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OPERATING ROOM


thetic techniques wherever suitable. In the event that intravenous sedation agents are unavailable, inhalational anesthetics have the potential to be used for sedation when anesthesia machines are being used for pro- longed periods as ICU ventilators. Use of these agents mandates the continuous pres- ence of a trained anesthesia professional on a 24/7 basis in order to facilitate their use.”


• FDA again – By September, the FDA re- versed an Emergency Use Authorization (EUA) they issued in May for infusion pump systems. The FDA wrote in a letter to manufactur-


ers, “This letter is to notify you of the revo- cation of the Emergency Use Authorization (EUA) issued May 13, 2020, for emergency use of infusion pumps and infusion pump accessories for use by healthcare providers (HCPs) to treat conditions caused by the Coronavirus Disease 2019 (COVID-19) with the controlled infusion of medications, total parenteral nutrition (TPN), and/or other  uids.6


The agency went on, “FDA has deter- mined that circumstances make revocation of this EUA appropriate to protect the public health or safety. Based on informa- tion and experience since issuance of the umbrella EUA, FDA has determined that circumstances support revocation of the umbrella EUA. Instead, FDA may issue individual EUAs for infusion pumps and infusion pump accessories that meet the requisite EUA statutory criteria.”


Focus on system performance, safety and education Today, manufacturers of IV systems and related technology forge ahead with design, function and safety. Several organizations, as well, provide educational resources and training for staff. With regard to monitoring infusion dur-


ing MRI imaging, B. Braun Medical Inc. announced in a press release that they have “received 510(k) clearance from the US Food and Drug Administration for the SpaceStation MRI to allow Space infusion pumps to continuously deliver medications to patients within the MRI suite.”7 Additionally, they explained, “The SpaceStation MRI is designed to shield Space infusion pumps against 1.5-T and 3.- magnetic fi elds to protect the  scan- ner and provide interference-free images. Long infusion lines are no longer needed and hospital-wide Space infusion pumps are now able to safely transition patients into the imaging suite with the SpaceSta- tion MRI.”


Concentrated on monitoring blood cul- ture, Magnolia Medical Technologies, Inc.


reported in a press release that they were “selected as the Innovative Technology Supplier of the Year by Vizient Inc. The award was presented in a virtual Awards Ceremony as part of the 2020 Vizient Con- nections Education Summit.”8


Criteria for the award included, “the supplier whose technology has advanced patient care, advanced patient safety and health care worker safety, and/or delivered solutions that drive incremental improve- ment to an organization’s care or business model,” they noted. About their technology, they added, “The patented Steripath Gen2 ISDD product portfolio, including both direct-to-media and syringe confi gurations, is the only  510(k)-cleared device platform indicated to reduce blood culture contamination. This indication was cleared by the FDA based on peer-reviewed published controlled clinical studies demonstrating Steripath’s ability to reduce blood culture contamination by 83% and 88%. Steripath has been clinically proven for use with blood cultures drawn via both venipuncture and peripheral IV starts. ”


between 33-69% of PIVCs fail before the completion of treatment and more than 50% of adults describe insertion as mod- erately painful or worse. Collectively, this can lead to serious implications for patients, including increased costs and length of treatment.”


Steripath Gen2 ISDD by Magnolia Medical Technologies


Focusing on IV education and skill building for staff, the Association for Vas- cular Access (AVA) announced in a press release that they and B. Braun Medical Inc. have entered, “a long-term collaboration to improve training on the placement of peripheral intravenous catheters (PIVCs). Together the organizations will develop and provide a new series of online courses free of charge to medical, nursing, respira- tory therapist, and other allied healthcare schools – the fi rst of which is being piloted at several leading nursing schools.”9 Further, they stressed, “Vascular access is the most common invasive procedure performed in healthcare, with more than 380 million PIVCs placed in patients annually in the United States. However,


18 November 2020 • HEALTHCARE PURCHASING NEWS • hpnonline.com


Additionally, they noted that they will work together to “create a certificate program for students who complete the courses that will attest to their founda- tional knowledge in PIVC placements with future employers. The eLearning module will feature interactive graphics and hi-defi nition videos in addition to the necessary text critical to enhancing the PIVC education in healthcare. It will focus on key aspects like proper device place- ment, assessment, and insertion to instill confi dence in students of all skill levels. Committed to safety in care in today’s cri- sis and beyond, the Institute for Safe Medi- cation Practices (ISMP) reported in a press release that they and ECRI have launched “a joint Patient Safety Organization (PSO), an important step in making medication, medical devices, and healthcare practices safer for patients across all care settings, now during the COVID-19 pandemic, and into the future. he nonprofi t organizations had each been federally designated PSOs since the program began in 2008.”10 pecifi cally, they indicated, In an effort to reduce nursing exposure, conserve PPE in short supply, and quickly respond to pump alarms, hospitals overrun with COVID-19 patients moved bedside IV infusion pumps and administration sets into hallways outside patient rooms. The risks and challenges from this innova- tive process included potential shortage of extension tubing sets, more frequent alarms at high  ow rates, and other tech- nology challenges. ISMP medication safety experts and ECRI’s clinical engineering team worked together to provide real-time guidance to ensure safety for this technol- ogy work-around.” HPN


Visit https://hpnonline.com/21158203 for references.


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