Surgical instruments and other critical devices – those that enter sterile tissues1 – are reprocessed and reused every day in hospitals, ambulatory surgery centers, and other health care facilities. Because of the costs of physical space, supplies, equipment, and personnel to perform reprocessing and sterilization of reusable devices, some organizations choose to use disposable instruments and devices for critical procedures in some or all areas of their facility. For organizations performing reprocessing, ensuring that those instruments and devices are reusable – that they are in good condition, and can be cleaned and sterilized following validated manufacturer’s instructions – is critical to patient safety.
In the United States, the Food and Drug Administration (FDA) considers reprocessing instructions part of labeling and in 2015 provided guidance to ensure that the appropriate level of reprocessing is addressed based on the intended use of the device. The FDA also provided guidance for manufacturers to assist in the formulation and scientific validation of reprocessing instructions for reusable medical devices.
Manufacturers of medical devices must submit evidence to the FDA to demonstrate that the device to be marketed is safe and effective. Reprocessing instructions for medical devices should be validated. However, because of the greater risks to the public health posed by some devices, 510(k) submissions for those devices, but not all, must include protocols and complete test reports of the validation of the reprocessing instructions. Manufacturers of devices intended to be used as a critical device and sterilized are required to provide instructions for decontamination, cleaning, and sterilization. Sterilization instructions for medical devices provide the critical parameters that must be followed to achieve sterility of that device – sterilization method, time, temperature, pressure, and dry times. Instructions for reprocessing are not provided for single use items, also called single use devices (SUDs), and may include instruments or devices. . .