Group items tagged

Course "Effective and Efficient Internal and Supplier Quality System Auditing for Medical Devices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Do you want to understand how to do efficient and effective internal and supplier audits that meet all the requirements of your external auditors, but also add value to your company? Are you confused by all the requirements and guidance documents for medical device quality management systems and are tired of wading through all the regulatory language they contain. This course is for those who will do internal or supplier audits, manage an audit process for these or other company audits. This course will provide you with an easy to understand presentation on the auditing process as well as the requirements you will need to audit under ISO 13485 and the FDA Quality System Regulation (cGMP) Both FDA Quality System Regulation (QSR) and ISO 13485 require that companies do internal audits. However, because the FDA does not look at the content of internal audits, some companies do not get feedback on the true effectiveness of their internal audit system from the FDA during FDA Inspections. ISO 13485 auditors do look at internal audits, but are most concerned that you define a process that meets the requirements of the standard and are following your process. Both require that you define Auditor training is required, but this sometimes just requires reading the company's procedure, although most external auditors will look for more than this. Do you need to train new auditors for yours medical device quality management system or to audit your suppliers? Or do you need to improve the training of your internal and supplier auditors so that they add value to these audits? If you need to do either of these, this seminar will provide this training. In addition to auditing skills and hands-on auditing exercises, this seminar will provide an ove

Medical Informatics : Medical informatics is an area that is growing at a fervid pace. Its growth is not likely to get hindered or slow down in the near future, due to the surge in its use in the healthcare and IT industries. Medical Informatics is a relatively recent development in the field of healthcare. It is interwoven into the development and application of IT-based innovations in the healthcare industry. Medical informatics is often synonymously and loosely used with other related words such as clinical informatics, nursing informatics, healthcare informatics and so on. Its associations with related or similar disciplines notwithstanding, one can draw a fairly clear idea of medical informatics. It can be described as the application, adoption, design and development of IT into activities relating to the healthcare industry. What is the objective of medical informatics? Medical informatics seeks to enhance knowledge and innovate in the healthcare field by using IT and its applications. Towards this end, it uses and merges the principles, knowledge, data, application, and the tools needed for applying these in the process of decision-making. Who are involved in the use of medical informatics? Medical informatics is used by almost everyone in the healthcare industry. These include physicians, nurses, billers, coders, many others who provide healthcare, and medical librarians. In addition, there are specialists who are tasked purely with working with medical informatics, such as Data analysts Hospital record managers, and Programmers and analysts in the industry. The rise and rise of medical informatics: The birth and growth of medical informatics has been tied to those of the IT industry, the Internet in particular. In a sense, they are twins, having started and grown in almost a conjoined fashion. Its early development started in the 1960s, very nearly contemporaneous with that of the Net. While the medium that brought it into existenc

Medical Informatics is a story of phenomenal growth: Medical informatics is an area that is growing at a fervid pace. Its growth is not likely to get hindered or slow down in the near future, due to the surge in its use in the healthcare and IT industries. Medical Informatics is a relatively recent development in the field of healthcare. It is interwoven into the development and application of IT-based innovations in the healthcare industry. Medical informatics is often synonymously and loosely used with other related words such as clinical informatics, nursing informatics, healthcare informatics and so on. Its associations with related or similar disciplines notwithstanding, one can draw a fairly clear idea of medical informatics. It can be described as the application, adoption, design and development of IT into activities relating to the healthcare industry. What is the objective of medical informatics? Medical informatics seeks to enhance knowledge and innovate in the healthcare field by using IT and its applications. Towards this end, it uses and merges the principles, knowledge, data, application, and the tools needed for applying these in the process of decision-making. Who are involved in the use of medical informatics? Medical informatics is used by almost everyone in the healthcare industry. These include physicians, nurses, billers, coders, many others who provide healthcare, and medical librarians. In addition, there are specialists who are tasked purely with working with medical informatics, such as Data analysts Hospital record managers, and Programmers and analysts in the industry. The rise and rise of medical informatics The birth and growth of medical informatics has been tied to those of the IT industry, the Internet in particular. In a sense, they are twins, having started and grown in almost a conjoined fashion. Its early development started in the 1960s, very nearly contemporaneous with that of the Net. While the medium that brought

