Literature review for the open-source surgical fracture table
Regulatory aspect
1. Jarow, J. P., & Baxley, J. H. (2015, March). Medical devices: US medical device regulation. In Urologic Oncology: Seminars and Original Investigations (Vol. 33, No. 3, pp. 128-132). Elsevier.
- FDA regulates since 1976 under CDRH
- 4 step process for medical devices = 1. Is it a medical device?, 2. Device classification (based on risk and complexity), 3. Premarket pathway, 4. Clinical data needed or not
- Most class 1 devices use general controls and are exempted from premarket notification (demonstrating safety) so do 510(k) process (equivalence to on-market commercial existing device)
- Some class 1 may be exempt from GMP compliance
2. Tettey, F., Parupelli, S. K., & Desai, S. (2024). A review of biomedical devices: classification, regulatory guidelines, human factors, software as a medical device, and cybersecurity. Biomedical Materials & Devices, 2(1), 316-341.
- Class 1 devices are low risk, neither life-saving nor threatening so have no risk of illness or harm
- 47% of medical devices are class 1
- 95% of those are exempt from stringent regulatory processes
3. Martin, J. L., Norris, B. J., Murphy, E., & Crowe, J. A. (2008). Medical device development: The challenge for ergonomics. Applied ergonomics, 39(3), 271-283.
- Medical device design should consider the environment where they’ll function+ working pattern of end users (ergonomics)
- Test for functionality and usability
- Addressing clinical need is important but so is a user friendly, efficient and effective design
4. Di Prima, M., Coburn, J., Hwang, D., Kelly, J., Khairuzzaman, A., & Ricles, L. (2016). Additively manufactured medical products–the FDA perspective. 3D printing in medicine, 2, 1-6.
- 3D printed medical devices already in clinical use
- QMS and GMP apply as for other medical devices unless exempted by FDA
5. Guerra-Bretaña, R. M., & Flórez-Rendón, A. L. (2018). Impact of regulations on innovation in the field of medical devices. Research on biomedical engineering, 34(4), 356-367.
- National Rgulatory Agencies usually subrcribe to International Harmonization guidelines
- Regulations depend on risk level by class
- Medical devices reach end users at a slower rate due to stringent regulations that “ensure device and end user safety”
6. Pietzsch, J. B., Aquino, L. M., Yock, P. G., Paté-Cornell, M. E., & Linehan, J. H. (2007). Review of US medical device regulation.
- Medical device regulation is important in design, development and commercialization
- US FDA bases on risk to classify device and determine its regulatory pathway
7. Chen, Y. J., Chiou, C. M., Huang, Y. W., Tu, P. W., Lee, Y. C., & Chien, C. H. (2018). A comparative study of medical device regulations: US, Europe, Canada, and Taiwan. Therapeutic innovation & regulatory science, 52(1), 62-69.
- Canada Medical Devices Regulation (CMDR) developed off FDA to regulate devices in Canada
- Manufacturers classify their devices
- Class 1s don’t need defined quality systems or clinical investigations
- Though Class 1s are exempt, manufacturers to sell in Canada need a medical device establishment license (MDEL), devices must satisfy safety requirements (CMDR section 10-20) and labelling (CMDR section 21)
8. Kaplan, A. V., Baim, D. S., Smith, J. J., Feigal, D. A., Simons, M., Jefferys, D., ... & Leon, M. B. (2004). Medical device development: from prototype to regulatory approval. Circulation, 109(25), 3068-3072.
- Class 1 devices are lowest risk.
- General controls include published standards on labelling, manufacturing, post-market surveillance, device registration, GMP, adverse event reporting
9. Morrison, R. J., Kashlan, K. N., Flanangan, C. L., Wright, J. K., Green, G. E., Hollister, S. J., & Weatherwax, K. J. (2015). Regulatory considerations in the design and manufacturing of implantable 3D‐printed medical devices. Clinical and translational science, 8(5), 594-600.
- Considerations on their class III device = Design, Manufacturing, biocompatibility, sterilization
10. Jin, Z., He, C., Fu, J., Han, Q., & He, Y. (2022). Balancing the customization and standardization: exploration and layout surrounding the regulation of the growing field of 3D-printed medical devices in China. Bio-design and Manufacturing, 5(3), 580-606.
