Health & Safety in Medical Device Handling

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Questions and Answers

What is the minimum distance that packs should be kept from walls and windows to reduce condensation risks?

1 cm

10 cm

5 cm (correct)

15 cm

How far above the floor should packs be maintained to prevent contamination?

5-10 cm

35-40 cm

25-30 cm (correct)

15-20 cm

What should be avoided when removing items from a shelf?

Lifting the package from the back (correct)

Using both hands to lift

Lifting packages that are too heavy

Moving quickly while lifting

Which type of boxes should be avoided due to the risk of harboring contamination?

Corrugated boxes Signup and view all the answers

What is a critical consideration regarding the handling of packages?

It should be minimized Signup and view all the answers

What can happen if items are forced or stacked on shelves?

It can lead to contamination from forced air Signup and view all the answers

What is the minimum incubation time required for biological indicators before release?

1 hour Signup and view all the answers

What should be checked regarding chemical indicators before using items on a patient?

External indicators must be verified, especially on non-viewable packages. Signup and view all the answers

How long should items typically cool after sterilization before being moved to storage?

30 minutes Signup and view all the answers

What is required during the physical inspection of sterilization packs?

No residual moisture should be present on the outside of packages. Signup and view all the answers

What happens if the product release checks are not fully met?

The items will not be released and must go through full reprocessing. Signup and view all the answers

What is a critical step to ensure proper sterilization packaging?

All packages must have their identification labels correctly attached. Signup and view all the answers

What should facilities be aware of regarding product recalls?

Items may have been released that should have been rejected. Signup and view all the answers

What is essential to confirm before releasing sterile products for use?

Completion of biological monitoring Signup and view all the answers

Which of the following procedures is not part of the product recall process?

Conducting a market analysis Signup and view all the answers

What could potentially damage sterile items during transportation?

All of the above Signup and view all the answers

What are the time related and event related expiration practices primarily concerned with?

The lifespan and handling of items Signup and view all the answers

Which key environmental aspect is essential to monitor for sterile storage?

All of the above Signup and view all the answers

Which type of personal protective equipment (PPE) is NOT typically required when transporting sterile items?

Face shield Signup and view all the answers

Where do risks primarily occur when transporting sterile sets?

While in transit Signup and view all the answers

What is a critical step when a biological or chemical indicator fails?

Use documentation to identify affected items Signup and view all the answers

What must a procedure for recall include?

Notifying all users impacted Signup and view all the answers

What distinguishes the sterile storage room from other storage areas?

It holds only items released from the sterilizer room Signup and view all the answers

Which of the following describes event related sterility?

Items remain sterile unless the integrity of the packaging is compromised Signup and view all the answers

What is an important consideration when handling items in a sterile storage room?

Avoiding dragging items against surfaces Signup and view all the answers

What should never be done to maintain the sterility of items?

Drag or push items against surfaces Signup and view all the answers

Which of the following actions is crucial for maintaining integrity in a sterile storage room?

Correct handling to avoid friction or abrasion Signup and view all the answers

Study Notes

Health and Safety in Manual Handling

Adhere to health and safety requirements to prevent injury during manual handling tasks.
Utilize appropriate Personal Protective Equipment (PPE) when transporting sterile items.

Tracking and Traceability for Medical Devices

Medical devices require comprehensive tracking and traceability to ensure safety and compliance.
Proper documentation of sterilization processes is essential for accountability and quality control.

Risks During Transportation of Sterile Items

Potential damage to sterile items can occur during transport due to mishandling or improper storage.
Adhere to strict protocols when handling and moving sterile sets to avoid contamination.

Product Recall Procedures

Implement a proper recall procedure to address any discrepancies found in released products.
Key reasons for recalls may include failure of biological or chemical indicators, improper documentation, or manufacturer defect alerts.

Time-related expiration involves a predetermined expiration period for sterilized items.
Event-related expiration states items remain sterile unless packaging is compromised, irrespective of the sterilization date.

Product Release Criteria

Ensure biological monitoring confirms successful sterilization; indicators may take 1-48 hours to confirm.
Employ chemical monitoring by using internal indicators in all packages and external indicators for opaque packaging.

Cooling Requirements

Allow sufficient cooling time post-sterilization, generally 30 minutes, before transferring items to storage.

Importance of Physical Inspections

Conduct thorough physical inspections of all sterilized items to confirm correct packaging, absence of moisture, and correct labeling.

Handling Product Rejections

If any aspect of the product release fails, items must undergo complete reprocessing from decontamination.

Sterile Storage Room Guidelines

Maintain separate storage locations for sterile and clean supplies to prevent cross-contamination.
Ensure sterile items are stored at a minimum distance from walls and floors to mitigate risks of contamination.

Safe Storage Practices

Shelves should adequately hold items, avoiding clutter and potential contamination risks from dust accumulation.
Lift items correctly from shelves to avoid damaging packaging integrity.

General Sterile Supply Room Regulations

Prohibit food or drink in sterile supply areas to eliminate contamination risks.
Avoid using corrugated boxes for storage to prevent moisture and mold buildup.

Events Affecting Sterility

Minimize handling of packages as each interaction is considered an event that could compromise sterility.
Do not force or stack items on shelves, preventing damage to packaging that could allow contamination.

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Description

This quiz focuses on understanding health and safety requirements related to manual handling and movement of medical devices. It covers tracking and traceability requirements, potential damage to sterile items during transportation, and procedures for product recalls. Enhance your knowledge on maintaining sterility and safety in the medical field.