Medical Device Recalls – How to Handle in a Compliant, Diligent Manner

How to link these processes link to other parts of your Quality Management System. We’ll cover best practices so you can be prepared for a possible post-recall FDA inspection.

A Medical Device Recall (MDR) can be a handful to deal with. It not only indicates that the device has a quality issue; failing to address an MDR rightly can lead to loss of reputation, not to speak of regulatory penal actions from the FDA. It is up to the company whose device has been recalled, to take prompt, prescribed action. Its actions should be proportionate to the level of risk the faulty device poses.

An MDR should be planned well in advance, for it is not something that a medical device can handle hastily, in a piecemeal fashion. The ways by which to prepare for an MDR is thus a matter of crucial importance. GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance, will offer this valuable learning at a six-hour webinar it is organizing on October 28.

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Susanne Manz, an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma, will be the speaker at this session. To enroll for this webinar, please visit https://www.globalcompliancepanel.com/virtual-seminar/6-hour-virtual-seminar-on-medical-device-recalls—how-to-handle-in-a-compliant,-diligent-manner-10304LIVE

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Even a high degree of preparation by a medical device company cannot completely rule out quality issues that result in a recall. There is no substitute for preparation. The objective of this webinar is to offer learning to its participants on how to prepare for an MDR. Susanne will explain how to decipher signals that could trigger a recall. She will also explain how to face the investigation and what actions are required, what corrective and preventive actions need to be taken, and how to send out notifications to customers and the regulatory bodies.

The expert will give a thorough understanding of the regulatory requirements for dealing with an MDR. She will help understand FDA expectations and regulations, and what to understand and learn from 483s and Warning Letters. The ways of putting robust processes, the basis to efficiently and effectively managing failure investigations, will be explained.

This webinar will also give a proper understanding of recalls, and explain the appropriate corrective and preventive actions that need to be taken. The ways in which these processes link to other aspects of the Quality Management System will be explained. It will give an idea of the best practices for making an MDR efficient. This will help participants prepare for a possible post-recall FDA inspection.

This webinar will have the following agenda:

  • Regulatory Expectations
  • Medical device authority and guidance
  • Complaint Handling, Medical Device Reporting, and Recall requirements
  • Recall Types and Classifications
  • Failure Investigation
  • Difference between a product enhancement and a recall
  • Roles and responsibilities
  • Non-conforming material control
  • Recall strategy and FDA notification
  • Required Communications
  • Firm’s MDR reporting and FDA’s handling of MDRs
  • Lessons learned and enforcement case studies
  • Processes and Procedures
  • Linkages between Complaint Handling, MDRs, Recalls, and CAPA
  • Corrective and Preventive Action
  • Minimize your risk of regulatory actions
  • FDA’s new guidance on risk
  • Preparing for an FDA Inspection

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About the expert: Black Belt, Master Black Belt, Regulatory Affairs Certification (RAC) and Certified Quality Auditor (CQA) Susanne Manz brings an extensive background in quality and compliance for medical devices, which spans all areas from new product development, to operations, to post-market activities. Her consulting business provides services to help medical device companies achieve world-class quality and compliance.

To understand AI advancements in health care, there are two storylines we must follow

The common thread running through Topol’s books is that medicine is a mess and technology will save it.

If ever there were an industry that could reap the benefits of AI, it is healthcare. The adoption of this technology to actually make medicine better is obvious. However, with this adoption comes a slew of ethical issues.

Let’s start with some numbers: In 2018, the US spent $3.65 trillion on healthcare. That works out to $11,121 per capita, a 4.4% increase over 2017. In addition:

  • Spending on hospitals, doctors, and other clinic services was $2.16 trillion, holding steady at 59% of total health care spending.
  • The spending category that experienced the most substantial year-over-year increase was the general cost of administering health insurance, which rose 7.7% in 2018.
  • Spending on prescription drugs purchased in retail pharmacies went up 3.3% in 2018, higher than the 0.4% rate in 2017.
  • A majority of the more significant spending totals were due to higher overall prices, while the “use and intensity” of health care services played a smaller role.

