Dyadem for Medical Devices

As a medical device manufacturer, you face tremendous challenges, including stringent regulations, competition, consumer advocate groups, product liability lawsuits and their implications. As a result, you must create safe, reliable, and cost-effective products. You also have to manage and reduce risk effectively throughout your product’s life cycle. In other words, you have to balance risk, cost and performance.

If you do not properly manage and reduce your risks, the results can be disastrous. For example, in the case of a defective heart valve, the marketplace quickly reacted to the news of the defect. When the valve was introduced in 1979, the annual net sales were 6,489. This rose to 20,719 in 1981. During this time period, there were 12 fractures reported to the FDA. By 1984, cumulative fractures reached 117 and the annual sales dropped to 8,472. When the large diameter valves were withdrawn from the market, the cumulative fractures had reached 159 and sales were 1,897. Although some of the lost market share can be attributed to the introduction of a competitor’s heart valve, nonetheless, it can be seen that the market did not react well to the news of the defect. There were also approximately 12,000 individual claims filed against the manufacturer for wrongful death and personal injury in a class action suit. Under the terms of the settlement, victims of heart valve fracture could receive between $500,000 and $2 million, depending on age, income and family status.

To reduce product failures and recalls, many manufacturing companies use the FMEA methodology. FMEA is a risk analysis technique used to improve the product and process designs. Although FMEA is primarily used for material and equipment failures, it can also include human errors, performance and software errors. Despite its use, maintaining quality in product design and production is a global problem, and product recalls are occurring every day. One reason for this problem is that many manufacturers view risk management as something that must be carried out to fulfill regulatory requirements and often carry it out on a pro forma basis. As a result of this attitude, many companies often do not perform their FMEA’s properly and they do not realize that the study was not comprehensive enough until it is too late. This realization often occurs as the result of an undesired incident that has financial and legal implications.

In the United States the quality management system requirements are covered under the Quality System (QS) regulation (Current Good Manufacturing Practice for Medical Devices, 21 CFR Parts 808, 812 and 820.) For the E.U., they are covered by Directive 93/42/EEC – Medical Device Directive. Risk analysis is one of the quality system requirements. The FDA has recommended Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis (FTA) and Hazard and Operability Analysis (HAZOP) as tools for conducting risk guidance. For guidance on risk analysis, the FDA refers to EN 1441 Medical Devices – Risk Management and ISO 14971 – Medical devices – Application of risk management to medical devices.

Under the Quality System regulations of the Federal Food, Drug and Cosmetic Act (FD&C Act), the FDA monitors manufacturing quality and labeling. If a firm does not recall a defective product, then the FDA can seek legal action under the FD&C Act. These actions include seizure of available product, and/or injunction of the firm, including a court request for recall of the product.

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