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If you look at the previous iterations of ECRI Institute’s top 10 tech hazards lists, you will see some items that seem to make the list every year. But this year, there are six new things added by the experts who were convened to go through event reports, to review the literature, and to share the results of their investigations in order to come up with a relevant list of technology-related items that people in healthcare need to worry may cause harm to patients in some way.
Alarm hazards, for instance, has been at the top of the list for four years, while data integrity went from number four to number two this year. Then there is recall and safety alert management, which made it to the list for the first time at number 10 — an issue of how organizations manage all the various equipment and machinery they have, and the potential recalls and alerts related to those machines and equipment that may come in during a given year.
Just think about all the machines you own in your home and car and whether you can keep track of the recalls and notices related to them, and imagine the problem keeping track of such things is for a hospital — and yet how vital it would be to know about a recall on a ventilator part or an alert about some vital piece of machinery in an NICU. "This item points to the potential to serious consequences for healthcare facilities and patients," says Rob Schluth, senior project officer in ECRI Institute’s Health Devices Group. "Our experts are concerned that hospital tracking programs are not keeping pace with the growth in the number of medical device recalls issued each year." He notes that the FDA reported there were more than 1,100 such recalls for medical devices in 2012, more than double the number a decade earlier.
The 45-year-old consulting and research organization, which also serves as a PSO, involves staff from multiple areas, including engineering, risk management, and patient safety in the discussion to create the list. Schluth says the group doesn’t consider what has been on the previous year’s list or its ranking, although they understand that having the same list year after year would eventually lead to people paying less attention than if new things appeared now and again.
He went over the current list with Hospital Peer Review and talked about each entry.
Alarm hazards. Inadequate alarm configuration policies and practices. ECRI Institute is aware of several deaths and other cases of severe patient harm that may have been prevented with more effective alarm policies and practices, he says. This is about more than alarm fatigue, which has been the subject of concern and discussion by The Joint Commission and other regulatory, professional and research bodies. Among the other things to worry about are whether alarms have been set to activate at appropriate levels — heart rate or blood pressure alarm limits, for instance — or making sure the volume of the alarm you set is appropriate.
Data integrity. Fourth on the list last time the list was released, it bumps up two places this year, he says. The focus is on missing and incorrect data in electronic records and other systems. This is not simply misspellings of names or incorrect addresses. It could be as serious as test results, medication orders, or other data for one patient mistakenly appearing in the record for another patient.
Mix up of IV lines. This is a new entry, Schluth says. "This is the first time we have included something outside the pump," he says, noting that this issue involves more than just the use of Luer connectors for different applications, which has been in the news. Rather, this is about having a patient with multiple IV lines and mixing up the tubing — connecting the tubing to the wrong medication bag, putting the tubing in the wrong infusion pump channel, or connecting the tubing to the wrong infusion site. Such errors could lead to infusing the wrong drug, or at the wrong rate, or in the wrong place or some combination. "This has always existed, but it hasn’t gotten a lot of attention," he says. "It’s really a low-tech issue, but it requires vigilance, and mistakes can and do happen."
There hasn’t been a sudden spike in the number of such errors, he explains. "The purpose of the list isn’t to give a mathematical accounting of problems and list them in rank order of their occurrence," Schluth says. Certainly things that happen very often get the attention of the people who sit around the table hashing out the list. But what matters more is helping the people using the list drive positive change. "We want to promote safe patient care," and if the occurrences are rarer but still of concern, ECRI will make note and offer solutions and resources. "We look for issues where you can take the information and really make a difference. It may be an issue where it can be a fatal hazard, or a common hazard that is easily avoidable. Either way, we try to identify topics that will help make a positive difference. Each year we do it fresh, without regard to where something was on the list last time."
Inadequate reprocessing of endoscopes and surgical instruments. According to the ECRI report, of the 13 immediate threat-to-life discoveries during Joint Commission surveys in 2013, seven related to inadequate sterilization or reprocessing of equipment. "Our accident and forensic investigation group gets something on this topic just about every year," Schluth says. "It isn’t going away." Among the chief issues: an initial cleaning of items at the site of use. While it may be fine not to rinse your dishes before they go into the dishwasher, it’s not okay to leave all the work to the autoclave.
