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Solutions for many issues faced by medical device manufacturers could be well followed by other manufacturers. Many of these approaches could help with any product where quality is important, including most manufactured products.

At a recent meeting of Medical Device and Manufacturing (MD&M) in Minneapolis, there was considerable interest in the topics of:

• QMS (Quality Management System)
• Risk management
• Process mapping

ISO AND U.S. STANDARDS FOR QMS
Manufacturers of medical devices for use within the U.S. must have a QMS that complies with Federal Regulation 21CFR-820. Devices for use in most of the rest of the world must comply with ISO Standard 13485:2003. Both the Federal Regulation and the ISO Standard place a collaborative responsibility on demonstrating appropriate and adequate medical device cleaning as part of their risk management program and as part of the QMS.

The ISO and U.S. standards are complementary, not conflicting. There is a very large amount of overlap.1This means that a company can fairly easily develop a QMS to comply with both the ISO standard and the Federal regulation. The U.S. regulation is more specific or pointed in requiring the reporting to and communication with regulatory agencies. Figure 1 is a schematic of many of the elements that feed into a comprehensive QMS.

For complex devices where fabrication and assembly occur at two or more locations (sometimes in two or more companies), a greater emphasis on cleaning and contamination control and a greater transparency among companies will be called for. Achieving those two goals will require a paradigm shift.

THE BUCK STOPS HERE
Actually, the buck stops in several places. Both in the ISO standard and with the FDA, risk management has become important. Risk management programs require the input and buy-in of upper management. At the same time, risk management is not restricted to the final assembler of the device. There is the concept that all groups involved in device build and assembly be involved in risk management. Some companies involved at earlier stages of device manufacturing have become concerned about cleaning and contamination issues. Based on informal discussions with vendors in the device industry,²more of them operate on the assumption that the final assembler would do the bulk of the cleaning. As we have previously discussed,³ incompletely removed soils and residue from inappropriately performed early cleaning processes can cause severe contamination problems for the final assembly.

SECRECY
Historically, and perhaps understandably, the medical device industry has been exceedingly competition-sensitive. Manufacturers of sub-assemblies may be reluctant to share their processes with the final assemblers, their customers. In an atmosphere that emphasizes risk management, it would seem counterproductive for this situation to continue. In order to assess the potential impact of leachable residues, using the approach of ISO 10993-17,4the final assembler would need to understand the process chemicals, including metalworking fluids, rouges, blocking agents, and cleaning agents, as well as the processes. Having a sub-vendor/supplier assert that a certain total organic compound (TOC) or nonvolatile residue (NVR) level has been achieved might not be adequate.

RENEWED INTEREST, AGE-OLD QUESTIONS
How clean is clean enough? That is a question we again received in our MD&M session.3Answering this question through a risk assessment, such as described in ISO 10993-17, can be a key portion of a QMS designed to satisfy the ISO Standard 13485:2003 or the Federal Regulation 21CFR-820.

Designing a part to be easily cleaned can also make answering this question easier. The concept of Design for Manufacture (including cleaning) has been around for decades. A comment we received at the MD&M show indicated that the concept really has not been implemented by many medical device manufacturers; that it is still process-specific.

PROJECT MAPPING
One way to monitor cleaning processes and other manufacturing steps is by project mapping. This is a technique that has long been used in aerospace and automotive industries but which is frequently underutilized in building medical devices. Simple and complex flow charts, indicating each process step with decision points, can be an invaluable method for determining potential production bottlenecks and inefficiencies. They can also play a key role in documenting a quality system.

References:

1. J. Gagliardi and E. Kimmelman. “Building Compliant and Effective Quality Processes Using ISO 13485:2003/21CFR, Part 820/ISO 1469:200,” MD&M Minneapolis 2006, Session 202, Oct 25, 2006.
2. MD&M Minneapolis Exposition, Oct. 25-26, 2006.
3. B. Kanegsberg and E. Kanegsberg. “Critical Cleaning, Surface Attributes, and Contamination Control for Current and Future Medical Devices,” MD&M Minneapolis, Session 104, October 24, 2006.
4. B. Kanegsberg and E. Kanegsberg with D. Albert. “Toxicological Risk Assessment For Medical Devices-What is it?” Controlled Environments, October, 2005.

Barbara Kanegsberg and Ed Kanegsberg are independent consultants in critical and precision cleaning,surface preparation,and contamination control.They are the editors of Handbook for Critical Cleaning,CRC Press.Contact them at BFK Solutions LLC., 310-459 3614; info@bfksolutions.com; www.bfksolutions.com.