All posts by Turacoz Group

Why was my manuscript rejected? – Talking about 5 most common reasons for rejection in journals

Medical Writing, Publication Writing, , , , , , ,

“We are sorry to inform you that your submission is rejected”- This is something you never want to hear or read but this is most often experienced. These words are disheartening. When we start research, it becomes a dream to see that work turning into pages of a journal. But after so much hard work and research what is something that we lack? This blog will unlock your mysteries and let you know the reasons behind that NO, that rejection. Let’s find out what goes wrong and what one should do.

  1. Technical Screening turning into a failure

The first problem can be in your basic check. From plagiarism to figures, something has gone wrong. In technical Screening, manuscript is rejected if: –

  • There is some issue with language
  • Imprecise hypothesis  
  • Main titles, references, list of authors etc. crucial elements are missing
  • There is no proper conclusion
  • Flaws in study design

2. Deviation from aim and outlook of journal

The biggest and smallest mistake we can do is not finding the perfect journal. Before sending your submission, one must know what the aim and scope of the journal is. If your manuscript is not adding any value to the journal, they will reject it. To learn how to find where to publish and how to find that right key visit https://lnkd.in/drKKnPHe

3. Do not Put your feet in two boats

Journals usually mention that if your work is under review at some other place then they will not consider it. So, do not submit your work at two journals, you might sink. Find the journal interested in your research and focus in one direction.

4. Format it before sending

Journals have their own writing style, their way of transforming the manuscript. It begins from font size, font style and can never end because definitive amount of margin is also essential for a journal. So, it is especially important to meet the standards set by a journal and follow the instructions about guidelines.

5. Finding Originality and Significance

If your submission is extension or another version of some research paper, you have high chances of getting a NO. If the journal does not find any significance in what you are trying to convey then also your submission is rejected.

Take Away Points

For the buds of researching world, it is challenging to get their manuscript accepted. But if you know the secrets and tips to the road, this world is welcoming. The world of publishing and medical writing is a place where you need to know what, why and where. Planning matters here.

To turn the “NO” into “YES”, Turacoz is conducting a webinar on Publishing Planning, and this is your chance to track https://lnkd.in/drKKnPHe

References:

  1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3035881/
  2. https://www.elsevier.com/connect/8-reasons-i-rejected-your-article

Why numb fingers are left helpless – Leprosy

Awareness, Awareness Day/Month, , , , ,

She was unfamiliar with the bacteria inside her and hence even after taking Multi-Drug- Therapy she didn’t eat or sleep with her children for more than four years. The universe might be testing her as she lost her husband during this span of her life. She was denied her rights towards her husband’s estate. From economic support to emotional care, every door was closed for her. Her tale is not of a patient, this is about a single mother who was an unaware Leprosy patient. But this lady turned out to be a winner. With her will and strength, she changed her dim days into brighter ones.

Rachna Kumari – the story of a Leprosy Hero

Reciting a story about the journey of the woman who went from closed rooms of her house to an international stage. Once upon a time, she was not able to meet her kids and now she is addressing the world and helping women. Her struggle speaks about a lady who was diagnosed with Leprosy and was not aware of the disease. She was diagnosed at a later stage by the AIIMS professionals when the pain and numbness in her fingers became unbearable. Leprosy is a chronic infectious, transmissible, curable, and less talked about disease. The awareness about the disease is next to negligible and hence patients suffer the social dilemma more than the pain due to disease. Leprosy or Hansen’s disease is caused by the bacteria Mycobacterium Leprae, affecting the skin, mucosa, and peripheral nerves. The most common symptom is pale-coloured skin sores, lumps, or bumps that do not go away easily.

Patients also undergo leprosy-related nerve damage, which will lead to loss of feeling. 

This disease is not transmitted through hug or touch and being uninformed she stayed away.

