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.
A Partnership for patient safety
ECRI has been in the business of making healthcare safer for more than 50 years, and our cooperative relationship with industry has been a key component of our success. Through its device evaluations, hazard reports, and other investigations, ECRI has identified shortcomings in thousands of individual models and systems, as well as many technology-wide hazards that put patients and others at risk. Responsive manufacturers, then, have developed solutions to address those concerns and provide users with safer alternatives. In some cases, their work has yielded truly innovative technological advancements.
Together, we've driven significant improvements in medical technology, saving countless patients from preventable harm and death. The advancement of free-flow protection mechanisms is just one example. Others include improvements to manual resuscitators to prevent inadequate lung inflation, bed safety assessments to prevent entrapment and strangulation within bedrails, drug libraries and infusion pump integration to prevent wrong-dose and wrong-drug errors, CT scanner dose-control technologies to protect patients from unnecessarily high radiation exposures, and improved endoscope reprocessing procedures and technologies to prevent cross-contamination.
Hazards that warrant industry attention
In this year's report, we've highlighted five areas where we believe industry can advance the cause of patient safety through better product designs or quality processes:
- Gaps in Recalls for At-Home Medical Devices Cause Patient Confusion and Harm. When a medical device that is used in the home is recalled, too often the actual users of the device don't learn about the recall in a timely manner; and whatever information they do receive may be too technical for them to comprehend. Without a clear understanding of the risks, patients may be harmed by continuing to use an unsafe device—or by inappropriately stopping use of a device whose benefits outweigh the risks. In ECRI's view, medical device manufacturers should be more proactive in creating clear, easy-to-understand recall notices and getting those notices into the hands of the people using their devices.
- Growing Number of Defective Single-Use Medical Devices Puts Patients at Risk. Disposable products and other types of single-use medical devices play a role in virtually every patient encounter, which is why the high number of defective products in the supply chain is of such concern. Product defects can lead to waste, delays, incorrect treatment, healthcare-acquired infections, or other patient harm. Concerningly, rather than seeing improvements over time, ECRI has observed a continuing increase in problem reports. There are steps that healthcare providers can take to protect patients, staff, and others. However, the greatest impact will come from manufacturers improving their quality control practices to prevent defective products from reaching the market.
- Undetected Venous Needle Dislodgement or Access-Bloodline Separation during Hemodialysis Can Lead to Death. Needle dislodgements or bloodline detachments during hemodialysis can quickly lead to a massive loss of blood. Current hemodialysis machines are not equipped to detect such events reliably. ECRI challenges manufacturers to develop systems that reduce the risk of fatal exsanguination during hemodialysis.
- Inflatable Pressure Infusers (IPIs) Can Deliver Fatal Air Emboli from IV Solution Bags. In a specific combination of circumstances, using an IPI to administer fluids can lead to an embolism caused by air from the IV bag being infused into the patient. Depending on its size and location, an embolism could lead to circulatory collapse, stroke, or death. Using IPIs to infuse through intracardiac catheters and sheaths is of particular concern. ECRI challenges manufacturers to develop technical solutions that eliminate or minimize the risk of infusing air from an IV bag.
- Confusion Surrounding Ventilator Cleaning and Disinfection Requirements Can Lead to Cross-Contamination. Reprocessing instructions provided by ventilator manufacturers are, in some cases, incomplete or confusing, leading to questions about which components need to be cleaned and disinfected, and when. To reduce the risk of cross-contamination, ECRI calls on ventilator manufacturers to verify that their reprocessing instructions are complete, clear, well documented, and realistically achievable.
Now, more than ever
With the COVID-19 pandemic leaving healthcare facilities understaffed and healthcare workers overstressed, it's more important than ever that medical technologies be designed in ways that help ensure their safe use. An engineering solution that eliminates a hazard will always be preferable to a training solution that can only warn of a hazard. As it has done for 50 years, ECRI will continue advocating for meaningful progress on this front.
Download your copy free today
ECRI’s 2023 Top 10 Health Technology Hazards report is available now, so download your copy to learn more about hazards that may put patients at risk and what you can do about them. Members of any ECRI program can access the report through their member web pages. Others can access an overview of the report by downloading the free Executive Brief.