ECRI Blog

Ethylene oxide (EtO) sterilization has been in the news a lot lately, and healthcare has much at stake. According to officials at the U.S. Food and Drug Administration (FDA), approximately 56% of all critical medical devices are sterilized using industrial EtO sterilization. Currently, there are no validated industrial alternatives, so additional closures of EtO processing facilities would have the potential to impair the U.S. healthcare system.

While some state legislators are considering bans on industrial EtO sterilization facilities, healthcare leaders, manufacturers, and FDA have been reviewing options to ensure the availability of sterile medical devices and supplies necessary for patient care.

In the United States, there are 30 times more outpatient visits as hospital discharges. As a result of the high volumes and complexities inherent to ambulatory settings, one in twenty patients can expect to experience a diagnostic error in their lifetime. According to the Agency for Healthcare Research and Quality, 55 percent of patients said that diagnostic errors were a chief concern to them. 

Earlier this fall, ECRI Institute Patient Safety Organization took an in-depth look at patient safety events in ambulatory care, specifically physician practices and healthcare clinics. Nearly half of the 4,355 analyzed events were related to diagnostic testing. Errors that occur during diagnostic testing can have potentially devastating consequences for patients. The majority of these events occurred after tests had taken place, often due to a gap in communication.

Editorial Note: This blog was also co-authored by Shari Medina, MD, of Harris Healthcare, chair of EHRA’s Patient Safety Work Group who led the Partnership for Health IT Patient Safety’s workgroup on this joint project; and Mark Segal, PhD, FHIMSS, principal, Digital Health Policy Advisors.

The United States is in the midst of an opioid use epidemic. Patients, providers, pharmacists, pharmaceutical companies, and electronic health record (EHR) developers have each been highlighted for their role in responding to the crisis. This blog focuses on the role of health IT in particular, and the safe practices that can be put in place for opioid prescribing.

As conveners of the Partnership for Health IT Patient Safety, a multi-stakeholder collaborative, ECRI Institute sees a very important role for developers of EHRs and other health IT in promoting opioid-related patient safety. Employing health information technology (IT) for early identification of at-risk patients and for safer prescribing can promote more efficient deployment of preventive resources and help reduce the risk of persistent opioid use or abuse.

Anti-microbial resistance (AMR) presents serious global concerns, now and in the future. The World Health Organization (WHO) lists AMR as a top ten threat to public health. Last year, there were 700,000 deaths worldwide from AMR. That number is expected rise to 10 million a year in 2050—more lethal than cancer—if we fail to change what we are doing today.

Google the term “superbug” and you’ll see close to 4,000,000 hits. The rise of superbugs—microbes resistant to powerful drugs—led the Centers for Disease Control (CDC) to create the AMR Challenge, a year-long effort to accelerate the fight against antimicrobial resistance across the globe. CDC mobilized commitments from more than 270 countries and organizations around the world, including my organization, ECRI Institute. Action-based commitments are key. Without action, many nations risk slipping back into the pre-antibiotic era, compromising the success of major surgery, cancer chemotherapy, and other health care—and serious economic impacts, too. 

After heart disease and cancer, medical errors are the third leading cause of death in the United States and include misdiagnoses, incorrect anesthesia, delayed treatment, and patient misidentification.

Patient identification has been on the minds of healthcare leaders and policy makers for more than two decades. When the Health Insurance Portability and Accountability Act (HIPAA) was signed into law in 1996, it called for developing a national patient identifier that would solve patient misidentification by assigning a unique, permanent number to every individual in the United States. The idea was to implement a uniform approach for accessing a patient’s medical history across the healthcare system. After HIPAA became law, Congress blocked this effort over privacy concerns, and the issue gradually faded from public attention.

If you’ve been following medical device safety issues this year, there’s a good chance you’ve seen the headlines about patient injuries and deaths related to internal surgical staplers. The devices are commonly used in many high-risk surgical procedures. Misuse and malfunction of surgical staplers can lead to serious complications—as we’ve seen during our own research and accident investigations.

The stapler cases we investigate tend to be associated with serious injuries or fatalities, some of which could have been prevented. The overall adverse event rate is low relative to the number of times staplers are used; however, cases of preventable death are chilling. This has led ECRI Institute to thoroughly research and evaluate staplers and to publish safety hazards to our members. In fact, surgical staplers have appeared twice on our annual list of Top 10 Health Technology Hazards— first in 2010 and again in 2017.

So, why is this decades-old technology in the news now? And, more importantly, what can you do to keep patients safe?

In late 2017, a catastrophic medication error led to a patient death at Vanderbilt University Medical Center. While waiting for a PET scan, an elderly woman was incorrectly administered vecuronium, a paralyzing neuromuscular blocker, rather than the prescribed sedative Versed. It was reported that, because vecuronium suppresses normal respiration and the patient was left unattended while waiting for the test, she suffered cardiopulmonary arrest. Although she was resuscitated, it was too late to prevent brain death, and she was later removed from life support.

This case was widely reported in the media as an example of preventable medical errors that injure or kill too many patients, despite our efforts to make healthcare safer. As we reach the 20-year anniversary of To Err Is Human, the landmark Institute of Medicine report that crystalized the patient safety movement in the U.S., we must humble ourselves with the knowledge that while we’ve made many improvements, there is still much more work to do.