Ask HRC: Certificate of Medical Necessity Following Device Recall

January 15, 2013 | Healthcare Risk, Quality, & Safety Guidance

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The manufacturer of a high-frequency ventilator initiated a voluntary recall of a disposable breathing circuit for its ventilator after receiving reports that the heater wire insulation of the circuit can melt, causing the circuit to overheat and emit smoke. Although the company had not received any reports of patient injury or death associated with the problem, it said the potential exists for adverse events to occur, such as patient burns as a result of fire in an oxygen-rich environment, and categorized the recall as Class I to indicate that the defective product can cause serious health problems or death. Until the company could introduce a modified breathing circuit with a heater wire insulation with a higher melting temperature rating, it gave users of the ventilator two options: to continue to use the breathing circuits after following measures recommended by the company to reduce the likelihood of a device failure or to return the defective products to the company for credit. If a healthcare organization chose to continue to use the breathing circuit, the company required the organization to return a signed certificate of medical necessity to the company. The certificate authorizes the company to continue to ship the breathing circuit to the healthcare organization. The authorized signer attests that the organization has “a medical necessity to use these circuits and feels that the benefit of their use will outweigh the risk to patients and healthcare providers.”

An HRC member asked for ECRI Institute’s opinion about signing the certificate. Occasionally, other device manufacturers have required a certificate of medical necessity if a healthcare organization is...

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