Minnesota Hospital Association

Quality & Patient Safety

April 30, 2009

Minnesota Patient Safety Alert: Ensuring objects used during invasive procedures are intact

Background

The Minnesota Hospital Association (MHA) and the Minnesota Department of Health (MDH) have reviewed data from the adverse health event reporting system and have noted a cluster of retained foreign objects involving devices or instruments in which a component of the object (e.g., an insertion tip or sleeve) is retained or a piece of an object breaks and is retained (e.g., a guide wire used during a biopsy, a catheter tip breaking upon removal or a piece of a drill bit used during an orthopedic procedure). The root cause analyses reviewed for these events indicate that there may not be clear policies in place to assign responsibility for visual inspection of devices and instruments pre- or post-procedure to check for broken or missing components. In some cases, surgical teams may not be aware that a particular device has multiple components that can break or separate, or are not aware that certain components need to be removed when a device is implanted, indicating training and communication as additional contributing factors.

Recommendations

MHA and MDH recommend that facilities revisit their surgical and other invasive procedure policies and processes to address the issue of ensuring objects used in procedures are intact. The following suggestions should be considered in developing processes within your organization:

  • Responsibility is assigned to a specific team role for visualization of equipment/devices that will be used during the procedure to ensure the device and all of its components are intact prior to the procedure and that the device is intact and all components are accounted for following the procedure.
  • Before deployment of a new device or equipment, staff should be educated on all component parts of the object that could potentially be retained or may be at higher risk for breakage.   
  • Any breakage or separation of device components during a procedure, even if the object is not retained, should be tracked to identify potentially higher-risk devices or instruments for breakage.

Additional Actions Implemented by Hospitals Reporting Broken Retained Objects

  • Verification of wire barb removal will take place prior to skin closure through either mammogram or pathology examination of specimen.
  • When possible, device or equipment with removable parts will be replaced with equally effective devices or equipment without removable parts.
  • Work with vendor to modify devices or equipment at higher-risk for breakage or separation.

For more information on this alert, contact Julie Apold, MHA director of patient safety, at japold@mnhospitals.org or (651) 641-1121 or toll-free at (800) 462-5393 or Diane Rydrych, Assistant Director, Division of Health Policy, MN Department of Health, 651-201-3564