Policy Manual sample

MDT Home Health Care Agency, Inc. REUSE OF SINGLE USE MEDICAL DEVICES POLICY PURPOSE: Procedures for the design and implementation of a systematic approach for the set up, proper use, reprocessing, and maintenance of all reusable Single-Use Devices (SUD). Definitions: Critical – Devices that come in contact with blood or normally sterile tissue, such as surgical forceps Semi-critical – Devices that come in contact with mucous membranes, such as endoscopes Non-critical – Devices that come in contact with unbroken skin, such as stethoscopes. Reprocessing a medical device encompasses cleaning, reconditioning, function testing, and disinfection or sterilization to ensure that a medical device can safely be reused. To reuse a single-use device without considering the consequences could expose patients and staff to risks which outweigh the perceived benefits of using the devices. These perceived benefits are questionable as many of the processes required to ensure that the device is safe and fit for its intended purpose cannot be undertaken by the reprocessor (a person who undertakes the reprocessing of a medical device). Infection Control considerations: . draw to the attention of staff, hazards and risks associated with reprocessing and reusing single- use medical devices . use medical devices safely and appropriately . not reuse single use items Single-use – The expression ‘single-use’ means that the medical device is intended to be used on an individual patient during a single procedure and then discarded. It is not intended to be reprocessed and used on another patient. Cleaning – A process that physically removes contamination but does not necessarily destroy micro-organisms Decontamination – A process which removes or destroys contamination and thereby prevents micro-organisms or other contaminants reaching a susceptible site in sufficient quantities to initiate infection or any other harmful response. Three processes of decontamination are commonly used: cleaning, disinfection and sterilization. Disinfection – A process used to reduce the number of viable microorganisms but which may not necessarily inactivate some bacterial agents, such as certain viruses and bacterial spores. Intended purpose – The use for which the device is intended according to the information supplied by the manufacturer on the labelling, in the instructions and/or promotional materials Manufacturer – The person with responsibility for the design, manufacture, packaging and labelling of a device before placing it on the market under its own name, this can be a company or an individual Medical device – Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, intended by the manufacturer to be used for human beings for the purpose of: . Control of conception . Diagnosis, prevention, monitoring, treatment or alleviation of Disease . Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability . Investigation, replacement or modification of the anatomy or physiological process. Home Health Agency Nursing Care & Procedures K-178

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