The hazards were chosen on the basis of potential for injury or death, frequency of occurrence, how many patients are affected, notoriety in the media, and measures hospitals can take to lessen these risks.
Alarms on infusion pumps, ventilators, and other devices are designed to inform medical staff of a problem that needs prompt attention. But the sheer number of alarms in a hospital can overwhelm staff, leading to complacency and delayed response. Caregivers often turn down the volume of alarms.
"If too many alarms are sounding, then all alarms start to lose their meaning," said Rob Schluth, Senior Project Officer of ECRI's Health Devices Group. "Focus on reducing audible alarms for events that don't require action on the part of the staff. Perhaps a visual indicator is sufficient for some conditions.
"Facilities can fix problems that cause alarms to sound in the first place," he said. "For example, reinforcing skin prep techniques and replacing electrodes on a regular basis can prevent ECG leads from coming off and thus prevent leads-off alarm conditions from developing."
Infusion devices are the subject of more adverse incident reports to the US Food and Drug Administration than any other medical technology, according to the Association for the Advancement of Medical Instrumentation. From 2005 through 2009, more than 700 deaths associated with infusion devices were reported.
Data-entry mistakes such as mistyping information or entering it into the wrong field can be dangerous. Errors are caused by illegible orders or drugs that are improperly prepared or given to the wrong patient.
"It's essential to build in time and resources for clinical and technical staff to determine which data flows will meet clinical needs, and then develop and refine workflows, policies, and procedures around using the integrated system," said Erin Sparnon, Senior Project Officer in ECRI's Health Devices Group
Inappropriate use and dose levels of CT can lead to unnecessary radiation exposure for patients. Image quality typically improves as the dose increases. As a result, there is a tendency to use higher doses that are associated with greater risk to the patient. Acute reactions such as radiation burns and hair loss are relatively rare but still occur too frequently, the ECRI report states.
Radiation-induced burns occur because the radiation beam may stay on the same area of skin for too long, said Jason Launders, Director of Operations of ECRI's Health Devices Group. "Alternative projections can reduce the incidence of burns," he said. "It is difficult to track the dose to a specific area of skin. Fluoroscopy systems keep track of the exposure time and alarm after a pre-set time. The alarms are usually ignored
Mistakes that cause one patient's data to end up in another patient's record aren't new.
"Getting the right patient's data into the right record doesn't just happen automatically," said Rob Schluth. "It requires well-designed systems, careful implementations, and attention to workflow processes. For example, a physiologic monitor may be set up to transmit data to a patient's electronic health record. But what happens when the monitor is connected to a different patient? Or if that patient is moved to a different monitor? Correctly associating and disassociating a device with the patient's record are key steps in the process."
Interfaces between medical devices don't always function as intended and can allow dangerous conditions to exist. For example, ECRI found that one monitoring system didn't communicate audible or visual alarms from an interfaced ventilator to warn caregivers of a critical patient circuit disconnection.
"Interoperability provides a pathway for good things to be shared across devices and systems," said Rob Schluth. "Patient data and test results can be transmitted without lengthy delays or the need for repeated data entry. Bad things can also travel along those pathways. A fault in one system could affect other connected systems. A pathway could be incomplete, meaning that some vital information isn't transmitted.
Intravascular air embolism is a potentially lethal complication of certain medical and surgical procedures. While relatively rare, fatal incidents do occur. The Pennsylvania Patient Safety Authority found 59 confirmed or suspected air embolism adverse events from 2004 through 2011, including 7 cases of permanent harm and 6 deaths. The largest percentage of reported events is associated with the use of central venous access devices.
"It's hard to say whether incidents are because of complacency, because specific individuals didn't understand the risks in a particular situation, or because of an unusual combination of factors," said Rob Schluth. "These incidents illustrate that even well-known hazards warrant attention to remind caregivers of the risks, as well as steps to take to minimize them."
ECRI recommends instituting a time-out procedure for activities that present a high embolism risk, reinforcing the appropriate procedures to follow for removing air from solution delivery systems, and requiring clinicians to trace any line to its source before connecting the line to a patient's IV access device
Technology designed for adult patients often needs to be used on children, in some cases because no alternatives exist. Pediatric-specific devices are slow to reach the market because of the small numbers of patients available to study, the devices' high-risk nature, and high development costs.
Children can be placed at risk when "adult" technologies need to be used in their care. Examples include the use of inappropriate dose settings during radiology procedures, a lack of child-appropriate selection options in medication administration and computerized provider order-entry systems, and the absence of pediatric emergency supplies in care areas where children may be seen.
Cross-contamination hazards that occur when flexible endoscopes aren't properly reprocessed have been on ECRI's top 10 hazards list for years. ECRI wants facilities to address the reprocessing function more broadly in their patient safety efforts. Numerous reported incidents involved "dirty" instruments being processed for use in surgery and other medical procedures. The contamination was often not detected until after the item had been used on a patient.
"It's important that reprocessing staff be taught proper protocols," said Rob Schluth. "It is helpful to explain why each step is needed, describing exactly what can happen if a step is skipped. Frontline workers need to be aware of the hazards.
"Look at the root causes for any failure. Is the issue that the staff doesn't know the correct procedure, or are other factors contributing to the problem?" he asked. "For example, is sufficient time allotted to perform the procedure correctly, or does staff feel pressured to take short cuts? Are the necessary supplies available? Are the instructions unclear or out of date? Is reprocessing too difficult because the device wasn't adequately precleaned in the procedure room?"
Interruptions from pagers and other devices have long been part of medicine, but smartphones and other mobile devices now make it easier for clinicians to be interrupted for non-work-related reasons -- and to make their own interruptions.
Half of the respondents to a 2010 survey of perfusionists acknowledged texting during heart-lung bypass procedures, with 15% further admitting that they accessed the Internet and 3% reporting that they visited social networking sites during procedures. Additional distractions occur more frequently than people think, exposing patients to danger.
"These devices can be used for any number of clinically useful purposes," said Rob Schluth. "But they can divert the caregiver's attention away from the patient or the task at hand. Receiving personal text messages or using the devices to check social media during patient care are questionable behaviors. Even the act of focusing on the device rather than observing the patient, or listening to information being exchanged, can affect the quality of care."
There are an estimated 600 surgical fires per year. Although that's only a miniscule percentage of the millions of operations performed, these almost entirely preventable events still occur too frequently. The hazard remains on ECRI's top 10 list because of the potential devastating consequences, including disfigurement and death.
"A quick assessment of the potential fire risks before the start of a procedure can help staff guard against bringing together the elements of the fire triangle -- oxidizers, ignition sources, and fuel," said Rob Schluth.
