Earlier this week six medical groups sent a letter to FDA’s General Hospital and Personal Use Devices Panel to voice concern over limiting ethylene oxide (EtO) sterilization of critical medical devices, as it could in turn limit the availability of those devices to patients. The letter was sent in advance of the Medical Devices Advisory Committee meeting, which will discuss the use of EtO sterilization of devices as well as maintaining public health. The meeting will take place on November 6 and 7.
The groups acknowledge that minimizing health risks to employees and the environment is important but state that many critical devices, such as pacemakers and leads, angioplasty balloons, stents and catheters, use the EtO method for sterilization, and the availability of alternative sterilization processes is “limited”.
“Given that the FDA mandates that medical device approval applications for these complex devices contain appropriate data to support the required sterilization process, not only would a new process need to be developed, but the process would also need to be tested and validated in each medical device,” the letter states. “Thus, any shift would require an appropriate period to develop the necessary protocols, test those protocols, then replicate them throughout various supply chains with an acknowledgement that these additional steps will likely increase costs to our patients.”
The letter was sent by the American College of Cardiology, American Society for Gastrointestinal Endoscope, the Heart Rhythm Society, the Society for Cardiovascular Angiography and Interventions, the Society of Interventional Radiology and the Society of Thoracic Surgeons and has been made available by AdvaMed.