CMS SOM App. H, Tag V356

494.50(b)(1)

13.2.3 Recording

Any significant events such as the occurrence of symptoms listed in [AAMI] 13.2.1 and

13.2.2 should be recorded on an incident report form which would include the results of the

evaluations conducted by the physician and others[, and] the event should be considered

for reporting to the manufacturer(s) in accordance with the FDA’s Medical Device User

Reporting procedures. The resolution of actual or suspected problems caused by

reprocessed dialyzers should be indicated. This report should be kept in the complaint

investigation record file (see [AAMI] 4.5).

4 Records

4.5 Complaint investigation record

Records shall be kept of all complaints by patients and staff members about failures of

preprocessed and reprocessed dialyzers or possible adverse reactions to any dialyzers; the

results of a comprehensive investigation of these alleged problems; and, if appropriate, the

corrective actions taken. The records shall be reviewed periodically for trends of adverse

reactions. . . Compliance with the FDA’s Medical Device User Reporting procedures [shall

be demonstrated.]

Interpretive Guidance § 494.50(b)(1)

Page 160 of 420

In dialyzer reprocessing, the term “complaint” refers to deviations from expected outcomes (e.g.

dialyzer failures, patient reactions, blood leaks), as well as to patient complaints related to

reused dialyzers.

The facility must maintain a record of dialyzer complaints. Each complaint should be

investigated, and any reuse incidents reported in the QAPI records with corrective actions as

indicated.

Responsible staff (e.g., the chief technician, area technical manager, nurse administrator,

medical director) should consider if there have been any trends in complaints, and take indicated

action. This information should be incorporated into the facility’s QAPI program. Refer to V635.

Facility staff must comply with the FDA’s Medical Device User Reporting requirements. Refer to

V383.