Surgical staples now top ECRI Institute’s annual list of potential healthcare device concerns that need the industry’s closest attention. ECRI believes staples are the danger area most in need of prioritizing now.
Their 2020 report says their list represents “problems that can be avoided or risks that can be minimized through the careful management of technologies.”
The ECRI Institute is a nonprofit authority on medical practices and products. It provides systematic studies for federal and state agencies and for healthcare organizations worldwide.
Surgical staples are a major factor in medical errors
The common office paper stapler seems simple, but ECRI calls surgical staplers “complex devices requiring meticulous technique to operate.”
Generally, the staples and stapling devices do not cause the problems. Instead, using the wrong staple size, stapling tissue that is too thick or thin, or stapling over other staples cause most errors.
The rate of problems is low, but surgeons use these staples so often that the number of incidents is large.
The FDA reports that since 2011 staples factored into:
- 100,000 incidents.
- 412 deaths.
- 11,181 serious injuries.
- 98,404 malfunctions.
Institute calls for practice, practice and more practice
Unwanted incidents involving surgical staplers sometimes include:
- Damaged tissue.
- Inadequately joined tissue.
- Heavy or uncontrollable bleeding during operations.
- Unexpected bleeding after operations.
ECRI has a strong suggestion for how healthcare providers might try to avoid future problems.
It suggests focusing on hands-on practice for health care practitioners using the specific model of stapler they will use in surgery.
The 2020 list includes nine other major areas
A few other places where ECRI sees outsized risks to patients for this year’s list include:
- Sterile processing in medical and dental offices.
- Robotic surgery procedures.
- Alarms, alerts and notifications.
- In-home healthcare cybersecurity.
- Medication based on electronic health records.
Number 10 in the list for 2020 is loose nuts, bolts and screws in medical devices in need of maintenance. These can result in machines falling and injuring patients, staff or bystanders. These malfunctions can also mean dangerous care-scheduling problems.