FDA Patient Safety News: Show #8, September 2002

Cochlear Implants and Meningitis

The FDA is notifying health professionals about a possible association between cochlear implants and bacterial meningitis. Cochlear implants are devices that are permanently positioned in the inner ear of deaf patients to help improve their hearing. The implants activate auditory nerve fibers, allowing sound signals to be transmitted to the brain. Several dozen cases of meningitis have occurred in patients with cochlear implants, and twelve known deaths have occurred. Most of the patients have been children under the age of five, but some adults have also been affected. The time between the implant and the illness has ranged from 24 hours to more than five years.

At this point, it's not certain whether the implants themselves are raising the risk of meningitis, by serving as a focal point for infection, or whether some predisposing factor might be responsible. For example, some deaf patients may have congenital abnormalities of the inner ear which make them more susceptible to meningitis. In other cases, patients might have had otitis media prior to the surgery. Nonetheless, in response to this issue, one manufacturer, Advanced Bionics, has recalled its Clarion model cochlear implants.

Here's what the FDA notification recommends to deal with this problem:
First, it encourages physicians to consider prophylactic antibiotic treatment prior to implanting these devices.

Second, it encourages physicians to promptly diagnose and treat otitis media in patients who already have the implants.

And third, it suggests that people, who are going to receive cochlear implants, as well as those who already have them, might benefit from vaccinations against the organisms that commonly cause bacterial meningitis.
The notification gives some suggested immunization schedules.

Additional Information:

FDA Public Health Web Notification: Cochlear Implant Recipients may be at Greater Risk for Meningitis.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/UCM062104


Recall of Cryolife Human Tissue Allografts

Here's news about a recent recall. FDA is notifying health professionals about a recall of human allograft tissues processed by CryoLife Incorporated of Kennesaw, Georgia. FDA ordered this recall because CryoLife had not validated procedures to prevent infectious disease contamination during processing. Therefore, it could not ensure that its processed human tissue was free from fungal and bacterial contamination.
Tissue processed by CryoLife has been associated with the death of a patient who received a soft tissue implant during reconstructive knee surgery.

FDA's recall order describes manufacturing deficiencies that could result in contamination of soft tissues, such as cartilage and tendons. If bacterial or fungal infection were to occur following tissue implantation, signs and symptoms would usually appear within days to weeks after surgery.

If you're caring for a patient who was recently implanted with CryoLife processed tissue, the notification recommends that you carefully monitor the patient for both fungal and bacterial infections. If you have CryoLife processed tissue that's covered by the recall order, and you haven't used it yet, FDA recommends that you first quarantine it, and then follow disposal instructions from CryoLife. You should consider using processed allografts from other manufacturers or processors.

The reason that heart valves aren't included in the recall order is because these devices are essential in treating congenital cardiac lesions in children, and there's no satisfactory alternative device. So even though CryoLife's heart valves carry the same potential contamination risk as the company's other allograft tissues, FDA's notification says that the benefit of using the heart valves under these circumstances may outweigh the potential risk.

Even though heart valves aren't covered by the recall order, FDA is still concerned that the patients who receive them may be at increased risk of infection. If you're caring for a patient who was recently implanted with a CryoLife allograft heart valve, you should carefully monitor the patient for bacterial and fungal infection. Report all adverse reactions to both FDA and CryoLife.

FDA has recently reached an agreement with CryoLife that will allow the company to begin limited distribution of some of its human allograft products, provided that the use is medically urgent and that all alternative treatments have been exhausted or are unavailable. Under these circumstances, certain specific conditions must be met in order for the product to be used.

Additional Information:

FDA Public Health Web Notification: Human Tissue Processed.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/UCM064529


Recall of Cryolife Human Tissue Allografts

Here's news about a recent recall. FDA is notifying health professionals about a recall of human allograft tissues processed by CryoLife Incorporated of Kennesaw, Georgia. FDA ordered this recall because CryoLife had not validated procedures to prevent infectious disease contamination during processing. Therefore, it could not ensure that its processed human tissue was free from fungal and bacterial contamination.
Tissue processed by CryoLife has been associated with the death of a patient who received a soft tissue implant during reconstructive knee surgery.

FDA's recall order describes manufacturing deficiencies that could result in contamination of soft tissues, such as cartilage and tendons. If bacterial or fungal infection were to occur following tissue implantation, signs and symptoms would usually appear within days to weeks after surgery.

If you're caring for a patient who was recently implanted with CryoLife processed tissue, the notification recommends that you carefully monitor the patient for both fungal and bacterial infections. If you have CryoLife processed tissue that's covered by the recall order, and you haven't used it yet, FDA recommends that you first quarantine it, and then follow disposal instructions from CryoLife. You should consider using processed allografts from other manufacturers or processors.

The reason that heart valves aren't included in the recall order is because these devices are essential in treating congenital cardiac lesions in children, and there's no satisfactory alternative device. So even though CryoLife's heart valves carry the same potential contamination risk as the company's other allograft tissues, FDA's notification says that the benefit of using the heart valves under these circumstances may outweigh the potential risk.

Even though heart valves aren't covered by the recall order, FDA is still concerned that the patients who receive them may be at increased risk of infection. If you're caring for a patient who was recently implanted with a CryoLife allograft heart valve, you should carefully monitor the patient for bacterial and fungal infection. Report all adverse reactions to both FDA and CryoLife.

FDA has recently reached an agreement with CryoLife that will allow the company to begin limited distribution of some of its human allograft products, provided that the use is medically urgent and that all alternative treatments have been exhausted or are unavailable. Under these circumstances, certain specific conditions must be met in order for the product to be used.

Additional Information:

FDA order for retention, recall and/or destruction.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2002/ucm144977.htm



FDA Patient Safety News is available at www.fda.gov/psn