- Lack of evaluation standards and regulatory system for 3D printed medical devise causing a lag in practical clinical use
- 3D printing is not only for personalized medical devices (i.e. custom, patient-matched, adaptable devices)
11. Fiedler, B. A. (2017). Review Regulatory Guidelines by Device Classification Type. Managing Medical Devices Within a Regulatory Framework, 33-50.
- Class 1 devices conform to general controls, QSR, probably 510(k)
- Exemption from 510(k) is if: 1) device is low risk to patients, 2) is a modification of a marketed device.
- Exempted devices still meet general controls + other conditions in the Medical Device Reporting Regulation 21 CFR part 807, subpart E (FDA 2014(K))
12. 21 CFR part 888: orthopedic device (https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-888) (Medical device exemptions from 510(k) and GMP requirements/ classify your medical device)
- "§ 888.5850 Nonpowered orthopedic traction apparatus and accessories.
- (a) Identification. A nonpowered orthopedic traction apparatus is a device that consists of a rigid frame with nonpowered traction accessories, such as cords, pulleys, or weights, and that is intended to apply a therapeutic pulling force to the skeletal system.
- (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records, and § 820.198, regarding complaint files.
- Follow through to 888.9 to confirm exemption. Also does the OS SFT really qualify to be a traction apparatus or is it bigger than that – anyway, orthopedic tables were not part of the classification list."
13. Manero, A., Smith, P., Koontz, A., Dombrowski, M., Sparkman, J., Courbin, D., & Chi, A. (2020). Leveraging 3D printing capacity in times of crisis: recommendations for COVID-19 distributed manufacturing for medical equipment rapid response. International journal of environmental research and public health, 17(13), 4634.
- FDA authorizes emergency use authorization (EUA) for critical devices and in emergencies eg covid time
- FDA encouraged going beyond traditional manufacturing (..end of March)
- Distributed manufacturing supplemented additive manufacturing to meet device supply shortages during covid eg face masks, face shields, ventilators, nasal swabs
- Distributed manufacturing eased local production (imports were impossible since countries were saving their own), files accessible on sites like Thingiverse, Grab CAD, NIH 3D print exchange
- Open source files were harder to standardize so collaborations with authorities like FDA, department of veteran affairs (VA) engaged to review designs later labelled “clinically reviewed”
- Community based distributed manufacturing will be more successful with vetted and standardized files before they are made readily accessible
14. Kermavnar, T., Shannon, A., O'Sullivan, K. J., McCarthy, C., Dunne, C. P., & O'Sullivan, L. W. (2021). Three-dimensional printing of medical devices used directly to treat patients: a systematic review. 3D Printing and Additive Manufacturing, 8(6), 366-408.
- Advantages of 3D printing: recreate complex geometry, on-demand fabrication, customization, in-house/ local production in areas with supply chain challenges
- Disadvantages/ worries: bioavailability and bioactivity – mainly for implants
- FDA set guidelines in 2017 for 3D printing medical devices inclusive of design, manufacturing, testing specifications
- Use of 3D printed medical devices mostly prevalent in surgery eg orthopedic, maxillofacial bone defects, … Non surgical applications: orthotics, prosthetics (amputations), immobilization (fractures), devices (teeth, endoscope caps, casts, swabs, tissue retractors previously made of stainless steel but failed due to local magnetic field interference etc
- Metals eg titanium, plastics eg resins, ABS, PLA, PETG, PA, TPU ninjaflex, silicone, PCL,… commonly used
- 3D printed devices are to conform to regular stands to be legally used
- ¼ of the reviewed studies outsourced device design and fabrication from certified medical companies and ¾ got IRB permission to use their devices
15. Mamo, H. B., Adamiak, M., & Kunwar, A. (2023). 3D printed biomedical devices and their applications: A review on state-of-the-art technologies, existing challenges, and future perspectives. Journal of the Mechanical Behavior of Biomedical Materials, 143, 105930.
- Challenges with medical 3D printing: 1) materials (biocompatible, sterilizable, safe for human use), 2) material properties to match intended application (in strength, flexibility, wear resistance), regulatory compliance (country dependant)
- Commonly used biocompatible plastics include PLA, PETG…
16. Liaw, C. Y., & Guvendiren, M. (2017). Current and emerging applications of 3D printing in medicine. Biofabrication, 9(2), 024102.
