The maintenance and safety testing of medical devices play a crucial role in ensuring patient safety and compliance with regulatory standards. In Malaysia, the Medical Device Authority (MDA) regulates these activities through various guidelines, including the Good Distribution Practice for Medical Devices (GDPMD) and MS 2058. However, there exists a fundamental concern regarding impartiality when medical device importers and distributors conduct Planned Preventive Maintenance (PPM) and Electrical Safety Testing (EST) on their own equipment.
The Conflict of Interest in Self-Testing
Currently, MDA regulations allow medical device importers and distributors to perform PPM and EST on the very devices they supply to healthcare facilities. This practice presents an inherent conflict of interest, as companies may have financial incentives to minimize maintenance costs or bypass critical safety checks in order to reduce downtime and expenses.
Without strict oversight, there is a risk that maintenance and testing reports could be biased, incomplete, or even manipulated to ensure compliance without actually meeting safety standards. This poses a significant threat to patient safety, as undetected faults or improper calibrations could lead to device failures in critical situations.
How to Ensure Impartiality in PPM & EST
To address this issue, several measures can be implemented to enhance transparency, accountability, and impartiality in medical device maintenance:
1. Mandatory Third-Party Audits
- The MDA should require independent third-party audits to validate PPM and EST reports.
- Random verification of maintenance records against actual device conditions should be conducted to prevent falsification.
2. Separation of Maintenance and Sales Divisions
- Medical device companies should establish independent maintenance divisions separate from their sales and distribution departments.
- This prevents financial motivations from influencing maintenance decisions.
3. Accreditation Under ISO 17025 for Testing & Calibration
- Any company conducting EST or calibration should be ISO 17025 accredited to ensure competence and technical impartiality.
- Without proper accreditation, internal safety test reports should not be accepted for regulatory compliance.
4. Digital Record-Keeping and Transparency
- Implement tamper-proof digital records to track maintenance activities and prevent data manipulation.
- Require timestamped evidence, including before-and-after test results, sensor logs, and automated maintenance reports.
5. Regulatory Separation of Duties
- Importers and distributors should be allowed to conduct PPM but not certify their own EST.
- Certification of safety tests and critical calibrations should be performed by an independent third-party lab.
Moving Towards a More Transparent System
The current regulatory framework leaves too much room for biased reporting and potential safety risks. Medical devices are critical to patient care, and their maintenance should be held to the highest standards. By implementing stricter impartiality measures, Malaysia’s healthcare industry can strengthen trust, improve patient safety, and ensure compliance with international best practices.
As an industry leader in medical device engineering and compliance, NIQ Engineering advocates for greater transparency and regulatory reform in the maintenance and testing sector. We believe that independent verification, stringent oversight, and adherence to global standards will help build a safer and more accountable medical device ecosystem in Malaysia.
For more information about our compliance services and medical device maintenance solutions, feel free to contact us.