ECRI releases top 10 list of technology hazards
Reprocessing, retained items, robotic surgery listed
Several areas of outpatient surgery practices were included in this year’s Top 10 Health Technology Hazards from Plymouth Meeting, PA-based ECRI Institute. ECRI Institute is an independent nonprofit that researches approaches to improving patient care. New topics on this year’s list include hazards related to radiation exposure in hybrid operating rooms and complications arising from insufficient training in the application of robotic surgery.
This year’s top 10 list include:
6. Inadequate reprocessing of endoscopes and surgical instruments.
Reprocessing staff may be pressured to take shortcuts, warns Chris Lavanchy, engineering director, Health Devices Group at ECRI. "Facilities may not have enough instruments for demand, which puts even more pressure on processing folks to turn around and make sure everything is in shape for the next patient," Lavanchy says.
Communication also is a key factor, he says. "What we’ve seen, at accident investigations in hospitals or other facilities, that when there is good communication between reprocessing and surgical staff, it is less likely that problems can exist for long period of time and not be discovered," Lavanchy says. "When a good partnership exists between the surgical and reprocessing staff, and there’s a more seamless operation, it is less likely that instruments not being properly reprocessed is going to be a problem."
No instrument should ever be reused without proper cleaning, says Steve Trosty, JD, MHA, CPHRM, ARM, president of Risk Management Consulting Corp. in Haslett, MI. "This should be in the policy and procedure manual, included in training for all staff involved in surgery or procedures, and be part of what all physicians are told is required for all surgeries and procedures," Trosty says.
Single-use instruments should be used only the one time, he says. "This should be contained in appropriate policies and procedures, included in training for staff, and clearly told to all physicians," Trosty says. "Reusing single-use instruments can increase liability to the clinic and negate any warranty that comes with the instruments, since they would not be used as intended and not in conformity with instructions for their use that would have been provided by the manufacturer."
Also, items that can be reprocessed should be sent to a reprocessor approved by the Food and Drug Administration that is insured, says Mark Mayo, executive director of the ASC Association of Illinois and principal in Mark Mayo Health Care Consultants in Round Lake, IL.
9. Robotic surgery complications due to insufficient training.
There are major concerns due to an increase in the number of adverse events from robotic surgery reported to the Manufacturer and User Facility Device Experience Database (MAUDE), says Christopher Schabowsky, PhD, senior project officer, Health devices Group, ECRI. However, the Food and Drug Administration (FDA) doesn’t validate the accuracy of those reports, Schawbowsky says.
"Although there are increases in voluntary reports, it’s harder to determine if root cause is the robotic system, surgical team training issues, or hospitals that have more robust adverse event and near miss reporting," he says. Another variable is the increase in the number of robotic procedures performed worldwide, Schabowsky says.
There should be an established strict credentialing and privileging program for surgical staff who use the robotic systems, he says. For example, the program should include observing robotic surgery cases, participating in dry surgery runs, and undergoing a competency exam by a skilled proctor. Also have annual skill audits, he says.
Create a multidisciplinary, leadership level, surgical robotic safety committee, Schabowsky advises. Include senior clinical and technical staff from each service line and risk management staff, he says. "This committee should be tasked with developing and reviewing and updating robotic surgery safety policy and procedures," he says.
Establish a centralized incident reporting and investigating system for robotic surgery, Schabowsky says. "This system should encourage reporting of near misses and incidents to assess the root causes of these problems and educate staff about these issues," he says.
10. Retained devices and unretrieved fragments.
Scan patients using radiofrequency detection systems before closing to ensure you removed all sponges, says Lavanchy.
To avoid unretrieved fragments, surgeons should examine instruments briefly before using them, he says. At the end of the surgery, a staff person should examine them again to ensure there is no obvious component missing, Lavanchy says. Take an X-ray if there is any serious concern regarding a potential item left inside the patient, Trosty adds.
The other items in the top 10 list include:
1. Alarm hazards.
2. Infusion pump medication errors.
3. CT radiation exposure in pediatric patients.
4. Data integrity failures in EHRs and other health IT systems.
5. Occupational radiation hazards in hybrid ORs.
7. Neglecting change management for networked devices and systems.
8. Risks to pediatric patients from "adult" technologies.
Clinical alarm hazards remain at the top of the list due to their prevalence, their potential to result in serious patient harm, and the increased attention they will receive from The Joint Commission this year. In an April 2013 Sentinel Event Alert, The Joint Commission cited 98 alarm-related events over three and one-half years, with 80 of those events resulting in death and 13 resulting in permanent loss of function. (For more information, see "Teen’s death, $6 million settlement put the spotlight on alarm fatigue The Joint Commission issues `Sentinel Event Alert,’ considers NPSG," Same-Day Surgery, June 2013, p. 61.)
The executive brief version of ECRI Institute’s annual Top 10 list of health technology hazards is free at www.ecri.org/2014hazards.