Quality Digest’s picture

By: Quality Digest

Avoiding blood trauma is a concern when pumping cardiac patients’ blood during surgery. With this in mind, a medical-device manufacturer decided to reuse the flow-path geometry of an existing arterial filter that had been proven safe and effective in many patients. The problem was ensuring that the as-built arterial filter geometry truly matched the complex computer-aided design (CAD) model that the company planned to use as the starting point for the new design.Re-using geometry for a new filter
Veins carry blood from all organs of the body back to the heart. A number of conditions can occur as a result of localized inflammation and clotting of veins, particularly in the legs. Deep vein thrombosis is the term often used for a blood clot that develops in the deep veins of the legs. There’s some risk that a part of the clot will break loose and travel in the bloodstream to lodge in the lung, which is a condition known as a pulmonary embolus. The mainstay of treatment is anticoagulant therapy using prescription drugs, but in some circumstances a venous filter is inserted to prevent blood clots from reaching the lung.

William L. Roper’s default image

By: William L. Roper

A revolution is working its way through America’s health care systems. Like many great revolutions, it’s about empowerment and the creation of a new paradigm. It won’t happen overnight, but the forces at work are irresistible and will bring new hope and new responsibilities. The agent of change in this revolution is our long, national quest to improve the quality of health care. Its army comprises every consumer of health care—in other words, every single person reading this article, and every single person you see. Although not the ones making the diagnosis and holding the scalpel, you consumers will ultimately determine the quality of your health care. It’s time to understand the roots of this revolution, its progress and what it means for all of us.

Quality Digest’s picture

By: Quality Digest

ANSI/ASQ National Accreditation Board (ANAB) is developing an accreditation program for the recycling industry. The scheme, called the Recycling Industry Operations Standard (RIOS) is a comprehensive, integrated standard based on ISO 9001 and ISO 14001. It includes six components: general requirements, policy, planning, implementation, checking and corrective action, and management. It was developed by ANAB with the help of the Institute of Scrap Recycling Industries Inc., a trade group that represents more than 1,200 recycling-industry professionals.

“RIOS is expected to save recyclers time and money by improving product quality, reducing accidents and improving regulatory compliance,” says Robert H. King Jr., ANAB president. “Our accreditation program is intended to meet the needs of the recycling industry for an accredited certification program.”

The program will be available to registrars in the second quarter of 2006. The Institute of Scrap Recycling Industries Inc represents more than 1,200 companies that process, broker and consume scrap commodities such as metals, paper, plastics, glass, rubber, electronics and textiles. For more information, visit www.anab.org or www.isri.org.

Quality Digest’s picture

By: Quality Digest

ANSI/ASQ National Accreditation Board (ANAB) is developing an accreditation program for the recycling industry. The scheme, called the Recycling Industry Operations Standard (RIOS) is a comprehensive, integrated standard based on ISO 9001 and ISO 14001. It includes six components: general requirements, policy, planning, implementation, checking and corrective action, and management. It was developed by ANAB with the help of the Institute of Scrap Recycling Industries Inc., a trade group that represents more than 1,200 recycling-industry professionals.

“RIOS is expected to save recyclers time and money by improving product quality, reducing accidents and improving regulatory compliance,” says Robert H. King Jr., ANAB president. “Our accreditation program is intended to meet the needs of the recycling industry for an accredited certification program.”

The program will be available to registrars in the second quarter of 2006. The Institute of Scrap Recycling Industries Inc represents more than 1,200 companies that process, broker and consume scrap commodities such as metals, paper, plastics, glass, rubber, electronics and textiles. For more information, visit www.anab.org or www.isri.org.

Tim Postema’s default image

By: Tim Postema

The Dutch public health care system is being transformed in various ways. With an increasing focus on efficiency and consumer driven care, health institutions in The Netherlands are forced to critically evaluate their actions and processes. With recent political developments creating a more liberal health care system, the role of the patient is steadily changing to the one of a demanding consumer, taking more and more control of his or her own choice of care, all for the best price available. In that sense, health care services are forced to negotiate in a complex matrix of insurer, consumer and government, where good and structural quality of care plays a decisive role. But what exactly is quality of care? Who determines the value? Is it possible to create measurable attributes for quality of care?

The deliverance of accountable quality of care requires an operational and functional quality system. This system plays a key role in the evaluation and improvement (Deming’s plan-do-check-act) of process and outcome quality.

To gain an accurate insight in the different aspects of this system, the use of performance indicators can be a useful tool.

