Dev Raheja
President | Patient System Safety
Dev Raheja, MS,CSP, author of the books Safer Hospital Care and Preventing Medical Device Recalls, is an international risk management, patient safety and quality assurance consultant for medical device, healthcare and aerospace industry for over 25 years. Prior to becoming a consultant in 1982 he worked at GE Healthcare as Supervisor of Quality Assurance/Manager of Manufacturing, and at Booz-Allen & Hamilton as Risk Management consultant for variety of systems. Currently he is an Adjunct Professor at the Florida Tech for its BBA degree in Healthcare Management and the online faculty at University of Maryland where he teaches courses on Reliability. He is a Founding Fellow of American College of Healthcare Trustees and a member of American College of Healthcare Executives, He is a former National Malcolm Baldrige Quality Award Examiner in the first batch of examiners.

He serves on the Patient and Families Advisory Council at Johns Hopkins Hospital. He helped them in providing 24/7 access to family members of patients and reduced the number of alarms for nurses so they recognize critical patient needs early.
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Recorded Webinar
Complying With Telemedicine Requirements
Laws governing telemedicine are enacted through state legislative action, with authority to implement the practice acts delegated to the respective state licensing board. The purpose of licensing health care professionals is to protect the public from unqualified practitioners. Practicing medicine requires a certificate of licensure from the state in which the practitioner is working and may require licensure in the state where the patient is located. Similar laws cover other practitioners such as physicians, nurses, pharmacists, therapists and other professionals dispensing health care services. Anyone starting a telemedicine service must be familiar with regulatory requirements, benefits, barriers, exceptions to licensure requirements.
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FMEA and Fault Tree Analysis for Preventing Hospital Risks
Before performing any healthcare act, it is important to understand and identify the possible risks. Once we understand and identify what the risks are, healthcare providers need to decide on their response to that risk and the different scenarios they may be faced with. This has to be done before any harm is done to patients. Two methods of doing this are the Failure Mode and Effects Analysis (FMEA) and Fault Tree Analysis (FTA). The FMEA is a preventative approach to measure and analyze the probability of error. The FTA is an analytical approach that shows the events that can lead to failure from unexpected life threatening scenarios. The FTA diagram appears as a tree, hence the "tree" analysis. It contains many different branches of causes and outcomes based on the scenario. Although both the methods provide information on the causes and effects harm, each analysis is done from different angles. Because healthcare organizations have been traditionally reactive rather than proactive, the Joint Commission began requiring use of FMEA as an accreditation standard in 2002. The purpose of FMEA is to deliver reliability of medical interventions for a standardized process while FTA focuses on delivering patient safety from unexpected mishaps.
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Software FMEA for Medical Devices
Software related device recalls are steadily going up for the last 10 years. The biggest reason is that missing and vague requirements in software specifications are responsible for at least 50% failures. Therefore risks are inherent in software design and development, even after so much attention paid to the design control process. You can identify more risks than you know if you use the Software Failure Mode and Effects Analysis (FMEA). This tool predicts many life cycle failures; assess risk of each failure, and helps design out risks by using the best practices in risk mitigation strategies. Understanding how mishaps can happen before they happen and preventing them by design is the key to efficient risk management.
Recorded Session Get life time access for one participant with download option!

Final Rules for Electronic Health Records Stage 3 Meaningful Use Update
Centers for Medicare and Medicaid Services (CMS) has issued the final rules for implementing Stage 3 "meaningful use" (MU) standards for the Electronic Health Record Incentive Program. This program adjusts payments to Medicare and Medicaid providers for implementing and "meaningfully using" (or not) interoperable electronic health records (EHR) systems. This means that doctors and hospitals will need to evaluate how to meet the tougher requirements but benefit from reduced requirements for certain standards.
Recorded Session Get life time access for one participant with download option!

Software FMEA for Medical Devices
Software related device recalls are steadily going up for the last 10 years. The biggest reason is that missing and vague requirements in software specifications are responsible for at least 50% failures. Therefore risks are inherent in software design and development, even after so much attention paid to the design control process. You can identify more risks than you know if you use the Software Failure Mode and Effects Analysis (FMEA). This tool predicts many life cycle failures; assess risk of each failure, and helps design out risks by using the best practices in risk mitigation strategies. Understanding how mishaps can happen before they happen and preventing them by design is the key to efficient risk management.
Recorded Session Get life time access for one participant with download option!

Design Reviews and Design Controls to meet FDA Requirements
This webinar is intended to assist manufacturers in understanding the intent of the design controls regulations. Design controls are based upon quality assurance and engineering principles. Managers, engineers and regulatory staff must work together to make the process efficient and flawless. This webinar is conducted by the risk management consultant who turned around a Midwest company from going out of business to becoming the world leader in quality and reliability.
Recorded Session Get life time access for one participant with download option!

