December 16, 1996
TO: Director of Hemodialysis
We are writing to inform you of a recent occurrence involving serious patient injury following hemodialysis treatment. We expect that it will take several months to complete our investigation, at which time we will notify the dialysis community of our findings. In addition, we are asking that you let us know of any similar events.
Reported Event
In September of 1996, seven patients received in-patient hemodialysis, using cellulose acetate dialyzers, at an Alabama hospital. In six of these seven patients, dialysis machine blood leak alarms sounded. Within 24 hours of treatment, all seven patients developed one or more of the following symptoms: conjunctivitis, visual loss, and hearing loss. According to the Centers for Disease Control and Prevention (CDC), the agency which initially investigated the incident, these symptoms were associated with the use of the cellulose acetate dialyzers, and, as yet, the exact mechanism of the reactions is unknown.
Previous Event
A similar incident involving cellulose acetate dialyzers occurred in Japan in 1982 as reported by Oba et al1. In that episode, scleritis, iritis, and in some patients, tinnitus, were observed during dialysis or within ten hours of treatment. In follow-up research, acetylated carbohydrate derivatives and other materials were extracted from cellulose acetate dialyzers similar to those used on the affected patients. They concluded, based on animal tests, that acetylated carbohydrate derivatives played a primary role in the incident.
Possible Causes
The cellulose acetate dialyzers involved in the September 1996 incident are believed to have been manufactured more than ten years ago. It is not known to what extent age or storage conditions played a role in this incident. The Food and Drug Administration (FDA) is currently analyzing cellulose acetate dialyzers in an attempt to identify leachable materials that may be produced by storage at extreme temperatures and/or over long periods of time. The epidemiological analysis suggests a causal relationship between the dialyzers used during the September 1996 incident and the injuries exhibited by the affected patients. The mechanism and extent to which the dialyzers contributed to the reported injuries has not been conclusively determined. To that end, we plan to collaborate with current manufacturers or distributors of cellulose acetate dialyzers to research and determine the etiology of the reported events. We expect our investigation to conclude within the next several months, at which time we will notify the dialysis community of our findings.
Recommendation
In the meantime, due to potential adverse effects of storing cellulose acetate dialyzers at warm temperatures or over long periods of time, we recommend that you rotate your dialysis stock using "first-in-first-out" practices. If you are unsure of the age of any cellulose acetate dialyzers that you have in stock, you should contact the dialyzer manufacturer to determine if they are appropriate for use.
Reporting Information
Any observations of neurologic symptoms, such as those described above, in patients who have received hemodialysis using cellulose acetate dialyzers, should be reported to FDA under the Safe Medical Devices Act of 1990 (SMDA), which requires hospitals and other user facilities to report deaths and serious illnesses and injuries associated with the use of medical devices. Practitioners who become aware of medical device-related adverse events should report them to their Medical Device User Facility Reporting contact and should follow the procedures established by their facility for such mandatory reporting.
For problems and/or malfunctions, not required to be reported under SMDA, we encourage you to report directly to MedWatch, the FDA's voluntary reporting program, by phone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; or by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane (HF-2), Rockville, MD 20857.
Finally, the Center for Devices and Radiological Health (CDRH) is interested in obtaining, for testing purposes, cellulose acetate dialyzers that were manufactured prior to 1986. Please contact Judy Kalson (FAX 301-443-2296) if you have a pre-1986 unit(s) that you are willing to provide to CDRH for testing.
Getting more information
If you have questions regarding this letter, please contact the Issues Management Staff, Office of Surveillance and Biometrics (HFZ-510), 1350 Piccard Drive, Rockville, Maryland, 20850, by fax at 240-276-3356, or by e-mail at phann@cdrh.fda.gov. Additionally, a voice mail message may be left at 240-276-3357 and your call will be returned as soon as possible.
Sincerely yours,
| Larry G. Kessler, Sc.D Director Office of Surveillance and Biometrics Center for Devices and Radiological Health Food and Drug Administration | William R. Jarvis, M.D. Acting Director Hospital Infections Program National Center for Infectious Diseases Centers for Disease Control and Prevention |
Reference:
1. Oba T, Tsuji K, Nakamura A, et al. Migration of Acetylated Hemicellulose from Capillary Hemodialyzer to Blood, Causing Scleritis and/or Iritis, Artificial Organs 1984; 8(4):429-435.
Updated December 19, 1996
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