A gynecological device is a medical device that is used to promote female health or to protect and preserve reproductive health for females. This is a very broad category and includes products such as watches, calculators, bandages, and hygienic towels. While many of these products have been clinically tested and found to be safe for female health, there are still a few devices in the market that pose threats to female reproductive health. Gynecological devices usually fall into three categories: medical devices, biological safety devices, and mechanical devices. Medical devices are those that prevent the risk of injury or trauma to a woman's reproductive organs from medical interventions. Biologic safety devices are those that protect a female's health by promoting female reproductive health. Finally, mechanical devices are those that help maintain a woman's reproductive health and allow her to achieve or reach their desired fertility or pregnancy. The use of any of these unsupervised or unsafe medical procedures poses a risk to a woman's reproductive health and should be avoided at all costs. The main factors driving the growth of the gynecological devices market are the rapid increase of gynecological diseases such as uterine fibroids, endometriosis, and vaginitis and the introduction of new innovative gynecological devices in the market. For instance, according to the U.S. National Center for Biotechnology Information, approximately 97 per 1000 women suffer from gynecological diseases in the U.S., among which approximately 53 per 1000 women suffer from menstrual disorders. Rising awareness about gynecological health and preventive check-up to avoid sexually transmitted diseases (STD) is expected to boost the market growth. Moreover soaring numbers of surgical procedures such as female sterilization, endoscopy, laparoscopy, and ablation are driving the demand for gynecological devices. However strict regulatory orders by governmental bodies across the globe rel

Single-use medical device reprocessing refers to cleaning, disinfection, testing, sterilization, and remanufacturing of a used medical device to be put in service again. The reuse of single-use medical devices first began in the late 1970s. According to the Centers for Disease Control and Prevention (CDC), around 20 to 30% of the U.S. hospitals reported having reused at least one type of single-use device. The reuse of single-use devices involves ethical, regulatory, legal, medical, and economic issues, which have faced controversy in the last two decades. The reuse of single-use medical devices has increased typically due to the COVID-19 pandemic outbreak. In general, there are two categories of products that can be reused: active and inert. Active products are required for making new products, while inert products are used for making old products stronger, newer, longer-lasting, and more effective. The useful products that are generated are called inert products. These are products that have a certain amount of value because of their function. They are available in different forms like paper, paperboard, metals, plastic, etc. These products can either be reclaimed from the environment, or produced by industries and used for manufacturing purposes. The mobile devices that need to be recycled for single-use medical device reprocessing include diagnostic devices, sterilization equipment, biopsy instruments, blood glucose analyzers, blood pressure monitors, disposable gloves, medical imaging devices, and many more. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/single-use-medical-device-reprocessing.html

Course "Supplier Management for Medical Device Manufacturers" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment. How well do you understand the requirements for supplier management? Could you pass a regulatory audit or inspection without any issues? This course delivers the tools, templates, and methods to help participants implement an effective and efficient supplier management program. This two-day hands-on course provides a clear understanding of the underlying principles of supplier management. The course uses exercises to solidify understanding. In addition, the course uses FDA Warning Letters to illustrate the points and help you learn from others. As part of the practical implementation, the course includes receiving acceptance activities, outsourced processes, process validation at the suppliers' location, supplier auditing techniques, and supplier issues in management review. The course uses the Global Harmonization Task Force (GHTF) framework, but expands it to cover other issues and techniques important in effective implementation. Why should you attend: Since FDA regulations do not allow them to audit your suppliers unless they make finished medical devices, they require that you have sufficient control over them. But from time to time the FDA makes a reinterpretation of what this means. This happened within the last f 5 years, so if you supplier management program is older than that, you need to make major changes in you supp

Course "Texting and E-mail with Patients: Patient Requests and Complying with HIPAA " has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: With the recent advances in portable technology, more and more organizations and their users are taking advantage of mobile devices to save time and get work done more efficiently. Texting, portable e-mail, and Apps are revolutionizing the ways health care providers interact with their patients and get their work done. But the use of these devices comes with hidden costs of compliance, especially if they lead to a reportable breach under HIPAA or state laws. HIPAA Privacy and Security Officers have been struggling to keep up with the use of the devices to protect patient privacy and avoid compliance issues. Even if these devices aren't in formal use in your organization, you need to act now to anticipate their use and make sure they are used properly. This session is designed to provide intensive, two-day training in HIPAA compliance as it relates to the use of mobile devices, including how to use them with Protected Health Information, the policies and procedures you need to have in place to use them securely, and how to manage issues of the "BYOD" phenomenon. The session provides the background and details for any manager of health information privacy and security to know what issues to look for with mobile devices, what needs to be done for HIPAA compliance, and what can happen when compliance is not adequate. Audits and enforcement will be explained, as well as privacy and security breaches and how to prevent them. Numerous references and sample documents will be provided. The session will be valuable for both newcomers to HIPAA compliance as well as seasoned veterans. HIPAA compliance will be explained and discussed in detail, from the basics through the latest changes and new technology issues, so that the attendee will have a coherent u