The per capita spend in western economies, other than Switzerland, which was about 80%, was 50% or less. The worse news is that the US has slipped to 36th in the world in quality of healthcare. (The above data is from Centers for Medicare & Medicaid Services and CIA World FactBook.)

Another lesser-known statistic is the magnitude of iatrogenic disease. From Wikipedia: an iatrogenic disorder occurs when the deleterious effects of the therapeutic or diagnostic regimen causes pathology independent of the condition for which the regimen is advised.

In other words, they are harmed by medical practice. According to a Johns Hopkins study, 251,454 deaths stemmed from a medical error – making it the third leading cause of death in the US, just behind cancer and heart disease.

All industries are facing the problem of which areas to apply AI. In an article in Healthcare IT News, some advice for the healthcare industry was: while AI may have the potential to discover new treatment methods, the report finds strongly entrenched ‘ways of working’ in the healthcare industry that are resistant to change. The authors warn that ‘simply adding AI applications to a fragmented system will not create sustainable change.’ Good advice for any industry.

To continue this: http://bit.ly/2lUwsZj

Robotic surgeons set to spark ‘revolution in healthcare’

The robots have four flexible joints like a human arm and are controlled by a surgeon using a joystick and a 3D screen.

Specialists working on patients while controlling automated arms could turn into another standard in medical clinics.

The help of robots in careful rooms are anticipated to change the manner in which activities are performed by enabling medical procedures to be done as keyhole techniques.

As the utilization of mechanical medical procedure turns out to be progressively well known, an expanding number of surgeons are being prepared in how to utilize them. They enable specialists to perform complex strategies utilizing an insignificantly obtrusive methodology.

Expert colorectal specialist Jonathan Morton is among a bunch of doctors who have evaluated the hardware.

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He said: “It’s quite exciting to see robotic techniques rolled out – from an ergonomic point of view, the system is set up better so that the stresses on the body are less, reducing injury rates for surgeons.

“It’s not actually the robot doing the surgery – it’s the surgeon with the experience and the knowledge telling the robot what to do, effectively it’s the same as keyhole surgery with robotics.”

The robots have four flexible joints like a human arm and are controlled by a surgeon using a joystick and a 3D screen. The technology is capable of carrying out a wide range of tasks.

CMR Surgical, the company behind the robot, claims the technology will revolutionise healthcare.

The firm’s chief medical officer, Mark Slack, said: “The vision we have is that we have built a system to enable many more patients to get MAS (minimal access surgery) and all the benefits that that brings for them – like reduced complications, reduced pain – and the aim is to put these in as many hospitals as we can.”

The NHS is developing a £50m framework for robotic surgical equipment, soon to be rolled out across the country.

So does the future of surgical procedures rest in non-human hands?

Richard Kerr, of The Royal College of Surgeons (RCS), believes it’s poised to change the nature of surgery forever.

“The robots are not going to be taking over what surgeons do. They will become an integral part of the tools surgeon use to carryout operations on their patients,” he said.

“Maybe in the long-distance future some aspects of surgery may potentially be delivered by robots.”

The RCS says a majority of NHS trusts have guidelines which surgeons are expected to follow when using robotics

More at https://news.sky.com/story/robotic-surgeons-set-to-spark-revolution-in-healthcare-11810158

Directives on active implantable medical devices (90/385/EEC)

Impact of the MDR on Quality Management Systems (QMS), technical documentation, clinical trial requirements, UDI and combination products.

The Commission adopted a package of measures on innovation in health. The package consisted of a Communication and two regulation proposals to revise existing legislation on general medical devices and in vitro diagnostic medical devices. In particular, the Directives on active implantable medical devices (90/385/EEC) and on medical devices (93/42/EEC) are intended to be replaced by a Regulation on medical devices, while the Directive on in-vitro diagnostic medical devices (98/79/EC) is intended to be replaced by a Regulation on the same subject.

Medical device Regulation

The revisions therefore affected all kinds of medical devices including in vitro diagnostic medical devices, from home-use items like sticking plasters, pregnancy tests and contact lenses, to X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.

