For the past 13 years, patient safety organization ECRI Institute has published a Top 10 Health Technology Hazards list. The list serves to make healthcare organizations aware of potential dangers the organization deems the highest priority for the coming year. Although ECRI targets its list to healthcare facilities, medical device manufacturers can use this list to develop safer products.
For 2020, the highest priority health tech hazards reflect our changing healthcare environment. Instead of receiving care primarily in hospitals, patients spend more time at ambulatory surgical centers, outpatient offices, and their own homes. The report suggests medtech would do well to consider all environments when developing products.
For example, what happens when an infusion pump, designed to be used by trained clinicians in a controlled hospital environment, starts beeping in a patient’s home? A caregiver may not know what the alarm means or what steps to take. They just know they want the noise to stop.
Infection risks that stem from improper cleaning of medical and dental devices rank third on ECRI’s 2020 list. Erin Sparnon, ECRI’s Health Devices Group senior engineering manager, suggests suppliers stay vigilant about providing updated, validated cleaning methods and addressing cleaning and sterilization protocols in all types of environments.
“Making sure these facilities have validated cleaning and inspection procedures that are reasonable and achievable is extremely important,” says Sparnon. “Perhaps they need to ask questions such as, ‘What type of staff are going to reprocess these devices? Is there a central sterilization department that can handle complex cleaning needs or is it a busy nurse who has no time?’ All facilities, whether a hospital or an offsite center, should have an easier time following instructions.”
Too Many Alarms
Alarms, in many guises, have made ECRI’s lists for at least the past seven years (the number of reports reviewed). Improperly set ventilator alarms, inadequate alarm configuration policies, missed alarms and—this year—alarm, alert and notification overload put patients’ health at risk.
Alarm fatigue is a known issue among clinicians. An article in AACN Advanced Critical Care reports an alarm analysis at The John Hopkins Hospital in Baltimore, Maryland, revealed an average of 350 alarms per patient per day over a 12-day period. Clinicians become desensitized to all the beeps and blips and miss critical warnings about a patient’s condition.
At the hospital level, ECRI recommends implementing measures that reduce the number of notifications from phones, EHR portals and devices combined. Addressing it at the device level—reducing the number of false alarms or advanced customization, for example—is one piece of a more holistic alarm management approach that can help reduce clinical errors.
Radiation exposure hasn’t made ECRI’s list since 2018, but it remains a top concern. Surgeons are routinely exposed to intraoperative radiation, while patients risk overexposure during exams. Both face an increased risk of cancer and other diseases caused by radiation exposure.
Shielding, dose-reduction techniques, and advanced navigation technologies help reduce radiation exposure. The latter method, however, has not been widely adopted due to cost, lack of training and increased operating time.
In 2010, FDA launched an initiativeto reduce radiation exposure among patients through justification of the procedure and dose optimization. Education and awareness, combined with technological advances and the rise of dose-monitoring tools, have led to a decrease in radiation use and dose. However, it takes policy change to effect real change.
“These technologies and approaches need to actually be used in order to provide safety gains,” says Sparnon. “So even though it's possible that hospitals have machines equipped with dose-limiting technologies, it's important that they have policies and procedures in place to make sure they are enacted when needed.”
Other hazards that have remained a consistent Top 10 concern over the past five-plus years include:
• Security breaches and ransomware attacks (#7 this year)
• Technology issues, which includes insufficient training and documentation, software management gaps and EHR discrepancies
• Misuse of surgical staplers
Generally, Sparnon says medical devices do a good job of performing their required functions. However, developers can use ECRI’s hazard lists as guides for future product development. Can developers introduce a feature that would help reduce or eliminate one of these risks? Patient safety advocates would like to think so.
“We’ve taken time to derive the causes and effects of health hazards and provided recommendations for addressing them,” says Sparnon. “Device suppliers and manufacturers are important partners in making devices that are safe to use, safe to clean, safe to operate, and safe to maintain. All of these components can help our patients stay healthy.”