INDIANAPOLIS, Aug. 13, 2019 /PRNewswire/ -- Recalls in the
second quarter remained flat across industries but serious and
deadly incidents were on the rise – an indication of lagging
activity by regulatory agencies, according to the second
quarter 2019 Recall Index released today by Stericycle
Expert Solutions (NASDAQ: SRCL).
"The numbers in this Index are just one data point in the
product safety story. Over the last six months, regulators have
been the target of consumer advocates, victims, and even Congress,"
said Chris Harvey, Director of Recall Solutions at Stericycle
Expert Solutions. "Perhaps the most obvious has been the criticism
lodged at the Consumer Product Safety Commission for its handling
of safety-related issues. Then there are the cries for the
Food and Drug Administration to act quicker on CBD and cannabis
while behind the scenes food safety inspections continue to
lag."
While there may be fewer regulations, the actions have been
stricter and even severe according to food, drug, and medical
device companies that have found themselves under scrutiny.
"The warning to companies in this regulatory environment is
'don't become the poster child.' Regulators will be looking for
ways to shift the spotlight to a bad actor and show they have
control," Harvey added. "So when you learn about a potential safety
issue, act quickly. Consumers will applaud you for doing the right
thing."
Consumer Products
Deaths from recalled consumer products are the highest
they've been since 1998. The fact that deaths were largely
linked to children's products begins to shine a light on the
challenges facing companies in the children's and infant product
category. Products in this category, especially in big families,
have a long life. They are played with by a series of children,
passed along to family friends, sold as secondhand products, and
end up in daycares and childcare environments. It's difficult to
protect children completely in these situations.
"While the Consumer Product Safety Commission has taken the
brunt of criticism for its alleged feet dragging on a variety of
safety issues to date, it's important we all are reminded of our
role in product safety," said Harvey. "Companies need to think
through their plan for reaching the second-hand marketplace and
childcare environments. But we as parents, aunts and uncles,
grandparents and caregivers need to be an active part of this
process."
Pharmaceutical
The top reason for recalls in Q2 was cGMP deviations, and we
have seen an increasing number of recalls for this reason over the
last few quarters. In fact, 90 percent of units recalled were a
result of cGMP deviations.
"Expect a spike in drug recalls. At the beginning of Q3, the FDA
issued a warning to four repackers of active pharmaceutical
ingredients (APIs) – an indication that additional action may
follow," said Harvey. "So while the agency is getting criticized
for dragging its feet on issues like CBD and cannabis, and
regulatory inspections are lagging, the agency is getting stricter
on manufacturing processes and recalls will undoubtedly
follow."
Medical Device
Software is a weak link for medical devices, and it will only
get worse. Software issues remained the top cause of
recalls for the 13th straight quarter.
"As we become increasingly reliant on AI and data collection,
software becomes an even bigger vulnerability for patients,
physicians, and wrongdoers. If the software that is used to operate
a device is inadequate, how can we be sure that it is protected
from cybersecurity vulnerabilities?" Harvey asked. "Add to that the
fact that companies have only recently been laser-focused on
mitigating cyber threats associated with medical devices. It's a
recipe for disaster."
Food & Beverage
Processed foods are no longer safer than fresh foods. For
the eighth consecutive quarter, undeclared allergens was the top
cause of FDA food recalls at 48.4%. Foreign material was the top
cause for FDA recalled units. Among the FDA food categories
impacted by recalls were prepared foods, supplements and baked
goods.
"The more processed a product is, the higher the risk of
contamination, adulteration, foreign material, and undeclared
allergens," said Harvey. "The good news is that technology has
enabled us to find contaminants and adulterants we couldn't find
before. The unfortunate news is that the testing and inspections
that would catch these issues hasn't been fully utilized,
particularly as FDA and USDA inspections lag."
Auto
Despite the headlines, auto recalls remain flat over the last
two years. While we continue to see the long-tail of OEM
recalls, parts and construction of autos are safer than ever.
"The perceived increase in recalls is in part psychological,"
Harvey said. "We remember all recalls in this category as auto
recalls, rather than an airbag or windshield wiper recall. That's
why they stand out in people's minds."
The full Q2 2019 Recall Index is available
at https://www.stericycleexpertsolutions.com/recall-index/.
About the Stericycle Recall Index
The Stericycle
Recall Index is the only report that aggregates and tracks recall
data to help manufacturers and other industry stakeholders navigate
the regulatory environment and identify trends. Each quarter
Stericycle analyzes data from the U.S. Consumer Product Safety
Commission (CPSC), the National Highway Traffic Safety
Administration (NHTSA), the FDA, and the USDA. For more
information, please
visit www.stericycleexpertsolutions.com/thought-leadership.
About Stericycle Expert Solutions™
Stericycle Inc. is
a NASDAQ-listed global business-to-business services company which
provides highly specialized solutions to healthcare and commercial
businesses of all sizes. Founded in 1989, Stericycle Inc. has grown
to become a leader across a range of complex and highly regulated
market sectors and operates in 550 locations. Stericycle Expert
Solutions™ is the industry leader in managing automotive, consumer
product, pharmaceutical, medical device, juvenile product, and food
and beverage recalls. Expert Solutions streamlines the entire
product recall process and manages Notification & Response,
Processing & Tracking, and Compliance & Reporting for
leading global companies. For more information, visit
www.stericycleexpertsolutions.com.
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SOURCE Stericycle Expert Solutions