ABSTRACT
Like all other medical devices, mechanical ventilators are subjected to regulations issued by government authorities. These regulations vary in accordance with the country in which the medical device is commercially available, e.g. the European Directives 93/42/CEE on Medical Devices amended by Directive 2007/47/EC in Europe and the Code of Federal Regulations Title 21 (CFR 21) of the Food and Drug Administration (FDA) in the USA market.8-10 The main aim of these regulations is to guarantee the safety of the patients, users and third parties by minimizing the occurrence and effects of potential risks, and to ensure the device performs in accordance with the manufacturer’s intentions.8,9 To this end, the regulations define a number of essential requirements that medical devices have to satisfy before they can be put on the market or into service. These requirements are related to issues such as risk
physician. It is important to note that the patient and the prescriber also have roles in equipment maintenance that are relevant in the quality control of HMV, as inadequate cleaning and maintenance of the ventilator at home has been associated with an increased risk of equipment contamination and patient colonization.23 The education of patients, families and caregivers is a key aspect of any homecare programme, as it helps them to use the equipment confidently and safely and to promptly identify simple problems, and encourages them to seek help or advice when necessary.4
