3D printing medical devices: Stakeholders weigh in on FDA’s discussion paper

Regulatory NewsRegulatory News
| 15 February 2022 | By Jeff Craven 

The US Food and Drug Administration (FDA) has started thinking about how 3D printing of medical devices at the point of care (PoC) would be regulated, and asked stakeholders to weigh in late last year.
 
While not a draft or final guidance, the discussion paper from December 2021 is a step toward exploring how FDA could oversee 3D printing of medical devices that fall under the purview of the Center for Devices and Radiological Health (CDRH). The implementation of 3D printing could help healthcare facilities (HCF) develop rapid personal care solutions for patients in need of medical devices and would also allow for the quick manufacturing of 3D-printed devices near where the patient is being seen, FDA said.
 
“FDA recognizes that 3D printing at the PoC contributes to the development of new device designs, clinical solutions, and enhanced approaches to rare and complex cases (e.g., invasive tumor resection, congenital heart defects). As 3D printing brings more product development opportunities to the PoC, FDA intends to continue facilitating innovation in a manner that still provides a reasonable assurance of device safety and effectiveness,” the agency wrote in the discussion paper.
 
During the COVID-19 pandemic, HCFs became more interested in using 3D printing at PoC to address shortages for medical devices and some personal protective equipment, FDA said. However, 3D printing could also be used in non-emergency situations, they noted. “A rational and understandable approach for 3D printing at the PoC can facilitate HCFs’ rapid response to future supply chain disruptions in a safe and effective manner,” they wrote.
 
As 3D printing is a developing technology, FDA also said it wants to ensure any implemented solution is durable and “built on a foundation of strong science, sensible clinical guidelines, and an appropriate regulatory approach that balances innovation with regulatory oversight.”
 
The discussion paper included a list of 16 questions for stakeholders to consider across a number of different issues in 3D printing at PoC, such as manufacturing challenges HCFs would face in staying compliant with regulations, the role of post-processing activities, how adverse events would be reported, design changes, assessing device risk, variability of 3D printing capability and expertise across HCFs, practices that could contribute to development of very low-risk devices, application of regulatory flexibility for very low-risk devices, clarification of terminology, oversight of 3D printing entities and experiences specific to the COVID-19 pandemic that could contribute to 3D printing of future products.
 
 
Comments from stakeholders
 
Comments from industry groups, health technology companies and medical specialty societies were broadly positive, with most responses focusing on answering FDA’s questions within their area of expertise.
 
In their comment to FDA, the Advanced Medical Technology Association (AdvaMed) said the agency setting regulatory expectations for 3D printing of medical devices at PoC is “of paramount importance.” AdvaMed also agreed with FDA’s potential risk-based approach to regulating 3D-printed medical devices manufactured at PoC, that the device specification doesn’t need to rely on where a product is manufactured, and that what 3D printing at PoC may occur in different scenarios that would change how it needs to be regulated.
 
One thing AdvaMed would like to see in future discussions is consideration for repair or remanufacture of devices using 3D printing. “We would request a firm statement in any guidance that emerges as a result of this discussion paper that 3D printing of repair parts or remanufactured devices should fall within the auspices of this guidance,” they wrote.
 
The Medical Imaging & Technology Alliance (MITA) said that FDA needs to ensure good manufacturing practices are being followed by HCFs manufacturing 3D-printed medical devices or replacement parts and that these devices are “held to the same quality, safety, and regulatory requirements” as traditionally manufactured devices.
 
“As manufacturers of reusable capital equipment, we are particularly concerned about ensuring the quality of replacement parts for our devices,” they wrote. “Currently replacement parts must undergo significant verification and validation to ensure the finished product meets manufacturer specifications for safety and efficacy. This standard practice must also apply to 3D printed parts. This is a patient safety issue.”
 
The standards organization ASTM International noted that 3D printing of devices at PoC will create “a need for training and certifications” that should “rely on existing standards and processes and enable the development of additional standards as gaps are identified.”
 
“One main area of focus for the future should be training programs for the HCF, independent of the scenario. Currently, training programs have been developed or are in development that could allow the faster and safer adoption of 3D printing at the PoC by building confidence in 3D printing devices at or near an HCF,” they wrote.
 
Engineering company 3D Systems said it believes HCFs should be subject to traditional oversight when manufacturing 3D-printed devices at PoC, while acknowledging the potential hurdles HCFs would need to overcome in complying with regulatory obligations as entities typically unfamiliar with the regulatory landscape. “Patient safety should be the utmost priority, irrespective of site of manufacturing or manufacturer being HCF at PoC; they should have the same burden, expectations, and regulatory obligations as a traditional manufacturer,” they wrote.
 
If a HCF wanted to manufacture medical devices at PoC through 3D printing, “a trained or certified staff” member should be available or hired “to implement and comply with the appropriate regulatory framework.”
 
“To make it least burdensome FDA can establish a risk-based approach and provide appropriate guidelines to be followed based on the classification and intended clinical use of the device to be manufactured by HCF at PoC. HCF can then manufacture only those devices that they can comply with or falls under that class and guidelines that HCF can adhere to,” 3D Systems wrote.
 
One example of a “very low risk” 3D-printed device includes anatomic models used in radiology, the American College of Radiology wrote in its comment to FDA. These models are secondary products used to inform patient care, and FDA should exercise enforcement discretion when considering these 3D printed devices, the college noted.
 
Additionally, the American College of Radiology questioned the use of “point of care” as a term to describe where 3D printing will occur in a healthcare setting, preferring the broader description of “HCF” instead. “In general, ‘point of care’ in other areas of medical practice (e.g., ultrasound imaging, testing) is often used to describe procedures at the patient's bedside. This is not accurate terminology for describing 3D printing activities currently performed by HCFs, as 3D printers are not located in patient procedure rooms,” they explained.
 
The Mayo Clinic, which has used 3D-printed devices in one form or another since 2006, agreed that the “point of care” descriptor should be broader to encompass larger health systems that may not have 3D printing within the same building where patients are seen. “Our electronic medical records, data storage systems, and communications are enterprise wide,” the clinic wrote. “In the current digital, virtual world it is often not clear where the point of care is. Doctors and patients are not necessarily in the same location. It is quite common for staff in one of our locations to support care in another Mayo Clinic location. We should be able to 3D print a device at any of our facilities and transfer it to any other facility without location constraints.”
 
Regarding regulatory registration and oversight, the Mayo Clinic stated medical societies are defining clinical appropriateness for 3D-printed devices such as diagnostic anatomic models, patient-specific guides and virtual surgical planning, and these societies also are creating best practices guidelines for these devices. Medical societies likewise also create and award certification standards, while the Joint Commission or other approved bodies audit healthcare facilities, it explained.
 
“We believe PoC 3D printing should follow this same model,” Mayo Clinic wrote. “It is critical that PoC 3D printing quality systems integrate with existing clinical workflows. Necessary and sufficient quality systems should be defined by a medical society and compliance should be ensured through audits performed by the current approved bodies.”
 
3D Printing Medical Devices at the Point of Care: Discussion Paper

 

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