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Health Sciences Thought Leadership
Healthcare systems around the world are about as diverse as the people who rely on them for accurate diagnosis and effective treatment. Through the following white papers, articles and updates, UL regulatory, clinical and engineering experts help keep you informed on a wide range of topics that impact your ability to innovate, deliver and receive safe healthcare
Physical and Chemical Characterization: The First Stage in Assessing the Biocompatibility of Medical Device Materials- NEW!
From programmable pacemakers and laser surgical devices to inactive medical devices such as intraocular lenses, resorbable bone screws or intravascular catheters, today’s state-of-the-art medical devices are a vital tool in the diagnosis and treatment of diseases and illnesses. Despite their numerous benefits, however, all medical devices present some degree of risk to a patient, even when used appropriately. For this reason, a risk assessment of any medical device must include an evaluation of the inherent safety of a device and its components.
A particular safety concern associated with the use of medical devices is the risk presented by simple contact with the human body. Even when used as designed, medical devices and their constituent materials may have the potential to produce unintended local or systemic effects. Depending on the duration of contact, some materials may also be harmful or toxic to the body, or may have adverse developmental or reproductive effects. Further, processes such as manufacturing, packaging, shipping and routine sterilization may adversely affect a material’s composition, rendering an otherwise safe device potentially harmful.
Biocompatibility testing represents a series of staged assessments to determine the potential harmful effects that can result from human contact with a medical device or component, and is an essential aspect of the overall product safety assessment required for global regulatory approval. The physical and chemical characterization of materials is the first stage of biocompatibility testing, and involves the analysis of substances that can potentially leach from a medical device during normal, anticipated use. When conducted in advance of other biocompatibility testing, material characterization testing may reduce overall testing time and speed regulatory approval.
This UL white paper discusses the physical and chemical characterization of medical device materials in the context of an overall biocompatibility assessment. Beginning with background information on biocompatibility issues associated with medical devices, the white paper reviews specific physical and chemical effects and the testing specified under ISO 10993-18 dealing with the chemical characterization of materials. The white paper then outlines a structured approach to the development of an effective material equivalency program to speed material selection, and concludes with a discussion of the benefits of maintaining such a program throughout a product’s development and production cycle.
 Click here to download the full technical white paper.
UL 2560 and Emergency Call Systems: Expanding the Standards Framework- NEW!
Emergency call systems have been used for years in assisted living and long-term care facilities to provide a vital communications link between residents and healthcare professionals. Emergency call systems used in non-acute care settings must have unique characteristics for use in their intended operating environment. Confusion exists among manufacturers and healthcare providers about the distinct requirements that are applicable to call systems operating in various environments, and specifically to those requirements that apply to emergency call systems. This confusion can potentially put patients at risk.
This UL white paper provides an overview of the safety standards applicable to call systems and discusses the requirements of UL 2560, the Standard for Safety of Emergency Call Systems for Assisted Living and Independent Living Facilities. The paper begins with a summary of the various types of call systems based on their respective use environments and offers a brief history of the origins of UL 2560. The white paper then outlines the key requirements of UL 2560, and delineates the differences between UL 2560 and UL 1069, the Standard for Safety of Hospital Signaling and Nurse Call Equipment. The paper concludes with a discussion of the advantages of obtaining system certification.
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Safety of Personal Hygiene & Beauty Therapy Equipment used in Commercial Settings- NEW!
In a society that emphasizes a healthy and attractive personal appearance, manufacturers and service providers are offering consumers an ever-widening array of products and services designed to maintain and enhance their physical appearance and overall well-being. One aspect of that trend is the growth in the number and type of electrical grooming, personal hygiene and beauty therapy devices available for use in both commercial settings and in homes. Currently available standards address safety concerns related to the use of many personal grooming appliances in commercial establishments. However, standards covering certain types equipment address their use only in a home environment. This UL white paper discusses the safety issues related to the use of personal hygiene and beauty therapy equipment in commercial settings. The paper then reviews current standards covering this class of equipment and the usage considerations addressed in these standards. The white paper will conclude with suggestions for manufacturers on actions that can mitigate the potential safety risks associated with the inappropriate use of personal hygiene and beauty therapy equipment.
