Medical Device Recall Hurts Everyone

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Article Title:

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Medical Device Recall Hurts Everyone

Article Description:

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What happens when a medical device is produced with a defect? Of

course the health of the consumer is placed in jeopardy. But

what about the manufacturer and the physician? Everyone along

the supply chain gets hurt. How can you reduce your risk? One

of the easiest ways to avoid defects in medical device recalls is

through proper validation of the design and manufacturing

processes for such devices.

Additional Article Information:

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581 Words; formatted to 65 Characters per Line

Distribution Date and Time: 2007-12-11 10:24:00

Written By: Norm Howe

Copyright: 2007

Contact Email: mailto:info@...

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Medical Device Recall Hurts Everyone

Copyright © 2007 Norm Howe

Validation and Compliance Institute

http://www.vcillc.com

What happens when a medical device is produced with a defect? Of

course the health of the consumer is placed in jeopardy. But

what about the manufacturer and the physician? Everyone along

the supply chain gets hurt. How can you reduce your risk? One

of the easiest ways to avoid defects in medical device recalls is

through proper validation of the design and manufacturing

processes for such devices.

One example is the recall of Welch Allyn AED 10 Automatic

External Defibrillators, affecting emergency services personnel

and consumers. It stems from a Food and Drug Administration

(FDA)-issued Class I recall for the defibrillators manufactured

between March 29 and August 9, 2007 (part numbers 970302E,

970308E, 970310E, and 970311E).

The devices analyze an unconscious patient's heart rhythm and

automatically deliver an electrical shock to the heart if needed

to restore normal heart rhythm. The recalled devices may

experience failure or unacceptable delay in analyzing a patient?s

ECG, resulting in possible failure to deliver the appropriate

therapy.

On the heels of that recall is another recent warning regarding

Unretrieved Device Fragments as a result of cardiac

catheterization. Typically, this involves a fractured guide wire

lodged in a coronary artery that if left there, causing coronary

artery perforation. In at least one instance, attempts to

retrieve it failed, and the patient died from cardiac tamponade.

An Unretrieved Device Fragment (UDF) is a broken or fractured

portion of a medical device that was never intended to remain in

a person?s body after surgery. Instead, it was left behind either

because no attempt was made to retrieve it or because the attempt

was unsuccessful.

According to A. Fischer, RN, MSN, a device that has flaws

in its manufacture, design, or materials, or one that has been

damaged in shipment or storage, may cause problems and failure of

a device. In addition, the retained devices may be made of

materials that aren?t intended for extended internal use.

The FDA?s Center for Devices and Radiological Health receives

over UDF 1,000 reports annually regarding many types of devices

and several serious injuries and patient deaths. According to the

FDA, some patients don?t even know they have a potentially

harmful device fragment in their body, so they don?t report it.

So, what can you do to reduce your risk? If you're a consumer

or a physician you can monitor medical device recalls and FDA

Warning Letters to manufacturers by going to www.fda.org and

looking up either Recalls or Warning Letters. If you're a

manufacturer you need to follow FDA's regulations and procedures

for the design and manufacture of the medical device.

All steps being taken to minimize the risks of UDFs after they

are found are reactive. A proactive approach involves proper

validation of the design and manufacturing processes for these

devices, which could have prevented these kinds of failures.

If the manufacturer does not have that expertise in-house, there

are a number of companies that offer just that service. They can

help develop, implement and maintain quality systems through

expertise in validation, production, quality, and research and

development. When choosing such a company the manufacturer should

ask if the consultants have had actual manufacturing experience

living day-to-day with a validated process.

When a manufacturing process is properly validated the

manufacturer will have a system allows flexibility and continued

success for years into the future, which, in the case of the

above-mentioned medical devices, translates into a better product

and less worry on the part of both healthcare providers and

consumers.

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Norm Howe, Senior Partner at Validation and Compliance Institute,

consultants for the pharmaceutical and medical device industries.

He got his BS at UC, Berkeley, and a Ph.D. in chemistry at UCLA.

He has held many management positions in FDA regulated industries,

most at BASF. http://www.vcillc.com