Ventilator disconnections not caught because of mis-set or missed alarms. While Schluth says this could have fit into the first item on the list as a subset of alarm errors, they opted to make it its own item. "We didn’t want to dilute the issue," he says. "Alarm hazards are a National Patient Safety Goal, and we want to draw particular attention to them." Slicing and dicing the issue into smaller bits makes sense when there are so many ways mistakes can happen. Again, alarm volume, not setting alarm parameters correctly, or relying on factory default settings or other people’s work rather than checking to make sure everything is set appropriately are common issues ECRI cites in the report.
Patient-handling device use errors and device failures. This is another new entry to the list. It evolves from a study by the Occupational Safety and Health Administration (OSHA) that showed hospitals as one of the most dangerous places to work. Chief complaints among staff are musculoskeletal injuries that come from lifting and positioning patients, he says. "There are techniques and specifically created tools you can use to facilitate these kinds of movements — patient lifts, transfer boards — and using them is vital to avoiding injury to caregiver and patient alike," he says.
The item made the list because often the very things designed to make such work safer and easier are not used or not used properly, or may have mechanical parts that have weakened and need repair. "They may be unavailable, or broken or on another floor," Schluth says. "The ancillary issues around using those technologies are what we are concerned about."
Dose creep. Unnoticed variations in diagnostic radiation exposures. As diagnostic radiology moves from film to digital, Schluth says, there are definite advantages. One is that digital plates have wider dynamic range. "You don’t have to be as precise with settings to get a good quality image, and you worry less about over- or under-exposure except at the very far extremes," he says. That means there are fewer repeat scans. But hidden in that is that in adjusting the radiation dose to get a clear image, you are increasing settings to do so and the settings stay there, so that the next time someone comes in it is not reset to a lower level, but stays at that higher level. Over time, the dosage creeps up. That may not be a significant problem for one patient and one scan. But for a patient who has to have multiple scans over multiple weeks, it’s an additional risk. If a dose doesn’t have to be that high to get a clear image, it shouldn’t be. "Tools are becoming available to deal with this — software and a standard for measuring exposure index. Healthcare facilities should be looking into incorporating these into their processes. This is a fixable problem. It won’t kill someone, but why over-expose the patient if you don’t have to?" he says.
Robotic surgery. Complications due to insufficient training. This item was on the list last year, and the concerns remain the same, says Schluth, only a little more so as robotic surgery is more widespread now than it was before.
"How do you manage the use of this technology?" he asks. "This isn’t like introducing a new surgical procedure to your hospital. How do you decide who participates? What training do they need, and how will credentialing be managed? How do you set up the OR? Where will people stand now that there is all this space taken up by machinery? How will the new physical environment impact their job? These are all things that have to be considered."
Cybersecurity. Insufficient protections for medical devices and systems. Schluth notes that there are more and more devices connected to each other, to hospital networks, to servers. The risk of malware only increases. "You have to be vigilant, and it can be a real headache." The harm may not be physical — although you can’t rule that out, either — but the complications of your systems being down and unavailable can be tremendous. And protecting patient data remains a significant issue, Schluth continues. There are reports in the media regularly about hospitals and other healthcare organizations that have had data stolen or have otherwise had patient information mishandled. It’s not a place you want your hospital to be.
Overwhelmed recall and safety alert management programs. Every facility has some form of alert management process, Schluth says, but a lot of them are old, and the volume of alerts has increased so dramatically that your program may not have evolved with the volume of alerts. "Whatever you were doing a decade ago may no longer be sufficient. A process that might have been treated as a routine clerical task really needs to be managed today as a robust patient safety initiative." For instance, what had been directed by clerical staff hoping to get people to pay attention to an email blast now has to be leadership-driven with buy-in from key players to make sure that everyone who uses a piece of equipment and who needs to know about an alert or recall knows. "Part of it is just knowing what devices you have in inventory," he says. "When you receive an alert or recall, you need to identify affected devices, locate and fix them if necessary, and document those fixes. It’s a way of closing the loop. It can be difficult to do that effectively with an old-fashioned paper process."
Schluth says he hopes that hospitals will look through the list and the report and see what is relevant to their facilities. Maybe no hospital will need to worry about all of them, but no hospital will need to worry about none. "There are things our experts have tracked as deserving a place in the conversation," he says. "Prioritize which you need to tackle first. Start a conversation. We have information there for a starting point, some practical tips for preventing hazards and resources, as well."
The entire report can be found at www.ecri.org/2015hazards.
For more information contact Rob Schluth, Senior Project Director, Devices Group, ECRI. Plymouth Meeting, PA. Telephone: (610) 825-6000.