Professor
recommends facilities publicize SUD reuse 
by
Todd Shields 
If dental offices and even tattoo parlors publicly display them, why
don't hospitals post informative notices for patients on how single-use
devices and other medical tools are reprocessed and sterilized?
Michelle Alfa, an associate professor of clinical laboratory sciences
at Wayne State University, Detroit, is an advocate of "going public"
with reprocessing information. She places faith in patients' ability
to make sound medical choices once they get the facts. That's why she
likes to pose the question above.
"Especially
with a single-use device, if a manufacturer labels it single-use only
and a hospital decides to reprocess it, then patients have a right to
know this," Alfa said.
In
August, the Food and Drug Administration issued its much-anticipated
guidance on reprocessing of single-use devices. One of the issues put
off for possible future debate, however, was whether patients should
give consent, or even be notified, if reprocessed single-use items are
to be used on them.
"The
public assumes and expects endoscopes to be sterile, but as critical
consumers they must know when to ask the right questions. Without the
correct knowledge, they can't ask the relevant questions of single-use
devices," Alfa said.
Pointing to newspaper accounts of reused devices breaking during surgery
in Michigan and Kansas hospitals - thus threatening patients with internal
injuries and infections - some university scientists believe news organizations
can play a role by providing "noninflammatory" reports to readers.
"The
media should get involved with professional organizations and hospitals.
What's critical is getting out the news because until patients understand
the risk's, there will be no changes," said David Lewis, a research
microbiologist at the University of Georgia, Athens.
In
Alfa's recent work at a Winnipeg hospital in Manitoba, Canada, administrators
there informed the press of a faulty validation process after government
officials stepped in to investigate the problem.
Fearing lawsuits and credibility loss Ð though no patient infections
occurred Ð the hospital released detailed reports of what procedures
the sterile processing department was and wasn't performing.
"The
public's reaction was positive, and they were appreciative of how upfront
our hospital turned out. We actually gained more credibility in eyes
of the public, we think," Alfa recounted.
Legal
retribution
Yet,
unlike for-profit healthcare providers, the campus-based academic community
has less to lose from backing a public-education effort on reusing single-use
items.
For instance, some central service and infection control managers said
the public may mount a fault-finding legal mission even though a hospital
has sterilization protocols in place and the Food and Drug Administration
has approved its validation process.
"Of
course patients have the right to know if instruments are sterile, but
by doing that we are also assuring them that the process is validated
and, yes, it works. If hospitals can show how safe their validation
process is, why would they need to inform patients of that safety?"
asked Nyla "Skee" Japp, president of the American Society for Healthcare
Central Service Professionals, Chicago.
Japp, also the infection control regional coordinator for Providence
Medical Center, Kansas City, KS, added that hospitals that reprocess
critical devices such as heart implants are "putting themselves at risk
and probably have not validated that this can be done correctly." Still,
Linda Keeling, central service processing coordinator for Western Baptist
Hospital, Paducah, KY, believes too much information will fuel an already
"sue-happy" public. Instead, she says more attention should be given
to educating healthcare workers outside central service who know little
of instrument integrity, packaging and other sterilization indicators.
Government,
public pressures
The
American Society for Healthcare Central Service Professionals said the
next logical step is a government-enforced validation plan.
Alfa said the Food and Drug Administration has traditionally accepted
the practice of device manufacturers not stamping items with "single-use
only" labels. The confusing result, she explained, is central service
departments often don't know whether to reprocess the items or dispose
of them.
"I
don't think manufacturers or the FDA are being deceiving, but how they've
handled this labeling issue has infiltrated into hospitals. There needs
to be a next step in stamping single-use equipment and not just its
packaging," Alfa said.
In bridging the gap between manufacturers and central service units,
Mary Ellen Fortenberry, sterile processing director of Hurley Medical
Center, Flint, MI, believes public demand for safer devices will eventually
force a solution.
"Nothing
enforces a standard faster than public opinion, and patients will demand
someday to know what's being used on them," Fortenberry, said.
HPN
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