Terumo & The FDA
Terumo & the FDA
I placed this article here, because it impacts so many of us in the field.
I firmly support Terumo cv. and the quality of their products-
AND I completely respect the integrity and professionalism of their staff.
I hope the article below- published by AnnArbor.com helps clear up some questions or uncertainties.
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From : AnnArbor.com
[“The issues cited by the FDA investigators included an incident in which a patient died some time after Terumo CVS’ “soft flow arterial cannula” was removed from the patient with a blood “clot found entangled in the diffuser tip of the cannula.”
“Your firm did not document the attempts to retrieve the product from the hospital, or document the reason why no products were returned for investigation,” the Detroit-based FDA investigators concluded in their report. “The investigation conducted by your firm did not include any attempts to try and recreate the problem on the remaining inventory in stock. Only a visual inspection of the remaining stock was conducted.”
The investigators added: “The investigation did not determine if your firm’s product caused or contributed to the patient’s death.”
In response to the FDA’s assertions, Terumo and the hospital that treated the patient jointly investigated the incident and found that the cannula had nothing to do with the patient’s death, said Barbara Schmid, Terumo CVS’ director of corporate communications.
“We are 100 percent convinced and so is the hospital that there is no relation between that cannula and that patient’s death,” she said. “Cardiac surgery is a very, very common procedure and our products are used many, many times every day.”
The FDA, she said, only “felt that we did not do adequate investigation into the incident. That needs to be clear.” ] (AnnArbor.com)
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