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Prevention versus response
Published in Vicki Bier, Risk in Extreme Environments, 2018
Amy Hagerman, Bruce McCarl, Aklesso Egbendewe-Mondzozo, Levan Elbakidze
Prevention activities focus on reducing or eliminating the probability of the adverse event. For many illnesses, prevention activities can range from vaccinations in at-risk areas to biosecurity practices as simple as regularly washing hands. Preparedness activities are those that either enable or enhance the effectiveness of response activities once an event occurs. Some examples of preparedness activities are surveillance and detection capability enhancement, responder training and education, building diagnostic capabilities, stockpiling vaccine, screening of imported animals, sanitation guidelines and protocols, and inspection and testing of biological materials (for example, semen). Prevention can also occur in other ways, such as through investment in disease eradication initiatives in the countries with endemic disease statuses. Such activities were crucial in the U.S. response to H1N1.
Measurement, analysis, and improvement
Published in Itay Abuhav, ISO 13485:2016 A Complete Guide to Quality Management in the Medical Device Industry, 2018
Before we start to unfold the ISO 13485 Standard requirements, let us review some of the terms and definitions that will be used in this chapter. Complaint—A communicated input given in text, electronically, or orally that expresses deficiencies related to the identity, quality, functionality, durability, reliability, usability, safety, or performance of a medical device that has been released from the organization's control or related to a service that affects the performance of such a medical device.Incident—An unusual or unexpected event associated with the use of a medical device that may or may not lead to a problem.Adverse event—A problem that can or does result in harm, injury, or death to the patient or the user.Complainant—A person, organization or its representative, or any other body involved in the life-cycle of the MD submitting a complaint.Interested parties—A person or a group involved in the life-cycle of the MD and their types of complaints. Interested parties may be a user, a customer (like a clinic or hospital), a distributor, regulatory authorities, and service technicians.
Hazard Analysis and Hazard-Control Hierarchy
Published in Michael S. Wogalter, Forensic Human Factors and Ergonomics, 2018
Manufacturers can collect their own data through customer inquiries and various other methods of obtaining consumer comments, complaints, and injury reports. Unfortunately, consumer injury reports are often haphazardly recorded. To complain or report injuries is often difficult. Some companies make consumers “jump through hoops” to communicate with them, although certain specific ways may be available. Some manufacturers limit contact with consumers by not publishing (or making it easy to find) email addresses and phone numbers. In some cases, the only way to contact some companies is through postal mail. These difficulties discourage reporting. Even with successful contact, information may only go to the legal department and not be forwarded to other groups in a company. Some U.S. governmental agencies (for example, FDA and the National Highway Traffic Safety Administration [NHTSA]) require reporting of adverse events. Underreporting of adverse events is a problem. Commonly, the collected information is incomplete. If the manufacturer does not collect injury reports or does it in a slipshod way, or does not save the information it collects, it thwarts efforts that try to find out the extent of the problem and what the issues might be. It can lead to ambiguous and deceptive statements that there are no (or few) prior notices of a problem, which suggests there is a low rate of injury when the reality may be that there were poor processes to collect these data. Underestimation of injury rates and ineffective hazard control can have negative consequences. Good data collection can aid proper remedial action and prevent additional problems in the future.
Clinical efficiency and safety of the oticon medical neuro cochlear implant system: a multicenter prospective longitudinal study
Published in Expert Review of Medical Devices, 2020
David Schramm, Joseph Chen, David P. Morris, Nael Shoman, Daniel Philippon, Per Cayé-Thomasen, Michel Hoen, Chadlia Karoui, Ariane Laplante-Lévesque, Dan Gnansia
The perioperative and postoperative safety of CIs has been described at length. Major complications include significant medical problems that are life-threatening, that require hospitalization or surgery with or without explantation or re-implantation, or that result in permanent disability or damage such as tinnitus, facial stimulation, or pain that electrode deactivation cannot alleviate [15]. Minor complications include conditions that resolve spontaneously, without surgical intervention, or with conservative medical management. Cohen and Hoffman [15] reported on CI safety based on a sample of over 1,000 CI recipients in the United States. They classified adverse events into three categories: medical-surgical complications (intra-operative complications), adverse reactions (postoperative complications), and device-related problems (failure of any part of the device). Medical-surgical complications were further defined as major (required surgical intervention or hospitalization) or minor (resolved spontaneously or with noninvasive treatment such as medication). Flap breakdown, facial palsy, and incorrect electrode placement were the most common complications [15]. Subsequent retrospective file reviews have reported on CI surgical safety. In 180 adults implanted with one or two CIs at a Danish center, the overall complication incidence rate was 58.8% and the major complication incidence rate was 1.6% [16]. The most common complications were vertigo/imbalance (25.0%) and wound infection (8.9%). In 168 adults implanted with one CI at a French center, the complication incidence rate was 19.9% and the major complication incidence rate was 5.0% [17]. In 1,017 adults and children implanted with one or two CIs at an Irish center, the major complication incidence rate was 1.7% [18]. The safety of the Neuro Zti has yet to be reported.