ECRI Institute collects data on adverse events and near misses and releases an annual report on the top technology dangers in healthcare.
Occupational radiation hazards to healthcare workers in 'hybrid' operating rooms, failure to test EHR software or network devices before they're used, and surgical errors caused by insufficient training on robot devices are three new types of danger that made the ECRI Institute's top 10 technology hazards list for 2014.
"Every year that we've published this list it's continued to get more attention, and I believe it's helped healthcare organizations focus on important technology concerns," James P. Keller, ECRI's vice president of health technology evaluation and safety, said in an interview about the 7th annual report, which the institute released Monday.
"In my 29 years with ECRI, I don't believe hospitals have paid close enough attention to technology safety."
Keller added that "One simple example of where healthcare organizations can do a better job is to pay closer attention to training for clinical staff on the use of complicated technologies, and the robotics problem that we have on the list is one example of that."
ECRI's analysts determine which hazards make the list on the basis of the severity of potential harm, probability, extent of consequences, difficulty of detection, and the likelihood of generating negative media publicity. All of those on the list are considered preventable.
ECRI collects documentation of adverse events and near misses from a number of sources:
1. Hospitals across the country voluntarily and confidentially submit information about incidents that occurred in their organizations to ECRI's "Problem Reporting Network."
2. The U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience database.
3. ECRI's proprietary data culled from
- Its accident and forensic investigation program
- Its analysis of newer technologies
- Its device testing lab
Health technologies seen as likely to cause patient harm in 2014 are:
1. Alarm hazards
Device alarms have "doubtless saved many lives," the report says, but have overwhelmed, or distracted, or desensitized caregivers to their importance, so real alerts go unattended. In April, a sentinel alert from The Joint Commission noted 98 harm-related events, 80 of which resulted in death, and 13 resulting in permanent loss of patient function.
This hazard has been in each of ECRI's seven annual hazards lists and doesn't appear to be a problem that providers are able to solve.
"A big factor is the growth in number of devices with alarms," Keller says. "It's created a growing complexity that caregivers have to manage."
2. Infusion pump medication errors
Hospitals may have thousands of these pumps, whose misuse or failure produce more adverse incident reports to the FDA than any other medical technology. Because some patients are highly sensitive to fluids and drugs they receive through these pumps, wrong dosages can be lethal. Some 710 deaths were reported to the FDA between 2005 and 2009.
ECRI says that since the FDA's regulatory action against Baxter and Hospira pumps last year have prompted healthcare facilities "to switch to unfamiliar brands."
The report says "some pumps have buttons that are not labeled in an intuitive manner" or "involve user interfaces that are cumbersome to navigate. In a sample of events reported to ECRI's PSO, 29% involved wrong concentrations of drugs, 19% the wrong entry of more than one parameter, and 15% involved a piggyback infusion setup error.
3. CT radiation exposures in pediatric patients
While CT radiation overdoses made the previous four annual reports, this year's caution is issued specifically for CT in children because of concerns that ionizing radiation can be especially risky to growing human tissue.
The report's authors issue cautions about use of adult doses of radiation for children, and use of lower-radiation alternatives such as MRI, ultrasound, and X-rays, and avoiding repeat scans by checking on whether a CT has been done recently at another institution.
4. Data integrity failures in EHRs and other health IT systems
While electronic health record adoption has tripled between 2009 and 2012 in response to federal financial incentives and penalties, and more is underway, the opportunities for error with these systems is significant.
"Contributing factors include patient/data association errors, missing data or delayed data delivery, clock synchronization errors, inappropriate use of default values, use of dual workflows (paper and electronic), copying and pasting of older information into a new report, and even basic data-entry errors."
This hazard is similar to a hazard described in last year's report, which noted that even moving a patient from one room to another could result in that patient's medical data being sent to the wrong medical record.
5. Occupational radiation hazards in hybrid ORs
An increasing number of hospitals are moving sophisticated imaging equipment into the operating room in order to conduct angiography even during minimally invasive procedures.
