LAB MANAGEMENT :: SUPPLY FORECASTING & HANDLING
Medical Device Shortages During the COVID-19 Public Health Emergency Category
Product Code (Description)
Laboratory Reagents and Testing Supplies - Testing Supplies & Equipment
JJH (Clinical sample concentrator)
Availability and Estimated Shortage Duration2
• Limited supply available.
• Estimated for duration of the COVID-19 Public Health Emergency.
Laboratory Reagents and Testing Supplies - Testing Supplies & Equipment
NSU (Instrumentation for clinical multiplex test system)
• Limited supply available.
• Estimated for duration of the COVID-19 Public Health Emergency.
Laboratory Reagents and Testing Supplies - Testing Supplies & Equipment
PPM (General purpose reagents for in vitro diagnostic tests, including pipette tips4
)
• Limited supply available.
• Estimated for duration of the COVID-19 Public Health Emergency.
Specimen Collection, Swab - Testing
Supplies & Equipment
KXG (Absorbent tipped applicator)
• Limited supply available.
• Estimated for duration of the COVID-19 Public Health Emergency.
Additional Information
In an effort to mitigate ongoing shortages, the U.S. government continues to support mitigations including alternatives (see COVID-19 Testing Supplies FAQ).
In an effort to mitigate ongoing shortages, the U.S. government continues to support mitigations including alternatives (see COVID-19 Testing Supplies FAQ).
In an effort to mitigate ongoing shortages, the U.S. government continues to support mitigations including alternatives (see COVID-19 Testing Supplies FAQ).
In an effort to mitigate ongoing shortages, the U.S. government continues to support mitigations including alternatives (see COVID-19 Testing Supplies FAQ).
Reason for Interruption (per 506J)
Demand
increase for the device
Date (YYY/MM/DD)3
2020/08/14 Initial 2022/02/04 Reverified
Demand
increase for the device
2020/08/14 Initial 2022/02/04 Reverified
Demand
increase for the device
2020/08/14 Initial
Demand
increase for the device
2020/08/14 Initial 2022/02/04 Reverified
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/medical-device-shortages-during-covid-19-public-health-emergency
Our microbiology section head worked tirelessly to ensure lab staff were trained very quickly…because we still had to meet CLIA regulations with respect to introducing new tests. To keep all lab staff apprised of ongoing changes, we formed a channel in MS Teams called “COVID” and also devoted one of our white boards in the lab to just COVID related updates. We also communicated change of testing supply information to the nursing leaders of all affected departments.”
Changes due to COVID-19 pandemic The COVID-19 pandemic illuminated supply shortages, wreak- ing havoc on laboratories and hospitals. Fortunately, the evolu- tion of hyper-awareness and ingenuity became the norm for those labs that continued to provide necessary testing during a most difficult time. COVID-19 brought unprecedented challenges to clinical labo-
ratories. While U.S. labs strove to provide quality and accurate test results in the face of 2020’s adversity, the uncertainty and lack of supplies were a significant hurdle, hindering day-to-day laboratory operations and the ability to increase testing capacity. According to the article, Supply Shortages Impacting COVID-19
and Non-COVID Testing, “the uncertainty and lack of supplies were a significant hurdle, hindering day-to-day laboratory operations and the ability to increase testing capacity.”4 “In 2020, ASM partnered with the Association of Supply
Chain Management to collect testing supply status for both COVID-19 tests, as well as other microbiological tests to highlight, and ultimately alleviate, these debilitating supply chain issues. Starting Sept. 11, 2020, ASM began independently collecting shortage data directly from clinical labs using the Clinical Microbiology Supply Shortage Collection (CMSSC) tool, drawing attention to the data provided by laboratory directors, and practicing clinical microbiologists without external influence. This data reflects shortages of medium, reagents, collection devices and consumables that significantly impacted day-to-day testing for both COVID-19 and other infectious diseases during the time period of Sept. 11, 2020 to Jan. 15, 2021.”4
“147 CLIA-certified labs responded to the survey across the
U.S. The CMSSC tool results also show the following non- COVID-19 shortages: • 35.1% of labs have a shortage of supplies for the molecular detection of sexually transmitted infections.
• 47.5% of labs have a shortage of supplies for detection of routine bacteria (including the bacteria causing strep throat, pneumonia, bronchitis, and urinary tract infections).
• 29.4% of labs have a shortage of supplies for mycobacteria testing (including supplies for tuberculosis (TB), Buruli ulcer and pulmonary nontuberculous mycobacterial disease testing).
MLO-ONLINE.COM MAY 2022 35
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