If she was diagnosed early or proper care was provided to her, she might have recovered early. In such dark days, she needed her family and society to hold her, but the opposite was experienced by her. People are often forbidden and thrown behind doors when they need even more sunshine Today, she is speaking the heart of every woman and patient on an international platform. According to her, she got three lives, and this third one she is dedicating to empowering women and seeking proper health facilities for them. She is working for Lepra in the Bihar district; her roles and responsibilities took her to UN Human Rights and Anti-Leprosy Associations Advisory Board. She opened her wings and gave flight to millions of patients saying, “Treatment of leprosy should be combined into the general healthcare in order to promote inclusion.”

Open the doors

Millions of people are suffering from leprosy and lack of information is leading to chaos. we need to remember that this is curable and can be transmitted when you came in close contact with the mouth or nose of the patient. So, freezing out patients from your family or society is not the cure. The treatment lies in taking care of their mental health and not shutting doors for them. They need love, light, and MDT to feel healthy again.

References:

  1. https://www.webmd.com/skin-problems-and-treatments/guide/leprosy-symptoms-treatments-history
  2. https://en.wikipedia.org/wiki/Leprosy
  3. https://www.ohchr.org/EN/NewsEvents/Pages/LeprosySurvivorRachna.aspx#:~:text=After%20her%20eight%2Dyear%20battle,and%20campaign%20for%20their%20rights.

Eight Ways to Improve Clarity in Medical Writing

Medical Writing, Tips, , , ,

Introduction to Medical Writing

Medical writing involves producing clear, precise documents of high quality to effectively communicate scientific, medical, and clinical data to a wide range of target audiences. It also includes regulatory writing and medical communications.  With the constant advancements in clinical research, large amounts of data must be translated to target audiences such as regulatory authorities, healthcare professionals, patients, and the general public in a clear, explicit, and well-structured format. Apart from thorough technical knowledge, a medical writer must have excellent writing skills to convey complex scientific information credibly and clearly.

Types of Medical Writing

Clarity in Medical Writing

Clarity is the most valued quality required in medical writing to ensure that the audience perceives correct information without any ambiguity. Lack of clarity is the major issue affecting timely submission of research/regulatory documents, publication acceptance rate, and, accessibility of scientific information to health care providers and patients.

Eight Ways to Improve Clarity in Medical Writing:

  1. Clear and Concise Language:
    • Writing in clear language makes a document easy to understand and increases readability.   It is advisable to use simple words to convey accurate information; using sophisticated words often results in confusion and misinterpretation of data. The best practice is to write simple, short sentences containing one idea per sentence for easy interpretation and keeping it concise by using fewer words to communicate necessary information without eliminating any important data.
  2. Avoid Jargons:
    • Using jargon may hinder effective communication especially when the target audience are non-experts in the field of interest. Though experts like scientists or health care providers are aware of medical jargons, it is always recommended to use simpler words and phrases for better communication.
    • When writing for non-experts such as the general public, it is best to avoid jargons completely. For example, writing ‘fast heart rate’ instead of tachycardia, ‘muscle pain’ instead of myalgia, makes it easier to understand.
  3. Avoid Redundancy:
    • Contrary to the assumption that using more words enhances clarity, it may in fact distract the reader from the original idea. It merely adds length to the document without providing any additional information. Do not repeat information that is already presented in the form of tables and figures. This can be achieved by limiting the overuse of synonyms, double negatives, and intensifiers.
  4. Know your Audience:
    • A medical writer offers services to a diverse range of audiences including clinical and regulatory authorities, physicians, patients, and general public. For effective communication, the scientific content has to be tailored according to the target audience. Even cutting-edge research would not leave an impact on the industry experts if it is not documented to suit their level of comprehension. Similarly, when writing for non-experts, the use of plain language is advised to enhance accessibility. Graphical presentation or images can be considered as a good option to convey complex information in a simpler way.
  5. Active over Passive Voice:
    • Medical writers are encouraged to write in active voice for clarity. It helps to present data in a simple, straightforward, and concise manner.
  6. Grammar and Spellings:
    • Good grammar is instrumental to clear and effective medical writing. Grammatically accurate paper conveys precise meaning and in turn keeps the audience engaged. Proper use of punctuations, hyphens, commas aids facilitate comprehensive communication. Similarly, avoiding spelling mistakes helps decipher the right information; a single error in spelling may change the entire meaning of the sentence. A common challenge experienced is with homophones (words with same pronunciation but different meaning); one needs to be vigilant to avoid misinterpretations.
    • It is also important to consider whether to write in British English or US English depending on the target audience and maintain consistency throughout the document.
  7. Formatting:
    • A well written report without proper formatting appears misconstructed. Often standard documents are required to comply with specific regulatory formats. Implementing client specific formatting guidelines aids in improving clarity thereby increasing the level of acceptance.
  8. Proofreading:
    • Once the document is written, proofreading the entire work is extremely critical to check for any inconsistencies or errors in spelling, grammar, abbreviations, capitalizations, and formatting. This step significantly aids in the dissemination of clear, accurate scientific information.

