American
CS units warming slowly to parametric release
by
James M. Berklan
Fashions, beer, automobiles - Americans have imitated Europeans in many
ways over the years.
When it comes to one hospital steam sterilization practice, however,
mere admiration may have to do for now.
Although some U.S. sterile processing departments are becoming more
familiar with standardized quality-control systems, they still have
a long way to equal Europe's parametric release practices, experts said.
Members of a working group with the Association for Advanced Medical
Instrumentation (AAMI), Alexandria, VA, are now making recommendations
for draft documents on the pursuit of parametric release that will be
discussed at their next meeting in May.
Parametric release is the acceptance of steam sterilized items based
on physical or chemical process data. European industry and hospitals,
and U.S. industry, use it. But U.S. hospitals continue to rely on less
precise "overkill cycles" and periodic biological indicator tests.
The AAMI committee has geared itself toward placing emphasis on a "quality
system," the first step toward full-blown parametric release.
Worthy goal, but...
The costs of instituting true parametric release processes are considered
prohibitive, particularly for hospitals already facing fiscal crunches.
Building a new infrastructure, which includes a highly educated workforce,
may be possible only for new facilities with a lot of capital.
Central service managers also said that mandating standardized loads,
or restricting certain loading practices, would be impractical and could
cause productivity problems.
"The
full European mode is a worthy goal, but it will take a lot of effort
to get there. It's a different culture," said Thomas K. "Chip" Moore,
senior market manager of sterilization product systems for Getinge/Castle,
Rochester, NY, and a member of the AAMI working group.
Moore said hospitals will get a partial taste of what dealing with parametric
release might be like if they choose to enter the new regulatory web
of the Food and Drug Administration concerning the reuse of single-use
devices.
'Silent'
release
A recent Healthcare Purchasing News survey of 250 central service managers
showed that most (70%) did not plan to use a parametric release system
for steam sterilized items. Slightly more than 12% said they planned
to use it, and 5% said they currently employ a parametric release system.
Martin Favero, director of scientific affairs for Advanced Sterilization
Products, Irvine, CA, described the last group as practitioners of "silent"
parametric release.
"It's
not really conventional parametric release, but they believe they're
doing it because they have chemical integrators," Favero said. "Most
people in hospitals who do this think parametric release is the cheaper
way to go, but they're using 10-cent chemical integrators. In Europe,
they basically take their probes, put them in six to 12 places in the
load and have it hooked up to a computer to record temperature, moisture
and so on."
Yet, Favero expressed admiration for American departments using chemical
integrators. He said he was not aware of a single infection allowed
by the method.
Favero said he favors the European parametric release model but doubted
it would happen in U.S. hospitals. A highly trained work force might
be a problem, he added. "In Europe, the people who do that are pharmacists,"
he said.
Dealing with delays
Consultant Anne Cofiell, also a member of the AAMI committee studying
parametric release, said the issue was put off in the past to deal with
more pressing issues, and it could be shunted aside again in May.
"A
quality system is going to come into its own anyway," she said. "Everyone's
putting emphasis on that. Reuse of single-use devices brought that to
the fore. Now, you hear the average CS director is pretty familiar with
quality systems, whereas five or even three years ago, they may not
know what you're talking about."
She predicted a document that stops short of mandating parametric release
will eventually be finalized. "It should line up in some way with the
FDA mandate for quality systems," she said.
HPN
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