No 483 for Midwest ear tissue bank.

Midwest Ear Foundation, Cincinnati, OH, Cincinnati District

Midwest Ear Foundation, a procurer, processor and distributor of donated human ear tissues, received no 483 during its second inspection, which was conducted by Thomas Nojek and Allison Hunter from the Cincinnati District.

During the inspection, 300 donor records were reviewed including the following information:

1. Donor chart review forms

2. Medical histories

3. Determination of suitability of blood sample testings for infectious disease

4. Serology test reports

5. Donor medical history and behavioral risk assessment questionnaires

6. Donor disposition/autopsy results forms

"No significant deficiencies were noted during the inspection," the EIR stated.

The facility was previously inspected by FDA and classified as NAI.

Midwest Ear Foundation procures tympanic membranes and the bones of the middle ear, including the malleous, incus and stapes. All tissues are obtained from hospitals and funeral homes within a 50-mile radius of Cincinnati and include donors from Ohio, Kentucky and Indiana.

"Donated tissues must be obtained from cadavers within 24 hours of death or within 72 hours if the body is embalmed within 24 hours of death," the EIR stated. "If the coroner is involved in a death investigation of the deceased, tissues are not accepted."

Approximately 95% of tissues are obtained from funeral homes. The company uses one registered nurse and one eye bank technician to obtain tissues from donor cadavers. The firm also utilizes one dissection technician to process the tissues.

When a prospective donor is identified, the next of kin is requested to sign the consent form. If the next of kin agrees, the hospital calls a national hotline to inform the receptionist of the specific donated tissues or organs. If ear tissues are being donated, the hotline calls the Midwest Ear Foundation. A technician then performs an initial screening that includes a patient chart review and a donor social history for high-risk behavior from the next of kin.

"If the donation appears acceptable, a blood sample for HIV/HbsAg, HCV and RPR tests is obtained," the EIR stated.

A Midwest Ear Foundation technician removes the middle ear core from the donor at the funeral home and then places the tissue in 70% alcohol solution so it may be transported to the foundation's laboratory. There it is placed in quarantine.

"If negative test results are received and the donor's medical history is acceptable, the middle ear core is placed in formaldehyde for sterilization for 72 hours," the EIR stated. After sterilization, the dissection technician removes the tympanic membrane, malleus, incus and stapes from the ear core. The tissues are sterilized again in formaldehyde and paced in a plastic cup with buffered formaldehyde solution and sealed.

Once the tissues are processed, they can be stored for up to two years. The sample can be stored for an additional year for a total of three years if at the two-year point; the buffered formaldehyde solution is changed under sterile conditions.

The ear tissues are shipped to ear surgeons throughout the U.S. A tissue screening summary statement attests to the sterility and integrity of the tissue and accompanies the shipment. Unused ear tissue removed during dissection or ear tissues deemed unacceptable due to damage or any other reason are discarded as biohazardous waste, which is removed on a monthly basis.

Attempts to reach Midwest Ear Foundation for comment were unsuccessful before deadline.

Midwest Ear Foundation, Cincinnati, OH, 9/12/02, Doc. 109614M, $2.00 plus retrieval.