John Gagliardi

The global harmonization task force: what you need to know.

The Global Harmonization Task Force (GHTF) was founded in 1992 to respond to the growing need for international harmonization in the regulation of medical devices. With an increasingly global marketplace, national regulations and guidelines are often not enough to ensure patient safety and access to safe, effective, and clinically beneficial medical technologies around the world. The GHTF comprises a voluntary group of representatives from regulatory authorities and regulated industries. There are five founding members grouped into three geographical areas: Europe, Asia-Pacific, and North America. These three areas each have their own infrastructure for regulating medical devices. Because of this autonomy, the harmonization efforts of the GHTF over the years have benefited from the natural checks and balances system that can only strengthen a unified approach. In 2006, the member groups expanded to include three liaison body members: the Asian Harmonization Working Party (AHWP), the International Organization for Standardization (ISO), and the International Electrotechnical Commission (IEC).

Medical Equipment Management

A computer-implemented method for managing medical equipment is described that includes providing a medical equipment management software application. The method includes presenting, at an output device of a computing device, an user interface configured to capture user inputs, receiving inspection account information via the one or more user inputs, receiving a location of the computing device, providing, at the output device, identification information for at least one item of medical equipment that is associated with the inspection account information, receiving status information for the at least one item of medical equipment, and updating previously stored status information for the at least one item of medical equipment with the received status information and the location of the computing device. The status information may include inspection information and the location of the computing device may be a location of a mobile device associated with an equipment inspector during an equipment inspection.

Preamble to Quality System Regulation Serves as Valuable Compliance Tool

When is a preamble to a federal regulation worth reading? When it provides understandable guidance and practical advice on how to adhere to the regulation itself. That’s the case with the preamble to Title 21 Part 820 of the Code of Federal Regulations. Commonly called 21 CFR Part 820 or the QS (quality system) regulation in our industry, this regulation covers, among other thing, quality management and organization, medical device design, buildings, equipment, purchase and handling of components, production and process controls, packaging and labeling control, device evaluation, distribution, installation, complaint handling, servicing, and records. The preamble to that regulation—running some 43 pages in the Federal Register—is invaluable, both as a teaching tool and a roadmap of sorts for how to handle U.S. Food and Drug Administration (FDA) inspections, and third-party audits of contract and medical device manufacturers. Before I teach, conduct an audit, or embark on another FDA inspection, I pull out my dog-eared copy of this document and refresh my knowledge with this valuable insight into the meaning and intent of the QS regulation. The preamble is the mainstay in my permanent traveling files—on my “must-read” list at thirty-five thousand feet. Preambles are the notes that FDA publishes when it announces a proposed or final rule. They include comments submitted by industry and the public and the FDA response. As such, preambles often reveal the intent and FDA’s interpretation of a regulation. With the preamble to the QS regulation, these comments from the FDA have, over the years, become informal policy and are commonly referred to when, for example, establishing a regulatory position, defending an FDA inspection point, or training medical device professionals to the nuances of the regulation. Basically, the comments have been timeless. This is the “in-between-the-lines” information that supports and, in many cases, drives the regulatory verbiage. (Occasionally, FDA’s thinking has evolved. An example is comment #85 on page 52621 which states, Preamble to Quality System Regulation Serves as Valuable Compliance Tool

A Systems-Oriented Approach to Auditing the Design Controls Process: Part 2

Design Validation Auditors should confirm that the procedures in place controlling design validation are linked with design verification activities from a standpoint of assuring the success of this testing phase versus the essential requirements and acceptance criteria. Failing to assure that this objective evidence is in place can create a major void in the audit plan and the ultimate credibility of the design validation and ensuing data. This particular part of the total design controls process is linked strongly with production of product for use during this validation. Design validation shall ensure that devices conform to defined user needs and intended uses, and shall include testing of production units or their equivalent under actual or simulated use conditions. This rationale for design validation is not only auditable, but sets the stage for a linkage with process validation, ongoing confirmation of acceptable acceptance activities during manufacturing, and a defined basis for establishing the device master record. Design validation also includes software validation and risk analysis as part of the audit planning stage. The actual validation project is commonly protocol-driven and reports are summarily generated. For examples of auditable points during the design validation process, see Figure 1. Design Changes The details of the change-control system are left to the manufacturer to develop, document, and implement. As the design activity progresses toward the final stage, it is expected that the degree of change-control will increase. This is a fact that each audit checklist at every design phase needs to include to assure that changes made during the design control process are controlled and documented. The objective evidence will eventually be located in the design history file (DHF) and must have traceability not only to the change, but also to the ramifications of this change during design and, subsequently, in the quality management system. Because these following elements are under change-control, auditing the effects of the changes A Systems-Oriented Approach to Auditing the Design Controls Process: Part 2