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By: Marlo Brooke

The groundswell of radio frequency identification devices (RFID) in health care may be clouded by the stomping of Wal-Mart, but the biotechnology and pharmaceutical industries are quietly becoming one of the top innovators and users of RFID, and they’ll likely outpace other market segments in the very near future. Stripped of its media hype, RFID is essentially a tracking device. One might wonder what the big deal is. With the never-ending effort of improving patient safety and cutting costs, health care is certainly well-aware of the need to track its every activity. In an industry mandated by federal, state, county and local regulations, tracking is nothing new.

And yet, RFID offers a powerful benefit over other tracking technologies such as bar coding or manual processes. RFID can automatically trace any medical device, pharmaceutical or patient over a given period of time.

Because RFID tags have reading and writing capability, as well as sensors, an RFID-equipped medicine or surgical instrument can indicate in real-time whether the item has been introduced to contaminants, when and where it has moved over time, and environmental conditions, such as temperature and humidity. As such, RFID enables what is called the four-dimensional supply chain.

Thomas Erbach, Lisa Fan and Shari Kraber’s default image

By: Thomas Erbach, Lisa Fan and Shari Kraber

Optimizing biological assay conditions is a demanding process that scientists face every day. The requirement is to develop high-quality, robust assays that work across a wide range of biological conditions. The demand is to do this within a short development time frame. To overcome these obstacles, automated systems are often required to accommodate large numbers of samples. Setting up a model that systematically studies key experimental parameters, each across a defined range, is a challenge. Traditionally, one-factor-at-a-time (OFAT) testing studies individual experimental conditions, but this approach is time-consuming and tedious. More important, measuring how the change of one single factor affects the assay leaves the experimenter blind to interactions that may exist between two or more experimental factors. The information lost in OFAT designs may significantly reduce assay quality and robustness.

Laura Smith’s picture

By: Laura Smith

In hopes of cutting administrative costs and streamlining the amount of time it takes to get new drugs to consumers, eight global pharmaceutical manufacturers have formed a coalition, SAFE-BioPharma, to support the widespread adoption of the new global digital identity standard, Secure Access for Everyone (SAFE).As the biopharmaceutical industry has become more automated, it’s also become more collaborative. Inter-agency relations are more important than ever, but automation makes maintaining such relationships a challenge. This situation creates the need for a standardized communications approach to e-signatures that is both secure and legally enforceable.

SAFE was introduced in June 2004 and includes policies, procedures, guidelines, technical specifications and a liability risk management framework for ensuring the validity and identity of authorized users. The network on which it operates was designed to assure member companies complete security while reducing the risks and costs associated with creating internal, legally enforceable digital signatures.

Tamar June’s picture

By: Tamar June

Companies struggling to comply with the FDA’s myriad electronic recordkeeping regulations should take a deep breath and follow it up with a long, careful look at the FDA’s actual GxP and 21 CFR Part 11 rules. After a careful reading of the admittedly long and sometimes dry rules, it should become clear that the agency is quite clear in what it expects from companies when it comes to the kind of records they need to keep and how long they should hold onto them.“The regulations are specific about record retention,” notes Keith Benze, a consultant and compliance expert with SEC Associates and a co-author of The ‘New’ Part 11 and Drug Development: A Q&A Reference Guide (Barnett International, 2004). The FDA focuses on maintaining records for a certain period of time after an event. “For example, one year past the expiration of date of drug products,” Benze adds.

In other cases, that period is usually a year or two after the last distribution of the product or approval for the IND.  For example, Part 11’s section 820.140 states, "All records required by this part shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than two years from the date of release for commercial distribution by the manufacturer."

BSI’s picture

By: BSI

More than a decade ago, Osteoimplant Technology Inc. provided the orthopedic prosthesis for a complete hip replacement for Mikhail Lavrovsky, one of the most famous lead dancers with the Bolshoi Ballet. He was able to dance with the replacement and continued to make appearances around the world. When Lavrovsky needed a new hip replacement in 2004, OTI was more than happy to donate everything that was needed for the operation to be a success. Ian Murray, CEO and chairman of OTI, smiles with pride when he recounts this story. It’s a reflection of the company’s commitment to the high standards in an industry in which perfection isn’t just a goal, it’s a daily requirement.

Mikhail Lavrovsky stated in his recent letter of thanks to the company: “Your great gift means life to me.” For those who require such complex and life-changing procedures, the last thing they want to worry about is the quality of the medical device being used. The implementation and rigorous assessment of internationally accepted standards are essential.

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