Safe Medical Equipment Management Policy PDF

Safe Medical Equipment Management POLICY 1. PURPOSE Safe Medical Equipment Management Plan: 1.1. To assess and control the physical and clinical risks of all medical equipment used in the patient care setting. 1.2. To provides a safe and proper use of the medical equipment. 2. POLICY 2.1....

Safe Medical Equipment Management POLICY 1. PURPOSE Safe Medical Equipment Management Plan: 1.1. To assess and control the physical and clinical risks of all medical equipment used in the patient care setting. 1.2. To provides a safe and proper use of the medical equipment. 2. POLICY 2.1. Biomedical engineering department (BDM) shall provide, whenever required, the necessary engineering and technical expertise and consultation to develop and plan the immediate, short, and long-term needs of medical equipment in the healthcare facility. 2.2. Equipment planning shall be tied to the vision and strategic plan of the healthcare facility. 3. PROCEDURES: 3.1. Equipment Maintenance: The equipment maintenance program consists of: 3.2. New incoming equipment inspection & installation. 3.3. Preventive maintenance (PPM). 3.4. Corrective maintenance. 3.5. Managing manufacture service. 3.5.1. New Incoming Equipment Inspection & Installation: 3.5.1.1. All medical equipment must be inspected by BMD for electrical safety, performance assurance, conformance to standards and terms of purchase, and for tagging the equipment before use. 3.5.1.2. All incoming equipment must be tagged after all documents received. 3.5.1.3. Biomedical control number tag: e.g.: (LETTER.000.00.00) 3.5.1.4. Start with one letter (refer to the equipment categories), 3.5.1.5. Followed by digits (000.00.00) (first three digits refer to main number of the machine, second two digits refer to quantities of the same machine, and the last two digits refer to the sub-machines belongs to the main unit), 3.5.1.6. Details of categories are as follow: The letter The categories Group “A” To be maintained and repaired by the manufacturer Group “B” To be maintained and repaired by the Supplier Group “C” To be maintained and repaired by the Biomedical Engineer 3.5.2. Periodic Preventive Maintenance: 3.5.2.1. The PPM program is a scheduled inspection program, which verifies the proper operation, safety, and physical status of medical equipment. 3.5.2.2. BMD shall set up a PPM procedure and inspection, some Equipment will not require PPM and thus will not place in PPM program. 3.5.2.3. BMD staff or Vendor’s Engineer in accordance with the procedure and schedule will perform PPM. 3.5.3. Corrective Maintenance: 3.5.3.1. Biomedical Engineering Department shall respond to unscheduled corrective maintenance requests resulting from failures deficiencies in medical Equipment. 3.5.3.2. BMD Staff shall respond to service requests as they are received and shall strive to ensure that the equipment is repaired and returned to its proper operating condition, with minimal downtime and most cost-effective manner. 3.5.3.3. BMD staff will perform PPM or Vendor's Engineer in accordance with the procedure listed in the BMD's IPP. 3.5.3.4. When the medical Equipment thought to need repair, it is the responsibilities of the User to issue & send a Request for Repair to BMD. 3.6. Risk Management: 3.6.1. Medical equipment is inherently complex and can potentially harm the patient or user if not used or cared for appropriately. 3.6.2. Biomedical Engineering Department shall strive to reduce such risks through: 3.6.3. Equipment inspection. 3.6.4. PPM 3.6.5. User and BMD staff education. 3.6.6. Accident (OVR) review, investigation, and prevention. 3.6.7. Review and distribution of equipment hazard alerts. 3.6.8. The healthcare facility safety rounds. 3.7. Inventory and data base of all medical equipment: 3.7.1. Biomedical Engineering maintains an inventory of all medical Equipment has and keeps the data of each Machine individually. 3.8. Retirement of Equipment and Wish List: 3.8.1. Equipment planning is a multi-disciplined function where BMD shall play key role in identifying the status of existing equipment, proposing a replacement technology, and advising the leadership in capital equipment planning, and forecasting financial impact. 3.9. Users Training and Education: 3.9.1. The safe and effective use of such equipment relies heavily on the users’ level of understanding and experience of it. 3.9.2. Biomedical Engineering Department alongside equipment vendors shall provide the necessary education and training to ensure proper and safe equipment use for patient care. 3.10. Extension Cords: 3.10.1. The Biomedical Engineering is the only authority allowed to issue the extension cords after testing for use with medical devices, and that is in for absolutely necessary as determined by BMD. 3.10.2. The BMD shall do its best to coordinate with the facilities department to resolve the need for extension cord by making permanent outlets available in the required areas as possibility. 3.11. Laser Equipment: 3.11.1. Provide safety guidelines for BMD staff and Users of laser equipment's according to manufacturer's recommendation. 3.12. Hazard Recalls and Alerts: 3.12.1. Biomedical Engineering Department is following the prescribed course of action for recalls, take such action, and document actions taken. 3.13. OVR (Occurrence, Variance, Report): 3.13.1. OVR filled by BMD staff in case of danger of use the medical equipment for the patient and the users or in case of unusual failure occurred to any medical equipment due to miss use. 3.13.2. The filled OVR signed by the head of the department and then send to the TQM department to take the corrective action regarding the concerned incident. 3.13.3. The record must be kept in TQM department. 3.14. Monitoring: 3.14.1. The head of BMD is responsible to ensure the implementation the program including the database of all medical equipment and documented. 5. RESPONSIBILITIES : 5.1 Biomedical Engineering: maintaining all medical equipment in the healthcare facility. 5.2 Head of departments in the healthcare facility: 5.2.1 Orienting new staff members on :The capabilities, limitations, special applications of the available equipment. 5.2.2 Basic operating and safety procedures of the equipment. 5.2.3 Daily maintenances procedures (cleaning and calibration). 5.2.4 Emergency procedures if failure of equipment occurred occurs. 5.2.5 The reporting procedures for equipment problems, failures, and user errors. 5.2.6 Informing BMD when receiving new incoming equipment t 5.2.7 the department or transferring any equipment from one department to another. 5.2.8 nform BMD in case of needed training for any equipment.