Triage device

Fig. 1. An overview of the DCLD tier/triage flow chart Boxes 1, 2, and 3 are taken from the Office of Device Evaluation decision tree, which is routinely used to determine whether a product can be reviewed as a 510(k) and found substantially equivalent to a predicate (currently marked) device or whether the product must be handled as a fundamentally new product and submitted to a PMA review. Box 4 determines the novelty of the product in terms of analyte, matrix, and/or technology. If new issues of safety and effectiveness are raised, a highly novel product might require review as a PMA. If the issues of safety and effectiveness are not new but require high-level scrutiny, then a tier III review is warranted. Examples of products requiring a tier III review would include 1. Analyte troponin for diagnosis of MI (with creatinine kinase as the predicate) 2. Matrix sweat patches for drugs of abuse (with urine drugs of abuse tests as the predicate) and 3. Technology nucleic acid...

FDA s In Vitro Diagnostic Device Tier/Triage 5I0(k) Review Process... 

In June 1993, the Center for Devices and Radiological Health (CDRH) introduced tier/triage management initiatives to improve the efficiency of its administrative and scientific review of premarket applications. One key item in this plan was introduction of a tier/triage process for 510(k) applications. This proposal was designed to allow levels of 510(k) reviews adjusted according to the device risk. Three review levels were proposed as follows ... 

DT-236/PDR-75. NSN 6665-01-211-4217. The AN/PDR-75 provides the capability to monitor and record the exposure of individual personnel to gamma and neutron radiation through a wrist worn device. It is a tactical dosimeter with 1 to 1000 cGy indirect reading for neutron and gamma dose measurement by separate devices. It responds to and measures prompt radiation from nuclear bursts. The PRD-75 will be used to calculate unit radiation status, for medical triage, and for unit reconstitution. Elements are encased in a tamper resistant locket, which is worn on the wrist. Dosages are cumulative and are permanently recorded. 

Identify the best location for the command post, staging, and triage, and select another one (to avoid preplaced secondary devices or ambush). Stage at least 1,000 feet away from the scene, if possible. Stay alert and look around you for suspicious persons, vehicles, or olgects. 

Unusual clusters of illnesses Triage (first aid level) BLS procedures Portable gas-powered ventilation via mask and Guedel airway or bag-valve device with filter BLS levd management of haemorrhage contrd Patient conscious level s Salbutamol Situati( rqpoit ... 

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