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510(k) Accredited Persons Program
This article, written by Chantel Carson, Lead Engineering Instructor, UL Knowledge Services is reprinted from the April 2010 issue of Regulatory Focus with the permission of the Regulatory Affairs Professionals Society (RAPS). The article, "510(k) Accredited Persons Program, The Case for Third Parties" is focused on helping medical institutions provide quality patient care is the top priority for medical device manufacturers, making it critical for them to get products to market quickly. In recent years the US has made strides in simplifying and accelerating FDA clearance of premarket notifications, or 510(k) submissions.
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Home Healthcare Equipment: An Overview
The market for home healthcare equipment is expected to grow exponentially in the coming years, as the delivery of healthcare services shifts from clinical settings to the home. But manufacturers face a series of unique challenges in supplying home healthcare equipment that is both effective and safe. This white paper takes a look at the current and anticipated regulatory landscape for home healthcare equipment, and provides a brief look at what to expect in the future.
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A Review of Market Entry Requirements for Risk Management, with Special Emphasis on FDA and ISO 14971 Compliance
Many medical devices can carry a significant amount of risk, especially those used on particularly ill patients or those devices that are intended to be life sustaining or life supporting. The formal requirements for risk management and enforcement of risk management vary depending on where the device will be sold and used. In a two-part series, UL explores the market entry requirements for risk management with a special emphasis on FDA and ISO 14971 compliance. Parts 1 and 2.
Click here to download Part 1 of this industry report.
Click here to download Part 2 of this industry report.
Major Regulatory Decisions on the Third Edition of IEC 60601-1
New technology is entering the market at a faster pace than ever before. Medical device technology is no exception. Like consumer electronics and other technologies that enter the consumer market, there is a need to get safe medical devices to market faster. Standards have kept up with the globalization of medical devices, such that many of the recognized standards for medical devices are internationally harmonized, with national deviations as needed for local language and power grid requirements. Where there have been challenges is in providing flexibility for the introduction of new technologies to the market.
Click here to download the full industry report.
A Review of Market Entry Requirements for Risk Management, with Special Emphasis on FDA and ISO 14971 Compliance
Many medical devices can carry a significant amount of risk, especially those used on particularly ill patients or those devices that are intended to be life sustaining or life supporting. The formal requirements for risk management and enforcement of risk management vary depending on where the device will be sold and used. In a two-part series, UL explores the market entry requirements for risk management with a special emphasis on FDA and ISO 14971 compliance. Parts 1 and 2.
Click here to download Part 1 of this industry report.
Click here to download Part 2 of this industry report.
Medical Device Approvals in Brazil: A Review and Update- NEW!
This UL white paper reviews Brazil’s current regulatory framework for medical devices, and the requirements for those entities seeking to manufacture, import or sell medical devices in the country. It also discusses the registration and certification process required of all device manufacturers, importers and distributors, and the steps necessary to secure and maintain approval for medical devices. This white paper includes information on requirements found in RDC 27/IN-3 and Resolution 350, published by Brazilian regulatory authorities in June 2011.
Click here to download the full technical white paper.
Choices – IEC 60601-1 3rd Edition and Component Selection
When the 3rd edition of IEC 60601-1 was published, it marked the beginning of a new era. The standard now incorporates the concept and application of risk management in the design and production of devices. Implementation of risk management has implications for not only the end-product manufacturer, but component providers as well, and further cascades through the entire supply chain. All parties now face a series of choices and opportunities in determining how best to ensure, for the entire lifetime of a device, that basic safety and essential performance are preserved. This article explores some of those choices and their consequences.
Click here to download the full technical white paper.
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