Many hospitals are not carefully cleaning medical devices, a dangerous practice that sometimes leads to infections or even device failure, according to experts at the ECRI Institute.
Faults in device cleaning were a major recurring theme on ECRI's Top 10 Health Technology Hazards list for 2017, which warns providers and manufacturers about potential equipment dangers that need to be addressed in the coming year. The Plymouth Meeting, Pa.-based equipment research organization says that providers need more training for employees who clean devices and more guidance from manufacturers on how to best clean devices in order to avoid infections and device malfunctions.
Infections caused by inadequate cleaning of reusable devices were ranked as the second-biggest hazard on the list, and has been a recurring issue in the industry. Cleaning of flexible endoscopes was the biggest hazard on ECRI's list last year following a major recall of Olympus duodenoscopes that led to infections because they couldn't be cleaned adequately and didn't have good instructions for cleaning.
Scott Lucas, ECRI's associate director of accident and forensic investigation, said the institute expanded the issue to include other complex medical devices because they've received reports that go beyond endoscopes. Even after cleaning, clinicians have reported finding fragments or pieces of tissue remaining on devices like cannulated drills or orthoscopic shavers, he said.
Inadequate cleaning can be caused by untrained staff, but hospitals may also struggle with reprocessing if manufacturers aren't offering proper guidance on what methods should be used to clean devices, what types of brushes or solutions should be used for cleaning and how long the cleaning process should last, Lucas said. In instances like the Olympus duodenoscopes, a manufacturer may tweak a device if its design makes it harder to clean and prevent infection.
ECRI recommends that health systems arrange multidisciplinary and multidepartment committees of sterile processing department leadership, clinical staff, infection control professionals and other employees who deal with wiping down devices before they're used in the operating room and reprocessing in a hospital's central sterile processing unit. In addition to training, these administrators need to examine their reprocessing workflows, to ensure that sterile processing employees aren't working under unreasonable turnaround times that threaten patient safety.
“This really is a systemic challenge,” Lucas said. “It's not just (the sterile processing department) or clinicians. It's really everybody.”
Providers also need to pressure manufacturers to give them as much information as possible about how to best clean devices, Lucas said. He expects that the Food and Drug Administration will lean more on devicemakers to really consider cleaning processes when they're designing devices.
Some manufacturers have already homed in on the cleaning process in an effort to improve. Cincinnati-based Ethicon and its reprocessing subsidiary, Sterilmed, have a relationship with Salt Lake City-based Intermountain Healthcare in which the companies communicate best practices around device reprocessing, and Ethicon is able to learn how to better design devices for more efficient reprocessing.
Devices can also break if they're not cleaned properly, in what is called “environmental stress cracking,” and it ranks 10th on ECRI's list. This can happen as a result of employee ignorance or a lack of guidance from manufacturers. The problems cause serious damage to plastic components of their devices by using improper cleaning solutions or problematic cleaning processes, said Jaime Schlorff, senior project manager in ECRI's health devices group.
For example, a provider using cleaning solution that is not compatible with a device may be causing plastic components to corrode and expose wires, or a worker using too much solution may be causing liquids to seep into the device's interior and affect internal components such as a battery. Preventable cracks in robotic surgery equipment, ultrasound transducers and other equipment have forced hospitals to spend tens of thousands of dollars for replacement parts, Schlorff said.
Manufacturers are constantly investigating cleaning solution compatibility issues, Schlorff said. Hospitals need to stay on top of communications from devicemakers regarding reprocessing and disseminate information to their staff, instead of filing it away, she said.
Errors in large-volume pumps that deliver intravenous medication topped the ECRI list, as the organization has received multiple reports of incorrect infusion programming by staff or pump failures. Other issues included missed ventilator alarms, mismanagement of software updates and inadequate precautions taken to minimize radiation exposure in hybrid operating rooms that contain X-ray machines.