This Seminar will look at what to expect when the new regulation is implemented. Including: the transition period, Effect on Notified Bodies, Impact of the MDR on Quality Management Systems (QMS), technical documentation, clinical trial requirements, UDI and combination products.

  • The updated Regulation
  • Implementation dates and transition
  • Main changes and products affected
  • Effect on medical device manufacturers

Salma Michor , PhD, MSc, MBA, CMgr, RAC is founder and CEO of Michor Consulting Schweiz GmbH, serving such clients as Johnson & Johnson, Novartis, Shire, Pfizer and Colgate Palmolive. Previously, Michor worked for Chiesi-Torrex, Wyeth Whitehall Export Croma Pharma GmbH. She teaches regulatory affairs and clinical strategies at the University of Krems, Austria, and is an independent expert to the European Commission. She holds a PhD in thermal process engineering and an MSc in food and biotechnology from the University of Applied Life Sciences in Vienna, Austria; an MSc from King’s College, University of London in food technology; and an MBA from Open University, and has earned the RAC (EU), CQA and is a Chartered manager.

Medical Device Adverse Event Reporting Systems in EU, Canada and US

Medical device firms’ obligation doesn’t end upon obtaining a marketing clearance, approval, or certificates. Medical device manufacturers are required to report adverse events to the authorities (e.g., Competent Authorities, Health Canada and US FDA), where applicable.

To achieve compliance and to remain compliant with the adverse event reporting requirements, it is imperative that medical device manufacturers understand what requirements apply and how to meet the said requirements.

This webinar will walk you through to help you understand and stay in conformity with the adverse event reporting requirements in EU, Canada and US.

This webinar will help you profoundly change your way of planning, developing, implementing and following your relevant and applicable processes in a more efficient and effective manner.

Why should you attend : Medical device manufacturers are required to report adverse events to the authorities (e.g., Competent Authorities, Health Canada and US FDA), where applicable.

To achieve compliance and to remain compliant with the adverse event reporting requirements, it is critical to accurately interpret and understand what requirements apply and how to meet the said requirements.

This webinar will walk you through to help you understand and stay in conformity with the adverse event reporting requirements in EU, Canada and US.

Areas Covered in the Session

  • Applicable and relevant regulations in EU, Canada and US
  • Definitions
  • Medical device adverse event reporting requirements in EU, Canada and US.
  • Medical device vigilance system during the post-production phase in EU.
  • Mandatory medical device problem reporting requirements in Canada.
  • Mandatory medical device reporting requirements in US.
  • Review of actual reporting forms in EU, Canada and US
  • Applicable and relevant guidance documents
  • Conclusion

Who Will Benefit:

  • Regulatory Affairs Managers, Directors and VPs
  • Clinical Affairs Managers, Directors and VPs
  • Quality Managers, Directors and VPs
  • Quality Managers, Directors and VPs
  • Compliance Managers and Directors
  • Sales and Marketing Managers, Directors, and VPs
  • Complaint Handling and Risk Management Managers and Directors
  • Site Managers, Directors, and Consultants
  • Senior and Executive Management
  • Compliance Officers and Legal Counsel
  • Business Development Managers, Directors, and VPs

Click Here to Continue Learning

How to interpret and use more than just a standard tool-box

Metrology: QC Sampling Plans the statistical analysis of measurement uncertainty, and how it is used to establish QC specifications.

How to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows:

  • ISO standards and FDA/MDD regulations regarding the use of statistics.
  • Basic vocabulary and concepts, including distributions such as binomial, hypergeometric, and Normal, and transformations into Normality.
  • Statistical Process Control
  • Statistical methods for Design Verification
  • Statistical methods for Product/Process Qualification
  • Metrology: QC Sampling Plans the statistical analysis of measurement uncertainty, and how it is used to establish QC specifications
  • How to craft “statistically valid conclusion statements” (e.g., for reports)
  • Summary recommendations

The various statistical methods used to support such activities can be intimidating. If used incorrectly or inappropriately, statistical methods can result in new products being launched that should have been kept in R&D; or, conversely, new products not being launched that, if analyzed correctly, would have met all requirements. In QC, mistakenly chosen sample sizes and inappropriate statistical methods may result in purchased product being rejected that should have passed, and vice-versa.

