Pre-Use Inspection of Disposables (Update)
Hazard Update [Health Devices Mar 1997;26(3):125-6]
ECRI continues to receive and investigate problem reports involving
disposable medical devices. These problems range from packaging defects and mislabeling to
device defects. In some cases, the problems have been hazardous or
life-threatening—for example, breathing circuits occluded by mold flashing that could
cause barotrauma or hypoxia, and packaging with sterility breaches that could lead to
infections. Although some investigations reveal a significant problem with a device or a
particular lot that merits publication as a Hazard Report in Health Devices or an
Action Item in Health Devices Alerts, the majority of reports concern isolated or
Manufacturers' quality control (QC) procedures usually detect defective
disposables before they are distributed. But many QC procedures for disposables must be
based on statistical sampling methods, since a 100% inspection would be impractical or
could significantly increase costs. Furthermore, manufacturers' QC inspections cannot
catch defects in packaging that occur during or after shipping, or product degradation due
to storage under inappropriate conditions. In addition, some hospitals today are
resterilizing open but unused disposables or are reusing disposables, which could create
additional problems: 1) equipment might be damaged during sterilization; 2) this damage
could be missed, since sterilized equipment can be difficult to inspect; and 3) inasmuch
as the equipment was already inspected once, reinspection after sterilization might not be
performed. For these reasons, some defective devices will inevitably reach the clinical
To minimize the impact of defective disposables on patient care, ECRI
recommends pre-use inspection of every disposable medical device. General procedures for
pre-use inspection are given below in our Recommendations. In most cases, such inspection
will take only a few minutes. Note that, when practical, the first steps in pre-use
inspection should be to visually examine the disposable through the packaging for obvious
defects, check the condition of the packaging, and confirm that the device is appropriate
for the procedure. While "through the packaging" inspection cannot substitute
for inspection of the device outside of the packaging, it may reduce the number of
packaged sterile devices being opened in error.
Manufacturers are the first line of defense in device-related patient
safety, and improved inspection procedures on their part should reduce the incidence of
disposable device failure; but the user's role in detecting and reporting faulty or
defective devices to the manufacturer is essential. We urge readers to continue submitting
problem reports to ECRI so that we can evaluate them for trends or lot-specific problems.
- Consistently perform brief pre-use inspections,
focusing on both the packaging and the device. Typical steps include the
- Before opening the package, conduct a
visual through-the-packaging inspection of the device for obvious
- Check the package integrity. Are the
package and seals intact?
- Verify the package label. Is this the
correct device for the patient and procedure? Does the label
accurately identify the type and size of device contained in the
package? If the device has an expiration date, has the date passed?
- Is there any debris or unidentified
material within the package?
- Check the label instructions to ensure
proper usage. Instructions are sometimes changed, and the label may
not clearly indicate that a change has occurred.
- Is the device complete and properly
- Are all lumens patent and balloons intact?
- Are there any external defects (e.g.,
broken insulation of disposable electrodes, cracks or splits in
- Are all connections and junctions intact
- Are all valves and ports properly oriented and
- Record the device, model, lot number, and
expiration date (when applicable) of any defective product. Save the device
and its packaging if possible. In addition, when feasible, retain two or
three unused samples from the same lot for further examination and testing.
- Contact the manufacturer, ECRI, and the U.S. Food and Drug
Administration (FDA) to report any defective products or packaging.
Cause of Device-Related Incident
Device factors: Manufacturing error; Packaging error; Random component
User error: Failure to perform pre-use
Support system failure: Lack or failure of incoming and pre-use
Mechanism of Injury or Death