- 3D printing used for customization for patients and surgeon hand tools + complex geometry
- Allows for on-demand fabrication especially in remote areas
- Surgical instruments (scalpel hands, needle drivers, retractors, tissue forceps, surgical guides..), implants, assistive devices (prosthetic sockets, foot orthoses, wrist splints…) – items that are sterilizable, cheaper, with proved clinical efficiency
- Print thickness, orientation, should be considered for load bearing applications
- 3D printed medical devices so far cleared by FDA through 510(k) pathway but none yet through PMA
- Still unanswered questions by FDA workshops: 1) Is a CAD file considered a product? Is there liability to the CAD file creator who is not making the final product? 2) How does FDA treat PoC manufacturers eg hospitals? 3) Can FDA ensure device safety and effectiveness if the manufacturer is not well defined? (…OS devices…)
17. Shim, K. W. (2023). Medical applications of 3D printing and standardization issues. Brain Tumor Research and Treatment, 11(3), 159-165.
- 3D printed devices follow same safety and performance standards as other medical devices to be approved (eg give info on the design, materials, intended use, safety and effectiveness test, GMP…)
18. Beitler, B. G., Abraham, P. F., Glennon, A. R., Tommasini, S. M., Lattanza, L. L., Morris, J. M., & Wiznia, D. H. (2022). Interpretation of regulatory factors for 3D printing at hospitals and medical centers, or at the point of care. 3D Printing in Medicine, 8(1), 7.
- (their definition) – PoC manufacturing = healthcare provider/ organization as manufacturer for a patient specific 3D printed medical device. Liability is on the hospital
- PoC manufacturers aren’t subject to premarket notification/ approval as long as they don’t sell
- FDA still uncertain on how to regulate PoC manufacturers
- Class 1 devices typically exempt from premarket notification – follow general controls
- PoC devices are usually patient specific devices
- FDA created a tentative framework for regulating PoC manufacturers
- Recommend for PoC manufacturers to use internal regulations, use FDA cleared CAD software, do biocompatibility tests for patient contacting devices.
19. FDA on PoC manufacturing: https://www.fda.gov/media/154729/download
- 3D printers were initially made for general (non-medical) use which FDA doesn’t regulate
20. Choong, Y. Y. C., Tan, H. W., Patel, D. C., Choong, W. T. N., Chen, C. H., Low, H. Y., ... & Chua, C. K. (2020). The global rise of 3D printing during the COVID-19 pandemic. Nature Reviews Materials, 5(9), 637-639.
- 3D printing can address supply-demand imbalance caused by socio-economic factors and disruptions in supply chain
- Decentralized manufacturing involves sharing files online
- Medical devices 3D printed during covid include ventilator valves, masks for CPAPs, PPE (face shields, respiration filters), testing devices (swabs), isolation wards
- Regulations tend to lag behind innovations
- 3D printing allows for a greener more environmentally future
- More medical 3D printing happening since covid
21. D'Alessio, J., & Christensen, A. (2019). 3D printing for commercial orthopedic applications: advances and challenges. 3D printing in orthopaedic surgery, 65-83.
- Many hospitals especially in the US are installing 3D printers mainly for anatomical modelling eg for oral, cardiac, orthopedic surgery
22. Otero, J., Pearce, J. M., Gozal, D., & Farré, R. (2024). Open-source design of medical devices. Nature Reviews Bioengineering, 2(4), 280-281.
- The conventional medical devices market isn’t serving many in LMICs due to high costs
- Donations are not he best solution since they are sometimes old, and infrastructure to support and maintain them might be lacking
- Local manufacturing using open source tech could solve this (eg Tesla….) but open source uptake is slower in healthcare
- Some medical devices eg ventilators, EEG, ECG, oximeters… are freely distributed (some even no longer under patents)
- Device safety is paramount and approval for device use can be got from clinical / ethical boards.
23. Farré, R., Gozal, D., Nguyen, V. N., Pearce, J. M., & Dinh-Xuan, A. T. (2022). Open-source hardware may address the shortage in medical devices for patients with low-income and chronic respiratory diseases in low-resource countries. Journal of Personalized Medicine, 12(9), 1498.
