team members.

Mechanical ventilation, for example, was utilized heavily early in the COVID-19 pandemic. Historically, patients on ventilators would be monitored in-person and clinical data would be recorded manually. COVID-19 made in-person monitoring risky to providers and wasted PPE, in short supply early in the pandemic. During this time, hospitals implemented remote ventilation workstations, enabling centralized data collection integrated and analyzed with other device data so clinicians could intervene when they were truly needed.

By analyzing workflows and alert data from devices, hospitals can identify ways to silence most nuisance alerts and create a plan to help clinicians better understand and configure the alerts to maximize relevancy.

In-person monitoring continues to be risky but is still nevertheless necessary as clinicians always need to get eyes on and hands on the patient. Remote monitoring will not significantly lessen that need, but it can support and indicate when the patient’s condition is decompensating to trigger an intervention when necessary and prevent a potential SRE.

Ventilators are only one type of device that hospitals can integrate to support timely patient care and ease the burden on a smaller clinical staff. Integration and analysis of data across all medical devices can also enable hospitals to implement more clinically beneficial smart alerts that carry a higher likelihood of true interventional action and provide more information on physiologic status.

By analyzing workflows and alert data from devices, hospitals can identify ways to silence most nuisance alerts and create a plan to help clinicians better understand and configure the alerts to maximize relevancy. For example, in pediatric departments, nurses may receive frequent alerts because children tend to be more mobile and active than adult patients, which might generate false or non-actionable medical device alarms.

Instead of alarms based on individual physiologic parameters, clinical surveillance technology generates alert notifications triggered when specific combinations of conditions detected by connected medical devices occur. These smart alerts are configurable based on individual or population characteristics to make them more specific and relevant and enable nurses to avoid unnecessary visits to the patient’s room, saving them time and improving their experience.


Practical changes to enable continuous monitoring of patients in non-critical units and alleviate clinician burden include:

  • Incorporate automatically collected device data with non-device data in the electronic health record (EHR) and elsewhere to offer more relevant notifications and thoroughly and efficiently document care
  • Enable basic pulse oximetry and capnography monitoring reliably everywhere, particularly with patients receiving opioid pain medication and those on benzodiazepines, such as Versed (midazolam) and others.

Documentation is a crucial SRE prevention tool and far more than just a workflow requirement as it directly impacts patient care and is used to make diagnostic and care plan decisions. Complete, accurate and timely automated documentation, therefore, is not just a convenience, but rather a patient safety imperative.

As far as security, cybercriminals are using all available methods to gain access to servers and hold the hospital hostage until a ransom is paid, including gaining access to wired and wireless unprotected devices. Properly secured MDI systems that include encryption and other safeguards can prevent cyberattacks. Hospitals can also create mini networks around devices that are firewalled through a clinical computing hub that effectively blocks access to main hospital servers.

SRE Prevention Where Possible

Some adverse events occur without warning, but many are preventable by responding to early warning enabled through smarter notifications. Preventing SREs is like canoeing down a creek that leads to a waterfall. Canoers on an unfamiliar waterway need to watch for signs of a waterfall (faster current, sound of crashing water, changes in horizon) so they can easily steer to shore instead of visualizing waterfall ahead and trying to paddle like mad to get out of the water.

Through MDI technology, clinicians in medical-surgical and other non-critical care departments can have a similar advanced warning before an SRE occurs and intervene, potentially saving lives. Even when faced with significant staffing resource limitations, an efficient MDI strategy supported with clinical surveillance can better help protect patient safety, improve outcomes while also improving clinician experience.

John Zaleski, PhD, NREMT, CAP, CPHIMS, is head of clinical informatics at Philips Capsule. Reach him at jzaleski@capsuletech.com.

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