Infusion Errors, Instrument Cleaning Lead ECRI List of Top Tech Hazards
This article originally appeared in the April 2017 issue of Briefings on Accreditation and Safety.
The ECRI Institute published its annual list of the top 10 health technology hazards for the industry. Readers will note that several of the top hazards in 2017 are the same as those in 2016. To guide readers through the hazards, our sister publication Briefings on Accreditation and Safety (BOAQ) spoke to several experts on each issue and about steps that can be taken to prevent it.
1. Infusion errors
Summary: “Number 1 on ECRI’s 2017 list of health technology hazards is IV infusion errors caused by placing too much trust in advanced pump safety features and incorrect infusion programming,” says Jean S. Clark, RHIA, CSHA, an author and speaker on accreditation and regulatory compliance. “Other causes of IV infusion errors are related to wrong volume, mixture, intravenous rate, and drug incompatibility.”
“In addition, failure to check patient identification against the arm band, order, and patient name and date of birth; and failure to check appropriate vitals such as pulse and blood pressure have caused errors. Nurse experience, training, and continuing competency requirements also have a bearing on IV infusion errors.”
Steps you can take: “Nurse education and continued competency review is key in reducing errors,” she says. “Upon hiring and at intervals established by the nursing leadership, have strict competency requirements. Competency tests and direct observation are good methods to use. Determine how much experience is required prior to hire; or, for the new nurse, direct observation with an experienced nurse for a defined period of time is a good idea. Track IV infusion errors, aggregate the data according to cause, and perform root cause analyses to determine an action plan for eliminating errors.”
Resources:
• Food and Drug Administration (FDA), “Examples of Reported Infusion Pump Problems”
• Association for the Advancement of Medical Instrumentation, “Majority of IV Medication Errors Linked to Clinical Practice Not Technology”
• PSQH, “Interoperability Preparedness: What Hospitals Can Do to Be Ready for Smart Pump-EMR Interoperability”
• PSQH, “From Smart Pumps to Intelligent Infusion Systems – The Promise of Interoperability”
2. Inadequate instrument cleaning
Summary: “Inadequate cleaning of instrument is number 2 on ECRI’s list,” Clark says. “In particular, in areas where short cycle steam sterilization is used and where clean and dirty instruments pass through sterile and unsterile areas. For example, settings where eye surgery (cataract, laser, etc.) are being performed, GI labs and other areas where scopes/probes are being utilized. Inadequate training, not following manufacturer guidelines, not following heating, ventilation, and air conditioning parameters in decontamination areas, use of old instruments and delays in cleaning instruments are other factors leading to inadequate instrument cleaning.”
Steps you can take: “Follow the Association of Perioperative Registered Nurses (AORN) guidelines for cleaning, decontaminating, and handling instruments in all procedural, surgical, and central sterile areas and follow manufacturer guidelines,” she says. “Keep information on short cycle steam sterilization rates to ensure under sterilization is not occurring. Consider the use of disposable laryngoscope blades and make sure the blades are in some type of packaging. Keep up-to-date records on surveillance of negative and positive pressure areas. Ensure competency in cleaning, decontaminating, and handling of instruments to ensure adequate cleaning.”
Resources:
• AORN, “Guideline Implementation: Surgical Instrument Cleaning”
• AORN, “Guideline Implementation: Processing Flexible Endoscopes”
• FDA, “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling”
3. Missed ventilator alarms
Summary: ECRI has discussed the risks of alarm fatigue before; where staff become overloaded or desensitized to alarms going off. New this year ECRI also notes a new problem: the difficulty in identifying where your ventilator alarm vulnerabilities lie.
Steps you can take: Elizabeth Di Giacomo-Geffers, RN, MPH, CSHA, a former Joint Commission surveyor and consultant based in Trabuco Canyon, California, says that a comprehensive alarm management program is needed to address the full range of alarm hazards.
“This is not an activity that can be done from the top down,” she says. “Involve the nurses and staff who work with these alarms to get their input on methods to prevent alarm-related errors.”
