CTBS Storage and Distribution 4 — Questions and Answers
Question 1: A tissue bank discovers a mislabeled product after it has been shipped but before implantation. The MOST critical immediate action is to:
- Update the label remotely and notify the surgeon
- Initiate a recall and notify all consignees who received the product (Correct answer)
- Wait until the product is returned before taking action
- Only notify the receiving hospital of the specific unit
Correct answer: Initiate a recall and notify all consignees who received the product
Mislabeled tissue distributed to multiple sites requires a formal recall with notification to all consignees to prevent implantation of incorrectly labeled tissue.
Question 2: What is the purpose of a 'dry shipper' (liquid nitrogen dry shipper) in tissue distribution?
- To ship tissue at refrigerated temperatures during transit
- To transport cryopreserved tissue without free liquid nitrogen in a safe, compliant manner (Correct answer)
- To maintain tissue at room temperature for fresh tissue distribution
- To provide a sterile shipping environment for packaged allografts
Correct answer: To transport cryopreserved tissue without free liquid nitrogen in a safe, compliant manner
Dry shippers use nitrogen-saturated adsorbent material to maintain cryogenic temperatures without free liquid, making them compliant for air transport.
Question 3: Which federal regulation governs the establishment registration and listing requirements for human tissue establishments?
- 21 CFR Part 211
- 21 CFR Part 820
- 21 CFR Part 1271 (Correct answer)
- 21 CFR Part 606
Correct answer: 21 CFR Part 1271
21 CFR Part 1271 is the FDA regulation that governs human cells, tissues, and cellular and tissue-based products (HCT/Ps), including registration and listing.
Question 4: A tissue bank is validating a new freezer for bone allograft storage at -40°C. What is the MINIMUM requirement for the validation process?
- Run the freezer empty for 24 hours and record the temperature
- Map temperature distribution under loaded conditions and verify alarm function (Correct answer)
- Obtain manufacturer documentation only
- Test the freezer at maximum capacity for 1 hour
Correct answer: Map temperature distribution under loaded conditions and verify alarm function
Freezer validation requires temperature mapping under representative loaded conditions and functional alarm testing to confirm the unit maintains required temperatures throughout.
Question 5: When is a tissue bank REQUIRED to submit a Biological Product Deviation Report (BPDR) to the FDA?
- For any temperature excursion, regardless of impact
- When a deviation may have caused or contributed to a serious adverse reaction in a recipient (Correct answer)
- For all complaints received from hospitals
- Whenever a product is returned by a consignee
Correct answer: When a deviation may have caused or contributed to a serious adverse reaction in a recipient
BPDRs are required when a distributed HCT/P has a deviation that may have caused or contributed to a serious adverse reaction in a recipient.
Question 6: For freeze-dried (lyophilized) bone allograft, what storage condition is typically required to maintain product integrity?
- Cryogenic storage at -196°C
- Ultra-low freezer at -80°C
- Room temperature (15–25°C) in sealed, moisture-proof packaging (Correct answer)
- Refrigeration at 2–8°C
Correct answer: Room temperature (15–25°C) in sealed, moisture-proof packaging
Lyophilized bone allograft has moisture removed and can be stored at controlled room temperature in moisture-proof packaging, making it convenient for operating room storage.
Question 7: A consignee reports that a tissue shipment arrived with a broken cold pack but acceptable temperature log readings. The bank's BEST response is to:
- Accept the complaint as resolved since the data logger shows acceptable temperatures
- Document the complaint, investigate packaging performance, and evaluate whether tissue can be released (Correct answer)
- Immediately recall the tissue without reviewing temperature data
- Instruct the consignee to use the tissue since the logger data is acceptable
Correct answer: Document the complaint, investigate packaging performance, and evaluate whether tissue can be released
A packaging failure must be documented and investigated even if logger data is acceptable, as the investigation informs corrective action and risk assessment.
CTBS Storage and Distribution 4
A tissue bank discovers a mislabeled product after it has been shipped but before implantation.
The MOST critical immediate action is to: