Unproven surgical robotic procedures create health hazards

ECRI Institute, an independent nonprofit organization that protects patients from unsafe and ineffective medical technologies and practices, identified unproven surgical robotic procedures as one among the top 10 health technology hazards in its report on Top 10 Health Technology Hazards for 2020.

Produced by ECRI Institute’s Health Devices Group each year, the report identifies the potential sources of danger that warrant significant attention by healthcare leaders in the coming year. The hazards are selected based on an in-depth review of ECRI’s medical device testing, incident investigations, and public and private incident reporting databases.

All robotic surgical systems are used to assist surgeons in performing a comprehensive—and continually expanding—range of minimally invasive procedures. Although the use of surgical robots can help advance clinical practice, such applications can also lead to injury or unexpected complications and the potential for poorer long-term outcomes; the report pointed out.

With their mechanical wrists, surgical robots offer the surgeon benefits such as motion scaling, improved dexterity, and tremor reduction. However, they also have limitations. They, for instance, may not provide tactile feedback on forces exerted on tissue, and adverse events do occur. According to the report, in some cases, complications from a robotic procedure do not appear for years. Notably, in a 2019 Safety Communication, the FDA pointed out the dangers of potential for late-developing complications, which are associated with surgical robot use for some surgeries for cancer.

The report suggests that healthcare needs robust processes for approving the application of surgical robots in new procedures and comprehensive programs for training, credentialing, and privileging surgeons and OR staff for those procedures. For their part, prospective patients should recognize that robotic procedures are not inherently better or worse than traditional minimally invasive procedures. The various surgical options available are likely to have trade-offs in terms of risks and benefits.

This list also focuses on other generic hazards that result from the risks due to the use of certain types of technologies in healthcare, although it does not discuss dangers pertaining to specific models or suppliers.

The full list of 2020 hazards includes:

  • Surgical stapler misuse — malfunctions and misuse can lead to patient harm.
  • Point-of-care ultrasound—speed of adoption has outpaced policies and practices that could prevent misuse or misdiagnosis.
  • Sterile processing errors in medical/dental offices—failure to consistently and effectively sterilize contaminated items can lead to patient infections.
  • Central venous catheter (CVC) risk in at-home hemodialysis—risks associated with CVCs can be particularly dangerous in the home setting, where family members may be ill-equipped to manage the risks.
  • Unproven surgical robotic procedures—surgical robots are being used for an expanding range of methods, sometimes before the risks have been thoroughly assessed.
  • Alarm, alert, and notification overload—a high number of notifications can overwhelm clinicians, creating the potential for a significant event to go unaddressed.
  • Connected home healthcare security risks—an interruption in the transfer of patient monitoring data from cybersecurity issues can lead to misdiagnosis or delayed care.
  • Missing implant data and MRIs—being unaware of a patient’s implant information can put patients in danger and delay MRI scans.
  • Medication timing errors in EHRs—critical medications can be delayed if the order generated from the EHR does not match the dose administration time intended by the prescriber.
  • Loose nuts and bolts in devices—failure to maintain nuts and bolts on medical equipment can lead to catastrophic accidents, harming patients, clinicians, or bystanders.

The Top 10 Health Technology Hazards report is accessible to ECRI Institute members. It provides detailed steps that organizations can take proactively to prevent adverse incidents.

ECRI Institute’s mission is to improve the safety, quality, and cost-effectiveness of care across all healthcare settings. It has the only medical device testing labs in North America and the Asia Pacific, where biomedical engineers conduct hands-on independent device testing for safety and human factors usability. ECRI Institute is designated an Evidence-based Practice Center by the U.S. Agency for Healthcare Research and Quality. ECRI Institute PSO is listed as a federally certified Patient Safety Organization by the U.S. Department of Health and Human Services.