Responsibilities for Effective Medical Device Reprocessing Procedures and Instructions

摘要

In hospitals throughout the world, the reprocessing of reusable medical devices and instruments is a daily requirement. Medical devices intended for reprocessing are, in most cases, made of robust materials that can withstand the multiple reprocessing steps of cleaning, disinfection, and sterilization. However, there has been a recent increase in the United States in the number of new devices that are more challenging to reprocess.As surgeons seek better surgical therapies and develop new minimally invasive and image-guided procedures to improve patient outcomes, manufacturers are developing delicate and sophisticated reusable surgical devices, such as robotic surgical instruments, to enable these procedures. These cutting-edge technologies are, of course, a benefit to patients, but can also pose a risk, as some of these devices are challenging to reprocess.The U.S. Food and Drug Administration (FDA) mentions endoscopes as “an example of reusable medical devices that … pose particular challenges to reprocessing,” with 80 reports of inadequate reprocessing of endoscopes and 28 reports of infection that may have occurred from improperly reprocessed scopes between Jan. 1, 2007 and May 11, 2010.1Ultimately, the responsibility for ensuring correct reprocessing procedures and thorough instructions is shared by the FDA, the medical device industry, and healthcare facilities.2 This article serves as an introduction for healthcare professionals on responsibilities for optimizing the efficacy of all reprocessing procedures and instructions in their facilities, to promote ideal outcomes, and ensure patient safety.Due in part to the increasing complexity of device designs and components, the FDA requires cleaning validation studies of each device, from the device's manufacturer, to ensure adequate reprocessing of complex device designs and components.The FDA does not require disinfection unless the device is to be used on a patient. Manufacturers are also required to provide clear processing instructions for the user. Such procedures and instructions for use (IFU) are typically shipped with each medical device.3 Manufacturer requirements include:In addition, clear labeling that provides instructions for cleaning, decontaminating, sterilizing and performing preventive maintenance should be included in the documentation. FDA evaluation and guidance also extends to device design. For example, according to the FDA's analysis, features that facilitate correct reprocessing of medical devices such as endoscopes include:Healthcare facilities should ensure that everyone engaged in reprocessing medical devices adheres to the manufacturers' instructions and guidelines. This includes OR staff, who may be called upon to reprocess a medical device.However, in addition to reinforcing team-work, it is vital to designate responsibility for the oversight of reprocessing procedures. Specific members of the team should be designated responsibility for reprocessing equipment, and should have adequate training at periodic intervals. Verification of training must be documented in the hospital or facility. Well-trained personnel and effective teamwork translate into fewer reprocessing errors and superior outcomes.The operating room (OR) is a fast-paced environment, and OR staff members often feel pressure to turn over their suite as quickly as possible to prepare for the next case. When there are time constraints, point-of-use precleaning is not always performed thoroughly or completely, and this can lead to extended reprocessing times in the sterile processing department.The OR and sterile processing management teams can work together to develop specific procedures and instructions (PI) that are compliant with best practices, and train staff on the correct precleaning of medical devices. Good PI, if consistently adhered to, can help improve reprocessing outcomes and patient safety, enhance staff satisfaction, and optimize the reprocessing flow. The key componen