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

Clinical Specialty or Hospital Department
Anesthesia; Cardiology / Cardiac Catheterization; CCU / ICU / NICU; Clinical Laboratory; CSR / Materials Management; Dialysis; Emergency Medicine; 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 (Update)



Hazard Update [Health Devices Mar 1997;26(3):125-6]

Problem

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 random defects.

Discussion

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 setting.

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.

Recommendations

  1. Consistently perform brief pre-use inspections, focusing on both the packaging and the device. Typical steps include the following.
    • Before opening the package, conduct a visual through-the-packaging inspection of the device for obvious defects.
    • 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 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, 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 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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