Malaysia’s Medical Device Authority (MDA) Guidance: Control of Obsolete and Discontinued Medical Devices in Healthcare or Related Facilities

The Medical Device Authority (MDA) in Malaysia has released a comprehensive guidance "Control of Obsolete and Discontinued Medical Devices in Healthcare or Related Facilities" to address the management of obsolete and discontinued medical devices in healthcare and related facilities. This guidance provides clear procedures to ensure patient safety, regulatory compliance, and efficient disposal of outdated or withdrawn devices. Below is an overview of the guidance and its implications.

Obsolete Medical Device: A device no longer supported by the manufacturer due to technological advancements or safety concerns.

Discontinued Medical Device: A device whose production and support have ceased but may still be in use within facilities.

The primary objective of this guidance is to establish a systematic framework for the control, management, and disposal of obsolete or discontinued medical devices. It aims to:

1. Minimize potential safety hazards associated with outdated devices.

2. Ensure proper documentation and accountability.

3. Promote environmentally friendly disposal practices.

This guidance applies to:

• Healthcare facilities: Hospitals, clinics, diagnostic centers, and laboratories.

• Related facilities: Educational institutions, research labs, and medical device servicing companies.

• Devices: All medical devices listed under Malaysia’s regulatory framework, including diagnostic, therapeutic, and monitoring equipment.

A medical device may be exempt from the registration requirements specified in Act 737, Section 5 if it meets the following conditions:

1. its status has been declared by the manufacturer as an obsolete medical device; or

2. its status has been declared by the Authorized Representative/manufacturer as a discontinued medical device, and

3. the declaration of the status has been confirmed by the Authority.

The guidance emphasizes a systematic approach to managing obsolete and discontinued medical devices. It begins with the identification and assessment of such devices, which involves determining their status based on specific criteria.

A medical device may be deemed obsolete if the manufacturer no longer provides technical support, spare parts, or consumables, or if the device fails to meet current regulatory or safety standards. Similarly, a device is considered discontinued when its production ceases, or it is withdrawn from the market due to safety or efficacy concerns. Facilities are tasked with maintaining a detailed database of these devices, including their model, serial number, purchase history, and manufacturer notifications.

Once identified, facilities must conduct a risk assessment to evaluate the safety implications of continued use. This process helps prioritize devices critical to patient care while identifying safer alternatives or replacements. Decommissioning is a crucial step for obsolete and discontinued devices to prevent further usage.

The guidelines emphasize environmentally responsible disposal practices, requiring facilities to partner with licensed waste disposal firms. In cases where reuse or recycling is feasible, parts or materials that meet safety standards can be salvaged, ensuring compliance with environmental regulations.

To know more about the General Requirements, Criteria for applying for confirmation of medical device status, Manner of Application, etc click this LINK.