Biomedical Engineering Reference
In-Depth Information
follow-up, there is tilting of the femoral head about the short stem, pro-
viding appearance of a collapsed head (dashed lines).
Postretrieval
testing
On the basis of this initial classification or triage scheme, a series of
diagnostic tests will be ordered. Other tests may be desired for the pur-
poses of research or special studies; however, those described here fall
within the scope of normal diagnosis and should be chargeable to the
base costs of patient treatment. It is recommended that a single charge be
used that averages the costs of all studies (of removal class I, II, and III
devices) and that it be adjusted periodically on the basis of experience.
This strategy will tend to limit testing to essential studies only.
Table 16.1 outlines the possible procedures, on a case-by-case basis,
associated with DRA studies under this triage scheme. The normal
expectation is that 1%-2% of orthopaedic devices will fall in class I,
less than 10% in class II, and the balance in class III. The final deposi-
tion should be made by the review board, on the recommendation of the
service chief.
Dra disposition
After the results of all tests are available, the DRA service chief should
prepare a note describing the examination and his conclusions. This note
Table 16.1
Conduct of dra studies
Removal class
Steps
Class I
Class II
Class III
Retrieve
Package
Identify
Sterilize
Classify
Evaluate
Photographs
X
X
X
Culture reports
X
X
Histology
X
X
Metallography
X
Dimensional analysis
X
Mechanical analysis
X
Chemical analysis
X
Special tests
X
X
Mechanical testing (device portions)
X
Hardness
X
Specific histology stains
X
Metal analysis (AAS) (fluids, tissues)
X
Case disposition
X
X
X
Prepare report
X
X
X
Store device
X
X
X
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