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Article Title:
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Medical Device Recall Hurts Everyone

Article Description:
====================

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:
===============================

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 (c) 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 Robert 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


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