Pre-Use Inspection of Disposables
Hazard [Health Devices Feb 1989;18(2):87]
ECRI continues to receive and investigate problems involving disposable
medical devices. These problems range from packaging defects and mislabeling to defects in
the device itself, such as catheter lumen occlusions and breathing circuit connector
failures. Although some investigations reveal a significant or lot-specific problem and
merit publication as a hazard report in Health Devices or an Action Item in Health
Devices Alerts, the majority identify isolated or random defects.
Manufacturers' quality control (QC) procedures usually detect defective
disposables before they are distributed. But many QC procedures for disposables are based
on statistical sampling methods because a 100% inspection may not be practical for some
devices or, if implemented, could significantly increase costs. Furthermore,
manufacturers' QC inspections cannot catch defects introduced during shipping or caused by
inappropriate storage conditions. Inevitably, then, some defective devices will reach the
To minimize the impact of defective disposables on patient care, ECRI
recommends pre-use inspection of every disposable medical device. In most cases, such
inspection will take only a few minutes.
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. Please continue to submit 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.
- Check the package integrity. Are the package
and seals intact?
- Verify the package label. Is this the
correct device? Does the label indicate the device and size
contained in the package? If the device has an expiration date, has
this date passed?
- Is there any debris or unidentifiable
material within the package?
- Check the label instructions to ensure
proper usage. Instructions are sometimes changed, and the label may
not clearly indicate when 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 catheters)?
- Are all connections and junctions intact and
- 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 and ECRI to report any defective
Cause of Device-Related Incident
Device factors: Manufacturing error; Packaging
error; Random component failure
User error: Failure
to perform pre-use inspection
Support system failure: Lack or failure of
incoming and pre-use inspections
Mechanism of Injury or Death