Resources:
• ECRI, “Top 10 Health Technology Hazards, 2015”
• ECRI, “Evaluation Background: Ancillary Alarm Notification Systems”
• HealthLeaders Media, “Clinical Alarm Safety Improvements Are a Team Effort”
• PSQH, “Alarm Management: First Things First”
4. Opioid-induced respiratory depression (OIRD)
Summary: “Patients who receive postoperative opioids like hydromorphone, morphine, or fentanyl are at risk—even if they’re otherwise healthy—to experience drug-induced respiratory depression,” says Geffers. If not caught, OIRD can cause obstructive sleep apnea, brain damage, or death. Patients can be at risk for OIRD if:
• They’re taking a secondary medication with a sedating effect
• If they have sleep apnea or other respiratory compromising conditions
• If they are mistakenly given too much medication
Steps you can take: ECRI recommends assessing for whether the patient is on other drugs with a sedating effect; comorbidities like morbid obesity or sleep apnea; or are at risk to receive a higher dose than intended (e.g., wrong concentration, wrong medication, infusion pump programming errors). The institute also recommends implementing continuous ventilator monitoring for patients.
Geffers says that facilities should follow recommendations from The Joint Commission and the Anesthesia Patient Safety Foundation.
Resources
• Anesthesia Patient Safety Foundation, “No Patient Shall Be Harmed By Opioid-Induced Respiratory Depression”
5. Heater-cooler infection risks
Summary: “The Center for Disease Control and Prevention (CDC) has identified a potential increase in infection risks for particular types of surgical procedures related to the use of heater-cooler units,” says Tom Remy, RN, MBA, OR director at the University of Virginia Health System Medical Center. “Specifically, open heart and open chest surgical procedures.”
He says that there are three possible risk factors for heater-cooler infections:
• Aerosolization of bacteria
• Disruption of laminar flow
• Manufacturer design of the device
“My experience with this is that many operating rooms and staffs are looking for alternatives or potentially taking those particular units out of service,” he says. “But that’s not always the case and you can’t necessarily replace them all.”
Steps you can take: “Part of the solution really is—in conjunction with the surgeons and the risk management staff at the hospital—to make sure that patients and family are fully informed of those risks and benefits of using these particular devices during open heart surgery,” he says. “There’s not a whole lot of other alternatives. Related to that, fully educate the staff on the signs and symptoms of any potential infection that could occur.”
ECRI also recommends reading the FDA’s recommendations for all heater-cooler devices.
Resources
• Becker’s Hospital Review, “7 Hospitals Notifying Patients of Heater-Cooler Infection Risks”
• CDC, “Contaminated Heater-Cooler Devices”
• FDA, “Heater-Cooler Devices: Information for Patients”
• Accreditation Insider, “Safety Alert: Bacterial Infections Associated With Heater-Cooler Devices”
6. Software management gaps
Summary: “Healthcare organizations face a tidal wave of software proliferation brought on by the Internet of Healthcare Things (IOHT): mobile devices, sensors, apps, remote monitors, as well as traditional health information technology (HIT) software,” says Mitch Work, president and CEO of The Work Group, which provides marketing and public relations services to HIT companies. “Managing these systems, which are often silo’ed and do not communicate with each other, can cause gaps resulting in a wide range of errors impacting patient safety.”
“In addition, data security breaches are occurring with greater frequency caused by ransomware, data theft, or lost laptops with patient data. Effectively managing all software systems which impact every aspect of a healthcare organization can go a long way in improving patient care and outcomes.”
Steps you can take:
• Check for systemwide use of common patient identifiers, especially when acquiring new healthcare organizations.
• Ensure proper change management and training of staff when implementing new software systems including any networked devices.
• When upgrading to any new software, release test all connected medical devices for compatibility to avoid malfunctions.
• Establish biomed-IT collaboratives and communicate to ensure proper functioning of medical devices residing on hospital IT infrastructure.
• Ensure that security protocols, including up-to-date data encryption, fire walls, and antivirus software are in place, and then train (and regularly retrain) staff on security protocols.
• Involve clinicians to ensure that data extracted from diverse software systems is delivered in a useful way that supports their workflow and can deliver near real time patient data at the point of care to improve care. Be assertive with vendors when addressing integration issues.
7. Occupational radiation hazards from hybrid ORs
Summary: “The hybrid OR is quite common now with advanced imaging technologies coming into the operating room to assist in interventional procedures,” Clark says. “However, OR personnel may not be trained as well as the [catheterization laboratory] technician in protecting against radiation exposure. Staff, including the surgeon, may resist wearing lead aprons, or ignore badge readings that are too high.”
Steps you can take: “Train staff in radiation protection issues and use of protective equipment,” she says. “Provide individual badge readings to staff and explain what over exposure can result in. Ensure there is adequate protective equipment readily available in OR areas that include lead aprons, barriers, eye protection, and any other appropriate barriers.”
