PPE Supplies That Are In Shortage During The Covid-19 Pandemic
2020 marked the year that ushered in a worldwide pandemic and a shortage of critical PPE supplies needed to combat the pandemic. We are still experiencing that shortage today. This article will explore some statistical shortages that hospitals and medical facilities are facing, how the government determines and monitors PPE shortages and where you should go to stay updated and informed.
Hospital PPE supplies are hit the hardest
The CDC reported, “As of May 2020, 87% of nurses reported having to reuse a single-use disposable mask or N95 respirator, and 27% of nurses reported they had been exposed to confirmed COVID-19 patients without wearing appropriate PPE (NNU, 2020).”
During pandemics, hospital supplies are hit first. Healthcare workers are closely working with infected patients and thus need a constant supply and restock of essential PPE to prevent the spread of the virus.
The list of PPE supplies includes eye protection, gloves, gowns, masks, and filtering facepiece respirators. The FDA is responsible for providing an updated list of PPE supply shortages. They will continue to update the shortage list until the pandemic is over.
As of December 2020, which is the FDA’s most recent update, here are the PPE items that are in short supply:
- LYY (Latex, non-powered patient examination glove)
- LYZ (Vinyl patient examination glove)
- LZA (Polymer, non-powdered patient examination glove, includes nitrile gloves)
- LZC (Specialty, non-powdered patient examination glove, includes nitrile gloves)
- FME (Examination gown)
- FYA (Surgical gown)
- OEA (Non-surgical isolation gown, Level 2 only)
- FXX (Surgical mask)
- MSH (Surgical respirator)
- JRC (Micro pipette)
- LXG (Equipment, laboratory, general purposes, labeled or promoted specifically for medical use)
- PPM (General purpose reagents for in vitro diagnostic tests, including pipette tips4)
- JJH (Clinical sample concentrator)
- NSU (Instrumentation for clinical multiplex test system)
- OOI (Real time nucleic acid amplification system)
- KXG (Absorbent tipped applicator)
- JSM (Transport culture medium)
- LIO (Microbiological specimen collection and transport device)
- QBD (Microbial nucleic acid storage and stabilization device)
- CBK (Continuous ventilator, facility use)
- BZD (Non-continuous ventilator)
- NOU (Continuous ventilator, home use)
The FDA notes that each one of the PPE items above will most likely remain in shortage throughout the rest of the pandemic. Two new items were added to this shortage list in December - JRC (Micro pipette) and LXG (Equipment, laboratory, general purposes, labeled or promoted specifically for medical use). The rest of these items have been on FDA’s shortage list since at least August.
How the FDA creates their “PPE Shortage” list
A clear process is followed when determining each item on this PPE shortage list. Under the section 506J of the FD&C Act (“The Public Health Exception” Act), the FDA publicly discloses all items that are in shortage or discontinued.
Section 506J was added in 2020 as part of the Cares Act. It provides the FDA with new abilities to help manage the pandemic. This section is designed to help reduce medical device shortages “ "during, or in advance of, a public health emergency declared by the Secretary under section 319 of the PHS Act." Under this section, the FDA is required to publicly disclose the list of updated PPE devices that are in a shortage (and they must disclose medical devices that are also discontinued).
The FDA receives the list of discontinued supplies directly from manufacturers (who are required under this act to disclose any potential shortages of their supplies to the FDA). A shortage is defined under section 506J(i)(2) of the FD&C Act as "a period of time when the demand or projected demand for the device within the United States exceeds the supply of the device."
The FDA then uses the information from manufacturers, along with other information from various sources. They also evaluate projected demands for supplies, such as reports from hospitals, nursing homes, associations that represent these groups, etc. and evaluate if there is anticipated demand from these groups. Export restriction is another significant variable that affects the PPE shortage list. Other indications such as supply disruptions also have to be evaluated. During the Covid-19 pandemic, we have experienced a significant amount of supply disruptions that has contributed to the overall PPE shortage. A few other considerations the FDA takes into account are the disruption pressures from group purchasing organizations or distributors, and also possible/current actions from manufacturers and other stakeholders.
As you can see, there is no simple evaluation tool that the FDA uses to create this shortage list. The entire ecosystem of PPE includes multiple parts and dynamic processes that are complex, ever changing and sometimes unexpected. Because of our nation’s current state, the FDA does not factor in PPE device category supply levels within our SNS (strategic national stockpile).
These actions include issuing Emergency Use Authorizations (EUAs) and guidance documents to provide recommendations and help expand the availability and capability for various diagnostic, therapeutic, and protective medical devices in high demand during the COVID-19 public health emergency.
Sandpiper provides PPE in both the private and public sector. Our consistency and reliability allows organizations to plan based on their specific business needs and provide the needed supplies to their patients and staff with ease. Our strong manufacturing partnerships built on trust allow us to offer you products like disposable vinyl gloves, even in the midst of a shortage.