Central Sterile Services: The Critical Link between Manufacturer and Surgeon

Abstract

It is at the time of use that a medical device must perform exactly as it was designed and intended. It is the role of Central Sterile Services (CSS) to assure this objective. To accomplish this challenging task, CSS needs the support and expertise of device manufacturers.Often, as devices are introduced into a hospital, the manufacturer's representative instructs nurses and physicians on how to use the device. Unfortunately, the CSS staff may be overlooked entirely, which can lead to errors. Processing errors undermine patient care and can erode clinical satisfaction with the device. It is important to understand that the manufacturer's representative may be knowledgeable in the use of the device, but lack reprocessing knowledge.CSS plays a major role in device use. This is especially true for devices undergoing sterilization. Before the device is packaged, the CSS technician is the last one to handle it. Once the device is packaged, it is sterilized. When it is opened, it is intended to be used directly on a patient; there is no room for error. The device must be sterile and fully functional.To help ensure that a device is prepared exactly as intended, manufacturers should include CSS staff in device introduction and training. It is incumbent upon the manufacturer to consult the CSS manger when introducing new devices into the healthcare facility. This helps to ensure that the proper resources—such as staffing, time, equipment, and packaging—are available. Training CSS staff is every bit as important as training the direct caregivers. For best results, the initial training should take place with a manufacturer's representative. The training must be based on the manufacturer's “instructions for use” (IFU) and a standard CSS processes. Therefore, the representative must be fully educated on all facets of device processing that are stated in the IFU. It's essential that all CSS processes—including cleaning, quality assurance, assembly, disinfection or packaging requirements, and sterilization modalities—are addressed, starting when the device arrives in the decontamination room.Healthcare facilities must have current IFU on file for reference. Having additional training resources further helps in consistent accurate preparation of the device. Training material that CSS staff often find effective include training booklets, wall charts, and videos. Many manufacturers have their IFU, along with instructional videos, posted on their website. In addition, some manufacturers of complex devices have “train the trainer” programs or specialists trained for the reprocessing function. Periodic training programs might be needed to clear up any misunderstandings and ensure everyone understands proper procedures.The bottom line: Even though CSS professionals are not present in the delivery of patient care, they—along with nurses, physicians, or radiology technicians—are crucial members of the patient-care delivery team. To help assure that a device functions exactly as it was designed, the manufacturer must team up with CSS to provide the necessary training and support. After all, the CSS technician is the last person to handle a sterile device before it is presented to a surgeon and used on a patient.