STORAGE POLICY / SD-­‐PR-­‐1016 / V 1.4 Dated 1/10/2021

POLICY:

The company recognizes that the safe and appropriate use of medical devices is critical to the delivery of high quality patient care. This policy promotes the requirement for procedures, the overall objectives of which are to ensure safe, efficient and high quality management of medical devices, thereby minimizing the risks associated with the use of such medical devices.

POLICY SCOPE:

The policy applies to medical devices used within the company including devices supplied via the company for use by medical professionals and patients.

Storage and stock handling

1. (1)     The establishment shall—
   1. identify storage measures for specific medical devices and stored in accordance with the manufacturer’s instructions;
   1. provide suitable and adequate storage to ensure proper conservation the medical devices; and
   1. maintain an updated distribution records of medical devices it deals with, including the make, model, batch number, serial number, and quantity of the devices, as appropriate.
   1. establish adequate precautions and control to prevent deterioration or damage of the medical devices;
2. Medical device presenting special risks of abuse, fire or explosion (such as combustible/flammable liquids and solids and pressurized gases) should be stored in a dedicated area(s) that is subject to appropriate additional safety and security measures.
3. Broken or damaged medical device should be identified and withdrawn from usable stock and stored separately.

Stock rotation

• The establishment shall—
  • establish a system to ensure stock rotation;
  • separate medical devices beyond their expiry date or shelf life from usable stock and clearly labeled ; and
  • dispose the expired medical devices within 10 days of expiry.

COMPANY: SUPPLY DIRECT EST.	NO. SD-PR-1016	PAGE 2 OF 3
TITLE: STORAGE POLICY	ISSUED: Jan. 25, 2014	REVISED: Oct. 1, 2021

Process & Procedure:

Responsibility / Accountability: Operations and Logistics Supervisor

• Incoming shipment details (packing slip details) will be received from manufacture via the ERP system. The shipment details will include the AWB tracking number and a detailed inventory of Order numbers, Doctor Identification Numbers, Model Number, and Material Description included in the shipment.
• The logistics courier will notify the Operations and Logistics Supervisor of a shipments expected time/date of delivery. This is also tracked online using the AWB number.
• Orders will be delivered and signed by Operations and Logistics Supervisor. Proof of delivery will be made  available in digital format will be kept in record.
• Packages will be inspected for any physical damage within 24-48 hours of delivery. If physical damage if prevalent, further inspection will be conducted on tertiary packaging. If tertiary packaging is in stable condition, case will continue to be processed for delivery. This will be  recorded on the Stock Transfer record. Processing time: 24-48 hours.
• In the event that the tertiary packaging is compromised, the secondary packaging will be inspected to ensure the primary packaging has not been compromised.
• If primary packaging is compromised, the order will be set in the “Quarantine zone” for return to manufacture or disposal (depending on manufacture’s instructions).
• The manufacture will be made aware of the compromised packaging and a request to remanufacture the aligners will be made within 7 days.
• If tertiary/secondary packaging is uncompromised, physical audit verification and inventory count will be conducted. A Stock Transfer record will be completed.
• Physical audit and record of each order number will be compared to the original Shipment details/Packing Slip to assure all items have been delivered and verified. This will be verified on the Stock Transfer record. Processing time: 24-48 hours to be initiated within 24 hours of delivery.
• Packages will be placed in delivery dispatch area for delivery processing. Packages will be placed in delivery dispatch area, in a manner consistent with FIFO, for delivery processing within 24-48 hours.

COMPANY: SUPPLY DIRECT EST.	NO. SD-PR-1016	PAGE 3 OF 3
TITLE: STORAGE POLICY	ISSUED: Jan. 25, 2014	REVISED: Oct. 1, 2021

Protocol:

Responsibility / Accountability: Operations and Logistics Supervisor.

Orders will be kept in their original sealed packaging in distributors temperature controlled facility, until transported to doctor/medical institution via an express courier or collected by authorized representative of the medical institution. As the device is not a consumable item, transportation does not need to be kept frozen during storage or delivery.

Storage Requirements:

1. Original sealed packaging from manufacturer will be stored in temperature controlled facility maintained at room temperature (15-­‐30 degrees Celclius).
2. Packages will be stored out of direct sunlight.
3. Package to be kept a minimum of 45 centimeter from ground level.
4. Package will be kept in designated labeled areas.
5. The area will be clean and dry.
6. The area will be suitably spaced to allow cleaning and inspection.
7. All surfaces and shelves should be made of/covered by an impermeable material to enable proper and safe cleaning.
8. Areas are to be adequately lit in order for tasks to be performed in a correct and safe manner.
9. The establishment will monitor the expiry dates of products in the storage area through monthly inventories to avoid unintended dispatch of expired products. Monthly inventories will be completed on the 25^th day of each calendar month on the Monthly Inventory Report.
10. In case of a recall, the establishment will trace a product in the storage area by its Order/PID number and be able to specify/locate the product and quantity still available in the storage area of a given serial/order number.