Wednesday April 23, 2014

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Medical device recalled

BC Cancer Agency

The BC Cancer Agency has issued a letter to physicians and their patients who might be affected by faulty rectal paddle devices used during radiation therapy treatment of some patients with cancer of the cervix between November 2007 and April 2012.

BC Cancer Agency will be informing 131 patients and their physicians about a design flaw that has been discovered in one of the components of the instruments used during radiotherapy treatment.  

The problem with the rectal paddles was detected by the BC Cancer Agency, who subsequently immediately removed the paddles from service and notified the manufacturer.   

The manufacturer has now recalled the device. The rectal paddle design flaw made it possible for a small amount of body fluids/contaminants to be retained between components of the paddle over time.

Consultation with infectious disease experts has determined that the risk of infectious disease transmission is minimal therefore additional testing or treatment is not required. Also it should be noted that the design flaw would not have had any impact on the effectiveness of the radiation used to treat the woman’s cervix cancer.

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— Submitted



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