Materials retrieval and analysis - Orthopaedic Biomaterials in Research and Practice - page 399

Institutional setting for Dra studies
DRA is an institutional responsibility that practicing physicians should
insist on, as they insist on other forms of institutional support. Thus,
this section is intended for the guidance of administrators in setting up
DRA services and of physicians in measuring the performance of such
services. It is not intended that individual physicians be encouraged to
establish such studies in their own practices. In most cases, adequate
resources are not available and liability might be incurred through poor
conduct of studies.
Within a treating institution, the DRA service should be reasonably
autonomous, with a structure and chain of responsibility parallel to that
of the institutional clinical pathology service. Lack of resources may
require one DRA service to serve several institutions or even to function
on a regional basis. Such arrangements are possible but care must be
taken to maintain appropriate professional oversight.
A professional with a PhD degree in bioengineering/biomedical
engineering, materials science, or equivalent expertise with an engi-
neering background and some experience in DRA should supervise
the service and report to the institutional medical board. The service
should be permanent, after an initial experimental period, and ade-
quate funding must be provided. It should be physically housed within
the institution and be given access to all normal institutional services
(security, data processing, library, etc.) that other services enjoy. It ren-
ders clinical rather than research or administrative service and should
be situated accordingly within the treating institution's management
scheme.
A formal, continuing review board should be available to oversee
the operation of the DRA service and ratify the decisions of the ser-
vice chief, in much the same manner as a tissue committee. It should
meet periodically, on a regular schedule, to maintain immediacy and
retain disposition of cases. Major device-using services should be rep-
resented as well as external experts. Although it is strongly recom-
mended that such DRA services encompass all removed devices in a
given institution, the following comments focus specifically on ortho-
paedic devices.
Procedures for Dra studies
Beyond benefits to specific patients, the utility of DRA programs
depends strongly on their ability to collect all but a narrowly excluded
group of implants. The devices that should be recovered are as follows:
Metallic implants: all parts except for skin clips, isolated cancellous
and cortical bone screws, and cerclage and suture wires.
Nonmetallic implants: all parts except for sutures, drains, packings,
or other disposable items and fragments of bone cement smaller
than 1 cm in the largest dimension.