Change can bring either an opportunity or a setback, depending on how you handle it. This is true in life in general, but especially in regulated environments, where companies must contend with change constantly, such as evolving market conditions, stricter requirements, and tougher global competition. 

The principle of “change control” in ISO standards, GMP regulations, and CE Marking standards  is meant to help manufacturers ensure safe and high-quality products and services in spite of any changes in their product design, equipment, manufacturing materials, processes, computer systems, and all associated documentation. 

How does your company manage change in processes and materials? How does your change control system measure up to ISO, GMP, and CE Marking requirements? If your company belongs to the manufacturing industry, or if you are a supplier or a services provider for this industry, this white paper will help you understand critical elements of change control.

Download White Paper: Change Control – Continuous Quality Improvement in ISO Environments

White Paper Description
This white paper, “Change Control – Continuous Quality Improvement in FDA and ISO Environments,” discusses the following:

• The basis of FDA, CGMP, and ISO requirements for regulated companies, their CROs and suppliers
• Common challenges in implementing an effective change control process such as the following, and how to handle them
  • Poor Communication
  • Poor Turnaround
  • Ineffective Documentation
  • Training not Integrated with Change
• The advantages of automating the change control process

Watch Video Clip: Using MasterControl for FDA Compliance

In this short video, quality professionals from a general manufacturer, a provider of technical products and services, and a company that specializes in bioengineered therapeutics talk about how MasterControl has helped them in complying with ISO standards.

Many types of surgical implants and other medical devices are made of polymeric materials. A new ASTM standard covers the raw material properties for a high strength polymer used for surgical implants. 

ASTM F2820, Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications, has been developed by ASTM International Subcommittee F04.11 on Polymeric Materials, part of Committee F04 on Medical and Surgical Devices.

“Having ASTM F2820 available will make it easier to develop and obtain regulatory approval for new devices because the material requirements set forth in the standard were based on the properties of resins that have been proven to be biocompatible and have been used in successful long-term implantable devices,” says Jon Moseley, director of implant technology, Wright Medical Technology Inc., and chairman of F04.11.  

ASTM F2820 specifies allowable ranges for composition, mechanical and physical properties, as well as acceptable quality control practices, for PEKK polymers used in the manufacture of medical devices. Each of the factors covered by the standard is important in assuring that the materials used will perform as expected.

“This is of particular importance in permanent implant applications, where failure can lead to additional surgical procedures and potentially harm the patient,” says Moseley. “In addition, using materials that meet the requirements of ASTM F2820 can reduce or eliminate the need for animal testing for these materials.”

ASTM F2820 will be used by resin manufacturers for quality control and as a guide for developing master files, compilations of test data for use by device developers and regulatory agencies. The standard will be useful in the approval process for new devices, since both developers and agencies recognize the value of using standardized materials to help ensure the safety and efficacy of medical devices.

Interested parties are welcome to join in the standards developing activities of F04.11. In addition to the task group that developed ASTM F2820, other task groups are working on acrylics (for example, bone cement), absorbable polymers and ultra-high-molecular-weight-polyethylene. The subcommittee is particularly interested in participation from surgeons, since they are in the best position to provide feedback on the performance of devices fabricated from polymeric materials. 

To purchase ASTM standards, visit www.astm.org and search by the standard designation, or contact ASTM Customer Relations (phone: 877.909.ASTM; sales@astm.org).

Pioneer Surgical Technology Inc., a leader in innovative medical devices, announces its first clinical use of the Tritium Sternal Cable Plating (SCP) system for closing median sternotomies following an open-heart procedure.

The procedure was performed at St. Rose Dominican Hospital in Henderson, NV, by Dr. Robert Wiencek who notes, “The best part of the [Tritium SCP] system is that it takes the best of both worlds and puts it into one device.”

He continues, “Rather than relying on traditional cerclage cables or anterior plates alone, this new cable plating system provides the benefit of having both systems integrated into one simple technique. You can pull the cables tight, bring the sternum together, and then screw it all down. This eliminates micro-motion in the sternum and combines the best of both closure methods into this single device.”

The Tritium SCP system enhances the stability and strength of traditional sternal closure techniques by utilizing a unique load-sharing concept. The device incorporates the advantages of cerclage cables and cancellous screws, integrated with a low profile plate. “This unique combination creates a load-sharing design that uses cable tension to provide circumferential compression across the median sternotomy,” says Peter Didyk, director of sales and marketing, Pioneer Surgical. “The device complements our current Sternal Cable system by offering additional options to accommodate surgeon preferences and better address variances in patient anatomy.”

Pioneer Surgical received FDA clearance for the Tritium SCP system in October.

"Pioneer celebrated its 20th anniversary last year and this key product launch is a tremendous way to celebrate our past success and focus on our continued growth in and outside the United States,” states Shane Ray, executive vice president of surgical solutions and biologics, Pioneer Surgical Technology. “Within a year, our engineering, marketing, sales, and manufacturing teams took this idea from a napkin drawing to an FDA cleared product with many benefits. We are enthusiastic about our continued service to the Cardio Thoracic community, surgeons, and patients.”

The U.S. Food & Drug Administration (FDA) gave approval of the TriVascular Inc. Ovation Prime Abdominal Stent Graft System for the treatment of abdominal aortic aneurysms (AAA). Ovation Prime builds upon the strong clinical experience of TriVascular’s Ovation stent graft by improving delivery system attributes while further enhancing ease of use. Delivered through a 14 French (4.7mm) outer diameter catheter, Ovation Prime is the lowest profile commercially available system for endovascular aortic repair (EVAR). Ovation Prime utilizes innovative polymer-filled sealing ring technology and has the broadest indications for use (IFU) of any endovascular graft, thereby expanding the pool of patients eligible for EVAR.

“I was impressed by the Ovation Prime system,” comments Manish Mehta, MD, MPH, director of endovascular services, Vascular Institute for Health & Disease, Albany, NY, who performed the first U.S. implant of Ovation Prime. “We had a very favorable experience with Ovation in the clinical study and were excited to use Ovation Prime. The delivery system enhancements make Ovation even easier to use, while building upon the confidence that comes from the strong clinical data.”

Development of Ovation Prime was in close collaboration with a global network of endovascular specialists. The new delivery system is designed to simplify device preparation, enhance deliverability, increase visualization, and facilitate optimized orientation and cannulation, all while maintaining the excellent implant performance of Ovation.

The Ovation IDE pivotal study included 36 sites from the United States, Germany, and Chile, with a total of 161 patients treated. There were no device related major adverse events, no aneurysm ruptures, and no conversions from EVAR to open surgical repair reported in the study. An independent imaging core laboratory reported 0% type I and type III endoleaks and 0% migration. Nearly 40% of patients treated had complex anatomies, with proximal neck lengths shorter than 10 mm, distal access vessels smaller than 6 mm, or both. The method of vessel access was left to the discretion of the physician, with 43% of patients treated percutaneously. Worldwide, more than 1,300 patients have been treated with Ovation.

“Our central purpose is to help physicians improve the lives of patients suffering from aortic disease through excellence in research, manufacturing, and service,” states Christopher G. Chavez, chairman, CEO, and president, TriVascular, Inc. “We are pleased to have introduced Ovation Prime into Europe and now the United States. Ovation Prime is evidence of our commitment to listen to clinical feedback and provide innovative, timely, and relevant improvements that provide the best solution to physicians and their patients. We are very grateful to all of our clinical partners around the world whose commitment to patient care and innovation helped fuel this and other next generation products.”