This provides a practical approach to understanding how to interpret and use more than just a standard tool-box of statistical methods; topics include: Confidence intervals, t-tests, Normal K-tables, Normality tests, Confidence/reliability calculations, Reliability plotting (for extremely non-normal data), AQL sampling plans, Metrology (i.e., statistical analysis of measurement uncertainty ), and Statistical Process Control. Without a clear understanding and correct implementation of such methods, a company risks not only significantly increasing its complaint rates, scrap rates, and time-to-market, but also risks significantly reducing its product and service quality, its customer satisfaction levels, and its profit margins.

  • FDA, ISO 9001/13485, and MDD requirements related to statistical methods
  • How to apply statistical methods to manage product-related risks to patient, doctor, and the designing/manufacturing company
  • Design Control processes (verification, validation, risk management, design input)
  • QA/QC processes (sampling plans, monitoring of validated processes, setting of QC specifications, evaluation of measurement equipment)
  • Manufacturing processes (process validation, equipment qualification)

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  • QA/QC Supervisor
  • Process Engineer
  • Manufacturing Engineer
  • QC/QC Technician
  • Manufacturing Technician
  • R&D Engineer

Dont skip this with out reading fully

Heart surgery survival chances ‘better in the afternoon’

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Open heart surgery appears to be safer in the afternoon because of the body’s internal clock, scientists have said.

The body clock – or circadian rhythm – is the reason we want to sleep at night, but it also drives huge changes in the way our bodies work.

The research, published in the Lancet, suggests the heart is stronger and better able to withstand surgery in the afternoon than the morning.

And it says the difference is not down to surgeons being tired in the morning.

Doctors need to stop the heart to perform operations including heart valve replacements. This puts the organ under stress as the flow of oxygen to the heart tissue is reduced.

The doctors and researchers looked for complications including heart attacks, heart failure or death after surgery. They found:

  • 54 out of 298 morning patients had adverse events
  • 28 out of 298 afternoon patients had adverse events
  • Afternoon patients had around half the risk of complications
  • One major event would be avoided for every 11 patients operated on in the afternoon

One of those involved in the research, Prof Bart Staels, from the Institut Pasteur de Lille, told the BBC News website: “We don’t want to frighten people from having surgery – it’s life saving.”

He also said it would be impossible for hospitals to conduct surgery only after lunch.

But Prof Staels added: “If we can identify patients at highest risk, they will definitely benefit from being pushed into the afternoon and that would be reasonable.”

Obesity and type 2 diabetes have been shown to increase the risk of complications after surgery.

Heart health is already known to fluctuate over the course of a day.

The risk of a heart attack or stroke is highest first thing in the morning, while the heart and lungs work at their peak in the afternoon.

 The risk of a heart attac.jpg

Dr John O’Neill, from the UK Medical Research Council’s Laboratory of Molecular Biology, said: “Scientifically it is not hugely surprising, because just like every other cell in the body, heart cells have circadian rhythms that orchestrate their activity.

“Our cardiovascular system has the greatest output around mid/late-afternoon, which explains why professional athletes usually record their best performances around this time.”

Other possible explanations for the findings included surgeons being tired in the morning or their own body clock affecting their surgical skill, particularly if they are not “morning people”.

Read More: http://snip.ly/lr9h9#http://www.bbc.com/news/health-41763958

With Macy Foundation Grant, Drexel Teams with 12 Institutions to Enhance Professionalism in Medical Education

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The Josiah Macy Jr. Foundation has awarded a grant to Drexel University faculty to support the dissemination and enhancement of an online resource for teaching future health care providers about professionalism in medicine — including empathy, compassion, honesty, ethics and social justice.

Dennis Novack, MD, associate dean of medical education at the College of Medicine, was previously awarded a grant to create ProfessionalFormation.org (PFO), an online resource for professionalism learning, assessment, remediation and research in clinical education. With the support of the Macy Foundation, Novcack and Kymberlee Montgomery, DNP, chair of the Department of Advanced Practice Nursing in the College of Nursing and Health Professions, are working with a variety of institutions to disseminate and enhance this resource for over 30 health care education schools across the country.