Resources
• OSHA, “Radiation Exposure”
• American Society of Anesthesiologists (ASA), “2012 Operating Room Design Manual: Hybrid Operating Rooms”
8. Automated dispensing cabinet errors
Summary: ECRI reports that mistakes in setting up and using an Automated Dispensing Cabinet (ADU) can result in medication errors, such as placing the wrong drugs in an ADU pocket, understocking drugs, and leaving high-risk drugs in unsecured sections of the cabinet.
“Automated dispensing devices are becoming more frequently used in patient care areas,” says Remy. “The use is primarily to decrease errors, improve efficiency, and increase charge capture. Unfortunately, these units aren’t foolproof and come with some inherent risks.”
Steps you can take: “These [steps] are primarily with overrides and/or workarounds,” he says. “To decrease the risk of errors, nursing staff—and other providers—must be involved in the planning and installation. These must be careful consideration in the planning of the quantity and types of items to be stored. Additionally, the cabinets should be placed in an appropriate location to promote efficient and safe use.”
Remy recommends that organizations establish a quiet zone so nurses aren’t distracted when they’re removing items from the ADU. “It’s a value to have nurses involved in planning and implementation of the units [such as] what items are going to be stored in the units,” he says. “And I also think it’s critical that the cabinets are placed in the appropriate location to ensure appropriate use.”
Resources
• Institute for Safe Medical Practices (ISMP), “Follow ISMP Guidelines to Safeguard the Design and Use of Automated Dispensing Cabinets (ADCs)”
• National Coordinating Council for Medication Error Reporting and Prevention, “Recommendations to Enhance Accuracy of Dispensing Medications”
9. Surgical stapler misuse and malfunctions
Summary: ECRI says some of the problems due to misused or malfunctioning staplers are intraoperative hemorrhaging, tissue damage, unexpected postoperative bleeding, and failed anastomoses. The FDA and ECRI consistently receive thousands of adverse stapler event reports every year. Between 2010 and 2015, 90% of the 8,000–9,000 adverse stapler events reported to the FDA were due to device malfunctions. The remaining adverse events were 9% injuries and 1% deaths.
“The misuse and product failure potentially increases the risk of patient injury from the use of surgical staplers,” Remy says. “Errors can result from: missing staples, missing or incomplete firing, and incomplete or no cutting. All can result in injury to the surgical procedure site or the surrounding tissue.”
Steps you can take: “Keys to preventing injury include thorough and complete education and training for all those involved in the surgical procedure,” he says. “Which of course includes the surgeon using the device as well as the person who has scrubbed and is assisting with use of the device.”
Remy advises organizations to have a close relationship with the vendor who’s selling or providing the device. “They need to be involved with the very thorough and complete training of that device at the facility,” he says. “Typically, when an error occurs the user has an idea of what’s occurred. Often it’s sent back to the manufacturer to have them help determine what’s the reason for the malfunction. And after a malfunction occurs, organizations need to do a thorough evaluation and risk management of the item immediately after use.”
Resources
• FDA, “Surgical Stapler Information”
10. Device failures caused by cleaning products and practices
Summary: ECRI warns that repeated cleanings using incompatible cleaning agents can damage devices over time. These include degrading plastics and lubricants, damaging seals and surfaces, and causing fluid intrusion into the device. What’s particularly dangerous is that these breakages may not be noticeable to the person cleaning or using the device.
“Inherent in the use of device cleaning is the expectation that users follow manufacturers’ written instructions for use,” says Remy. “Manufacturers are obligated to provide details on how a particular product or piece of equipment is to be used and cleaned. At times during product failure analysis it is determined that the product failure, at least in part, was related to improper cleaning. Examples of this are well documented with endoscopy cleaning.”
Steps you can take: “The key is that unfortunately users aren’t fully aware of manufacturer’s instructions for use,” he says. “The manufacturers are obligated by the FDA to provide the instructions for use and how it’s to be cleaned. Likewise, the users have an obligation to follow the manufacturer’s written instructions for use. It’s been well documented in the healthcare industry that organizations aren’t specifically following all the instructions for use and cleaning endoscope scopes, which unfortunately resulted in some cross contamination of some patients. That’s just one example.
“Ultimately the solution to prevent these errors is that staff must be provided with appropriate training, education, and resources, not only on how to use the product but how to clean the product per manufacturers’ written instructions of use.”
Resources
• FDA “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling”