Medical Device Standards Research Articles

050 Meeting medical device standards with a closed system cryogenic Vial for Cellular Therapy Products

The use of closed systems for low volume processing and storage of cell therapy products is necessary for good manufacturing practices (GMP), yet compliance with medical device regulatory test standards is lacking. A sterile closed system vial (CellSeal® cryogenic vial, Cook General BioTechnology, LLC, IN, USA) that meets pharmaceutical quality requirements was evaluated to determine if the vial also meets medical device standards for storage of cellular therapy products at cryogenic temperatures. The post-sterile stability and shelf-life of the device was evaluated by subjecting the device packaging to hazardous situations (manufacturing, transportation, distribution, and aging) typically undergone prior to usage. The packaging was exposed to simulated dynamic environmental conditioning, and separately to aging conditions equal to 36 real-time months. Subsequent to both dynamic environmental conditioning and aging, a series of product tests were completed to determine if the device maintained sterility and strength/integrity throughout the hazardous environments. Also, the device was evaluated to address necessary related and potential biological and toxicological hazards associated with the device intended use. Additionally, the loaded, sealed, and frozen device was tested for durability and integrity utilizing a 1-meter drop test. In addition, these were transported and tested using pharmaceutical packaging tests including dye ingress and microbial challenge. Further, human umbilical cord blood hematopoietic progenitor cells (UCB) from 3 donors were used to establish the performance of the vials after 1-month of storage. For each donor, a 30 ml concentrated UCB was prepared after adding 10% dimethyl sulfoxide as cryoprotectant. Next, 10 ml of this was cryopreserved using 2 × 5ml vials with the remaining 20 ml cryopreserved in standard FDA-cleared Pall® Medical cord blood freezing bags as a control. For both CellSeal vials and bags, an integral test segment was retained. All samples were analyzed for total nucleated cell count, colony-forming unit (CFU) assay and viability using 7-AAD. This study confirms that the CellSeal cryogenic vial meets medical device testing standards for low volume cryopreservation of clinical cell therapy products. Source of funding: Cook General BioTechnology, LLC, 1102 Indiana Avenue, Indianapolis, IN, USA Conflict of interest: None declared. evonne.fearnot@cookgbt.com

의료용 전기기기에 대한 국제표준 현황

Medical devices separated by a committee of the International Electrotechnical Commission IEC TC (Technical Committee) 62 medical electrical equipment being promoted by the International standards. Actually, a lot of standards were existed, but many national and international standards for medical devices were lacking in practical standards that can be applied to their development. Most international standards were focused in electrical and mechanical safety of medical devices. Therefore, there were few practical standards which contain essential performance evaluation. Although medical device regulations do not enforce a fixed lifecycle model, activities are presented in a sequential manner, thus hinting at a waterfall process. Meanwhile, for a decade or more, software teams have benefitted from agile development methods. Several medical device manufacturers have adopted agile practices while keeping development in compliance with regulations, but conflicts arise and decisions have to be taken in favor of agility or formality. However, if there are new practical standards of medical devices, it must be possible to promote the medical devices industry in their nation. To do this, there is a need to develop a new standard could apply to the international market through the analysis of the medical device related technology. Consequently, new standards such as NP (New proposal) or NWIP (New Work Item Proposal) should be developed through international standardization of medical device technology.

Medical device standards' requirements for traceability during the software development lifecycle and implementation of a traceability assessment model

Developing safety critical software is a complex process. Due to the fact that medical device software failure can lead to catastrophic consequences, numerous standards have been developed which govern software development in the medical device domain. Risk management has an important role in medical device software development as it is important to ensure that safe software is developed. Demonstrating traceability of requirements right throughout the medical device software development and maintenance lifecycles is an important part of demonstrating that ‘safe’ software has been produced through adopting defined processes. Consequently, medical device standards and guidelines emphasise the need for traceability.This paper outlines the extent and diversity of traceability requirements within medical device standards and guidelines, and identifies the requirements for traceability through each phase of the software development lifecycle. The paper also summarises the findings obtained when a lightweight assessment method (Med-Trace), which we created, based upon the traceability practices within these standards, was implemented in two SME organisations. Finally we highlight how the findings indicate a lack of guidance as to what is required when implementing and maintaining a traceability process.

