SAFE
to HANDLE
GETINGE Infection Control
Volume 5
■
Issue 1
■
March 2010
A Message From
The ABCs of 510(k)
the President
R
ecent events in the infection control
equipment industry over the past several
months have focused attention on the
I
was both intrigued and
impressed by Domino’s
Food and Drug Administration’s (FDA) 510(k)
process for introducing medical devices to the
Pizza’s recent
U.S. market.
advertising campaign that
510(k) is actually a section of the Federal
admitted consumers Food, Drug and Cosmetic Act from which the
thought their product could
following six-step process was derived:
stand to be improved.
• Manufacturers must confirm the
classification of their devices to ensure they
Domino’s said they listened to the criticism
qualify for the 510(k) process. 510(k)
and did something about it.
approval is required for selected Class I
While at first, the approach seemed to be a
devices, nearly all Class II devices and a
little risky, I ultimately came to the conclusion it small assortment of Class III devices.
was refreshing that a dominant player in its
• Manufacturers must identify predicate
industry could be confident enough to go
(similar) devices already cleared for sale in
the United States by the FDA. In short, any
public with their quest to achieve continual
new model of a device is compared for safety and effectiveness with
improvement.
another lawfully marketed model.
Like Domino’s Pizza, Getinge is committed • Equipment vendors must use the product Classification Code to
to listening to our customers and being more
determine whether any special guidance documents or international
responsive to their needs. In fact, over the
standards apply to the medical device, and must be acknowledged in
the process.
years, many of our product improvements continued on page 2
were influenced by input we actively solicited
from our customers all over the world.
Now we are turning our attention to making Putting the Science of
Getinge an easier company to do business
with by realigning our sales and service
Detergent Management
organizations to better reflect how institutions,
to Work in Your SPD
like yours, prefer to interact with a full-service
solutions provider such as ours.
In the process, I have challenged each of
T
oo little and you compromise
cleaning efficacy. Too much
and thousands of dollars in
our employees to better align our goals with
wasted consumption can be rinsed
yours—recognizing that all of us shares a down the drain each year. SPD
common ambition to help preserve, sustain
managers have long struggled to
and improve the quality of human life.
optimize their detergent management
strategies to achieve repeatable
We take that responsibility seriously,
results, control costs and improve
understanding you are on the front line of
productivity load after load.
providing quality care. And you can count on
Even though programmable
the fact that, behind the scenes, we will controls on today’s washer-
support your efforts every step of the way.
disinfectors offer a measure of
Andy Ray
detergent dosage control, automation lacks the ability to account for the many
President
variables that impact detergent effectiveness and cost efficiency. For example,
Getinge USA, Inc.
washers cannot automatically adjust to changes in chemistry when detergent
continued on page 2
1003-Getinge Insert.pmd 17 2/10/2010, 4:28 PM
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