Materials retrieval and analysis - Orthopaedic Biomaterials in Research and Practice - page 405

A standard practice for retrieval of medical devices has been
developed (F 561-05: Standard Practice for Retrieval and Analysis
of Medical Devices, and Associated Tissues and Fluids; American
Society for Testing and Materials, Philadelphia). The recommen-
dations made elsewhere in this chapter are in general agreement
with this practice.
5. Who is responsible for initiating the retrieval and analysis of a
particular implant?
Answer : A workshop was held at the National Bureau of
Standards in March 1976, in conjunction with a symposium on
the retrieval and analysis of orthopaedic implants. The members
of the workshop, drawn from industry, government, and the spon-
soring organizations (including the National Bureau of Standards,
the Orthopaedic Research Society, the ASTM, the American
Academy of Orthopaedic Surgeons [AAOS], the American
College of Surgeons [ACOS], and the FDA) recommended to both
the AAOS and ACOS that this responsibility be recognized to be
that of the senior treating physician.
6. What implants should be retrieved?
Answer : In general, all implants should be retrieved (as previ-
ously described), with exceptions being made only for small, iso-
lated, noncritical devices such as skin clips, cerclage wire, and so
on. However, any excluded device that shows evidence of frank
failure, either preoperatively or intraoperatively, or, in the sur-
geon's opinion, has failed to fulfill its intended function, should
also be retrieved.
7. Who owns retrieved implants?
Answer : The weight of expert and legal opinion is that the
implant belongs to the patient despite any role of third-party pay-
ers or insurers. The practical requirements for accountability and
the impact that analysis of implants may have on diagnosis and
treatment suggests that the hospital should routinely retain custody
of the implants for a period exceeding the statute of limitations
in its jurisdiction after retrieval. Release before this time, either
to the patients or their agents or for the purpose of research and
teaching, should be only at the specific written direction of the
patient.
8. Who should pay for DRA studies?
Answer : Study of retrieved implants is part of the process of
diagnosis and treatment in the same way that radiography and
laboratory studies are. Thus, the responsibility for payment for
retrieval and initial studies should reside with the patients and
such third-party insurers that they may retain. Initial studies are
defined as those indicated by and contributing to the treatment of
the patient's condition and specifically excluding tests desirable
for research and teaching purposes. On the other hand, research-
ers may decide to fund such studies, with patient permission, to