Human Factors and IT Medical Device Standards at AAMI

Human Factors and IT Medical Device Standards at AAMI

‘An Obligation to Join Forces’

Editor's Note: Michele DeMeo wrote this letter for the AAMI/FDA International Conference on Medical Device Standards and Regulation, held March 21–22 in Reston, VA.Dear attendees,Good morning/afternoon and thank you for this opportunity and your time. My name is Michele DeMeo. I was a hospital manager, independent consultant, a committee member for several AAMI work groups, a member of AORN' sterile processing and materials management's specialty assembly, a SGE and committee member for the FDA, and a healthcare author and columnist and an approved IAHCSMM instructor, among other obligations until recently. My 20-year healthcare career has been stalled due to my terminal ALS health status.However, I heard of this summit and felt the need to reach out since I cannot join you. I am impressed by this joint meeting and effort. Our citizens deserve the very best care in the world, which means improving on good and even great; there is always room for improvement. We have an obligation to join forces and work with all critical stakeholders, including manufactures, hospitals and other healthcare providers, standard developers, and lawmakers. We owe this to not only consumers of care, but to those who provide care and those who support care providers, such as sterile processing technicians. One example would be appropriate cleaning, disinfection and sterilization instructions that are available, make sense, are easy to comply with in our healthcare facilities, and are understood by those selling the products to help reduce the spread of misinformation. That's one example out of many.This message is nothing new or else you would not be here, but I wanted you to know in the face of dying, I needed to use my energy that I do have left to voice just how important and time sensitive this topic is for all of us who make healthcare processing an imperative. Our issues related to what needs improvement are not insurmountable. I wish I could be here and be a part of your hard work. I will provide my information if any member here has any questions about our opportunities and areas for improvement. My email is mddemeo@yahoo.com. With every ounce I have left, I remain passionate for our mutual goals for this profession and related interdependences. I have full faith in you, my peers, that progress has begun and will remain moving forward because of your passion, commitment, and sheer talent. Thank you for your work. It is needed more than ever. I am proud you are here today and send my best wishes for a productive session!Thank you for ear and time.Respectfully,Michele DeMeo

Time for a New Standard In Developing Standards

No more than a decade ago, standards development was seen as important to the quality, safety, and effectiveness of medical devices, but it proceeded without much regulatory support. Today, medical device standards are the workhorse of the regulatory clearance process in the United States and, increasingly, abroad. The review process of the Center for Devices and Radiological Health (CDRH), part of the U.S. Food and Drug Administration (FDA), incorporates their use. The European model requires the use of standards to achieve harmonization, and most Asian regulators either require them by law or highly encourage their use. More recently, Brazil and other South American countries have joined the small world of medical device standards development.So with the growth in the industry, interest in new and revised standards, and improved development infrastructure (e.g., virtual meetings, virtual document development and editing, online balloting), why is it so hard to get the right people involved in the development process, why do standards take so to develop, and what would it take to turn it around?We need more users, clinicians, and academics involved in standards development. Regulators and manufacturers can write the standards, but it is still a wobbly stool that needs the input of users. If standards developers could find a way to support and/or reward the users, they may be more willing to participate. In some cases, the standards development organizations (SDOs) can support user participation through reimbursement of expenses such as travel. But what if we could offer something akin to continuing education credits (CEUs)? The FDA has long believed that participating in the standards development process is as good as continuing education. I don't know what this would take or if it is even feasible, but I know I have been asked about this more than once.Medical device standards cannot nor should not routinely follow a fast-track development model because of obvious risk and patient safety considerations. But the development process takes far longer than it needs to. In many cases, this contributes to development fatigue and impedes getting good, cross-cultural participation. Some of this can be due to ineffective committee leadership, but a reluctance to embrace new meeting technologies is also eating up valuable time. No technology will take the place of face-to-face meetings, nor should it, but medical device technology is changing faster than the standards process— meaning that these changes are necessary if we are going to remain relevant. Finding a balance between meeting around a table to discuss the important issues, and virtually meeting to edit documents and resolve comments is critical.Turning it around will take time, but the process has begun. While availability is spotty and acceptance is mixed, virtual meetings are gradually become the norm. The document collaboration tools should eventually become routine. But for these changes to work, the SDOs need to take a leadership role. We need to ensure the committees are staffed with and led by qualified and motivated people. When that is not the case, we need to make the necessary changes to improve productivity and, ultimately, the product.Last but not least, SDOs need to be the champions for the standards and not just the administrators. They need to invest in the infrastructure necessary to facilitate change and promote a true partnership with the liaisons who staff the committees and bring their expertise to the development of the product. Neither can be successful without the other!

