Health technology hazards can be the result of IT-related problems such as improperly configured systems, incomplete data, or inappropriate malware protection. They can be caused by inappropriate human-device interactions. They can also be problems that are intrinsic to the devices themselves.
It’s vitally important to recognize such hazards and address them before they cause problems. But the big question is, where do you start? That’s where ECRI Institute’s Top 10 Health Technology Hazards list comes in. The purpose of ECRI’s list is to help prioritize technology-related safety efforts on issues ECRI has judged to be the most serious.
1. Alarm Hazards: Inadequate Alarm Configuration Policies and Practices
Alarm hazards again occupy the No. 1 spot on our list of the Top 10 health technology hazards. With the Joint Commission establishing clinical alarm safety as a National Patient Safety Goal, this should come as no surprise. This year, we encourage healthcare facilities to expand their alarm safety efforts beyond alarm fatigue to include an assessment of alarm configuration practices. Such practices include determining which alarms should be enabled, selecting the alarm limits to use, and establishing the default alarm priority level.
Alarm management strategies that focus too narrowly on alarm fatigue don’t address unrecognized alarm conditions. Scrutiny of alarm configuration practices can help prevent a wider range of alarm-related adverse events. ECRI Institute has investigated several deaths and other cases of severe patient harm that could have been prevented with more effective alarm configuration policies and practices.
2. Data Integrity: Incorrect or Missing Data in EHRs and Other Health IT Systems
Many care decisions are based on data in an electronic health record (EHR) or other IT-based system. When functioning well, these systems provide the information clinicians need for making appropriate treatment decisions. When faults or errors exist, however, incomplete, inaccurate, or out-of-date information can end up in a patient’s electronic record, potentially leading to incorrect treatment decisions and patient harm.
For example: Data entry delays or interface issues could prevent updated test results from being displayed. Clinicians could fail to sever the link between a medical device and a discharged patient’s record, resulting in the next patient’s data being included in the previous patient’s record. Default values could be used by mistake, or fields could be prepopulated with erroneous data. These are just a few of the ways that the integrity of patient data can be compromised.
3. Mix-Up of IV Lines Leading to Misadministration of Drugs and Solutions
In previous Top 10 lists, we’ve addressed the role that infusion pump programming errors play in infusion-related adverse events. This year, we focus on the tangle of tubing that exists when multiple intravenous (IV) infusions need to be administered to a single patient. If care is not taken to clearly distinguish one infusion line from another, a fluid or medication could be delivered at the wrong rate, leading to an overdose or underdose, or via the wrong administration route, as in the case of an IV solution mistakenly being delivered into an epidural catheter.
4. Inadequate Reprocessing of Endoscopes and Surgical Instruments
With the Ebola virus dominating the news, the importance of the reprocessing function — that is, the cleaning and disinfecting or sterilizing of objects that may have been contaminated with body fluids — has gained increased attention. For healthcare facilities, the reprocessing of reusable surgical instruments and devices is a matter of routine. But when the routine involves shortcuts or improper procedures, pathogens can be spread to subsequent patients, potentially leading to hospital-acquired infections or the spread of disease.
Despite our inclusion of this topic on previous Top 10 lists, we continue to see media reports, receive problem reports, and investigate cases involving the use of potentially contaminated instruments on patients.
5. Ventilator Disconnections Not Caught because of Mis-set or Missed Alarms
A disconnection at any point along the ventilator breathing circuit could quickly lead to anoxic brain injury and ultimately could be fatal. To prevent such outcomes, ventilators incorporate sensors and alarms to warn caregivers when a disconnection occurs. To be effective, however, such alarms must be set to appropriate levels and must be heeded when they sound. ECRI Institute has investigated cases in which serious patient harm resulted from alarms being set to inappropriate levels, and thus not activating to warn of a disconnection, or from staff not hearing the alarms that had been activating.
6. Patient-Handling Device Use Errors and Device Failures
Staff injuries associated with the lifting, transfer, or movement of patients are a key factor contributing to OSHA’s conclusion that hospitals are among the most hazardous places to work in the U.S. Furthermore, patients themselves can be injured if patient-handling activities are not carried out effectively.
A diverse range of patient lifts and other patient-handling technologies are available to help prevent staff and patient injuries during such activities. While use of these devices can help reduce the risk of injury compared with manual techniques, reports show that improper use, failure to maintain the devices appropriately, or failures associated with the devices themselves can likewise result in injuries.
7. “Dose Creep”: Unnoticed Variations in Diagnostic Radiation Exposures
“Dose creep” refers to a pattern of increasing radiation exposure levels (i.e., dose) over time in an attempt to achieve better image quality in digital diagnostic radiography. The consequence is that patients may routinely be exposed to unnecessarily high levels of ionizing radiation during diagnostic imaging exams. While the effect of any increase in dose for a single exam would likely be negligible, the cumulative effect on patients subjected to multiple studies during the course of their treatment — particularly neonatal patients — can become significant.
Fortunately, tools are now becoming available to help healthcare facilities identify exposure trends that might indicate variation from the optimal values.
8. Robotic Surgery: Complications due to Insufficient Training
Robotic surgical systems are particularly complex devices that change the circumstances of surgery for all involved. Thus, adverse events can result if surgeons, the rest of the surgical team, and associated staff are not sufficiently prepared to manage these conditions. ECRI Institute has investigated several incidents in which situations unique to robot-assisted surgery likely contributed to patient harm.
9. Cybersecurity: Insufficient Protections for Medical Devices and Systems
The growing trend toward the networking and connectivity of medical devices is associated with a corresponding increase in the vulnerability of these devices to malware and malicious attacks. It is important to keep this issue in context: there is little evidence to date of direct harm to patients. Nevertheless, cybersecurity is a potential threat that healthcare facilities must begin addressing. The exploitation of medical device cyber vulnerabilities could lead to device malfunctions, the disruption of healthcare services, or the inappropriate access to patient data.
10. Overwhelmed Recall and Safety-Alert Management Programs
Despite the best intentions of manufacturers and healthcare professionals, defective medical devices sometimes make it onto the market, failures and use errors occasionally occur, and hazardous situations do develop. Given that reality, it is essential that healthcare facilities have an effective program for identifying and addressing defective devices and other sources of danger or difficulty involving medical technologies before patients are harmed.
While all healthcare facilities have some form of recall and safety-alert management program, some of these programs have not kept pace with the growth over the last decade in the number of recalls and other alerts that have been issued. In addition, several challenging technology management scenarios can lead to gaps that result in missed recalls or alerts.
11. Promote Safety
Spread the word about ECRI Institute’s 2015 Top 10 Health Technology Hazards – and let it help your facility focus its patient safety efforts. A free version of the report can be downloaded at www.ecri.org/2015hazards. The free report contains detailed recommendations from ECRI Institute on how to address each of the hazards on its list.
Let ECRI Institute know how your hospital is using the list to help manage health technology related safety. Feel free to contact Jim Keller, Vice President, Health Technology Evaluation & Safety, ECRI Institute, at email@example.com if you have some best practices that you’d like to share.
This article is based on the report that was posted on ECRI Institute’s membership website on November 24, 2014. To learn more about the Health Devices System or any ECRI Institute services, visit www.ecri.org or call (610) 825-6000, ext. 5891.
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