“This generous grant will enable us to address the challenge of generating new educational resources for the entire health care education community. We will also publish educational research that contributes to a growing national understanding of the components of effective teaching and learning of professionalism and interprofessional care,” Novack said.

Teaming up with Drexel University are 12 institutions including: Alabama College of Osteopathic Medicine, Albert Einstein College of Medicine, Commonwealth Medical College, Duquesne University, Indiana University, Jefferson College, Ohio State University, Southeastern Louisiana University, Stony Brook, University of Pennsylvania, University of Texas – Rio Grande Valley and Western Michigan University School of Medicine. Each of these institutions is affiliating with colleges, such as nursing, pharmacy, physician assistants, dentistry and others for this unique collaboration.

“Leaders in health professions education have worried about the professional image of health care clinicians, and the public’s declining trust in health professionals. Managed care has grown, clinical care has become more fragmented, and there has been adverse publicity about errors in care,” Montgomery said. “A new paradigm for care demands commitments to professional values, and skills in working in teams. We are partnering with these institutions to enhance and expand their education in professionalism and interprofessional care. To practice together, it is essential to learn together.”

The American Board of Medical Specialties defines medical professionalism as a “belief system in which group members declare to each other and the public the shared competency standard and ethical values they promise to uphold in their work and what the public and individual patients can and should expect from medical professionals.” Central to those decelerations is a focus on an ethical value system, the knowledge and technical skills necessary for good medical practice and the interpersonal skills necessary for working with patients and colleagues.

Read More: http://snip.ly/4km9u#http://drexel.edu/now/archive/2017/September/Macy-Foundation-Grant-Professionalism/

Regenerative Medicine and Stem Cells

Currently, regenerative medicine through stem cells is a game-changing field that has great potential to change everything. Recent advances have unlocked new opportunities and approaches for the use of stem cells such as rejuvenation, replacement, and regeneration according to The Center for Regenerative Medicine. With stem cells, it is possible to grow organs and tissues specifically for the needed person, reducing the chance of transplant rejection. Moreover, since stem cells can be grown in cultures, the shortage problem currently associated with transplants could be fixed entirely with the use of growth factors. Stem cells can also treat neurodegenerative diseases like Parkinson’s and Alzheimer’s among others, which do not have a cure currently, by working as replacement cells or tissues.

stemcell

Stem cells are unique because they are unspecialized, they can differentiate, and they can self-renew. Stem cells do not have a tissue-specific structure yet, and they can differentiate, meaning they can become a wide variety of specialized cells. Unlike muscle, blood, and nerve cells, stem cells can immortally make millions of more of themselves. There are three main types of stem cells that I will address: totipotent, pluripotent, and multipotent stem cells. Three days after fertilization, there is a clump of sixteen cells called the morula, which is made up of totipotent stem cells because they can become anything in the body, including the placenta. Soon after, the cells begin to differentiate more with the outer layer becoming the blastocyst while the inner cell mass continues to divide. The inner cell mass is made up of pluripotent stem cells, which can also be referred to as embryonic stem cells. These stem cells can become anything except for the placenta because the blastocyst itself is the pre-placental cells. After the egg’s implantation in the uterus, gastrulation begins, and the embryo separates into three distinct layers, which are the ectoderm, mesoderm, and endoderm. Stem cells in each of these layers are multipotent or adult stem cells because they are more restricted in the variety of mature cells they can become. Adult stem cells can also be harvested from the bone marrow of an adult as well. Researchers generally experiment more with embryonic and adult stem cells rather than totipotent stem cells because they are a little more mature and specialized.

stem cell transplant

While stem cells hold extreme potential, there are some reasonable ethical concerns that need to be addressed because they are currently holding back research and experimentation. Some believe that an embryo, at the blastocyst stage, is a living human being rather than a group of cells. They believe that life starts at conception rather than in the womb or at birth. Thus, those people believe that it is essentially “murder” when researchers destroy the embryo to extract the pluripotent stem cells. A counterargument to this takes a more utilitarian standpoint, arguing that it is worth the possible death of one to save maybe hundreds of others. I do not agree nor disagree with these arguments, but maybe one day scientists do have arguments that appease everyone.