第22回 AAMI/FDA 国際医療機器基準規制会議

第22回 AAMI/FDA 国際医療機器基準規制会議

A lightweight traceability assessment method for medical device software

SUMMARYTraceability is central to medical device software development and essential for regulatory approval. For compliance to be achieved, an effective traceability process needs to be in place. This process must ensure the need for clear linkages and traceability from software requirements – including risks – through the different stages of the software development and maintenance lifecycles. This is difficult to achieve because of the lack of specific guidance within the medical device standards and documentation. This has resulted in many medical device companies employing inefficient software traceability processes. In this paper, we outline the development and implementation of Med‐Trace, a lightweight software traceability process assessment and improvement method developed specifically for the medical device industry. We also present and discuss findings from two industry‐based Med‐Trace assessments. Copyright © 2011 John Wiley & Sons, Ltd.

Using 80001 to Manage Medical Devices on the IT Network

Healthcare technology today is considerably different than it was 20 to 40 years ago. Yet, much of what is done by healthcare technology managers in support of medical technology has not changed. The tools and procedures still used by most clinical engineering services have evolved little to address some of the unique challenges posed by new healthcare technologies that are at once more pervasive, more complex and more susceptible to failures that may have catastrophic consequences for patients and healthcare operations. Just how has the healthcare technology landscape changed?

