and accessories, as well as other respiratory devices, during
the COVID-19 pandemic to support patients with respiratory
failure or difficulty breathing.
Health and Human Services secretary Alex Azar said in a
statement that with the Trump administration’s removal of
barriers through an executive order invoking the Defense
Production Act, “Medical device makers can more easily make
changes to existing products, such as changes to suppliers or
materials, to help address current manufacturing limitations
or supply shortages. Other manufacturers, such as auto
makers, can more easily repurpose production lines to help
increase supply. Hospitals and other healthcare providers can
repurpose machines they have now to serve as ventilators.”
Guidance issued by the FDA outlines several key steps.
First, the FDA will exercise enforcement discretion for certain
modifications to these FDA-cleared devices. Normally, any
time a manufacturer or user makes a modification to a
ventilator device, those modifications can often trigger an
FDA premarket review, which can delay the time it takes to
get these devices to the bedside. The guidance also helps
manufacturers ramp up their manufacturing by adding
production lines or alternative sites, for instance, using
non-medical device manufacturers such as automobile
manufacturers, to start manufacturing ventilator parts. In
recognition of the current pandemic situation, and to ease
regulatory burden on manufacturers, the FDA is being
flexible in not enforcing the premarket review requirement
for these modifications.
Second, hospitals and healthcare professionals may use
ventilators intended for other environments. For example,
the guidance notes hospitals that could repurpose ventilators
normally used for transporting patients in an ambulance into
the hospital setting for long-term use. The FDA’s policy also
applies to healthcare facilities that use ventilators beyond their
indicated shelf life, which should increase ventilator capacity.
The FDA says it has been working closely with PPE
manufacturers to understand their supply capabilities during
this pandemic. “The agency is also aware of challenges
throughout the supply chain that are presently impacting the
availability of PPE products and is taking steps to mitigate
shortages that healthcare facilities are already experiencing,”
Azar said in a statement. “For example, on March 2, the
FDA granted an Emergency Use Authorization to allow
NIOSH-approved respirators typically used in industrial
settings to be used in healthcare settings.”
The FDA also published a Letter to Healthcare Providers
and FAQs that provide conservation strategies for gowns
and masks and continues to coordinate and communicate
with interagency and state partners to help ensure that they
are more readily available.
The FDA’s strategies include two tiers of conservation:
Conventional Capacity Strategies (supply levels are
adequate to provide patient care without any change in
routine practice):
● ● Nonsterile disposable patient examination gloves, which
are used for routine patient care in healthcare settings,
are appropriate for the care of patients with suspected
or confirmed COVID-19.
● ● Use FDA-cleared medical gloves according to labeling
and local, state, and federal requirements.
www.healthcarehygienemagazine.com • april 2020
● ● Employ engineering and administrative controls following
the CDC’s and HICPAC guidelines to reduce the need
for medical gloves while minimizing risks to healthcare
providers and patients. Some of the CDC’s Strategies for
Optimizing the Supply of N95 Respirators may also be
useful for gloves conservation.
● ● Reserve use of sterile gloves for procedures in which
sterility is required.
Contingency Capacity Strategies (limited supply levels
may change patient care, but may not have a significant
impact on patient care and health care provider safety)
● ● For training or demonstration in which broad barrier
protection is not needed, use gloves that are beyond the
manufacturer-designated shelf life, if available.
Crisis or Alternate Strategies if Medical Gloves are
Running Low or Not Available (may need to be considered
if medical glove supplies are critically low and demand is high)
● ● Refer to the CDC’s Hand Hygiene in Healthcare Settings
guidance
● ● Use medical gloves beyond the manufacturer-designated
shelf life in a setting where there is a lower risk of
transmission (for example, non-surgical, non-sterile). The
user should visibly inspect the gloves prior to use and,
if there are concerns (for example, discolored or visible
tears, holes), discard the gloves.
● ● Extend the use of medical gloves for healthcare providers
without changing the gloves between patients with the
same infectious disease diagnosis or exposure and no
other infections. Gloved hands can be cleaned between
patients and at other times when hand hygiene would
normally be performed during routine patient care.
Alcohol-based hand sanitizers may degrade vinyl gloves.
If a glove becomes damaged or contaminated, replace it.
● ● Consider using non-medical gloves such as those
used for food service, embalming, cleaning, or other
industrial-grade gloves that most closely align with the
ASTM standards for medical gloves as outlined in the
FDA’s Medical Glove Guidance Manual.
● ● Be aware that counterfeit medical and non-medical
gloves may be on the market, especially during this time
of reduced supply.
The FDA’s Letter to Health Care Providers refers specifically
to potential shortages relating to surgeons’ gloves and
patient examination gloves, which are regulated by the
FDA under 21 CFR 880.6250 and 21 CFR 878.4460 as
Class I medical devices that require a 510(k) premarket
notification. These devices are reviewed by the FDA to ensure
performance criteria such as leak resistance, tear resistance,
and biocompatibility are met. A surgeon’s glove is a device
made of natural or synthetic rubber intended to be worn by
operating room personnel to protect a surgical wound from
contamination. A patient examination glove is a disposable
device intended for medical purposes that is worn on the
examiner’s hand or finger to prevent contamination between
the patient and examiner.
The FDA says it is collaborating with manufacturers of
medical gloves to better understand the current supply chain
issues related to the COVID-19 pandemic and to help mitigate
any widespread shortages of these products.
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