CMS SOM App. H, Tag V355

494.50(b)(1)

13.2 Symptoms

13.2.1 Fever and chills

Patients’ temperatures should be measured and recorded at least before and after dialysis

with new and reprocessed dialyzers. A temperature of over 37.8° C or 100° F, taken orally,

or chills should be reported to the physician, [advanced practice registered nurse or

physician assistant]. Any patient with an unexplained fever and/or chills should be

evaluated for the possibility of a pre-existing infection (e.g., [at an] access site). The dialysis

procedure should also be evaluated to rule out the use of contaminated water, errors in

treatment delivery, or incorrect dialyzer reprocessing.

13.2.2 Other symptoms

Other unexplained symptoms such as pain in the blood- access arm at the onset of dialysis

should be evaluated by the physician, [advanced practice registered nurse or physician

assistant] [and[consideration given to the possibility that the symptom may be attributable

to residual disinfectant in the new or reprocessed dialyzer or contamination of the water

treatment equipment.

Suspected reactions to the residual germicide should prompt reevaluation of the rinsing

procedure and tests for residual germicide (see [AAMI] 12.4.1).

Interpretive Guidance § 494.50(b)(1)

AAMI Rationale for the Development and Provisions of this Recommended Practice

A.13.2 Symptoms

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Evaluation by a physician is required to determine whether symptoms might constitute an

adverse reaction to the reprocessed dialyzer because symptoms during dialysis are commonly

the result of other factors, such as infections not attributable to dialysis, and to hypovolemia.

First-use syndrome is a symptom complex characterized by nervousness, chest pain, back pain,

palpitations, pruritus, and other usually mild symptoms, occurring minutes following the

initiation of dialysis with a new dialyzer. [The syndrome is defined by some authorities] to

include the anaphylactoid reaction [occurring usually] immediately after the initiation of

dialysis in some patients using dialyzers sterilized with ethylene oxide. In addition to first-use

syndrome, serious reactions have been reported in patients taking ACE (angiotensin-converting

enzyme) inhibitors and dialyzed on certain synthetic membranes. This reaction is now known to

involve increased bradykinin release accompanied by suppression of bradykinin degradation.

Additional Guidance:

Physicians or non-physician practitioners (i.e., advanced practice registered nurses or physician

assistants) functioning in lieu of physicians are responsible for evaluating the symptoms

discussed in this regulation. Patient temperatures must be checked pre- and post-treatment, and

signs of infection must be evaluated for any potential relationship to reprocessing/reuse.

One of the symptoms of germicide infusion is severe pain and burning in the patient’s vascular

access. Patients may interpret pain in the vascular access site at the onset of dialysis as being

related to needle insertion pain.