Handling of Spurious, Expired, and Damaged Medical Devices: A Complete SOP Guide

In the medical device industry, maintaining safety standards doesn't end at the point of sale. Effective handling of spurious, expired, or damaged medical devices is critical for patient safety and regulatory compliance.

This guide outlines the standard operating procedure (SOP) for managing non-conforming products within a warehouse or returned from the market, ensuring alignment with Good Distribution Practices for Medical Devices (GDPMD).

1. Purpose and Scope

The primary objective of this procedure is to establish a rigorous framework for identifying, segregating, and disposing of medical devices that are no longer fit for use. This includes:

• Expired Products: Devices that have surpassed their shelf life.
• Damaged Goods: Items with compromised packaging or structural integrity.
• Spurious/Market Returns: Products returned from the field due to quality concerns.

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2. Roles and Responsibilities

Clear accountability is the backbone of warehouse safety. The following roles are responsible for the execution of this SOP:

Role	Key Responsibility
Warehouse Officer	Responsible for daily implementation, labeling, and physical movement of stock.
Incharge Warehouse	Oversees investigation into causes of expiry/damage and determines destruction methods.
Managing Partner	Provides final authorization for disposal and financial reconciliation.

3. Operational Procedure: Step-by-Step

Following a standardized workflow prevents the accidental release of faulty medical devices into the supply chain.

Step 1: Identification and Quarantine

As soon as a product is identified as expired or damaged, it must be removed from saleable inventory.

• Action: Store personnel must apply a distinct "EXPIRED: NOT FOR SALE" label.
• Segregation: Shift the items immediately to a designated Rejected/Quarantine Area to prevent accidental dispatch.

Step 2: Documentation and Investigation

The Warehouse Officer initiates the "Material(s) History Report" (Annexure-I).

• This report tracks the product description, batch numbers, and quantities.
• The Incharge Warehouse conducts an investigation to determine why the product expired (e.g., overstocking, low turnover) or how it was damaged.

Step 3: Approval and Destruction

Medical devices cannot be discarded like regular waste; they require formal decommissioning.

• Decision: The Incharge Warehouse proposes a mode of destruction (e.g., incineration or crushing).
• Authorization: The Managing Partner reviews the report and provides the final approval for destruction.
• Final Step: A Destruction Certificate (Annexure-II) is issued, and inventory/finance records are updated to reflect the loss.

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4. Compliance with GDPMD

This SOP is designed to meet the Guidelines on Good Distribution Practices for Medical Devices (GDPMD). Proper record-keeping ensures that during an audit, the facility can prove that no spurious or expired materials were re-entered into the market.

Essential Records for Audit:

• Annexure-I: Material(s) History Report
• Annexure-II: Destruction Certificate

MEDICAL HISTORY RECORD

FOR THE MONH OF:-___________________________________

 

Date	SUMMARY OF PURCHASE
Date of Purchase	Company Name	Qty.	Amount	Mode of Payment	PO NO	Remarks

 

Reason for return: _________________________________________________________

_________________________________________________________

_________________________________________________________

_________________________________________________________

Department;________________         Signature_____________________

Department Code:________________

            MATERIAL DESTUCTION FORM

Material / Product:_________________     Batch / Lot No__________

Mfg. Date:_______________________    Exp. Date:______________

Department: ___________________    Section:_________________

Reason of Destruction__________________________________________

_________________________________________________________

_________________________________________________________

_________________________________________________________

Rasised by:__________ Date: ____________ Approved by:__________ Date: _________

Sr. No	Product / Material	Quantity	Destroyed By	Verified By

 

 

Department;_____________________         Signature_____________

Department Code:________________