21st AAMI/FDA International Conference of Medical Devices Standards Regulations

21st AAMI/FDA International Conference of Medical Devices Standards Regulations

Inside AAMI

Are you looking for an opportunity to interact with FDA officials and stay up-to-date on medical device standards and regulations? Mark your calendar. The 20th Annual AAMI/FDA 2010 International Conference on Medical Device Standards and Regulation, which will be held on March 9–10 in Reston, VA, just outside of Washington, D.C.The conference will provide detailed information about the latest standards and regulatory initiatives for both the United States and overseas; and offer attendees a unique opportunity to interact with FDA and standards committee authors and leaders.FDA officials often unveil the latest regulatory initiatives at the conference as well. The conference focuses not only on the latest U.S. regulations, but also international regulatory initiatives—which attracts attendees from around the world.For more information about the 2010 conference, including up-to-date speaker and topic information, visit www.aami.org/meetings/isc, or contact Chris Dinegar at (703) 525-4890, ext. 210, or e-mail cdinegar@aami.org.Applications are now being accepted for the AAMI Foundation's new Michael J. Miller Scholarship Program, which aims to provide scholarships to students pursuing careers in medical technology.Fundraising efforts also have ramped up with a goal of raising $500,000 to endow the scholarship program that was created last year to honor Michael J. Miller, AAMI's longtime president who retired in 2009 after 40 years of service.The program will award an annual $2,500 scholarship to a clinical engineering student and $2,500 to a biomedical equipment technician (BMET) student. A task force has developed eligibility requirements and set the scholarship limits based on the amount members determined could help make a difference in a recipient's life, says task force leader Marcy Petrini, PhD, professor at the University of Mississippi Medical Center. “There aren't a lot of opportunities for financial aid for needy students.”For more information on the requirements or to apply for the scholarship, visit www.aami.org/foundation/scholarship.To donate, send a tax-deductible contribution to AAMI Foundation, c/o The Michael J. Miller Scholarship Program, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201. Donations can also be made online at www.aami.org/foundation/scholarship.AAMI has joined three standards organizations to deliver unprecedented access to more than 2,000 standards and regulations through a convenient online clearinghouse.The Medical Device Standards Portal allows users online access to standards from AAMI, ASTM International, the American National Standards Institute (ANSI), and the German Institute for Standardization (DIN). This new portal also offers regulations from the U.S. Food and Drug Administration (FDA), and international standards and regulations from the International Electrotechnical Commission (IEC), International Organization for Standardization (ISO), and more.Currently, all of the documents in the portal are available in a PDF format that can be easily downloaded. By the end of the second quarter of 2010, it is anticipated that all of the documents also will be available in an HTML format, which provides greater functionality. Also, users will be able to add comments and attachments directly into the standards and share them with others. Users could also integrate company practices alongside the standards. The standards and regulations are updated throughout the year. The portal includes a red-line feature which outlines in red all of the changes that have been made to a standard or regulation.The portal is available for an annual subscription of $19,500 for a single site network, although the product can be customized for wide area networks. Some companies spend more than double that amount a year on standards.For more information about the Medical Device Standards Portal, visit www.medicaldevicestandards.com or call Jim Thomas at ASTM at 215-431-2411 or Mark Brown at ANSI at 212-642-4935.

Disinfectants in Australia

The use of disinfectants can be a controversial topic, particularly in healthcare settings. The TGA has regulated the higher risk products for healthcare applications since 1996, but the impact of this regulatory framework is largely unseen in what has become a relatively condensed and specialised market place. The APVMA regulates disinfectants and sanitisers and supervises critical use through AUSVETPLAN. The use of disinfectants in healthcare is completely user-dependent and the latest literature suggests that understanding the regulatory framework and the vulnerabilities of an intended application will assist in promoting appropriate hygiene standards for surfaces and medical devices (instruments).

Impacts of Wireless Power on Medical Device Design Safety

Wireless power holds great promise for solving many power distribution problems. Medical device designers will need to understand the impact of the electromagnetic coupling used for wireless power systems to design safe electromagnetic environments and safe medical devices. One question for designers will be whether or not current standards and requirements used for testing the electromagnetic compatibility (EMC) of medical devices and human exposure go far enough to insure safe environments and safe and reliable medical devices in the presence of wireless power. Electromagnetic energy can be transferred in three ways: through induction, radio frequency waves, or resonant evanescent coupling. Nonradiative inductive coupling uses the magnetic fields created when current is passed through one coil to create a current in a second coil that is located very near the first coil. These systems usually operate in the 50 KHz to 10 MHz range. Radio frequency energy can be transferred through radiating electromagnetic waves over great distances at frequencies from the upper KHz to many GHz. Most recently, work has been done on resonant evanescent coupling which transfers power between resonant objects over a distance of a couple of meters at frequencies from 1–10 MHz. Safety and reliability of medical devices is confirmed by testing EMC emissions and susceptibility to IEC60601-1-2 and supporting standards. For example, one of the supporting standards, CISPR 11 calls for measuring the electric field of radiated emissions over 30 MHz and the magnetic field below 30 MHz at distances of 3–10 meters. Many of the effects of wireless power systems are in the near field and are not covered in the current test standards. The AAMI PC69 series of standards have some near field requirements but these standards tend to be industry specific – such as drug pumps or pacemakers. EMC immunity standards used to test EMC susceptibility barely mention magnetic immunity. The only test for magnetic fields recommends testing fields at the power frequencies of 50 and 60 Hz. There are few standards detailing safe limits for human exposure to the near field effects of wireless power as well. Historically human exposure standards have been based on time average thermal effects on tissue and not medical devices. IEEE's C95.1b has requirements for specific absorption rate limits averaged over a 6 minute period. A pulsed wireless power system could meet these requirements and be safe for exposed tissue, but if a patient has an implanted device, or is wearing an external medical device, the pulsed EM energy could affect it during the pulse. The German BGV B11 standard lists human exposure limits for electric and magnetic fields based on a time average and limits exposure based on which portion of the body is exposed. However, it is meant as a workplace standard not a medical device standard. Currently the FDA does not require meeting either of these standards. It is necessary to determine the appropriate limits and tests to ensure that medical devices safely use wireless power and continue to operate safely in the presence of wireless power.

