Caveat Emptor (Let the Buyer Beware)
By David Adams, MBA  With both sons in college, I thought it was
prudent to build a computer from scratch for one of them. I
purchased several new parts recommended by the store clerk. After
seemingly endless hours of frustration and troubleshooting, I
determined that a part was defective. I wish there was a way to
assure that the parts I purchased would work, such as labeling that
would give me confidence.
This type of quality problem can be even worse when, as a
prosthetist and or orthotist, you are selling a service, and it
turns out that the medical devices you purchased for your patient
failed to meet an acceptable standard.
I have heard stories about patients driving six hours to have a
limb fitted, only to have it fail after they left the facility.
Talk about dissatisfied customers! And the parts failure wasn't
even your fault, but guess who gets the blame?
As customers, we all expect the products we purchase to meet
minimum quality requirements. Your customers have a minimum
expectation that they will be satisfied with your efforts. It's a
risky venture for your customers when they often pay significant
sums of hard-earned cash to improve the way they feel. Their
expectations are high.
How do you ensure that they are happy with your service, and
will thus become repeat customers who improve your business through
word of mouth?
Let's start with product selection. Make sure that you buy
products that have been strength- and fatigue-tested. As you know,
tremendous forces are applied to prosthetic and orthotic
components. In extreme cases, a lower-limb prosthesis experiences
forces that are over five times the body weight on heel strike. For
a 200-lb. patient, that is 1,000 lbs. of impact!
How do you know that the parts and products that you buy will
withstand the forces applied by your patients? Is there a marking
system to indicate proper design and testing? There are two such
markings that you should look for. One is ISO 9000 /
9001 registration and the other is CE
marking.
ISO 9000 and 9001 are quality management standards designed by
an international committee of quality experts. The standards
provide a structure for a written quality assurance system.
Companies integrating these standards into their business
operations create systems that focus on their customers' needs.
Once a company implements an internationally recognized quality
assurance system, the company invites external auditors to validate
their system.
These companies identify themselves as ISO 9000-registered. At
the very least, you can feel confident that they are evaluated on
their quality control practices every six months.
CE marking is a regulatory requirement in Europe that sets
minimum standards for product safety. This mark is placed on the
product and product packaging. For medical devices, products that
exhibit the CE mark have been tested to applicable standards, such
as standards for bio-compatibility, fatigue life, and ultimate
strength. They also undergo critical evaluation to determine
possible causes and modes of product failure.
So even though you are not going to find a "Good Housekeeping"
seal of approval on the prosthetic and orthotic devices that you
purchase, you should look for CE marking labels and ISO
registration statements. In addition, products imported into the
United States are required to show the country of origin on the
product.
Armed with this information, you should be able to determine
where the product was made and whether or not it has undergone
extensive product testing.
The devices you purchase are designed to work within certain
parameters such as patient weight, activity, and recommended torque
values. Failure to follow ordering and installation
guides will be risky for both you and your patient, so
please pay careful attention to these instructions.
Major manufacturers in our industry have made significant
investments in implementing quality standards and product test
equipment to verify the safety of their product designs. Don't take
chances; look for the ISO 9000 and CE marks, or your patients may
wish that you had. David Adams, MBA, is director of sales and marketing for Seattle Systems, Poulsbo, Washington. 
Table Of Contents - April 2003
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