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Medical Device Recalls Hurt Everybody

Dec 17, 2007
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.
About the Author
Norm Howe, Senior Partner at Validation and Compliance Institute, consultants for FDA regulated industries. He got his BS at UC, Berkeley, and a Ph.D. in chemistry at UCLA. He has held many management positions, most at BASF. vcillc.com
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