OPERATING ROOM IV systems strive for access, fl uidity
Maintaining steady fl ow of equipment, supplies and safety during continuing healthcare crisis by Ebony Smith
I
n recent history, intravenous (IV) systems, medications and other neces- sary devices and items for patient care
have undergone shortages. Phenomena, like these, consequently, were the ripple effects of devastating public health and environmental crises. As Healthcare Purchasing News reported in an article last year, “A series of unfortunate IV events, Crisis = Recalls + Seasonal Virus + Supplier Exit + Natural Disaster,” “Within the last decade, healthcare providers and sup- pliers have experienced at least two notable shortages of IV and pharma solutions.” “The first emerged in the 2013-2014 timeframe, following a Food and Drug Administration recall, coupled with an aggressive u strain season and the eit of the No. 2 supplier,” HPN reported. “The second emerged in the 2016-2017 timeframe, following a hurricane that damaged the Puerto Rican manufacturing plant of the No. 1 supplier, but also cut out power by damaging the electrical grid on the island nation it hit, which further hampered production.”1
Pandemic-drawn direction for resources
COVID-19, of course, is the newest and most catastrophic public health emergency disrupting the healthcare landscape and lives around the world today. This time, however, the high demand for inventory in hospital and critical care spanned from medical, testing, and personal protective resources.
“As organizations that represent or col- laborate with individuals and institutions at the forefront of delivering health care in the midst of the COVID-19 pandemic, we are vitally concerned with the shortages of masks, face shields and other personal pro- tective equipment (PPE), ventilators, swab kits, and testing capacity that are criti- cally needed by frontline caregivers and patients,” emphasized several healthcare
associations in a March statement released by the American Hospital Association.2 The associations expressed, “We strongly support emergency efforts at the federal level to dramatically increase the produc- tion and distribution of PPE and other nec- essary medical equipment and supplies. We also support the availability of telehealth services during this time to use less PPE while preventing the spread of infection.” As far as IV systems go, national poli- cies and recommendations were issued to ensure availability for any care needed. This guidance included:
•FDA – In April, as the number of cases magnified, the U.S. Food and Drug Administration (FDA) released new guidance on the manufacture and avail- ability of infusion pump systems. “FDA is issuing this guidance to provide a policy to help expand the availability and remote capabilities of infusion pumps and their accessories for health care profession- als during the COVID-19 pandemic,”3
stated
the FDA in a guidance document. While an enforcement policy from the
outlined the specifi c scope of devices needed for care. “FDA believes it is important to help facilitate availability of the devices, which includes large volume parenteral (LVP) infusion pumps, syringe infusion pumps, PCA infusion pumps, and ambulatory infu- sion pump devices, and their accessories, in order to support patients who require sustained infusion therapy in the context of the COVID-19 public health emergency,”4 the FDA addressed. The agency noted, “Patients infected with COVID-19 may require continuous infusion of medications, nutrition, and/or other uids. s such, recognizes the need to help increase access to an adequate supply of devices to treat patients who need these therapies and to help foster technologies that maintain a safer physical
16 November 2020 • HEALTHCARE PURCHASING NEWS •
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distance between the health care provider and patient affected by COVID-19.” The policy went on to describe measures manufacturers may take to adequately produce and supply needed equipment. “Wherever possible, health care facilities should use FDA-cleared infusion pumps and accessories to provide infusion therapy, or a device authorized by an Emergency Use Authorization (EUA),” they explained. Additionally, they indicated, “More
specifi cally, this policy will create more e- ibility for manufacturers that make device modifi cations to address manufacturing limitations or supply shortages related to the public health emergency.”
• ASA – In June, as the crisis surged on, the American Society of Anesthesiolo- gists (ASA) made recommendations on the availability and preservation of IV drugs.
“Because of the COVID-19 pandemic, many institutions throughout the country are anticipating or currently experiencing shortages of vital anesthetic drugs that are also commonly used in intensive care units (ICUs),”5
set forth the ASA in a press release.
he society specifi ed, hen institutions approach capacity status in their ICUs and have concerns regarding the availability of sedating and paralytic drugs, anesthesiolo- gists should strive to conserve vital drugs for use in ICUs. Shortages of particular con- cern include propofol, dexmedetomidine, midazolam, and neuromuscular blocking agents.” urther, they directed on specifi c proto-
cols for use of IV anesthetics and agents in surgical care.
“Surgeries that are performed in the operating room should avoid use of total intravenous anesthetics (TIVA) whenever possible to preserve the supply of intrave- nous agents,” the society stated. They continued, “Efforts should be made to employ the use of regional anes-
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