The medical devices industry is a key component of our healthcare system, contributing not only to medical devices manufacturing but also to the development of medical technology that can help diagnose and treat various illnesses. The medical devices industry covers a wide array of items, from common supplies such as surgical masks to high tech imaging equipment. Section 201 of the Federal Food, Drug and Cosmetics Act defines this category broadly as any item used for the “diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease” and is not absorbed or metabolized by the body.
With the medical device manufacturing industry currently valued at $4.2 billion, there has been a defined pattern of steady growth in recent years. But with the responsibility of manufacturing medical devices comes certain standards set by the Food and Drug Administration (FDA). What regulations and practices must be followed in order to bring your devices into the stream of commerce? Here at Prodsmart, we value efficient, quality production and customize processes for your chosen industry. Read on to learn whether your company is following good manufacturing practices for the medical devices industry.
The medical devices industry has seen leaps and bounds as it grows alongside today’s fast growing technological evolution. Apple has been given the go-ahead to test ECG monitoring functions on the Apple Watch. Bose, the well known audio equipment manufacturer, is developing tech to improve hearing aid abilities. With an eye toward the future, the medical device industry has even explored virtual reality therapy and transcranial magnetic stimulation to treat drug addiction.
Medical analysts have even created a “microgel” covering for medical implant devices to detect bacteria that approaches the implants. This invention is believed to reduce a significant amount of patients becoming infected post-surgery. If successful, the microgel could help healthcare systems cut down on complications and reduce the need for antibiotic treatments for infections.
With such far-reaching effects, it is clear the medical device industry will continue to make exciting technological advances in the medical field.
Prior to the 1930s, the medical devices industry in America was largely unregulated. The FDA prosecuted individuals who misused medical devices on a case-by-case basis but there was no overarching area of law that defined standard practices in the field. It wasn’t until 1976 that Congress opened a system for the FDA to standardize the medical device industry. Interestingly, devices existing on the market prior to these amendments were not held to new standards and even today, devices that are substantially similar to pre-amendment devices are not held to post-amendment FDA standards.
By 1978, the FDA had issued a final rule in the Federal Register (43 FR 31 508), prescribing current good manufacturing practices (CGMP) for medical devices. In 1990, hoping to maintain consistency on an international level, the FDA revised the CGMP regulations to add design controls as mandated by the Safe Medical Devices Act. The revision finally went into effect in June 1997 and remains a basis for the industrial standards we follow today.
The system of CGMPs is enormously important to the manufacturing process because it ensures a level of quality, safety, purity, and strength in any products that are released to the public. Adhering to these practices aids a company in the reduction of product recalls, adverse effects, and defects that can lead to costly liability lawsuits in the future.
Because quality control and consistent testing environments are key factors in a successful manufacturing chain, the adoption of CGMPs will be instrumental in avoiding product contamination, failure, and quality deviation. Thus, by establishing a strong system of well-regulated operational management led by CGMPs, a medical device manufacturer has the opportunity to reduce costly delays and develop a greater volume of quality products.
The terms Current Good Manufacturing Practices (CGMPs) and Good Manufacturing Practices (GMPs) are sometimes used interchangeably. Specifically, however, CGMP is the term used by the FDA to describe up-to-date manufacturing practices required to maintain compliance with federal regulations. GMPs are an interrelated set of practices based on existing laws followed by manufacturers. Generally, if a manufacturer is informed and up to date on GMPs, it is likely following CGMPs as set forth in the Code of Federal Regulations.
Compliance with Good Manufacturing Practices (GMPs) starts with a close reading of the Code of Federal Regulations. Most of the language pertaining specifically to medical device GMPs is in Section 21 of the FDA Quality System Regulations (21 CFR Part 820). The portion mandates quality standards in the following areas:
GMP requirements are also set forth in other portions of the Code of Federal Regulations. 21 CFR 812 lists exemptions to allow a device that would normally be required to comply with performance standards or to have premarket approval to be shipped lawfully for the purpose of conducting investigations of that device. Part 808 of the same section (21 CFR 808) deals with state and local medical device laws that are exempt from federal regulation.
In order to stay compliant with GMPs, manufacturers of medical devices should be knowledgeable of the above sections and how they apply to their company’s products. In addition, staying up to date on any changes in regulations on an annual basis is crucial to continued compliance under federal rule. For assistance in compliance and quality control, check out Prodsmart’s Paperless Production Management Solutions.
There are numerous facets to GMPs depending on the purpose and nature of the device. The FDA frequently releases guidelines that shed light on proper practices in each field. The most comprehensive guidance the FDA released sets out seven key concepts for manufacturers to consider and adopt into their practices:
This step involves establishing a system that ensures “every pharmaceutical product has established identity, strength, purity, and other quality characteristics designed to ensure the required levels of safety and effectiveness.”
