Each industry will have different interpretations of the concept of Quality and how to prioritize its tenets within their own field of practice, expertise and work experience. Perhaps the best fundamental principle is the definition of Quality given by the International Organization for Standardization (ISO) as “the degree to which a set of inherent characteristics fulfills requirements where a requirement is a need or expectation.” This look at the Medical Devices sector is one in a series of blogs that provides a quick look at how the concept of Quality applies in different industries.
Quality in the medical device industry touches every stage of the manufacturing process and the organization. Most medical device manufactures have a dedicated Quality Assurance group that ensures compliance with regulations relating to design, manufacture, and records management. The fundamental principle of medical devices is safety for the user, whether that user is the patient or the caregiver. Safety of medical devices is based on the risk management[i] principles as defined in ISO 14971, which outlines the risk-based approach to ensure Quality and applies to elements such as product safety, operability, packaging, design, and use of these devices. Automated manufacturing processes in the medical devices and pharmaceutical industries are governed by GAMP5 (Good Automated Manufacturing Processes) as part of the International Society for Pharmaceutical Engineering.
Design validation is a vital component of medical devices manufacture. U.S. FDA regulation 21 CFR Part 820 defines validation as “establishing by objective evidence that device specifications conform with user needs and intended use(s).”[ii] Ensuring that the device meets the requirements of the user in a safe and effective way is one of the most important Quality principles in the medical devices industry, but was also the number one citation in U.S. Food and Drug Administration (FDA) warning letters between 2011 and 2015.[iii] U.S. FDA regulation CFR Part 820 complements the global international standard ISO 13485:2003/ISO 13485:2016.
In addition to the Quality of the devices, their documentation is another important location for Quality improvement. Device History Records (DHR) contain a complete record of the design, manufacture, and testing of a medical device. DHRs are signed at each step of manufacture and become the master record demonstrating that the unit was built to the required specifications. One device manufacturer did a routine audit to discover that as many as 20 percent of its DHRs had errors, which caused considerable delay in product release.[iv]
Electronic records and signatures are governed by U.S. FDA regulation 21 CFR Part 11. The FDA also recommends using a Quality approach in medical device testing involving human subjects.[v]
The complex nature of medical devices, the global markets they serve, and the diversity of patient needs all mean that a Quality approach to the trial process is vital to ensuring the safety of the subjects and the integrity of the trial results.
[i] Les Schnoll, “Ensure Medical Device Safety,” Quality Progress (February 2003): 73-74, accessed March 9, 2018, http://asq.org/medical-devices/pdf/ensure-medical-device-safety.pdf
[ii] 21 CFR 820.3, accessed March 9, 2018, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1.
[iii] “Design Validation and Regulatory Requirements,” Medical Design Briefs, January 1, 2017, accessed March 12, 2018, https://www.medicaldesignbriefs.com/component/content/article/mdb/features/26238.
[iv] Janet Jacobsen, “Medical Device Manufacturer’s Continuous Improvement Approach Reduces Errors in Records,” ASQ: Making the Case for Quality, February 2009, accessed March 9, 2018 http://asq.org/2009/02/continuous-improvement/medical-device-manufacturer-reduces-errors.pdf.
[v] Mary Lewis, “Ensuring Quality in Medical Device Trials,” GxP Lifeline, January 11, 2018, accessed March 9, 2018, https://www.mastercontrol.com/gxp-lifeline/ensuring-quality-in-medical-device-trials