Caveat Emptor (Let the Buyer Beware)

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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.