Compiled by Carrie Meadows

Static-dissipative binders for critical environments

Desco now offers its line of ESD three-ring binders with static-dissipative clear overlay pockets. Insert covers or documents in pockets on the front, back, and spine. Interior pockets allow additional storage for quick and easy access. Interior and exterior vinyl surfaces are static dissipative and are suitable for handling documents in ESD-protected areas; any charge will be removed when the binder is grounded. The format is 8 1/2

By George Miller

Construction subcontractors’ lack of awareness of their surroundings is perhaps one of the most frustrating issues, from a contamination control point of view, faced by health-care facility managers.

One example: “Information technology subcontractors will come in to string cable,” says Dennis Tremblay, senior scientist specializing in building and life safety issues at the environmental and engineering consultancy Environmental Health & Engineering (EH&E; Needham, MA). “They start lifting ceiling tiles without regard for containment of the site.”

Tremblay, who is also fire safety manager at Brigham & Women’s Hospital in Boston and a certified fire protection specialist, has penned the second release of the 2006 document Infection Control in the Healthcare Environment During Construction. In the document, he finds that it is possible to provide a “standardized and effective” infection control risk assessment (ICRA) program that causes a minimum of disruption in hospitals, which somehow always seem to be under construction. The key is a database that aids in program management by allowing all key personnel access to ICRA documents, and providing infection control training before contractors are allowed on site.

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Patient mortality could be reduced by 17 percent and reliability of care could improve by nearly 13 percent if the not-for-profit hospitals participating in a nationwide collaborative attained the project’s quality goals, according to a recently released analysis.

QUEST is a voluntary, three-year project with 166 not-for-profit hospitals across 31 states designed to improve hospital performance levels. Using benchmarked data from the Premier health-care alliance’s clinical database, Premier and the Institute for Healthcare Improvement (IHI) identified the main factors that lead to deaths, errors, and excessive costs.

The goals of QUEST are to improve the overall health of the patient population by reducing health-care acquired infections (HAIs), adverse events, and mortality; eliminating waste while ensuring appropriate care; and enhancing patient satisfaction with care.

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In findings recently published on the New England Journal of Medicine web site, researchers from the Centers for Disease Control and Prevention (CDC) confirmed the cause of serious adverse reactions reported in late 2007 were due to heparin contaminated with oversulfated chondroitin sulfate (OSCS). In the study, “Outbreak of Adverse Reactions Associated with Contaminated Heparin,” CDC identified 152 adverse reactions associated with heparin in 113 patients from Nov. 19, 2007 through Jan. 31, 2008.

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Medical device manufacturers can benefit from innovative surface analysis techniques to help them identify and quantify contaminants on devices, but only if they are willing and able to share information about what the device is made of, where it’s been, and what might be causing the contamination.

By Sarah Fister Gale

Surface contamination plagues manufacturers in every clean industry despite their best efforts to prevent equipment, air, and operators from collecting and distributing contaminants on delicate surface structures. Molecular-sized particles of organic and inorganic matter can wreak havoc in any clean industry

Know the impact of design specs and airflow patterns on your clean operations’ bottom line

By Raj Jaisinghani, Technovation Systems, Inc.

We are faced with a unique business climate in the design/build of cleanrooms and other facilities. There is a shortage of capital and a high incentive to reduce energy and other operating costs. This means that the cleanroom designer must accomplish high energy efficiency preferably without increasing initial costs

Productive cleaning validation relies upon knowing medical device requirements and clearly defining processes

By Barbara Kanegsberg and Ed Kanegsberg, BFK Solutions LLC

C leaning process validation is essential for the manufacture of many high-value products. The important steps in a cleaning validation program vary depending on the type of manufacturing as well as on the specific product under consideration. This article emphasizes considerations and principles that are important in medical device and other life-science area manufacturing processes; however, the approaches and principles can be used for many applications.

Why validate critical cleaning processes for medical devices?

In many cases, the initial response to this question is something akin to “well, we are required to.” The correct, critical cleaning processes are essential to achieving the appropriate surface quality, attributes, and levels of contamination for the particular needs of the product and application. Validating the critical cleaning processes used in fabricating implantable medical devices is an important factor in successful interaction with regulators and in achieving a high-quality, high-performing product.

It is important to define internal customers and external customers, as well as current and future customers. Who is your “audience”? Manufacturers have to demonstrate and document quality and consistency in terms of product performance and product safety. Increasingly they also must demonstrate environmental acceptability.

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Used equipment may be the answer in difficult financial times

By Ron Perry, RPA

In difficult financial times it can become even more challenging to fund capital expansions. Plant managers, financial officers, and procurement departments may need to look beyond new capital acquisitions and consider purchasing used equipment with their limited funds in order to fulfill anticipated production needs. This option becomes particularly attractive with late-model used equipment increasingly available as many high-tech companies cut back on production and look for ways to raise capital by liquidating assets that are under-utilized or no longer needed.

When deciding whether to purchase used vs. new equipment, there are three major factors of equipment ownership, all with pros and cons, associated with used capital equipment.

Price: The market for used capital equipment would probably be 50 to 85 percent of the original selling price depending on age, condition, performance, and appearance. However, high-tech, performance-based equipment can be very difficult to appraise for fair market value. Settling for lesser quality in appearance or performance, thinking the equipment can be enhanced or upgraded it once in an operator’s possession, can prove to be more costly than anticipated. Original manufacturers’ parts and service may increase the overall cost to a final price greater than what the same system would have cost if new, then or even now.

Delivery: Once located, used capital equipment should be immediately available, although sometimes the seller may prefer to continue to use the equipment for a specific product run or timeframe. Buyers should make sure availability and final condition of the equipment is fully defined. Bear in mind that disassembly, packing, moving, reassembly, and recommissioning can be delicate, complicated tasks. Original packing cartons and documentation may not always be available. Extensive damage can result if critical components are not adequately protected in transit and properly reassembled.

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