Conclusion

Medical writers play a crucial role in knowledge transfer among scientists, industry experts, healthcare providers, and the public. Accurate interpretation of sophisticated data is essential for good understanding. Articulating well-structured, precise documents can be achieved by implementing various techniques for improving clarity in medical writing.

Medical Writer: Trusted Partner for Medical Affairs Webinar

To get more detailed insights about Medical Writing, we encourage you to register for our upcoming live webinar on 8th January 2022: Webinar Registration Fee (razorpay.com).

DE-MYTHIFYING THE MONSTER- THE BREAST CANCER MONSTER

Awareness, Cancer, , , , , , , ,

Welcome to October, the Breast Cancer Awareness Month. Turacoz presents to you a de-mystified read on Breast Cancer and issues related to it.

Prevalence

In recent times, Breast Cancer has been one of the predominant cancers. How predominant? Let’s have a look at the numbers.  A total of 7.8 million women were diagnosed worldwide within the 5-year period according to the WHO (World Health Organization) statistics reported at the end of 2020. Among these 7.8 million patients, 2.8 million people were diagnosed in the year 2020 itself. Breast Cancer accounts for 14% of total cancers in Indian women with four reported cases every minute.

Risk Factors- the Uncontrollable and Healthy Lifestyle

The numbers are worrisome. Hence, understanding the risk factors are vital.

Gender: Well, being a woman is the highest risk factor of developing Breast Cancer. Unlike men, women’s breast development is much more elaborate and is highly sensitive to hormonal fluctuations, especially estrogen.

Age: Everyone ages and with aging, the risk of Breast Cancer development also increases until the seventh decade. Two prominent reasons behind this trend include:

  • Hormonal changes with age: The estrogen levels shoot up three-fold in 30s and plateaus by 60s. However, this ruckus of estrogen levels wreaks havoc on breast tissues.
  • Impaired repairing mechanism: Loss of organ function with age is common. But add on to that, with age even the DNA repairing capability decreases- more to say correct gene expressions and regulation, all gets affected after a certain age. So, this erroneous DNA fuels Breast Cancer.

Other inexorable risks include:

  • Giving birth after 30!
  • Menarche before 12 or Menopause after 55
  • Immediate family having Breast Cancer
  • Inherited genes
  • Race/Ethnicity

The risks aforesaid are unavoidable.

Now comes something that is in your control which include:

  • Maintaining a healthy weight
  • Drinking alcohol
  • Lack of exercise
  • Smoking
  • Low Vitamin D levels
  • Eating healthy food.

Basically, all the factors that are controllable are related to maintaining a healthy lifestyle.

From the risk factors checklist, it is evident Breast Cancer development is not under your control. Seems like an invisible monster, doesn’t it? But there must be something you all can do to keep it in check. Well, yes.

Other than self-examination of breasts, screening techniques such as MRI, Mammogram, Thermography or Tissue sampling are also done. However, the testing varies depending on age or certain causative factors.

And lastly, we must understand that cancer is a multifactorial phenomenon. Hence, it requires not only avoiding the controlling factors but avoiding the myths as well.

