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
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.
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.
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
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.
with vendor to modify devices or equipment
at higher-risk for breakage or separation.
more information on this alert, contact Julie
Apold, MHA director of patient
safety, at firstname.lastname@example.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