Guidance on 3-D Printing of Essential Medical Devices and Accessories for Use in COVID-19 (Coronavirus Disease 2019) Situation
The Heath Sciences Authority (HSA) is actively working to address the increased demand for critical medical products in response to the COVID-19 pandemic. The global demand for medical devices such as nasopharyngeal swabs, personal protective equipment (PPE), face shields and accessories for respiratory ventilators is increasing. Hence, organisations are considering 3D printing (3-DP) some of these essential devices locally to address our increased demand and the overall interruptions to global supply chains.
Regulatory controls applicable to medical devices manufactured by 3-DP
Regulatory controls are titrated based on the risk classification assigned to a medical device. As with all other medical devices, 3D printed devices are also classified into four risk classes (Class A to Class D, Class A being the lowest risk class) based on an international rule based risk classification system. Risk class depends on the nature of the device, its degree of invasiveness, duration of contact and its intended purposes. Class A 3-DP medical devices include external prosthetics, face shields and nasopharyngeal swabs. Examples of higher risk class 3-DP medical devices include Class B breathing circuits, ventilator tubes, and connectors, Class C dental or orthopaedic implants and Class D cranial implants and heart valves.
Organisations manufacturing, importing or wholesaling a 3-DP medical device are required to hold relevant dealer’s licences from HSA. Manufacturing activities must be performed in facilities with a Quality Management System (ISO 13485 or equivalent) for the 3-DP medical device. Healthcare institutions manufacturing 3-DP medical devices for use only on their own patients, and not supplied outside their own facility, will not require a manufacturing license.
Product Registration & Notification
All 3-DP medical devices must comply with the Essential Principles of Safety and Performance.
Commercially produced Class B, C and D 3-DP medical devices must be registered with HSA before they can be supplied. Class A 3-DP medical devices do not require registration with HSA. Manufacturers and Importers of Class A 3-DP medical devices are only required to notify their 3-DP devices to HSA here under the ‘change@medics’ tab before supplying in Singapore.
Healthcare institutions manufacturing 3-DP medical devices for use only on their own patients will not need to register the 3-DP medical devices. However, they are required to ensure that these devices comply with the Essential Principles of Safety and Performance.
Post-Market Duties and Obligations
Like all other medical devices, 3-DP medical devices undergo changes as part of their product life cycle, of which specified changes will need to be reported to HSA.
As with all medical devices, new risks or limitations may be identified with the real-world clinical use of a 3-DP medical device. It is important that the use of the 3-DP printed medical device is monitored closely to ensure that it continues to perform as intended and to identify any adverse effects, which may include problems that were not previously anticipated. Examples of adverse effects include allergies to the material used in the device, susceptibility to infections due to inappropriate sterilisation methods, and serious deterioration in health or even death when implants fail to perform as intended. All manufacturers, importers and wholesalers of medical devices are required to report adverse events, defects and recalls to HSA. They will also be required to carry out thorough investigation and implement the necessary mitigation measured to correct these issues and prevent them from recurring. Healthcare professionals and users of 3D printed medical devices should also report any adverse events related to the use of a medical device or device failure to HSA.
Key technical considerations for 3-DP medical devices
Organisations manufacturing 3-DP medical devices may wish to consider the following in verifying if their device conforms to the essential safety and performance requirements.
- Dimensional specifications should be specified for the final 3D printed device or component.
- Critical features (such as location and thickness of porous features) should be identified as these may have reduced mechanical properties.
- Material specification for the starting material used in 3D printing should be specified (e.g. Certificate of Analysis (CoA) or equivalent).
- Applicable material standards and test methods (e.g. ASTM, ISO standards) should be referenced.
- Where applicable, the possible range of physical parameters (e.g. size, dimensions) for the 3-DP medical device should be reasonably defined.
- When manufacturing 3-DP accessories or parts, compatibility and appropriate fit with the original equipment or devices must be verified to ensure that these accessories work safely and effectively in the clinical setting.
Device Validation Considerations
- Biocompatibility should be evaluated according to international standards (e.g. ISO10993-1) based on nature of contact, using final finished device. Material biocompatibility data could be considered where applicable.
- Type of mechanical or performance validation applicable would depend on the device type and it may include tensile strength, fatigue, or abrasive wear etc.
- Performance testing should be conducted on final finished device (worst case representative), with rationale provided on the determined worst case. The build orientation and location can affect the device mechanical properties and should be considered during the performance testing.
- Sterilisation process validation should account for the device’s complex geometry under worst case conditions (e.g. greatest amount of residual manufacturing materials, largest surface area, greatest porosity and most internal voids).
- Removal of manufacturing material residues to acceptable levels that do not adversely affect device safety and performance. Validation should consider the worst case scenario.
- Appropriate functional and usability testing for the 3-DP device should be considered especially to support safe and effective clinical use on the field for the proposed intended purpose of the device.
Labelling and expiration date
- For 3-DP medical devices, the labelling should include sufficient information to identify or to trace the device including but not limited to the manufacturing lot/batch information.
- Specific instructions for safe and effective use of the 3-DP medical device should be provided including essential warnings, precautions and contraindications if any.
- Information on the additive manufacturing method and starting material, additives or processing agents used to be specified.
- Additive manufacturing process flow chart (including the post printing processing steps) should be available.
- All manufacturing activities for the medical device including the additive manufacturing and post-manufacturing processes should be performed within a ISO 13485 compliant quality management system.
In addition to the above, where your device includes novel design, features and functionalities, these will require validation to ensure that the device can be used safely.
While 3-DP could improve the availability of certain essential medical devices during the current COVID-19 situation, ensuring the quality, safety and effectiveness of these 3-DP devices is important.
For specific questions regarding 3-DP medical devices, please contact us here with complete information on your device and the validation study reports.