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Significance and Use
The intent of this guide is to identify the general performance and good practice standards that a pelvic ring circumferential compression stabilization device (PRCCSD) should possess.
Currently, a number of base platforms such as full-body spinal immobilization devices (long boards) are used to immobilize patients during transport and before definitive treatment. These platforms limit gross movements of the spine and pelvis but do not specifically reduce and stabilize disruptions of the pelvic ring. The PRCCSD applied circumferentially about the patient exerts a compressive force to reduce and stabilize disruptions of the pelvic ring.
The PRCCSD may be used alone but, according to clinical situations, will commonly be used in conjunction with different supporting base platforms during transport and before definitive treatment.
The PRCCSD, when circumferentially applied, should be centered at the level of the greater trochanters and symphsis pubis.
A device intended for use with adult patients shall accommodate the 95th percentile adult American male.
The device should be able to be applied by a single practitioner.
1.1 This guide establishes minimum standards for devices designated here as pelvic ring circumferential compression stabilization devices(s) (PRCCSD), commonly known as pelvic slings, belts, or binders. The PRCCSD is used as the initial pelvic ring stabilization device on patients suspected of having sustained traumatic disruptions of the pelvic ring. It is used during patient transport by emergency personnel and before definitive treatment.
1.2 This guide addresses the recognized need to reduce and stabilize pelvic ring disruptions through the use of circumferential compression devices.
1.3 Peer-reviewed medical literature does describe specific testing methods used to determine the range of effective compression force, efficacy in reduction, stability, and safety for a particular (PRCCSD). This guide, however, does not identify specific testing methods as it is recognized such methods could vary according to device configuration and study design.
1.4 This guide does not address individual quantitative performance standards for any particular device, but does address general performance standards and good practice characteristics for all devices using circumferential compression to reduce and stabilize disruptions of the pelvic ring.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and to determine the applicability of regulatory limitations prior to use.
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)