Regulation of Health Care Services Delivered via Telehealth, Barriers and Exceptions
Laws governing telehealth are enacted through state legislative action, with authority to implement the practice acts delegated to the respective state licensing board. The purpose of licensing health care professionals is to protect the public from unqualified practitioners. Practicing medicine requires a certificate of licensure from the state in which the practitioner is working and may require licensure in the state where the patient is located. Similar laws cover other practitioners such as physicians, nurses, pharmacists, therapists and other professionals dispensing healthcare services. Anyone starting a telehealth service must be familiar with regulatory requirements, benefits, barriers, exceptions to licensure requirements.
Recorded Session Get life time access for one participant with download option!

Failure Mode and Effects Analysis for Design Excellence in Medical Devices
In this webinar "Failure Mode and Effects Analysis for Design Excellence in Medical Devices," attendees will learn how to design medical devices that enhance reliability, safety, durability and serviceability. They will also gain a thorough understanding of both the Design FMEA, and the Process FMEA.
Recorded Session Get life time access for one participant with download option!

Conducting Highly Effective FMEA to Address the Joint Commission Requirements
This webinar will cover the Failure Mode and Effects Analysis (FMEA) tool in details based on the presenter's experience of over 25 years with the tool in industries including nuclear and aerospace. Participants will be able to use this tool to not only comply with the Joint Commission requirements but also to prevent harm.
Recorded Session Get life time access for one participant with download option!

World Class Practices to Avoid Automobile Recalls
Over 48 million automobiles have been recalled in recent years involving the top companies including Toyota, GM, Honda and Ford. The problem is often the flawed production process requirements, flawed FRACAS (Failure Reporting and Corrective Action System), and lack of life cycle integration.
Recorded Session Get life time access for one participant with download option!

Software FMEA for Medical Devices
Software related device recalls are steadily going up for the last 10 years. The biggest reason is that missing and vague requirements in software specifications are responsible for at least 50% failures. Therefore risks are inherent in software design and development, even after so much attention paid to the design control process. You can identify more risks than you know if you use the Software Failure Mode and Effects Analysis (FMEA). This tool predicts many life cycle failures, assess risk of each failure, and helps design out risks by using the best practices in risk mitigation strategies. Understanding how mishaps can happen before they happen and preventing them by design is the key to efficient risk management.
Recorded Session Get life time access for one participant with download option!

Best Practices in Alarm Management
Hospitals rank alarm fatigue as top patient safety concern. There are even hospitals that logged more than 2.5 million patient monitoring alarms in just one month. When exposed to too many alarms, alarm fatigue develops. This situation can result in sensory overload, which may cause the person to become desensitized to the alarms. Consequently, the response to alarms may be delayed, or alarms may be missed altogether.
Recorded Session Get life time access for one participant with download option!

Software Reliability and Safety Fundamentals for Medical Devices
Software failures were behind 24 percent of all the medical device recalls in 2011, according to data from the FDA, which said it is gearing up its labs to spend more time analyzing the quality and security of software-based medical instruments and equipment. The FDA's Office of Science and Engineering Laboratories (OSEL) released the data in its 2011 Annual Report on June 15, amid reports of a compromise of a Web site used to distribute software updates for hospital respirators. According to the Agency, the absence of solid architecture and "principled engineering practices" in software development affects a wide range of medical devices, with potentially life-threatening consequences. Recent research done on the security of medical devices by a team of researchers would accept unsigned, counterfeit software updates.
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Designing for Safety to avoid Automobiles Recalls
Over 30 million automobiles have been recalled in recent years involving the top companies including Toyota, GM, Honda and Ford. The problem is often the flawed specifications, flawed production requirements, and lack of system integration.
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System Safety Principles and Practices
Mil-Std-882 is the primary standard for teaching system safety engineering and management. NASA and all DoD contractors are required to include this standard in the contracts.
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Design for Safety
Designing a system right depends on how early we perform the hazard analysis, which analysis tools we use, and understanding of the system of systems. Most aerospace contractors perform the hazard analysis too late and therefore have to depend on fixing one hazard at a time instead of fixing them before they cause the mishaps.
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Testing Medical Devices for Efficiency and Efficacy
Testing for safety, reliability, and durability are the most meaningful tests for adequacy of product, efficient performance (no down time, no recalls), and for the highest value (gaining more loyal customers). Unfortunately such knowledge is very thin in the literature. This webinar is based on consultant’s 30 years hands on experience with this knowledge.
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Software Process Verification and Validation
The FDA's analysis of 3140 medical device recalls reveals that 7.7% of them are attributable to software failures. Of those software related recalls, 79%) were caused by software defects that were introduced when changes were made to the software after its initial production and distribution. Software verification and validation practices discussed in this guidance are a principal means of avoiding such defects and resultant recalls.
Recorded Session Get life time access for one participant with download option!

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