Quality by Design and Product Development
This concept involves “designing and developing a product and associated manufacturing processes that will be used during product development to ensure that the product consistently attains a predefined quality at the end of the manufacturing process.”
Quality Risk Assessment
Depending on the product, this concept may include the “setting of specifications and process parameters for drug manufacturing, assess[ing] and mitigat[ing] the risk of changing a process or specification, and determin[ing] the extent of discrepancy investigations and corrective actions.”
CAPA (Corrective and Preventive Action)
This action step may involve “investigating, understanding,and correcting discrepancies while attempting to prevent their recurrence.”
This well-known GMP concept calls for “managing change to prevent unintended consequences.”
The Quality Unit
The guidelines specifically include this concept asking manufacturers to “create, monitor, and implement a quality system” of manufacturing its products. The guidance stresses that this step does not replace the importance of day-to-day responsibilities of manufacturing personnel to focus on production quality.
Six-System Inspection Model
The six system inspection model combines the quality system with five manufacturing systems that function alongside it. They are not to be seen as separate and discrete systems but as an integrated model as set out in the diagram below.
Source: Food and Drug Administration
It is important to keep in mind that these guidelines are meant to apply to both manufacturers of drug products as well as manufacturers of components used in the manufacturers of drug products. While this guidance seeks to harmonize varying regulations involving medical devices on an international level, there is language that may apply more appropriately to the manufacture of drug products. As such, medical device manufacturers should not rely solely on the above guidelines and should refer to the specific sections in FDA Quality System Regulations to stay abreast of CGMPs.
Related: Identifying and Avoiding QC Issues
The Quality System regulations (61 FR 52602) are a revision by the FDA of CMPGs to specifically address the manufacture of medical devices. This regulation sets forth requirements related to methods, facilities, and controls related to the designing, manufacturing, labeling, packaging, storing, installing, and servicing of medical devices for human use. This revision includes pre-production design controls and other updates in order to make the law consistent with international quality system requirements. Most importantly, QS provides a framework for device manufacturers to go by and allows them more flexibility to meet quality standards.
Because the QS regulations adopt a similar overarching approach as the FDA’s CGMPs, it grants both flexibility and autonomy to manufacturers, depending on the nature of the device manufactured. This is not to say that manufacturers of medical devices are exempt from compliance but to afford them the freedom of adopting best practices that suit the specific product or device: “it is the responsibility of each manufacturer to establish requirements for each type or family of devices that will result in devices that are safe and effective, and to establish methods and procedures to design, produce, distribute, etc. devices that meet the quality system requirements.”
QS regulations apply only to finished devices as defined under the CFR: “any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.” (21 CFR 820.3(l)). These are devices that are intended to be manufactured and commercially distributed. Even medical device accessories may count as finished devices so long as they are accessories to finished devices, such as x-ray machine components or blood tubing equipment.
Manufacturers of medical devices should be sure to check whether any devices fall under the GMP exemptions of 21 CFR 862 through 892. Even exempted device manufacturers must follow the general guidelines set forth in 21 CFR 820.180. In addition, medical devices exempt for inspection purposes under 21 CFR 812 are still subject to QS regulations.
From a business standpoint, it is clear that compliance is a priority for any manufacturer of medical devices. Straying from the standards of FDA regulations can result in a costly drain on time and resources. But it isn’t easy staying up to date on CGMPs while heavily involved with the responsibilities of managing a manufacturing business. How can an MES help businesses stay afloat among the busy day-to-day operations of your manufacturing plant?
An MES is a manufacturing execution system that helps companies track production progress from start to finish. An MES with mobile capabilities like Prodsmart’s allows businesses to specify and collect the data needed to ensure cost effective, on-time production with minimal waste. A real-time dashboard allows busy team members to stay connected even while off-site. The function even allows for setting up notifications and alerts for when a specific production issue arises.
Customized to exactly the way your company’s shop floor operates, Prodsmart’s mobile MES will meet your quality requirements while clearing the way for continuous improvement and quality production.
Maintaining compliance with Current Good Manufacturing Practices and Quality System Regulations under the FDA is a must-have for medical device manufacturers who prioritize safety, quality, product integrity, and operational excellence. It is apparent that the key to streamlined quality assurance and production traceability lies in comprehensive insights, simple accessible instructions, and efficient management. With the right tools, manufacturers can harness the power of Good Manufacturing Practices and QS regulations to create a compliant and dynamic system of high level medical device production.
Prodsmart’s tracking and real-time management system is the simplest solution for production insight and fully customized processes. Check out our Quality Module, which allows businesses to access all tracking and traceability information in one place, generate reports on demand, and simplify the audit process. With these tools at your fingertips, effective management, optimized workflow, and quality production are only a few clicks away.
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