Page 10 - Modern Healthcare (January 2020)

Providers
Gown recall entangles
Cardinal and the Food and Drug Ad-
healthcare supply chain
of any cases of patient harm at this time.
But pinpointing the source of an infec-
tion can be tricky, Schabacker said. “We
don’t know if it really started in Septem-
ber or before,” he said. “There is clearly a
By Alex Kacik
potential for it to be widespread.”
How the recall unfolded
Cardinal got a tip Dec. 10, 2019, that one
of its manufacturers, Siyang HolyMed in
PIEDMONT HEALTHCARE executives,
Sept. 1, 2018 – Jan. 10, 2020 ministration said they were not aware
supply chain experts and clinicians hud- Gowns shipped to hospitals China, was using two unauthorized sites
dled the night of Jan. 12 to mitigate one to produce AAMI Level 3 surgical gowns,
of the biggest supply chain disruptions Dec. 10, 2019 Cardinal receives a which are used for procedures like open-
the health system has encountered. tip that Siyang HolyMed, one of its heart surgery and knee replacements.
They had just gotten word that their manufacturers in China, used two The company confirmed the tip during
primary supplier of surgical gowns, unauthorized sites to produce the gowns an on-site investigation Dec. 20; it im-
Cardinal Health, distributed potentially Dec. 20, 2019 Cardinal confirms the mediately stopped doing business with
contaminated products. Around half of tip in an on-site inspection; stops Siyang and halted imports.
Atlanta-based Piedmont’s 11 hospitals doing business with Siyang and
were affected. halts exports The gowns had increased bioburden
It sequestered the affected gowns as levels, which identifies and quantifies
well as other supplies that Cardinal pack- Jan. 7, 2020 Cardinal places a hold bacteria before sterilization, but the exact
on several SKUs
aged them with. But the health system amounts are unknown. The windows at
did not have to cancel any surgeries as Jan. 10, 2020 Unable to identify the inspected site were open, it lacked
it worked with Cardinal and other stake- specific gowns from the unauthorized appropriate hand-washing stations, food
holders to source alternatives. plants, Cardinal puts a hold on all was in the manufacturing area and the
“Not of this scale, but supply disrup- lots from Siyang and notifies the Food door wasn’t secure, the company said.
tions have been occurring for years,” said and Drug Administration The gowns are shipped to sterilization
Joe Colonna, Piedmont’s vice president Jan. 21, 2020 Cardinal issues sites after they are made. But Cardinal
of supply chain. “The secret is having a recall notice cannot ensure the products are sterile
good relationship with clinical folks and because of their unquantified exposure
leadership—no one panicked.” to bacteria while they were made. Be-
ECRI Institute. Things get cloudier as the yond bacteria, the gowns may have had
Cardinal said that 2,807 facilities supply chain adds links. organic matter that could be deadly,
around the world received gowns Piedmont is creating a long-term mit- Schabacker said.
that may have been contaminated at igation strategy in case manufacturers Cardinal placed a hold on several
a manufacturing plant in China. The can’t sustain higher production levels. SKUs on Jan. 7. It then determined that it
wholesale distribution giant recalled In the meantime, it aims to develop a could not differentiate the product that
9.1 million gowns, 7.7 million of which more strategic, and less transactional, came from the two unauthorized sites
were distributed to hospitals, ambulato- relationship with suppliers. The goal is and other Siyang facilities, so it put all
ry surgery centers and labs from Sept. 1, to shed some light on where materials lots on hold on Jan. 10, notified the FDA
2018, to Jan. 10, 2020, Cardinal estimat- are sourced and how products are made and sent notices to customers.
ed in a Jan. 21 notice that warned of pos- to identify vulnerabilities, Colonna said. Cardinal, which has replaced prod-
sible surgical-site infections. Executives ECRI hasn’t heard of critical shortages ucts at no cost and deployed employ-
said they sincerely apolo- or a delay of lifesaving pro- ees to help providers, maintained that
gize and that patient safety cedures due to the recall, it acted as it gathered information and
is their top concern. THE TAKEAWAY so the initial supply chain determined the scope of the problem.
As more manufacturing With more production disruption seems to have Johnson City, Tenn.-based Ballad
occurs overseas, these is- moving overseas, been mitigated, Schaback- Health canceled about 200 elective sur-
sues will likely persist. It’s providers and er said. “But can it happen geries while Allegheny Health Network
difficult to ascertain where manufacturers need tomorrow with a different in Pittsburgh said it had to cancel about
first-line suppliers get their to be more strategic product? Totally,” he said. a dozen. Five other providers Modern
materials, said Dr. Marcus about supply chain “Hopefully stakeholders Healthcare contacted said there was
Schabacker, CEO of the management. take this as a red flag.” minimal or no impact. l

8 Modern Healthcare | January 27, 2020