The risk management of medical device-related pressure ulcers based on the Australian/New Zealand Standard.
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ABSTRACT:
SUBMITTER: Chen L
PROVIDER: S-EPMC6166323 | biostudies-literature | 2018 Oct
REPOSITORIES: biostudies-literature
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The risk management of medical device-related pressure ulcers based on the Australian/New Zealand Standard.
The Journal of international medical research 20180809 10
Objective To analyse medical device-related pressure ulcer (MDRPU) management modes and their possible risks and provide references to treat MDRPUs. Methods The Australian/New Zealand Standard (AS/NZS) 4360:2004 risk management standard is the first national risk management standard in the world. Zhongshan Hospital adopted the standard to establish risk management modes to improve the MDRPU risk management process and to register, assess and analyse the key risks for MDRPUs. Eight risk types wer ...[more]
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Project description:The offloading is crucial to heal neuropathic diabetic foot ulcer (DFU). Removable offloading are the most used devices. Orthèse diabète is a new customized removable knee-high offloading device immobilizing foot and ankle joints, with some specific and innovative features that may improve offloading. We aimed to evaluate the efficiency of this device in DFU healing. The evaluation of Offloading using a new removable ORTHOsis in DIABetic foot study is a French multicenter (13 centers) randomized controlled trial with blinded end points evaluation. Adults with neuropathic DFU were randomly assigned to either Orthèse Diabète (experimental device), or any type of conventional (usually used in France) removable offloading devices (control group). The primary outcome was the 3-month proportion of patients with fully healed DFU. Among 112 randomized patients (men 78%, age 62±10 years), the primary outcome occurred in 19 (33%) participants using conventional device vs 19 (35%) Orthèse Diabète users (p=0.79). Study groups were also comparable in terms of prespecified secondary end points including occurrence of new DFU (25% vs 27% in conventional and experimental groups), ipsilateral lower-limb amputation (4% vs 10%) or infectious complications (14% vs 13%) (p>0.05 for all). Adverse events were comparable between groups, including 4 deaths unrelated to study allocation (1 sudden death, 2 ventricular arrhythmias and 1 pancreatic cancer). Adverse events believed to be related to the device were higher in the Orthèse Diabète group than in the control group (15% vs 4%). Orthèse Diabète was less frequently worn than conventional devices (46% vs 66%, p=0.04). Orthèse Diabète, a new removable offloading orthosis immobilizing foot and ankle joints did not show superiority compared with conventional removable devices in neuropathic DFU healing and cannot be recommended to heal DFU. NCT01956162.
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