Standards for medical devices in MRI: Present and future

The purpose of this review is to define the current standards addressing safety of medical devices in MRI and to describe ongoing standards development efforts. The American Society for Testing and Materials (ASTM International) began developing standard test methods for determining the MR safety of medical devices in MRI in 1997. To date, five ASTM standards addressing testing and marking medical devices and other items for use in the MR environment have been published. International Standards Organization (ISO) 14630, the general requirements standard for nonactive surgical implants, is currently being revised to include information about MR safety of passive implants and to reference the ASTM standards. To address the unique safety issues of active implants, and in particular, active implants with leads, like pacemakers and neurostimulators, a joint working group between ISO TC150/SC6 on active implants and International Electrotechnical Commission (IEC) SC 62B MT40 on magnetic resonance equipment for medical diagnosis is working to develop a technical specification for active implantable medical devices (AIMDs) in MRI. While much progress has been made, work still needs to continue to develop a complete body of test methods to allow the evaluation of the safety of medical devices in the MR environment.

Standards for humidification and filtration devices.

This synopsis of the background to the standardization of medical devices allows a comparison of the functional operation of two regulatory authorities, the FDA and the European Commission. It can be seen that with time they have developed many common features. However, there remains a significant difference with the older style of regulation imposed by the FDA, in particular the obligation to comply with USA Federal Law and Federal Codes of Regulation. Further, the FDA expects manufacturers, when submitting medical devices for approval, to provide their own supportive evidence by showing compliance with ISO and IEC good manufacturing practice and safety standards. Finally, it is only pragmatic to accept that marketing permission for all devices is ultimately overseen, inspected and enforced solely by the FDA. By comparison, within Europe it is the more modern Medical Device Directives of the European Commission that are the statutory legislation. In order to market a medical device, the only fundamental responsibility of the manufacturer is that it must have a CE marking, which is achieved by showing compliance with the Essential Requirements. One means of accomplishing this is to conform with the provisions of relevant harmonized standards. Such concurrence may be verified if needed, by one of the international pool of independent Notified Bodies, who are ultimately overseen by the Competent Authorities of the individual States of the Community. The preparation of standards for medical devices is a slow process, involving the cooperation of the multiple stakeholders with an interest in the device. They are expected to produce a final document that is fair, consistent and practical for all the parties involved, from the initial designer to the final patient to whom the device is attached. Analysis of the three standards applicable to humidifiers, HME and BSF demonstrates some of the difficulties encountered in meeting these obligations. It is to be hoped that the solutions which were found achieve the ultimate goal of all medical device standards-specifically that the equipment should not cause a hazard to either the patient or user. But it is interesting to wonder whether it can be shown that any BSF meets one of the prime requirements of the FDA, to wit that all medical devices must be able to demonstrate efficacy. There is a dearth of clinical trials supporting the allegation of BSF manufacturers that the routine use of these devices improves patient care, which can only be taken to mean that to date such claims are difficult to vindicate. This paralogism must be countered by the indisputable fact that BSF can significantly increase the work of breath-ing, enlarge the deadspace and even, as has been shown recently, result ina complete blockage of the breathing system. Whatever standards are in place with reference to any particular medical device, it must never be forgotten that it is only the clinician who will finally be accountable for the safe and effective operation of the equipment. While caveat emptor must always be the shibboleth of the purchaser, statutory or advisory regulations are no defense for an incompetent user.

