The field of medical devices has been a shining light for implementing new technologies and innovations that can save lives in the world of modern healthcare. In this world of rapid change, regulatory organizations like the Food and Drug Administration (FDA) are essential for protecting patient health and making certain that medical devices are both safe and effective. The eCFR is a browsable, searchable version of the CFR that has been published on our website, and FDA Title 21, Chapter 1, Part 820 of the Code of Federal Regulations (CFR)
lays out detailed principles for medical device manufacturers to maintain high standards and quality in all their operations.
Leading the quality pillar in medical device manufacturing is the Quality System Regulation (QSR), or Part 820. This comprehensive regulatory structure mandates a range of stipulations that spotlight the need for quality systems to be implemented and maintained throughout the lifecycle of medical devices. The most notable feature in part 820 especially when looking at production and process controls would be Subpart G: Production and Process Controls, which comes to ensure that medical devices are produced with an accurate, precise manufacturing process based on a quality system.
In Subpart G, section 820.72 — Control of Inspection, Measuring, and Test Equipment covers the requirement for a medical device manufacturer to control and validate equipment used in inspection, measuring, and testing activities. Precise and truthful measurements are essential in the manufacture of regulated medical devices to comply with standards and exceed end-users expectations, as well as upholding patient health.
Calibration confirms that manufacturers’ inspection, measuring and test equipment are fit for use and can deliver consistent numbers of reliable results. The importance of calibration to the quality and effectiveness, and even safety of medical devices cannot be over-stressed. The instruments function goes beyond mere quality control but stretches to defining the trust which both healthcare practitioners and patients invest in these tools.
Calibrated equipment leads to the collection of information you can trust, or to put it another way: well-calibrated equipment means quality devices. Every manufacturer shall ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results.
Issues due to the Industry
The medical device industry must meet some of the most stringent standards available while facing a number of calibration equipment challenges for inspection, measuring, and test equipment. Challenges can be different by size of organization, complexity of equipment, and breadth of their manufacturing operations. Here are a few of the key difficulties.
This instruction limits the use of these controlled substances to situations in which compliance with specific directions and limitations imposed by the regulations is possible.
1. Calibration procedures (QSR-820.72(b)) provide acceptable directions and limits for accuracy and precision that should be adhered to by manufacturers.
This is a big issue especially for companies that have different types of plant equipment and applications. The calibration needs can be different depending on the specific nature of the medical device that is in production, and thus, detailed and/or far-reaching calibration procedures are needed for each particular equipment unit.
2. Corrective Action and Impact on Device Quality
For such cases wherein the calibration limits are not achieved, the regulation requires that there be arrangements for corrective action to bring back the limits. The difficulty is in quickly recognizing calibration deviations and deploying the correct corrective actions. Manufacturers must also determine whether any adverse impact on the quality of the medical device produced with it during the non-conforming period.
3. To National or International Standards — Traceability.
This calibration must be traceable to national or international standards in order to comply the rule with accurate and reliable calibration. In some cases, it may be not feasible or not available to attain traceability. The problem comes when you do not have the available calibration standards or when the medical devices need specific and unique calibration processes.
4. Specific Testing quality standards are followed at independent reproducible Standards: QC and inhouse QC test centers.
In the absence of corresponding standards, manufacturers need to create their own reproducible standards or proprietary standards Creating and maintaining such standards requires immense resources and skills. Developing separate standards that correspond with the quality of precision and accuracy necessary for medical devices can be an expensive and lengthy process.
5. Documentation and Record-Keeping
The rule places a high value on correct calibration record-keeping (equipment identification, calibration dates, who performed the calibration and scheduled next time for calibration) One of the most critical and laborious tasks for manufacturers is keeping accurate records that are current, especially with a plethora of equipment items requiring regular calibration.
6. Calibration and Maintenance Routing
The manufacturer shall establish and maintain procedures to ensure that all equipment used in the QM system is checked, calibrated or verified at specified intervals (i.e. maintain in a state of control). That includes juggling a difficult set of schedules and making sure calibrations happen on time without causing delays in production. The real task is to co-ordinate and plan calibration schedules in a way that there will be less down time of equipment whilemeeting regulatory requirements.
7. Personnel training and competency;
Whilst it is easy to say that calibration processes need to be done correctly, getting there requires a high level of competency by all the people who perform calibrations. This includes investing in sufficient training and certification programs to guarantee that personnel are sufficiently equipped to execute calibrations properly.
Adhering to the regulations concerning the calibration of inspection, measuring and test equipment is a corner stone for success in medical device industry. Subpart G, Section 820.72 of the Quality System Regulation is key to ensuring product quality, safety and efficacy. While it is a struggle for the industry to meet these requirements, rigorous calibration practices and accurate record-keeping are how manufacturers can continue manufacturing high quality lifesaving medical devices.
Technological challenges must be overcome by the manufacturers and they need to create further enhancements for producing safe and reliable medical devices for global healthcare. Adopting novel calibration tools, building strong training programs, and promoting a continuous improvement mindset can enable manufacturers to overcome these obstacles and meet compliance . In this manner, the medical device industry can continue to play a very important part in progressing healthcare and making improvements in patient outcomes.
If you would like more information, please contact BioBoston Consulting today or go to our website