ANSI AAMI ISO 8836:2015 pdf download – Suction catheters for use in the respiratory tract
Closed suction catheters are used for endotracheal or artificial airway suctioning to minimize disturbance of the VBS. Closed suction catheters are provided with a protective sleeve to protect the user and the immediate environment (room surfaces, room air) and reduce the risk of contamination with secretions. At the time of publication of this International Standard, it was common practice in critical care areas to use a closed suction catheter during simultaneous mechanical ventilation of a patient. Use of a closed suction catheter allows uninterrupted mechanical ventilation without disconnection of the VBS from the tracheal tube, tracheostomy tube or other airway device. This is in contrast to the use of a traditional open suction catheter which require the opening or disconnection of the VBS before the application of the subatmospheric pressure on the respiratory tract. When used as intended, an in-line or closed suction catheter and related suction equipment become an accessory to the ventilator and an extension of the VBS. When a VBS is equipped with a suction catheter adaptor, the connector at the patient end of the closed suction catheter adaptor becomes the ‘new’ patient connection port of the VBS.
Suction catheter devices should be designed in such a way that satisfies the performance, safety, clinical, and usability needs of patients and users. This section has been revised to include basic safety and essential performance and risk management principles associated with suction catheters. The need for a risk management file is a well recognized process through which the manufacturer of a medical device can identify hazards associated with a medical device, estimate and evaluate the risks associated with these hazards, control these risks, and monitor the effectiveness of that control. Clinical evaluation may also be necessary to confirm the adequacy of the controls. See ISO 1 4971 for additional information. Some elements of device design, as appropriate, may be evaluated using biophysical or modelling research whose validity has been established. Biophysical or modelling research includes the application of physics and engineering to biological processes and may include anatomical modelling or other means to simulate clinical use. Attention is drawn to the consideration of disclosure of specific labelling and instructions for intended use that might deviate from the currently accepted medical practice.
It is understood that small-bore connector systems cannot be designed to overcome all chances of misconnection or to eliminate deliberate misuse. For example, the possibility of the misconnection of a small-bore connector to a specialized patient-access port can still exist. Specialized patient-access ports often require the use of flexible materials which are intended to permit access by a range of medical devices or accessories, such as endoscopes, bronchoscopes and surgical instruments. These access ports can permit interconnection with some small-bore connectors. The risks associated with the use of these specialized patient-access ports are not addressed by this International Standard. Manufacturers of medical devices or accessories and the committees responsible for the development of standards for medical devices or accessories that incorporate these specialized patient-access ports will need to assess these risks.