Materials retrieval and analysis - Orthopaedic Biomaterials in Research and Practice - page 404

i. The user (patient) will be assured as to the cause for device
removal and that necessary corrective measures, if possible,
are being taken.

ii. The surgeon or doctor involved will be assured that causes of
removal are being investigated in a systematic way that will
tend to contain any possible liability within the bounds of
actual medical malpractice and reduce the risk of transmittal
of liability of others to him.

iii. The treating institution will be assured that the best possible
care is being provided, that patients' rights are being pre-
served, and that liability is being contained.

iv. The manufacturers will be assured that maximal effort is being

made to determine whether either singular or generic failures,
referable to engineering factors, have occurred in a manner that
will permit rapid corrective action to be taken if it is indicated.

v. Both academic investigators and regulatory agencies will be
assured that collection of clinical data, in a uniform and con-
trolled manner, is being facilitated so that identification of fail-
ure modes and mechanisms will be possible.

4. What are the necessary elements of a DRA program?
Answer : The American Society for Testing and Materials
(ASTM) has been examining this issue through their F 4
Committee and have identified the following general requirements
for DRA programs:

i. A general definition of implant failure (when programs are
restricted to study of “failures”)

ii. A classification system of clinical and engineering failure
indications specialized for the medical discipline involved

iii. A standard protocol for recovery of implants at surgery with
associated tissue and fluid specimens

iv. Identification of recommended clinical (intraoperative and
other) tests results to be obtained

v. A standard form (or computerized format) for reporting patient

history, observations at surgery, and immediate associated test
results, to be designated as the retrieval form

vi. Standard protocols for the study of retrieved devices and tis-
sues referenced to suitable standard (ASTM or other) proce-
dures and recommended practices

vii. Division of the investigation into three stages from essential
minimum analysis for routine examination (Stage I) to nonde-
structive but more detailed studies (Stage II) to destructive and
material-specific evaluations (Stage III)

viii. A scheme for analysis of data

ix. A classification system for assignment of failure mode and
mechanism