Infection Control Today

AUG 2018

ICT delivers to infection preventionists & their colleagues in the operating room, sterile processing/central sterile, environmental services & materials management, timely & relevant news, trends & information impacting the profession & the industry

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The only EPA registered solution and equipment combination utilizes the innovative technology of iHP™ for hospital-healthcare disinfecting of iHP™ for hospital-healthcare disinfecting No wipe, no rinse, and leaves no residue No wipe, no rinse, and leaves no residue Offers a shorter turnover time between patients Offers a shorter turnover time between patients 7.8% hydrogen peroxide only active ingredient 7.8% hydrogen peroxide only active ingredient provides compatibility with a variety of materials including provides compatibility with a variety of materials including rubbers, finished surfaces, and sensitive medical equipment rubbers, finished surfaces, and sensitive medical equipment Discover SteraMist™ Disinfection info@tomimist.com | www.tomimist.com Close the Gap on Efficacy and Efficiency Efficacy and Efficiency for each staff member. You should also inquire if the company has any instructional videos, manuals or poster to enhance staff education. Understand that without IFUs, the device may not be cleaned, packaged, disinfected or sterilized correctly. This can result in a processing failure which is inexcusable. Your facility assumes full responsibility for the safety and effcacy of the device. Also, when not following IFUs, you are using a product off-label. Regarding your specifc question, when IFUs are not clear or do not refect current standards or regulations (e.g., OSHA), frst contact the device manufacturer directly. Speak with the manufacturer's technical service department, not customer service. The technical service department has all the information on how the device was tested. Ask this department to clarify the information. Second, the Food and Drug Administration wants end users to report these problems on the FDA's Medwatch 3500 form, which is on the FDA webpage at: www.fda.gov. or at: http://www.fda.gov/Safety/ MedWatch/default.htm. The only way the FDA can take action against a manufacturer is to get the information from end users. The FDA is also asking manufacturers to consider human factors when developing their IFUs so the information is specifc and accurate for the end user. If the device manufacturer cannot provide you with comprehendible IFUs, the device should not be processed. You may need support from your institution's risk management and infection prevention departments with this. To ensure you can comply with the IFUs, ask questions when considering the purchase of a new device. The best practice is to obtain the IFU before the device is purchased. Why would any facility purchase a device when they did not have the equipment or sterilization cycles to effectively process it? The FDA cannot make a manufacturer update their IFU; however, if complaints are received from end users, the FDA will contact the manufacturer and take appropriate action which may include updating their IFU. In summary, healthcare facility personnel perform cleaning, disinfection and sterilization of various medical and surgical devices and instruments. To process them safely, compliance with IFUs is required. If IFUs are received that are not clear or do not comply with current standards, the device should not be processed in the best interest of patient safety. Nancy Chobin, RN, AAS, ACSP, CSPM, CRER, is a sterile processing consultant and educator. References: ANSI/AAMI: ST79:2017. "Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities." AAMI TIR 12 -Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers, 2010 Basics of Sterile Processing, 6th Edition. Sterile Processing University, LLC. Lebanon, N.J. Ò T he FDA cannot make a manufacturer update their IFU; however, if complaints are received from end users , the FDA will contact the manufacturer and take appropriate action which may include updating their IFU.

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