"However, as these angiography systems are introduced into the OR, so too" is the risk of ionizing radiation exposure to healthcare workers who may not have experience working in such settings as do their colleagues in radiology or catheterization labs.
"Knowledge of the risks and the experience in executing precautions may be lacking—a situation that could lead to unnecessary radiation exposures to those clinicians working in a hybrid OR on a daily basis," the report says.
Training, shielding, and monitoring are essential, the report says about this hazard, the first time it has been included on the list. "Radiation monitoring badges are used to keep track of clinician exposure," so doses are not exceeded.
6. Inadequate reprocessing of endoscopes and surgical instruments
On the list for every one of the last five years, problems with disinfection of endoscopes have resulted in transmission of hundreds of infectious-disease causing organisms. But this year, ECRI has added improper sterilization of other surgical devices, such as an arthroscopy shoulder cannula and a broncoscopy scope.
Additionally, "bone and tissue were observed in an instrument tray for joint replacement surgery," and "blood was observed on the instrument bin inside a surgical case cart before a procedure was started."
The report said inadequate processing of instruments "can damage an organization's reputation, reduce patient satisfaction, prompt review by accrediting agencies, and lead to citations and fines from regulatory bodies or lawsuits form patients."
7. Neglecting change management for network devices and systems
Also on the list for the first time, the report said, is the "underappreciated consequence" of that updates, upgrades or modifications made to one device or system have on other connected devices or systems.
For example, a Windows 7 upgrade at one hospital "caused the loss of remote-display capability for its fetal monitoring devices," which were incompatible. Also, an EHR software upgrade changed radiology reports, "causing fields for the date and time of the study to drop from the legal record.
The report recommends that "when making changes to interfaced systems, closely monitor the systems after the change is made to ensure their safe and effective performance."
8. Risks to pediatric patients from "adult" technologies
The report readdresses this problem, which was introduced as a top 10 hazard last year, saying many hospital systems are not configured for children.
An EHR system, for example, "may not facilitate the recording and review of important pediatric-specific data, such as vaccinations, or may not allow both height and weight to be viewed on the same screen, which in turn can contribute to vital information being overlooked."
Even a scale can generate information that results in harm, for example when a "mix-up involving the use of pounds versus kilograms to record weight contributed to the death of an infant."
In another incident, a toddler's weight was recorded at 25 lb. but was mistakenly recorded in the EHR as 25 kg., which led to a dose calculation twice what the child should get. The mother caught the error before the child experienced adverse effects.
9. Robotic surgery complications due to insufficient training
Also debuting on the list is the rise in reports of complications as a result of surgery assisted by robots, namely "Intuitive Surgical's da Vinci Surgical System," the "only multipurpose robotic surgery system on the market."
The report suggests that robotic systems "are being used for a greater number of cases or for additional kinds of procedures without adequate consideration of the surgical team's proficiency."
The report says that initial training by the device supplier "is intended to help users become familiar with the system and the supplier suggests ways surgeons can get specific training.
"However, the supplier's program does not teach trainees how to perform specific surgical procedures. Thus it is up to the hospital to verify that surgical staff have the necessary procedure-specific skills."
The report advises hospitals to make sure that surgeons maintain competency with sufficient caseload "so that the surgical teams' skills remain sharp."
10. Retained devices and unretrieved fragments
This hazard is back on the list after a three-year hiatus. ECRI was prompted to bring it back by information gleaned from these sources:
- A 2012 Pennsylvania patient safety reporting system found 452 retained surgical items in 2011, one third of which caused patient harm.
- A recent analysis of 9,744 malpractice settlements and judgments between 1990 and 2010 found nearly half involved a retention of a surgical item.
- A recent Sentinel Event alert from the Joint Commission noted 772 such incidents reported to the Sentinel Event Database from 2005 to 2012, including 16 resulting in patient death.