Medical Device Quality Management Systems

Strategy and Techniques for Improving Efficiency and Effectiveness

Susanne Manz

• Publisher: Academic Press
• Year: 2018
• ISBN:
  9780128142226
• Topic: Ciencias biológicas
• Subtopic: Biotecnología

Medical Devices Quality Management Systems: Strategy and Techniques for Improving Efficiency and Effectiveness is written for the needs of quality, compliance, and regulatory professionals in medical device companies. It includes secrets for developing an effective, yet efficient, Quality Management System (QMS) and explains how to create a vision, strategy, and tactical plans. Author Manz shares lessons on leadership, key roles and responsibilities within a medical device company, while also exploring the concepts of process ownership, individual accountability, and how to cultivate a culture of quality and compliance. This book is useful for all executive, functional leaders, and organizations in the highly regulated medical device industry.

• Provides practical, real-world guidance on developing an effective and efficient Quality Management System
• Presents a roadmap for QMS development
• Covers techniques to assess current state
• Includes discussions on tools, such as CAPA and Six Sigma that help define vision, strategy and quality plans

Part I

An effective quality system

Outline

• Chapter 1 Regulatory requirements
• Chapter 2 Increasing expectations
• Chapter 3 Establish and maintain
• Chapter 4 QMS structure

Chapter 1

Regulatory requirements

Abstract

The era of modern device regulation began in 1906 with the Pure Food and Drug Act. A history of specific issues shaped the regulations that medical device manufacturers must comply with today. The Food, Drug, and Cosmetic Act of 1938 and subsequent amendments are the basis of the regulations we know today in the United States. In order to meet the requirements of the regulations, medical device companies must establish and maintain an effective quality management system (QMS) to prevent adulterated or misbranded products. The QMS consists of the organizational structure and resources, skills and capabilities, a network of connected processes documented in policies and procedures, and the necessary enabling infrastructure. An effective QMS is the foundation for how medical device manufacturers ensure that their products are both safe and effective. An effective QMS requires ongoing effort and is always ready for a Food and Drug Administration inspection.

Keywords

Quality management system (QMS); compliance; quality; effective; regulation; Food and Drug Administration (FDA); customer; establish; Food Drug and Cosmetic Act; Pure Food and Drug Act; patent medicines; Great American Fraud; adulterated; misbranded; quality system regulation (QSR); Code of Federal Regulations; Medical Device Amendments; FD&C Act; appropriate; advertising; adulterated; misbranded; ISO13485; ISO14971; Snake Oil; Electropoise; Mrs. Winslow’s Soothing Syrup; Safe Medical Devices Act; Medical Device Amendments Act; preamble to the quality system regulation; classification panels; appropriate; good manufacturing practices (GMPs); Form 483; warning letter; recidivist warning letter; consent decree; injunction; recall; criminal prosecution; civil money penalty; internal audit; management responsibility; management review; behavior; MEDICS; Corrective and Preventive Action (CAPA); import detention; enforcement; International Medical Device Regulators Forum (IMDRF); Advamed; AAMI; Medical Device Innovation Consortium (MDIC)

Today, medical devices are highly regulated with a long history of regulations going back to the Pure Food and Drug Act of 1906. Prior to this, medical products were unregulated, promised to cure a wide variety of vague ailments, and were often ineffective or even hazardous. Patent medicines originated in England and were associated with proprietary “medicines” or concoctions that arrived in North America with the first settlers. The term “patent medicine” is a bit confusing and does not always mean medicines that have been patented. The phrase “patent medicine” comes from medical elixirs of the late 17th century when those who found favor with royalty were issued letters patent that allowed the use of royal endorsement for advertising.

Patent medicines, also known as nostrums, were products that were proprietary in nature, unproven, and marketed directly to the public. Patent medicines were sold with interesting names, bogus claims, and using advertising games. Pioneer (aggressive) advertising techniques with distinctive trademarks and packaging were common. Products were promoted as cure-alls and panaceas for all sorts of ailments. Entrepreneurs began to bottle and sell “old family recipes” with no proof of efficacy or safety. Networks of unscrupulous traveling salesmen sprang up and turned patent medicines into big business. Profit-making took priority over safe and effective products.