The Myths of Breast Cancer

Mammograms are dangerous!

Not at all. Mammograms are not at all dangerous. In fact, they are your best saviour for correct screening.

I self-examined. No lumps found!

Well, even if you self- examined, it’s better to double check by opting for screening tests.

I haven’t resorted to Hormone Replacement Therapy. I am safe!

No. Hormone Replacement Therapy may or may not fuel your cancer. But avoiding it has no relation to Breast cancer occurrence.

My mother/ sister had breast cancer. I will definitely get it!

Well, no. There is no “definite” in cancer. Had there been, treating them would have been much easier. So don’t resort to fear, rather report to your physician and opt for any screening test for a clinical confirmation.

Cancer is a monster? Yes. But keeping that monster out of the bay with your awareness can SAVE you.

Stay aware, Stay Healthy

References

  1. who.int (2021) Breast Cancer https://www.who.int/news-room/fact-sheets/detail/breast-cancer
  2. Benz C. C. (2008). Critical reviews in oncology/hematology, 66(1), 65–74. https://doi.org/10.1016/j.critrevonc.2007.09.001
  3. Husna, et al. (2019). Education for health (Abingdon, England), 32(2), 101–102. https://doi.org/10.4103/efh.EfH_226_18

Artificial Intelligence in Medical Device Industry

Medical Devices, , , , , , , , ,

What is artificial intelligence (AI)?

As per the Merriam Webster dictionary, AI is “the capability of a machine to imitate intelligent human behavior”.

The recently released proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL LAYING DOWN HARMONISED RULES ON ARTIFICIAL INTELLIGENCE (ARTIFICIAL INTELLIGENCE ACT) AND AMENDING CERTAIN UNION LEGISLATIVE ACTS defines AI system as a “software that is developed with one or more of the techniques and approaches that can, for a given set of human-defined objectives, generate outputs such as content, predictions, recommendations, or decisions influencing the environments they interact with”. According to this document, AI techniques and approaches include the following1:

(a) Machine learning approaches, including supervised, unsupervised and reinforcement learning, using a wide variety of methods including deep learning;

(b)Logic- and knowledge-based approaches, including knowledge representation, inductive (logic) programming, knowledge bases, inference and deductive engines, (symbolic) reasoning and expert systems;

(c)Statistical approaches, Bayesian estimation, search, and optimization methods;

Birth of AI into the Healthcare Field

Changes Brought by AI in the Medical Device Field

AI has brought about many revelations in healthcare field. It would be difficult to sum it all up in one blog hence we would be looking into some of the changes brought by AI into healthcare.

So, what do you think about an automatic blood pressure monitor at your homes? Well, yes, that is a change brought out by AI since it mimics the activity of a trained physician in detecting the sounds that are generated when a blood pressure cuff changes the flow of blood through the artery and in reporting the diastolic and systolic blood pressure measurements3.

Many such devices are available in the market that does not require a physician nearby, instead you can work on it by yourself.

And now companies are equipping themselves with machine learning to monitor patients using sensors and automate delivery of treatment using connected automated mobile apps. Ex: Medtronic launched the MiniMed 670G system, which is AI trained on algorithms that help to self-adjust insulin delivery once we feed the amount of insulin required for a given time 4.

So, as AI integrated medical devices are slowly becoming part of our lifestyles, shouldn’t the safety concerns around it be more stringent.

Regulations around AI integrated medical devices

An AI/ML screening tool for the eye disease occurring due to diabetic retinopathy, was cleared (in 2018) to aid in diagnostic decision by the FDA. It was cleared since it was a tool which was based on a ‘locked’ algorithm, which means that they don’t evolve over time and do not require new data to alter their performance. It is important that regulators follow stringent rules regarding software as a medical device using AI or machine learning (ML) so that they do not provide approval based on an already existing algorithm5.

