Regulatory Professionals Need Better Understanding of Medical Device Validation

Posted 16 April 2015 | By Zachary Brousseau 

Regulatory Professionals Need Better Understanding of Medical Device Validation

In RAPS’ new Medical Device Validation Handbook, edited by Max Sherman, regulatory and quality professionals, and others involved in device compliance, will find a resource for tackling one of the most common issues leading to warnings from the US Food and Drug Administration (FDA). Sherman says he hopes the book fills a void for those who have been waiting for a comprehensive resource on validation. “People need a greater understanding of what validation consists of, as well as the process of validation itself,” says Sherman. “I fortunately found authors who could make this a how-to book.”

What Is Validation?

FDA provides several different definitions. In the book’s introduction, Sherman writes that the broad definitions in 21 CFR 820 may be contributing to the problem of inadequate validation. The regulation defines process and design validation separately. “Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications,” and “design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s).” Both of these lack specificity, says Sherman. Adding to the confusion, FDA uses yet another definition in its 2011 Guidance for Industry: Process Validation: General Principles and Practices.

Validation vs. Verification

Validation is closely associated with the related concept of verification, but it is important to understand the difference, says Sherman. Verification involves ensuring each element of a device meets the appropriate specifications and standards, while validation is concerned with the end product. Sherman offers two analogies to help illustrate the point. “Verification always comes first,” he says, just as the ingredients and recipe come before preparing a meal, or building materials and their specifications come before building a house. Validation in terms of cooking, would be evaluating how the meal tastes. In building, it would be determining whether the house meets the residents’ needs.

Validation and the Role of the Regulatory Professional

In most companies, the team responsible for validation usually is headed up by someone in quality, such as a validation or software validation engineer, but typically, there are multiple parties involved from different departments. “Most companies have a number of disciplines reviewing the validation protocol,” says Sherman, and these should always include someone in regulatory. Regulatory personnel also are responsible for addressing 483s or Warning Letters that include validation deficiencies.

A Common Problem

In the Validation Handbook, Sherman writes that inadequate process validation was cited by FDA more than 600 times in 2013, but difficulty complying with FDA’s validation rules stretches back years. “There was a lack of training on validation early on,” says Sherman, “but even years later, there still is no straightforward guidance from the agency on how to do a process validation.” Validation can be confusing, he says. “It has a language all its own.”

Small companies are particularly challenged as they have fewer resources, and often use contract manufacturers that also must have properly validated processes. The Validation Handbook may be especially valuable to professionals in these smaller companies.

Pitfalls and Challenges

Today’s more sophisticated medical devices that use software to function require an entirely different type of validation than more traditional devices. “Any device with software is particularly vulnerable,” says Sherman, who adds that Internet-connected devices also can be subject to hacking. “There is a great need for software validation engineers,” he says, and the growing need to validate these types of devices is the reason there is an entire chapter devoted to software validation in the book.

It is critical to validate devices that carry the threat of injury or death if they were to malfunction, such as those used in surgery. “Any high risk device is a validation challenge,” says Sherman. In a recent example of a validation failure, duodenoscopes that were not properly cleaned resulted in the spread of deadly bacteria to multiple surgery patients, seven of whom died.

Who is the Validation Handbook for?

The Validation Handbook is intended for anybody who works in manufacturing, engineers, people involved in sterilization, and regulatory and quality personnel. Sherman says anyone in these fields, regardless of experience level, can and should learn more about validation. The book compiles information not available in one place from any other source, and includes several chapters Sherman says he hasn’t seen in any other book in his 40 years in regulatory. It also is well suited to be used as a textbook for a validation course.

The Medical Device Validation Handbook is available from the RAPS Store in print and e-book formats, or both versions can be purchased together in a discounted bundle

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