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• W2034211488 abstract "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 components of end-of-case PI (Figure 1) would include:Procedures and instructions should describe how a task is to be performed, with enough detail to ensure that each medical device is reprocessed in accordance with the manufacturer's guidelines. Procedures and instructions are generally presented as a structured list, with each level potentially including text, technical drawings, pictures, and assembly specifications.Because many current medical devices are highly complex, all procedures and instructions should include diagrams, photos, and other visual aids to augment the text and help the user. They should also be designed to provide a documented step-by-step sequence that offers the most efficient method to perform the designated task. If PI are poorly designed, errors or inefficiency may result, negatively impacting overall reprocessing quality and workflow.The volume and variety of medical devices used in modern healthcare facilities can be daunting. Developing specific procedures and instructions for every variation of a medical device would be extremely challenging, and could lead to reprocessing errors. In some cases, it may be more efficient and productive to generalize certain procedures or instructions for similar types of instruments.For example, it would not be necessary to create an inspection PI for every type of ringed forceps or scissor. There are always exceptions, but in general the procedures and instructions for inspecting these types of devices have much in common. Figure 2 shows an example of common procedure when inspecting medical devices and testing standard work.The complexity of a specific PI is determined by three primary factors: the total inventory of reusable medical devices, staff involved, and available equipment and operations. The efficiency of PI and their related processes has a direct and significant impact on a reprocessing department's overall performance. Ideally, PI in the SPD should be in a complete, accurate, and updated form. However, PI are not always readily accessible for reprocessing personnel, and are not always fully integrated into a reprocessing department's quality assurance program.With current advances in information technology, this task can be less daunting. Many of today's instrument management systems are capable of uploading PI directly to a software platform. These computer-based systems make it easier for sterile processing technicians and OR staff members to access the PI on a monitor at their workstation. If computer-based systems are not available, hard-copy manuals must be printed and distributed to all departments that reprocess medical devices. The responsibility for updating and scheduling regular reviews of all PI manuals should be assigned to a member of the sterile processing management team.All sterile processing personnel and other healthcare workers who may be called upon to reprocess a medical device should be trained with these manuals, and informed of updates. This includes surgical scrub personnel, who may occasionally be expected to work in other services that require precleaning or reprocessing activities. Verification of training is also essential to ensure that staff members remain current.Although manufacturers are required to provide instructions for use for their medical devices, there are many variations in format from one manufacturer and type of device to another, which may be challenging for users. For this reason, consistency is the key to developing clear, easily understood PI for healthcare employees.If reprocessing personnel can rely on PI, they can find what they are looking for more readily, and work more efficiently. Management and staff should collaborate on the development of a PI format that works well within their facility. Once thorough procedures and instructions have been developed, guidelines for consistent implementation can be instituted.Management should apply quality performance indicators to measure the efficacy of reprocessing PI. A “quality incidents indicator” should provide an easy and straightforward reporting method for reprocessing quality defects or issues. It should also include routine recording and trending of issues, by type, and by individual. Graphics and other visual layouts can be used to clarify such data for personnel.Such “dashboard” tools should also be utilized to identify and correct individual employee practices that result in error. Management is responsible for overseeing identification of quality defects, as well as developing, implementing, and following up on action plans to continually improve the department's individual and collective performance and results.It is clear that there are multiple benefits to thoughtfully designed, effective procedures and instructions, including satisfied surgical customers, satisfied staff, improved reprocessing quality, a potential decrease in medical device repair costs, productivity gains from improved compliance, and most importantly, a potential decrease in risk to patients.In order to achieve these benefits, a facility can begin to review and enhance PI by asking the following questions:Although the responsibility for ensuring first-rate reprocessing procedures and instructions is a shared one, healthcare professionals can have significant impact in their own departments. There is room for improvement in many facilities, but with a renewed understanding of how to begin making these improvements, healthcare providers can enhance their own processes, as well as contribute to the body of best practices nationwide." @default.
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• W2034211488 title "Responsibilities for Effective Medical Device Reprocessing Procedures and Instructions" @default.
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