What is Dialyzer Reuse?
For dialysis, specifically, 'reuse' refers to using a dialyzer (artificial kidney) more than one time for the same patient. 'Reprocessing' is the process that takes place in order to reuse a dialyzer safely for the same patient. The official definition is the “…act of restoring a previously used device so that it is suitable for using again,” according to the Association for the Advancement of Medical Instrumentation (AAMI) standards and recommended practices.

Reused dialyzers are safe and effective if all standards and requirements are followed. The water that is used to rinse them is treated, the chemicals that are used are tested to make sure they are strong enough to sterilize the dialyzer, and the dialyzer is tested before each treatment to make sure all of the chemicals have been removed. The performance of the dialyzers is measured before each treatment to make sure the dialyzers are able to remove fluid and wastes.

Standards and Regulatory Agencies
There are several agencies that either set standards for reprocessing dialyzers or monitor the performance of dialysis facilities in meeting the standards.

Association for the Advancement of Medical Instrumentation

AAMI is one of the organizations that sets standards for dialysis units to follow for reprocessing. As a consumer you should be aware of some of the AAMI requirements:

Complaints:
All units are required to have a 'Complaint Investigation Record' that keeps track of patient and staff complaints related to reprocessing.

Water:
The water that is used for reprocessing must be treated so that contaminants and bacteria are removed to within a safe level. The maximum levels are set by the AAMI regulatory agency.

Informed Consent:
The medical director and staff are responsible for fully informing patients of the dialysis facility’s practices with regard to reuse of hemodialyzers and other supplies.

Hemodialyzer Labeling:
The dialyzer must be labeled with the patient’s name, the number of previous uses and date of the last reprocessing. Dialyzers of patients with similar last names should have a warning to the user to take extra care in ensuring that the name or other identifying information on the label corresponds to that of the patient.

Germicide:
Various germicides (disinfectants) can be used for reprocessing. Dialysis units must follow manufacturer recommendations for use of germicides including diluting, testing and monitoring of the germicide.

Verification of Consumer Identification:
Two persons should check that the first and last names on the dialyzer and any other appropriate identifying information corresponds to the identifying information on the patients permanent record. If possible, one of the persons checking the dialyzer identification should be the consumer.

Rinsing:
The dialyzer must be rinsed so the germicide is reduced to an acceptable level and is safe.

Testing:
The dialyzers must be tested to make sure they are safe. Test results must be kept on file and monitored.

State Department of Health

The State Department of Health and Senior Services requires dialysis units to follow the AAMI standards and recommended practices. Site visits are made to facilities by staff to verify that all standards are followed.

If you need more information or have questions you should speak to the head nurse, administrator or medical director of the facility. If you think there are poor reuse practices in the facility, you should speak to the medical director or administrator of the facility. If nothing seems to change, you should discuss your concerns with the state Department of Health and Senior Services. The general complaint telephone number is 800-792-9770.

Health Care Financing Administration

The Health Care Financing Administration requires that the dialysis units follow the AAMI standards and recommended practices for reuse in order to be eligible for Medicare reimbursement.

Food and Drug Administration

The Food and Drug Administration (FDA) requires manufacturers of dialyzers to test their dialyzers and submit the results to the FDA for reuse approval. Dialyzers that are reused must be labeled that it is acceptable, and must have FDA approval for the type of germicide that the unit is using.