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Sterile Devices

Notice type: Advisory

Date: 14/10/2004

  

Product name or type:
Sterile Devices

Reference:
SN2004(09)

Manufacturer Or Supplier:
Various

Target Audience:
Risk Managers; Nursing Managers; Theatre Managers; Wound Care Departments; Stores Personnel; Laboratory Managers

Problem Or Issue:
Damaged packaging may compromise the sterility of a medical device

Background Information Or Related Documents:
Over the past three years, the IMB has been notified of medical devices that have been discovered with damaged packaging, which could potentially compromise the sterility of the device.  Several of these incidents have resulted in device recalls.

Sterile Devices Document

Actions To Be Taken:
  • Examine all packaging before use to ensure that there are no defects e.g. holes, tears,   items caught in the seal.
  • Do not use any devices that are found to have defective packaging.
  • Ensure that care is taken when using blades or sharp implements to open the outer packaging / boxes.  
  • Ensure that all devices are stored as recommended by the manufacturer, with adequate space and away from sharp edges or objects.
  • Advise the IMB of any devices that you discover with defective packaging

Further Information:
All adverse incidents relating to a medical device should be reported to the:   

Medical Devices Department 
Health Products Regulatory Authority
Earlsfort Centre 
Earlsfort Terrace 
Dublin 2   

If you have any enquiries, you may contact the Medical Devices Department at:   

Telephone:    +353-1-6764971 
Fax:              +353-1-6767836 
Email:           medicaldevices@imb.ie
Website:        www.hpra.ie 

SN2004(09): Sterile Devices

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