Overview: With the recent advances in portable technology, more and more organizations and their users are taking advantage of mobile devices to save time and get work done more efficiently. Texting, portable e-mail, and Apps are revolutionizing the ways health care providers interact with their patients and get their work done. But the use of these devices comes with hidden costs of compliance, especially if they lead to a reportable breach under HIPAA or state laws. HIPAA Privacy and Security Officers have been struggling to keep up with the use of the devices to protect patient privacy and avoid compliance issues. Even if these devices aren't in formal use in your organization, you need to act now to anticipate their use and make sure they are used properly. This session is designed to provide intensive, two-day training in HIPAA compliance as it relates to the use of mobile devices, including how to use them with Protected Health Information, the policies and procedures you need to have in place to use them securely, and how to manage issues of the "BYOD" phenomenon. The session provides the background and details for any manager of health information privacy and security to know what issues to look for with mobile devices, what needs to be done for HIPAA compliance, and what can happen when compliance is not adequate. Audits and enforcement will be explained, as well as privacy and security breaches and how to prevent them. Numerous references and sample documents will be provided. The session will be valuable for both newcomers to HIPAA compliance as well as seasoned veterans. HIPAA compliance will be explained and discussed in detail, from the basics through the latest changes and new technology issues, so that the attendee will have a coherent understanding of not only the rules, but also how to think about compliance and make sound compliance decisions on a day-to-day basis in the context of mobile devices. Agenda Day One Day one sets the stage with an ov

Patient warming devices come in many forms, each designed for a specific purpose. For example, some devices are made for offices that are out of the way or for doctor offices that are smaller in size. In addition, these applications are very easy to operate and can be used without requiring a great deal of training on the part of the patient or the medical professional using the device. However, there are certain devices that are extremely efficient and are recommended by both practitioners and medical associations across the country. An increasing number of surgical procedures is expected to drive the growth of the global patient warming devices market. According to the National Health Statistics Reports, in 2017, around 48.3 million surgical and nonsurgical procedures were performed in the U.S. with around 25.7 million ambulatory surgery procedures being performed in hospitals, while 22.5 million being performed in ambulatory surgery centers (ASCs). Patient warming devices are widely used in surgical procedures, which cover before and after surgery. As a result of this, the demand for patient warming devices has increased significantly. Hence, these factors are expected to drive growth of the global patient warming devices market. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/02/patient-warming-devices-market-is.html

Medical sensors are becoming an integral part of medical facilities throughout the world. They enable facilities to monitor all aspects of patient care, from room temperature to vital signs, from pulse rates to oxygen levels, and more. This is a new frontier in patient care that has the potential to dramatically save money and reduce staff fatigue. A medical sensor system can include a variety of different instruments in various formats, ranging from a simple temperature probe attached to a belt clip to highly sophisticated electronic devices capable of monitoring dozens of different parameters. The most common type of medical sensor is a small portable electronic device that is affixed to a person's skin or clothes. These are designed for use in a wide variety of patient care settings including hospitals, rehabilitation centers, and home health care agencies. They are often used by cardiologists and nurses to monitor heart rates and pulse rates as well as measurements of blood pressure and respiration. Increasing demand for medical sensors is expected to propel growth of the global medical sensors market. For instance, 2020, OSI Systems, Inc. announced that its Optoelectronics division received an order to provide optical sensors for use in medical devices from a leading healthcare original equipment manufacturer. Moreover, high prevalence of chronic diseases is also expected to aid in growth of the market. Read more @ https://sachinbhombe.blogspot.com/2021/03/increasing-demand-for-medical-sensors.html

Medical devices play an important role in the delivery of many health care services. Medical supplies refer to any item (basic medical products) that is necessary for treating injury or illness. In the medical parlance, medical supplies generally are understood to mean items that are low cost, disposable, easily available, and in high enough quantity so that the buying department has enough standing orders to ensure the supply of the items when they are in demand. Increasing prevalence of chronic diseases across the globe, especially in North America, is expected to propel the growth of the medical supplies market. According to the Centers for Disease Control and Prevention (CDC), chronic diseases such as diabetes, cancer, and heart disease are the leading causes of death and disability in the United States. Moreover, proactive government initiatives, increasing demand for infection control measures to curb the occurrence of hospital-acquired infections, the rising number of surgical procedures, and increasing demand for medical supplies are expected to augment the growth of the medical supplies market. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/03/increasing-demand-for-emergency-medical.html

