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Introduction to Updated IEC 62366 - Parts 1 & 2

In 2015, the International Electrotechnical Commission (IEC) is expected to release an updated version of IEC 62366:2007, Medical devices -- Application of usability engineering to medical devices. The updated version will have two parts. Part 1 will focus on medical device’s use-safety, describing usability engineering (aka human factors engineering) activities and end-products that will be the basis of future compliance assessments. Part 2 will have more of a tutorial nature, complementing Part 1 by describing best practices in the usability engineering of medical devices.
$135.00
$225.00
$225.00
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Machine Learning AI in Medical Devices

Adapting Regulatory Frameworks and Standards to Ensure Safety and Performance
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Medical Device Risk Management and Safety Assurance Cases

The FDA recently reported that class I recalls have increased from an average of 25 per year before 2008 to 50 in 2011 and 57 in 2012 (1). A class I recall is a situation in which there is a reasonable probability that use, or exposure to, a medical device will cause serious adverse health consequences or death. As the complexity and sophistication of medical technology and health care infrastructure continue to increase, assuring proper identification and adequate risk controls of these potential recall situations (i.e. hazardous situations) prior to the device being placed on the market is becoming more and more critical and challenging. How effective are the existing medical device risk management practices in assuring proper identification and controls of risks? Are there any gaps and opportunities? How can these gaps be addressed? What is FDA’s view on this issue?
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$199.00
$199.00
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Medical Device Symbols from ANSI/AAMI/ISO 15223-1:2016

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$690.00
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MP80601-2-49:2020 (IEC 80601-2-49:2020, MOD)

Medical electrical equipment—Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
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$228.00
$228.00
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Patient Safety: A Human Factors Approach

This in-depth practical publication covers a wide array of issues facing the human factors field and its importance for patient safety. Designed to provide advice for all levels of professionals in healthcare, the book includes the latest research with examples that connect theory to actual practice. The author, Sidney Dekker, presents information in easy-to-use bulleted lists and illustrations where possible. 261 pages.
$38.00
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$53.00

Personnel Safety in Sterile Processing Departments Video

This 60-minute instructional video provides information essential to the promotion of personnel safety in sterile processing departments.

Earn 1 credit hour CE through CBSPD and IAHCSMM.

The script was written by P. Richard Warburton, PhD, JD; CTO & General Counsel, ChemDAQ, Inc. It includes practical guidance on:
- Legal duties and who's who among the relevant regulatory agencies and professional organizations
- Common hazards encountered in the sterile processing department
- Bloodborne pathogens and infection prevention
- Proper selection, use, and disposal of personal protective equipment (PPE)
- Relevant standards that pertain to the use of PPE, steam and chemical sterilization, and ethylene oxide
- Safe storage, handling, and disposal of contaminated items and chemical agents
- Key elements of engineering controls that promote safe handling of sterilants and high-level disinfectants
- Appropriate labelling of chemicals
- Responsibilities of employers and staff in preventing, managing, and reporting accidents in the workplace
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$227.00

Risk and Reliability in Healthcare and Nuclear Power: Learning from Each Other (PDF Format)

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$60.00
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RTLS: Tracking Assets and Beyond

Real Time Location Systems have brought savings and efficiencies and are best known for tracking equipment and asset management. The systems now promote more efficient work and patient flow, enable nurse call and hand hygiene compliance, and monitor environmental conditions. As new applications are being developed, healthcare technology management (HTM) professionals play a key role in the assessment and selection of RTLS systems, and more departments and stakeholders looking to HTM to provide information and insights about the technologies.
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$85.00
$85.00
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Warnings and Safety Information in Device Labeling

While most companies would readily acknowledge the importance of identifying and clearly communicating the potential hazards associated with their devices, oftentimes they are perplexed about the best methods for accomplishing it. Unfortunately, there is a dearth of actionable resources on how to design and develop warnings and safety information that stakeholders can readily access. This two-part series will address this gap.
$135.00
$225.00
$225.00
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