Policy Manual sample

MDT Home Health Care Agency, Inc. • Standard Operating Procedure for Medicine Administration in Community Nursing (Home Health Services) Definition of a 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: • Diagnosis, prevention, monitoring treatment or alleviation of disease • Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap • Investigation, replacement or modification of the anatomy or physiology process • Control of conception Definition of single use The medical device is intended to be used on an individual patient during a single procedure and then discarded. The device is not intended to be reprocessed/sanitized and used on another patient. The labelling may identifies the device as disposable and not intended to be reprocessed and used again. Safety Issues • No way to adequately sanitize this device in the field • Single use devices may not be designed to allow thorough decontamination processes. • Reprocessing may alter its characteristics and performance may be compromised. • Single use devices have not undergone extensive testing validation and testing for reuse. • There may be the potential for cross-infection through design e.g. fine bores of tubes. • Some materials can absorb certain chemical which can gradually leach from the material over time. • Chemicals may cause corrosion or changes to the materials of the device. • The material may experience stress during reuse and may fail stretch or break. • Inadequately cleaned equipment can carry bacterial endotoxins which remain after bacterial are killed. Re-use of single use items may then transfer legal liability for that item from the manufacturer to themselves or their employer, unless reprocessing methods have been validated to prove the safety of both the process, and the end product. Single patient use Some items of equipment are identified as suitable for single patient use i.e. a non-disposable lancing device supplied by the blood glucose meter manufacturers, urethral catheters supplied within the community for intermittent use and continence treatment equipment. A medical device may be used for more than one episode on one patient only; the device may undergo some form of reprocessing between each use. Advice must be sought from the manufacturer and the Infection Prevention and Control Team on appropriate decontamination methods. Use of Medicines Medicines including topical medical products must be considered as single use items unless the label and/or the supporting manufacturers guidelines clearly state that they have been prepared as multi- dose items. A risk assessment must be carried out (in conjunction with Medicines Management) for each individual product. Disposal of single use equipment Single use equipment must be disposed of following the Agency’s waste disposal policies. Training In-service about this Policy must be included in Essential Infection Control training. Audit As part of the Infection Prevention and Control Audit program and regular field staff supervisory visits. Home Health Agency Nursing Care & Procedures K-177