Cause of Device-Related Incident
Device factors; Support system failures; User errors

Clinical Specialty or Hospital Department
Anesthesia; Cardiology / Cardiac Catheterization; CCU / ICU / NICU; CSR / Materials Management; Dialysis; Emergency Medicine; Infection Control; Nephrology; Nursery; Nursing; Obstetrics and Gynecology; OR / Surgery; Pediatrics; Pharmacy / IV therapy; Pulmonary / Respiratory Therapy

Device Factors
Manufacturing error; Packaging error; Random component failure

Document Type
Hazard Reports

External Factors
*Not stated

Mechanism of Injury or Death
Various

Support System Failures
Lack or failure of incoming and pre-use inspections

Tampering and/or Sabotage
*Not stated

User Errors
Failure to perform pre-use inspection

Pre-Use Inspection of Disposables



Hazard [Health Devices Feb 1989;18(2):87]

Problem

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.

Discussion

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 clinical setting.

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.

Recommendations

  1. 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 assembled?
    • 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 secure?
    • Are all valves and ports properly oriented and functional?
  2. 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.
  3. Contact the manufacturer and ECRI to report any defective products.

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

Various


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