These quack medicines were often not effective and did not contain the ingredients specified. Even worse, they were sometimes deadly. Often, they had high (and undisclosed) alcohol content which may explain why they were so popular. Ingredients were unregulated and could include those that were addictive and lethal. They often contained addictive ingredients such as morphine, opium, cocaine, or heroin. Mercury and arsenic were found in some products. One product containing opium, alcohol, and chloroform together promised to cure everything from toothache in 5 minutes to colds in 24 hours and deafness in 2 days! Even worse, patent medicines were frequently marketed as “infant soothers” and “teething cordials” for fussy, teething, or colicky babies, but caused tragic results. Mrs. Winslow’s Soothing Syrup claimed that it was “likely to soothe any human or animal.”

Newspapers became filled with advertisements promising quick, cheap cures for all ailments both dreadful and mundane. Advertisements for patent medicines were everywhere and referred to vague disorders such as female complaints and dyspepsia. Advertising cards (trade cards) were colorful, imaginative, and displayed distressing before pictures (when the card was closed) and happier after pictures when the card was opened. Testimonials were a common advertising technique.

Sellers made broad claims about patent medicines curing a variety of ailments. These concoctions were sold to the unsuspecting public with no controls. Salesmen often used innovative techniques to attract attention to their sales offerings. At the 1893 World Expo in Chicago, Clark Stanley, the “rattlesnake king,” caused a stir by publicly killing rattle snakes and processing their bodies to collect snake oil to “stop pain, reduce swelling, remove inflammation, and oil dry joints.”

Note

A visit to the Smithsonian Institution's National Museum of American History in Washington, DC or the Hagley Museum in Wilmington, Delaware provides many fascinating examples of patent medicines and their colorful bottles, advertisements, and quack claims. Items include:

• • Stetketee’s Neuralgia Drops
• • Aubergier’s Pastilles of Lacucarium
• • Kickapoo Indian Sagwa Renovator
• • Renne’s Magic Oil
• • One Minute Cough Cure

By the early 1900s, some physicians and medical societies were recognizing problems and becoming critical of these medicines. At this time, there were estimates of 50,000 patent medicines being manufactured and sold in the United States. Journalists began exposing injuries as well as proprietary formulas. American journalist and author, Samuel Hopkins Adams wrote a series of 11 articles in 1905 to 1906, The Great American Fraud, that called attention to these issues.

Other changes were occurring, and Upton Sinclair described the unsanitary conditions of meat-packing plants in The Jungle. This led to widespread public outrage and demand for regulation of food and drug products. With the strong support of President Theodore Roosevelt, the Pure Food and Drug Act was passed in 1906 and started an era of regulation to ensure that medical products were both safe and effective.

In 1917, the Bureau of Chemistry (later known as the Food and Drug Administration or FDA) seized a shipment of Stanley’s Snake Oil and found that it contained no snake oil at all. It was mainly mineral oil, red pepper, and turpentine. Clark Stanley was fined $20. The term “snake oil” was now well-established as a quack concoction marketed as a patent medicine. Even today, the term “snake-oil salesman” still conjures the image of a seedy salesman peddling his wares on a soapbox in a traveling show.

In 1911, the American Medical Association published Nostrums and Quackery, describing hundreds of products linked to serious injuries and deaths. Mrs. Winslow’s Soothing Syrup was featured in a section titled “Baby Killers.” By this time, there were also concerns about misleading advertising, quackery, and mechanical products (the early medical devices). An entire chapter was devoted to the advertising techniques of con men and quacks.

A chapter titled Mechanical Fakes, voiced concerns about unproven new medical devices. “It is sometimes hard to decide which is greater—the impudence of the quack or the credulity of his victims. The comparative ease with which the medical faker is able, by the most preposterous of claims, to separate the trusting from their money indicates the enormous potentialities in advertising. It might well be supposed that an individual who set out to sell, as a panacea for all the ills of the flesh, a piece of brass pipe with one or two wires attached to it, would commercially speaking have a hard and rocky road ahead of them. But such supposition would be incorrect. Not only would the enterprising faker find customers for his gas pipe, but there would be such a demand for this most inane of ‘therapeutic’ device that two or three imitators would immediately enter the market.” This described the Electropoise device, originated by “one Hercules Sanche, who modestly described himself as the ‘Discoverer of the Laws of Spontaneous Cure of Disease’.” The book goes on to state that, in order to minimize legal issues and maximize financial gain, “Sanche finally hit on a device that was negatively harmless—and positively worthless—and yet theatrical enough to make the purchaser feel that he was getting something for his money.” Advertisements for Electropoise made wild claims, even saying that it could cure previously determined incurable diseases. It was time for improved regulation to protect the public health.

The Pure Food and Drug Act of 1906 regulated only drugs and food and did not include medical devices. It was replaced in 1938 by The Food, ...