Health and Safety in Medical Device Handling

Health and Safety in Manual Handling

• Understand health and safety requirements for safe manual labor and movement of items.
• Follow specific protocols when transporting sterile items to prevent contamination.

Tracking and Traceability of Medical Devices

• Adhere to tracking and traceability requirements to maintain accountability and oversight of medical devices throughout their lifecycle.

Potential Damage During Transportation

• Recognize potential risks of damage to sterile items when transported, ensuring protective measures are in place.
• Monitor handling techniques to prevent compromising sterility during movement.

Product Recall Procedures

• Execute documented procedures for product recalls when defective items are discovered, ensuring user notification and documentation of actions taken.
• Identify affected items through process documentation for speedy and efficient recalls.

Time and Event Related Sterility Practices

• Differentiate between time-related and event-related sterility practices concerning product integrity post-sterilization.
• Acknowledge the impact of storage conditions and handling procedures on sterility.

Product Release Guidelines

• Conduct biological monitoring post-sterilization to confirm product safety for patient use.
• Ensure chemical indicators are used in all sterilization packages for additional safety.
• Allow adequate cooling time before storing sterilized items, typically 30 minutes or longer for larger sets.
• Perform thorough physical inspections of items for correct packaging, placement, and moisture control.

Consequences of Product Rejection

• Items that fail any release checks must undergo complete reprocessing, starting from decontamination, without shortcuts.

Importance of Sterile Storage Room

• Maintain separate storage areas for sterile and clean items within the Central Sterile Supply Department (CSSD).
• Ensure that sterile storage meets specific environmental and handling standards to maintain sterility.

Guidelines for Safe Sterile Storage

• Handle packages with minimal contact to reduce contamination risk.
• Install hand wash facilities away from sterile items to avoid spills.
• Ensure shelving design prevents items from dragging or pushing against surfaces, which could damage packaging.
• Keep sterile packs away from walls and windows to minimize condensation and dust accumulation.

Safe Handling Practices

• Lift packages properly to prevent damage when removing from shelves, avoiding friction and abrasion.
• Do not allow food or drinks in sterile storage areas to prevent contamination.
• Avoid using corrugated boxes as they can harbor contaminants.
• Prevent forcing or overstacking items on shelves to maintain packaging integrity.

Risks of Dropped Items

• Be aware that dropped items can introduce contaminants and must be thoroughly inspected before further use.
• Acknowledge that dirt can transfer from floors to sterile items; therefore, maintain cleanliness in handling environments.