- Using open source medtech is harder in regulated areas
- In the US, clinical use of open source non-FDA approved medtech required an IDE (investigational device exemption) temporarily followed by full approval application later except for emergencies like pandemics.
24. Brewster, R. C., Wu, A., & Carroll, R. W. (2023). Open source approaches for pediatric global health technologies. Journal of Medical Engineering & Technology, 47(8), 371-375.
25. Overhoff, M., Lumpe, T. S., & Shea, K. (2023, August). A Product Life Cycle Approach to Medical Device Development for Low-Resource Settings-A Systematic Literature Review. In International Design Engineering Technical Conferences and Computers and Information in Engineering Conference (Vol. 87349, p. V006T06A041). American Society of Mechanical Engineers.
Redesign of the surgical fracture table
1. Habibi, A. A., Bi, A. S., Owusu-Sarpong, S., Mahure, S. A., Ganta, A., & Konda, S. R. (2022). History, indications, and advantages of orthopaedic operating room tables: a review. European Journal of Orthopaedic Surgery & Traumatology, 32(6), 1207-1213.
- Orthopedic or surgical fracture or traction table
- Made especially for lower limb positioning and intraoperative traction.
- Allows for repair and reduction of injuries at the knee. Hip, pelvic eg fractures
- Made radiolucent for intraoperative fluoroscopy
- Maneuvers include height adjustment, Trendelenburg tilt, lateral tilt, leg adduction and abduction
2. Goldberg, T. D., Kreuzer, S., Randelli, F., & Macheras, G. A. (2021). Direct anterior approach total hip arthroplasty with an orthopedic traction table. Operative Orthopädie und Traumatologie, 33(4), 331-340.
- SFT disadvantages include: not universally available, expensive, training needed, complications (ankle fractures, prudendal nerve palsy in excess traction),…
- Despite advantages like reduced need for assistants (LMICS have low resource even human resource), intraoperative fluoroscopy, limb positioning for exposure and stability preventing further damage
3. Sarraj, M., Chen, A., Ekhtiari, S., & Rubinger, L. (2020). Traction table versus standard table total hip arthroplasty through the direct anterior approach: a systematic review. Hip International, 30(6), 662-672.
- Traction table vs standard operating table study comparison for DAA procedure
- Nerve injury observed more with standard operating table
- Traction table limitations include high cost, longer set up time therefore longer operative time
4. Hubner, S., Maloney, C., Phillips, S. D., Doshi, P., Mugaga, J., Ssekitoleko, R. T., ... & Fitzgerald, T. N. (2021). The evolving landscape of medical device regulation in east, central, and Southern Africa. Global Health: Science and Practice, 9(1), 136-148.
- Most medical devices are build on demand and resources in HICs and are not fit for challenges in LRS
5. Jyothi, G. V. S. S. N., Venkatesh, M. P., & Pramod Kumar, T. M. (2013). Regulations of medical devices in regulated countries: A comparative review. Therapeutic innovation & regulatory science, 47(5), 581-592.
6. IEC 60601-2-46: M2024:
- requirements for operation/ surgical tables - electrical or not
7. Kermavnar, T., Shannon, A., O'Sullivan, K. J., McCarthy, C., Dunne, C. P., & O'Sullivan, L. W. (2021). Three-dimensional printing of medical devices used directly to treat patients: a systematic review. 3D Printing and Additive Manufacturing, 8(6), 366-408.
- Advantages of 3D printing: recreate complex geometry, on-demand fabrication, customization, in-house/ local production in areas with supply chain challenges
- Disadvantages/ worries: bioavailability and bioactivity – mainly for implants
- FDA set guidelines in 2017 for 3D printing medical devices inclusive of design, manufacturing, testing specifications
- Use of 3D printed medical devices mostly prevalent in surgery eg orthopedic, maxillofacial bone defects, … Non surgical applications: orthotics, prosthetics (amputations), immobilization (fractures), devices (teeth, endoscope caps, casts, swabs, tissue retractors previously made of stainless steel but failed due to local magnetic field interference etc
- Metals eg titanium, plastics eg resins, ABS, PLA, PETG, PA, TPU ninjaflex, silicone, PCL,… commonly used
- 3D printed devices are to conform to regular stands to be legally used
- ¼ of the reviewed studies outsourced device design and fabrication from certified medical companies and ¾ got IRB permission to use their devices
8. Wiseman, J., Rawther, T., Langbart, M., Kernohan, M., & Ngo, Q. (2022). Sterilization of bedside 3D-printed devices for use in the operating room. Annals of 3D Printed Medicine, 5, 100045.
