In the healthcare industry, manufacturers, distributors, and importers must maintain product quality and safety standards. They hold significant responsibility for recalling and destroying medical devices and household health supplies (HHS) that fail to meet requirements. This process not only protects consumer safety but also ensures compliance with applicable regulations.
Destruction involves eliminating medical devices and HHS that have been withdrawn from circulation. If a recalled medical device or HHS cannot be repaired, the company must destroy it to prevent reuse. Typically, a regulatory order to destroy arises from inspections that reveal non-compliance with standards or regulations. The destruction process requires clear documentation, and companies must report these activities to the Ministry of Health by including a destruction report. Furthermore, a regulator from the local health office must witness the destruction to ensure compliance with procedures.
Regulations on Destruction Provisions
According to Regulation of the Minister of Health of the Republic of Indonesia Number 4 of 2014 concerning Good Distribution of Medical Devices, several critical provisions must guide the destruction process:
1. Standard Operating Procedures
Companies must establish clear procedures regarding product destruction to ensure consistency and compliance.
2. Destruction Criteria
Destruction applies to medical devices that:
- Fail to meet applicable requirements.
- Have expired.
- Do not meet criteria for use in health services or scientific and technological purposes.
- Have had their distribution license revoked.
3. Product Identification
Before destruction, companies must separate and clearly identify products to prevent accidental sales of items fit for sale.
4. Considerations for Destruction Activities
The destruction process must consider:
- Personnel safety.
- Potential product misuse.
- Environmental impact.
- Compliance with waste disposal regulations.
5. Destruction Report
Companies must report the destruction of medical devices to relevant authorities using a Destruction Report. This document should be signed by the company’s leadership, the technical person in charge, and witnesses. It must include:
- The time and place of destruction.
- The quantity and type of medical devices.
- The technical person in charge and witnesses.
6. Documentation
Companies must maintain documentation of destruction activities as valid evidence of execution.
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