BI 108- Spring 2007	Major Recalls of Organ Replacement Devices
HOME Recall Information Baxter Dialyzer Bjork-Shiley Heart Valve Guidant AAA Stent Guidant ICD Saint Gobain Desmarquest Hip Implant Sulzer Hip Implant Conclusions Brown University BI 108 Website CONTACT	Regulation Following the premarket approval from the FDA, the government provides little supervision over device adjustments or changes to the manufacturing processes. All of the recalled devices described in this website became defective for this reason. Unfortunately, the problems were not identified quickly enough because of the lack of communication between physicians and the manufacturing companies. In addition to initial market approval, the FDA must strengthen its postmarket surveillance of medical devices and not rely entirely on industry self-regulation. Since communication plays an important role in this surveillance, it should be continuous and open between device manufacturers and the FDA, so that as soon as a problem is identified, additional device implantations can be curtailed. There are several steps that can be taken in order to ensure that fewer recalls of other devices occur. First and foremost, the FDA must not approve devices that fail during premarket testing until the failure mechanism is understood, corrected, and the revised device retested. If marketed devices fail, they should immediately be removed from the market until the device is safe for patient use. Also, engineering changes to approved market products that become defective must be stringently controlled, evaluated, and monitored. Clinical registries should also be established to collect key data about device performance and increase information available to physicians and manufacturers. An independent review board similar to the American Society for Testing and Materials (ASTM) or the Institute of Electric or Electronic Engineers (IEEE) should be established to maintain high standards of quality control for medical devices. Should a company recall a device, it should assist the patients in any revision surgery necessary.[1] Return to top References Blackstone, Eugene H. Could It Happen Again? The Bjork-Shiley Convexo-Concave Heart Valve Story. May 31, 2005. Available online at: http://circ.ahajournals.org/cgi/content/full/111/21/2717 Return to top Last Updated: April 30, 2007

BI 108- Spring 2007

Major Recalls of Organ Replacement Devices

HOME

Recall Information

Baxter Dialyzer

Bjork-Shiley Heart Valve

Guidant AAA Stent

Guidant ICD

Saint Gobain Desmarquest Hip Implant

Conclusions

Regulation

Following the premarket approval from the FDA, the government provides little supervision over device adjustments or changes to the manufacturing processes. All of the recalled devices described in this website became defective for this reason. Unfortunately, the problems were not identified quickly enough because of the lack of communication between physicians and the manufacturing companies.

In addition to initial market approval, the FDA must strengthen its postmarket surveillance of medical devices and not rely entirely on industry self-regulation. Since communication plays an important role in this surveillance, it should be continuous and open between device manufacturers and the FDA, so that as soon as a problem is identified, additional device implantations can be curtailed.

There are several steps that can be taken in order to ensure that fewer recalls of other devices occur. First and foremost, the FDA must not approve devices that fail during premarket testing until the failure mechanism is understood, corrected, and the revised device retested. If marketed devices fail, they should immediately be removed from the market until the device is safe for patient use. Also, engineering changes to approved market products that become defective must be stringently controlled, evaluated, and monitored. Clinical registries should also be established to collect key data about device performance and increase information available to physicians and manufacturers. An independent review board similar to the American Society for Testing and Materials (ASTM) or the Institute of Electric or Electronic Engineers (IEEE) should be established to maintain high standards of quality control for medical devices. Should a company recall a device, it should assist the patients in any revision surgery necessary.[1]

Return to top

References

Blackstone, Eugene H. Could It Happen Again? The Bjork-Shiley Convexo-Concave Heart Valve Story. May 31, 2005. Available online at: http://circ.ahajournals.org/cgi/content/full/111/21/2717

Return to top

Last Updated: April 30, 2007