The potential for the malfunction and misuse of surgical staplers to cause harm to patients is the number one health technology hazard that hospitals should focus on in 2020, according to the ECRI Institute. "Injuries and deaths from the misuse of surgical staplers are substantial and preventable. We want hospitals and other medical institutions to be in a better position to take necessary actions to protect patients from harm," Marcus Schabacker, MD, PhD, president and CEO, ECRI Institute, said in a statement. Surgical staplers have garnered increased attention in the past year. In March, as reported by Medscape Medical News, the US Food and Drug Administration (FDA) sent an alert to clinicians about an increase in the number of medical device reports (MDRs) regarding the use of surgical staplers. From January 1, 2011, to March 31, 2018, the agency received more than 41,000 individual MDRs regarding surgical staplers and staples for internal use. There were reports of 366 deaths, more than 9000 serious injuries, and more than 32,000 malfunctions, the agency said in a March 8 letter to clinicians. In June, the FDA's General and Plastic Surgery Devices Panel recommended reclassifying surgical staplers from class I medical devices, which are subject only to general controls, to class II devices, which are subject to general and special controls. The ECRI Institute's Top 10 Health Technology Hazards, now in its 13th year, identifies health technology concerns that the organization believes warrant the greatest attention by healthcare leaders for the coming year. The hazards are selected on the basis of a rigorous review of ECRI's incident investigations, medical device testing, and public and private incident reporting databases. The list, which is produced by ECRI's Health Devices Group, is accompanied by practical strategies hospitals and healthcare providers can take to reduce the risks. Risks 2 to 5 Taking the number 2 spot on the list of top tech hazards for 2020 is point-of-care ultrasound (POCUS), because the increase in its use is outpacing policies and practices that could prevent misuse or misdiagnosis, the group notes. Patient safety concerns include POCUS's not being used when warranted, misdiagnoses, inappropriate use of the modality, and overreliance on POCUS when a more comprehensive examination by an imaging specialist is indicated, the group writes. "Policies and procedures should address institution-wide concerns, including user training and credentialing, exam documentation, and data archiving. And they should address specialty-specific issues, such as developing exam protocols that conform to established guidelines and recommendations," it suggests. Number 3 on this year's list is the risk for infection associated with sterile processing errors in medical and dental offices. Failure to consistently and effectively clean and disinfect or sterilize contaminated items before use can expose patients to virulent pathogens, the group notes. It suggests designating a qualified staff member or contractor to support office infection prevention and control practices; providing appropriate training for benchtop sterilizer operators; and conducting periodic competency testing. Number 4 on the list is central venous catheter (CVC) risks associated with at-home hemodialysis. The federal government recently announced a push to increase the use of home treatment for patients with kidney disease. The possibility that more patients with CVCs might receive hemodialysis in the home raises concerns. For patients who receive hemodialysis through a CVC, the risks associated with home dialysis may outweigh the benefits, the group says. Number 5 on the list is unproven surgical robotic procedures. "Surgical robots are being used for an expanding range of procedures, sometimes before the risks have been fully assessed," the group notes. They call on healthcare facilities to develop robust processes for approving the use of surgical robots for new procedures, as well as comprehensive programs for training, credentialing, and privileging surgeons and operating room staff for those procedures. The Final Five Rounding out the top 10 technology hazards ECRI says warrant the greatest attention in the coming year are the following: 6. Alarm, alert, and notification overload, which can overwhelm clinicians, creating the potential for a significant event to go unaddressed. 7. Cybersecurity risks in the connected home healthcare environment, which can lead to an interruption in transfer of patient monitoring data, potentially leading to misdiagnosis or delayed care. 8. Missing implant data in relation to MRI; being unaware of a patient's implant information can put patients in danger and delay MRI scans. 9. Medication errors from dose timing discrepancies in the electronic health record, which can have significant clinical consequences. 10. Loose nuts and bolts in devices, which can lead to catastrophic accidents, harming patients, clinicians, or bystanders. Source