The term "portable diagnostic device" (or PDD for short) refers to a wide range of medical devices that are either made for external use (that can be used in the field) or for internal use in the doctor's office. They are designed to be used quickly and easily by any patient and also provides continuous and non-invasive monitoring of health parameters. Moreover, they also provide real-time information to a healthcare provider through connectivity. Growing advancement in the field of medical device such as smart wearable's and image-guided therapy systems is predominantly fueling the growth of the portable diagnostic device market. For instance, in January 2019, Royal Philips announced Azurion with FlexArm, to set a new standard for patient imaging and positioning flexibility for image-guided procedures. Rising awareness regarding the advantage of portable medical devices is again anticipated to foster market growth. Increasing the manufacturer's focus on the development of compact, wireless, and user-friendly is again projected to foster the growth of the portable diagnostic device market. Growing advancement in the field of embedded systems, sensors, and electronics is contributing to market growth over the forecast period. Also, the growing geriatric population is increasing the prevalence of chronic diseases such as diabetes and cancer which is again driving demand for portable diagnostic devices. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/01/are-smart-wearable-and-image-guided.html

Overview: This lesson will be going into great detail regarding you practice or business information technology and how it relates to the HIPAA Security Rule, in particular portable devices and personally owned devices. Areas covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT. I will uncover myths versus reality as it relates to this very enigmatic law based on over 600 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors. I will also speak to real life audits conducted by the Federal government (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you). In addition this course will cover the highest risk factors for being sued for wrongful disclosures of PHI and the manner in which patients are now using state laws to sue for wrongful disclosures.  Don't always believe what you read online about HIPAA, especially as it relates to encryption and IT, there are a lot of groups selling more than is necessarily required.  Why should you Attend: HIPAA NOW HAS TEETH! Be prepared for what's new in 2016! Protect your practice or business! What factors might spurn a HIPAA audit? …are you doing these things? Why are the Feds enforcing after all these years?  It is important to understand the new changes going on at Health and Human Services as it relates to enforcement of HIPAA for both covered entities and business associates as it relates to portable devices, texting, and emailing of PHI. You need to know how to avoid being low hanging in terms of audit risk as well as being sued by individuals who have had their PHI wrongfully discloses due to bad IT practices. I have also been expert witness on multiple court cases where a business or medical practice is being sued for not doing their due diligence to minimize risk.  Areas Covered in the Session: Update

Patient Lateral Transfer Devices (PLDs) have been a mainstay of patient care in the healthcare industry. In this new age of technology, devices are quickly replacing traditional medical procedures. These devices are changing the way we do things and the way we move from one location to another. The introduction of PLDs has brought along with the changes and advancements in how we transfer our patients from one floor of a hospital to another. As this transition continues to happen, more changes will come forth along with it. The number of people using and accessing these services has increased drastically and the number of people who use these services is expected to continue growing. It is projected that within the next two years, there will be a majority of individuals who use the services provided by patient lateral transfer devices to move from their beds to waiting areas of the hospital. Patient lateral transfer includes the clinical settings that involve transporting an injured or ill patient to a medical facility. It can also include transferring an individual from a medical facility to a hospital in another location for treatment. When the patient is moved, it could include transporting the patient to the operating room or to another treatment facility. These services are very popular and serve as a huge industry. There are several different reasons why individuals are enticed to become part of this segment. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2021/01/patient-lateral-transfer-devices.html

"Medical Devices Survey 2013-2014: Market Trends, Marketing Spend and Sales Strategies in the Global Medical Devices Industry" is a new report by canadean that analyzes how medical devices industry supplier companies' media spend, marketing and sales strategies and practices, and business planning are set to change in 2013-2014.

