Implant Recall

Class I Recall Due to Lack of Cleaning Validation                                            and Controls to Ensure Product Cleanliness Last month (November 26, 2018), the FDA published yet another Class I recall notification for a medical device due to a lack of adequate cleaning validation and controls to ensure the cleanliness of the device. Zimmer Biomet, Inc. is recalling their Spinal Fusion and Long Bone Stimulators “due to a lack of adequate validation and controls to ensure that final products were clean and free from bacteria and chemical residue.”¹ According to the FDA, Class I product recalls are serious because the use of an adulterated or contaminated Class I recall device has the potential to expose a patient to great harm, or even death. The recall notification details can be found here. This recall was necessitated “due to a lack of adequate validation and controls to ensure that final products were clean and free from bacteria and chemical residue.”² This Class I recall clearly demonstrates the need for all device manufacturers to validate their cleaning controls and processes. In the absence of such validation, they have no way to ensure that their products are clean and free from organic debris and/or chemical residue. Just as device manufacturers need to validate their cleaning controls and processes during the manufacturing process, healthcare facilities also need to ensure that the devices they use have had their cleaning IFUs validated. This blog frequently discusses the need to demand validated cleaning instructions for use (IFUs) from all of your reusable medical device suppliers. In the absence of validated cleaning IFUs, you and your staff have no way of ensuring clean, sterile, moisture-free instruments for every patient, every time. 1. FDA Medical Device Recall November 26, 2018 https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm626704.htm 2. Op. Cite.