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Regenerative medicine is now on of the of priorities of researchers throughout the world because of how it could change the future of medicine. Diseases thought to be incurable before may very well be treatable within even the next decade as clinical trials come in and researchers experiment more and more. At the moment, there are almost 120,000 people waiting to receive an organ, and three people die every hour because they could not get an organ in time. Stem cells could solve many of these cases, making breakthroughs in every medical field, and there is a solid reason to trust that they will.

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References

“About Regenerative Medicine.” Mayo Clinic, 2017, mayo.edu/research/centers-programs/center-regenerative-medicine/patient-care/about-regenerative-medicine. Accessed 8 June 2017.

Autologous Stem Cell Transplant. 28 Feb. 2014. BioNews Texas, bionews-tx.com/news/2014/02/28/new-research-provides-insights-for-immune-system-development-after-autologous-stem-cell-transplant-for-multiple-sclerosis/. Accessed 8 June 2017.

CNN library. “Stem Cells Fast Facts.” CNN, 2 June 2017, cnn.com/2013/07/05/health/stem-cells-fast-facts/index.html. Accessed 8 June 2017.

“Data.” United Network for Organ Sharing, 2015, unos.org/data/. Accessed 8 June 2017.

Ernst, Liz. “What Are the Potential Uses of Human Stem Cells? What Obstacles Must Still Be Overcome before These Potential Uses Will Be Realized?” Global Stem Cells Group, 28 June 2016, stemcellsgroup.com/human-stem-cells/. Accessed 8 June 2017.

Potential Uses of Stem Cells. 2014. All Things Stem Cell, allthingsstemcell.com/glossary/. Accessed 8 June 2017.

“Stem Cell Therapy Ethics.” Biomedinvo4all, biomedinvo4all.com/en/research-themes/stem-cell-therapy/stem-cell-therapy-ethics. Accessed 8 June 2017.

Writes, Laura. “Ethical Problems of Human Embryonic Stem Cell Use in Scientific Research.” Soapboxie, 19 Dec. 2015, soapboxie.com/social-issues/Ethical-Problems-of-Human-Embryonic-Stem-Cell-use-in-Scientific-Research. Accessed 8 June 2017.

How stem cells could help solve the transplant problem and make breakthroughs in almost every disease

via Regenerative Medicine and Stem Cells — Medical Blog

Psychiatric care is postcode lottery, say medical experts

Psychiatric care is postcode lottery, say medical experts

There are not enough NHS psychiatrists in some parts of the UK and more should be recruited to improve care, says the Royal College of Psychiatrists.

In Scotland, there are 10 consultant psychiatrists per 100,000 people – but only eight for the same number in England and Northern Ireland, and just six in Wales.

London’s tally is more than double that of the east of England.

English health ministers said thousands of new posts were already planned.

The government in England recently announced there would be 570 extra consultant psychiatrists by 2020-21.

And the Welsh government said it was committed to improving mental health services in Wales.

But the Royal College of Psychiatrists said there were too few medical students specialising in psychiatry and not enough psychiatrists becoming consultants.

In England, in the past five years, it said there had been a 1.7% increase in psychiatry consultants compared with a 20.2% increase in other consultants across the NHS.

Areas such as London and the north-east of England have more than 11 psychiatrists per 100,000 people but the south-west has six and Yorkshire five.

‘Falling short’

Prof Wendy Burn, President of the Royal College of Psychiatrists, said: “People with a severe mental illness should expect to see a specialist consultant, just as you would for a severe physical illness.

“The huge variation in consultant psychiatrists across the country means reality is increasingly falling short of our expectations.

“As highly skilled medics, psychiatrists must be able to spot the nuance in symptoms, ask the right questions, and understand what the problem is.

 

Read More: http://snip.ly/u70ov#http://www.bbc.com/news/health-41201396