Course "Internal Auditing for the Medical Device Industry" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course provides an overview of internal auditing requirements and techniques for medical device companies as a method for risk management and quality improvement. The course will cover auditing requirements, audit planning, preparation, knowledge, auditor skills, interviews, documents and records review, objective evidence, audit report writing and corrective action. Why should you attend: Attendees should attend this seminar for risk management and improvement purposes to identify weaknesses, problems, compliance risks, and improvement opportunities. Who Will Benefit: * Quality Manager * Quality Associate * Quality Engineer * Quality Technician * Regulatory Associate Agenda: Day One Lecture 1: Overview of an auditing program, principles of quality management systems and how they related to auditing, benefits of auditing, and what is auditing. Lecture 2: Types of audits, auditor qualifications, ethics, responsibilities, audit phases, audit planning, and scheduling. Lecture 3: Conducting audits, interview techniques, objective evidence, data collection, tracing, use of checklists, and reviewing documents and records. Lecture 4: Conducting process audits, running closing meetings, audit report writing, corrective actions, and improvement Day Two Lecture 1: Overview to auditing to ISO 13485 and FDA QSR. Global differences which affect auditing approaches, auditing document control and record keeping, management responsibility, and resource management. Lecture 2: Auditing order handling, design control, purchasing, and supplier controls. Lecture 3: Auditing production, validation, and preservation. inspection and testing, control of test equipment, customer property, and sterilization Lecture 4: Auditing customer feedback, internal auditing programs, complaint

The term medical devices cover a wide range of medical equipment from common tongue depressors to highly sophisticated surgical and advanced diagnostic equipment that are used in various specialized medical disciplines. These different types of equipment are extensively used in various sized hospitals ranging from rural health clinics to multi-specialty hospitals providing tertiary patient care. Similar to medicines and medical technologies, the medical devices are also highly essential for maintaining proper patient care.

Surgical drain cleaning equipment plays an integral part in ensuring maximum productivity in the healthcare industry. These devices are meant to evacuate fluid and prevent the buildup of air at the surgical site. This is done with the use of vacuum or wall suction. Majority of these devices use negative pressure therapy to drain fluid from the surgical site. Demand for such medical devices has increased at a rapid pace due to their various advantages which make them highly useful. Increasing prevalence of chronic diseases such as cancer, cardiovascular disease, and kidney disease is expected to drive growth of the global surgical drainage devices market during the forecast period. According to the World Health Organization (WHO), in 2018, around 9.6 million deaths were attributed to cancer across the globe. According to the same source, around 70% of deaths from cancer occur in emerging economies. Moreover, according to the WHO, around 17.9 million people die from cardiovascular diseases each year globally. According to the same source, in 2010, around 2.3-3.7 million people were suffering from end-stage kidney disease. These above-mentioned diseases require significant surgical procedures and hence, it is boosting the demand for surgical drainage devices. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/surgical-drainage-devices-market-is.html

Enteral feeding devices technological advanced medical device used to deliver nutrition food directly to the stomach to the bedridden patient suffering from chronic diseases such as cancer and neurological disorder. The increase in the cases of malnutrition and premature birth cases around the globe is a prime factor driving growth of the enteral feeding devices market. Moreover, the growing prevalence of chronic diseases such as cancer and cardiovascular disease is another key factor fostering the market growth of the enteral feeding devices. According to the World Health Organization, cancer is the second leading cause of death globally and is responsible for an estimated 9.6 million deaths in 2018. Globally, about 1 in 6 deaths occur due to cancer. Around 70% of deaths from cancer occur in low- and middle-income countries. Furthermore, increasing global expenditure on the healthcare sector for improving the patient care is further projected to augment the growth of the enteral feeding devices market. From the geographical perspective, North America is projected to gain significant growth over the forecast period and this is attributed to the high presence of the geriatric population prone to chronic disease that leads to digestive ailments. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/enteral-feeding-devices-to-gain.html

Radiofrequency ablation is a relatively new method of reducing pain associated with back pain. In a recent review published by an organization that studies medical innovations, the Global Commission on Systemic Palliative Care (GCSPC) stated that the most common application for radiofrequency ablation is the treatment of pain in the spine, which has been used since the 1970s. There are many other applications, although these are two examples of the typical type of pain that this device is used to relieve. Rising prevalence of cancer is expected to drive growth of the global radiofrequency ablation device market during the forecast period. The number of cancer cases has increased over the years globally. According to the World Health Organization (WHO), in 2018, around 18.1 million new cases of cancer and 9.6 million deaths due to cancer were reported globally. According to the same source, around 70% of deaths from cancer occur in emerging economies with lung cancer accounting for the majority of deaths followed by breast cancer. Furthermore, according to the National Cancer Institute, in 2020, around 1,806,590 new cases of cancer are expected to be diagnosed in the U.S. with over 600,000 people dying from this disease. Such high incidence of cancer has led to increased demand for radiofrequency ablation devices. Hence, these factors are expected to drive growth global radiofrequency ablation device market during the forecast period. Furthermore, rising prevalence of cardiovascular disease combined with increasing number of ablation procedures is expected to boost the global radiofrequency ablation device market growth over the forecast period. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/radiofrequency-ablation-device-market.html