- PETG is commonly sterilized using hydrogen peroxide
9. Otero, J., Pearce, J. M., Gozal, D., & Farré, R. (2024). Open-source design of medical devices. Nature Reviews Bioengineering, 2(4), 280-281.
- The conventional medical devices market isn’t serving many in LMICs due to high costs
- Donations are not he best solution since they are sometimes old, and infrastructure to support and maintain them might be lacking
- Local manufacturing using open source tech could solve this (eg Tesla….) but open source uptake is slower in healthcare
- Some medical devices eg ventilators, EEG, ECG, oximeters… are freely distributed (some even no longer under patents)
- Device safety is paramount and approval for device use can be got from clinical / ethical boards.
10. Pearce, J. M. (2020). A review of open source ventilators for COVID-19 and future pandemics. F1000Research, 9, 218.
11. Frazer, J. S., Shard, A., & Herdman, J. (2020). Involvement of the open-source community in combating the worldwide COVID-19 pandemic: a review. Journal of medical engineering & technology, 44(4), 169-176.
12. Malkin, R. A. (2007). Barriers for medical devices for the developing world. Expert review of medical devices, 4(6), 759-763.
13. Pearce, J. M. (2020). Economic savings for scientific free and open source technology: A review. HardwareX, 8.
14. Brouillette, M. A., Kaiser, S. P., Konadu, P., Kumah-Ametepey, R. A., Aidoo, A. J., & Coughlin, R. C. (2014). Orthopedic surgery in the developing world: workforce and operative volumes in Ghana compared to those in the United States. World journal of surgery, 38(4), 849–857. https://doi.org/10.1007/s00268-013-2314-0
15. DeMaio, E. L., Marra, G., Suleiman, L. I., & Tjong, V. K. (2024). Global Health Inequities in Orthopaedic Care: Perspectives Beyond the US. Current reviews in musculoskeletal medicine, 17(11), 439–448. https://doi.org/10.1007/s12178-024-09917-8
16. Bow, J. K., Gallup, N., Sadat, S. A., & Pearce, J. M. (2022). Open source surgical fracture table for digitally distributed manufacturing. PloS one, 17(7), e0270328. https://doi.org/10.1371/journal.pone.0270328
- Challenges in surgical care access
- Medical/ surgical instrument 3D printing
- Digitally distributed manufacturing
- advantages of open source hardware
- The open-source surgical fracture table
17. Kulkarni, A., & Pearce, J. M. (2023). Open-source 3-D printable autoinjector: Design, testing, and regulatory limitations. PloS one, 18(7), e0288696. https://doi.org/10.1371/journal.pone.0288696
- normal device regulation = device + facility approval
- class 1 devices digitally distributed during covid
- guidelines on distributed manufacturing?
- risk analysis vital for proper device use
18. Wenzel, T. (2023). Open hardware: From DIY trend to global transformation in access to laboratory equipment. PLoS biology, 21(1), e3001931. https://doi.org/10.1371/journal.pbio.3001931
- Enhance local development
- Need for context appropriate designs
- Barrier to OS adoption (partial documentation, not seen in use in HICs)
19. Oberloier, S., Gallup, N., & Pearce, J. M. (2021). Overcoming supply disruptions during pandemics by utilizing found hardware for open source gentle ventilation. HardwareX, 11, e00255. https://doi.org/10.1016/j.ohx.2021.e00255
- Open source designing during the COVID pandemic
- Distributed manufacturing
- Gentle ventilator
20. Williams, E., Piaggio, D., Andellini, M., & Pecchia, L. (2022). 3D-printed activated charcoal inlet filters for oxygen concentrators: A circular economy approach. Development engineering, 7, 100094. https://doi.org/10.1016/j.deveng.2022.100094
- LMICs lack essential medical equipment
- poor health outcomes
- environmentally incompatibln donations
- poor infrastructure eg constant power
- developed an oxygen concentrator...