AAMI/FDA International Conference on Medical Devices Standards and Regulation

AAMI/FDA International Conference on Medical Devices Standards and Regulation

Readers' Round Table

To the Editor: A recent article, “In Vitro Cytotoxicity Of Traditional Versus Contemporary Dental Ceramics,” appeared in your journal. It was with great concern we read the conclusions of this article indicating that “Lithium-disilicate material exhibited cytotoxicity that would not be deemed biologically acceptable.” Please be assured that in our development of new materials and specifically with IPS Empress 2 as well, we evaluate and test our products to meet or exceed all biologic, physical, and clinical requirements for safety and effectiveness. IPS Empress 2 has been evaluated by independent toxicologic laboratories and has been in clinical trials for more than 6 years with no adverse effects. Furthermore, this product has received 510K clearance by the Food and Drug Administration and has been reviewed and accepted by numerous regulatory authorities around the globe without issue. Biologic acceptability is based on a series of evaluations of cellular and tissue response. Cytotoxicity is, on the other hand, recognized as a screening test and one of several steps to assess biologic compatibility. Cytotoxicity results will vary depending on cell culture, ratio, and specimen fabrication techniques. Therefore it is inappropriate to make a definitive conclusion on biocompatibility on the basis of a single screening evaluation. We reconfirm the biologic safety of IPS Empress 2 based on FDA, ISO and Medical Device Standards and strongly disagree with the conclusions of the authors.

Standards education in senior design courses.

Medical device standards provide many benefits to manufacturers and users of medical devices. Compliance with these standards is necessary to allow companies to market their devices. Standards contain requirements that affect the way medical devices are designed, developed, and tested. Students in biomedical engineering senior design courses need to be made aware of these standards and understand their impact on the design process for medical devices. They need to appreciate the value of considering them early in the design phase of a project. This article discusses how medical device standards education can be incorporated into senior design courses.

第13回年次AAMI-FDA医療機器国際基準規制会議 : 平成15年3月11日〜12日:ワシントンDCにおいて

第13回年次AAMI-FDA医療機器国際基準規制会議 : 平成15年3月11日〜12日:ワシントンDCにおいて

REAL WORLD EMI/RFI/ESD TESTING OF AN LVAD SYSTEM

PURPOSE: While designing new products, engineers look to standards to develop the envelope of the project. While these specifications help in determining design goals, the real world often has more strenuous requirements than any specification can foresee. METHODS: Evaluations were made of systems that a typical patient might encounter that emit EMI, RFI as well as ESD. The VAD system was exposed to these systems and the levels of EMI, RFI, and ESD were measured and the effects on the device analyzed. The system was exposed to the EMI/RFI of a fully responding fire station and the inside of an ambulance. The VAD system passed through different types of anti-theft systems, was exposed to household appliances and cellular telephone systems. Finally, the VAD systems received electrostatic shocks applied to various parts of the VAD system and were passed through current and next generation security systems as used in airports. RESULTS: Development of the MicroMed DeBakey VAD system began with close adherence to international specifications as well as systems that the patient might encounter in his/her everyday world. The MicroMed VAD system functioned properly throughout the testing performed. CONCLUSION: With the rise of complex electronic control systems for VAD products, close attention must be paid not only to medical device standards, but to devices and systems that a patient might encounter that were designed to different standards or to no standards at all. The design of a successful device requires that the control electronics be designed for these environments, rather than attempting to shield susceptible electronics from these EMI/RFI/ESD sources.