As per a recent (2020) article published in the Nature, regulators must not restrict their evaluation to the AI/ML-based medical devices only but also assess the entire systems associated with it, for approval. The key things that should be done to attain a full system approach include5:

a) Collecting entire data such as current regulatory and legal mandate information, reimbursement decision of insurers, data quality of any third-party providers, any ML algorithms developed by third parties etc.

b) Issuing a limited authorization which would track factors discussed above

c) Seeking approval from a specific hospital, with specific trained and authorized users, and

d) Obtaining detailed hospital level information such as how the AI/ML-based medical device software is integrated into the workflow and staffing levels, the practice style and training of the physician, etc.

As for European Union is concerned, it is planning to tighten its regulations regarding AI by implying additional requirements on the use of AI in medtech along with heavy fines for those companies that fail to adhere to the EU requirements on AI. An official from the European Commission’s health group stated that “An AI medical device… would be now more secure, in the sense that it will also be complying with the MDR obligations and in addition those aspects of AI that could be creating some worries and some concerns would be handled by the new AI regulations. So, the two would be ensuring that the system is secure and trustworthy and so on6.”

Since AI is a vast and rapidly evolving topic, stay tuned to reading more about in our upcoming blogs/posts. Also, if you find our blogs to be interesting and you want to take the next step in advancing your knowledge on EU MDR and CER, consider our CER training class. Our experts are also available to help you with end-to-end CER development and gap analysis. Please contact us at [email protected]

References:

1) Proposal for a Regulation of the European Parliament and of the Council LAYING DOWN HARMONISED RULES ON ARTIFICIAL INTELLIGENCE (ARTIFICIAL INTELLIGENCE ACT) AND AMENDING CERTAIN UNION LEGISLATIVE ACTS. https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1623335154975&uri=CELEX%3A52021PC0206

2) Demystifying AI in Healthcare: Historical Perspectives and Current Considerations. https://www.physicianleaders.org/news/demystifying-ai-in-healthcare-historical-perspectives-and-current-considerations

3) Machine Learning AI in Medical Devices: Adapting Regulatory Frameworks and Standards to Ensure Safety and Performance. https://www.ethos.co.im/wp-content/uploads/2020/11/MACHINE-LEARNING-AI-IN-MEDICAL-DEVICES-ADAPTING-REGULATORY-FRAMEWORKS-AND-STANDARDS-TO-ENSURE-SAFETY-AND-PERFORMANCE-2020-AAMI-and-BSI.pdf

4)https://emerj.com/ai-sector-overviews/ai-medical-devices-three-emerging-industry-applications/

5)https://www.nature.com/articles/s41746-020-0262-2#Sec4

6)https://www.medtechdive.com/news/eu-plans-to-impose-additional-regulations-on-medtech-ai-products-other-hi/600022/

LET’S TAKE NUTRITION SERIOUSLY INDIA – THE NATIONAL NUTRITION WEEK (1ST TO 7TH SEPTEMBER, 2021)

Health & Fitness, , ,

“Let food be thy medicine and medicine be thy food”

-Hippocrates

Introduction

Gluten free, Keto free, Dairy free- these are a few “terms” trending all around us on our Instagram, Twitter and Facebook feeds. However, have you ever questioned yourself why there is a sudden surge in opting for these diets? Where did we all go wrong in making diet choices? Are these diets necessary for everyone? The answer is NO. 

Food and nutrition is indeed fuel for our body. However, our continuous ignorance in over or mis-consuming this fuel has led to a drastic shift in our health. Obesity, PCOS, Diabetes, Hypertension, High BP- all these conditions indicate, something is seriously wrong with our lifestyle choices.  Nutrition is health. To remember this truth and make citizens more aware of nutritional choices, India observes the National Nutrition Week every year from September 1 to September 7. The 2021 theme for National Nutrition Week is ‘feeding smart right from start’.

So, it all started in India? – The History

No. National Nutrition week first started in 1973 when an United States organization namely Academy of Nutrition and Dietetics [formerly known as the American Dietetic Association or ADA) announced- “Invest in Yourself—Buy Nutrition.” This campaign was targeted to educate people on importance of nutrition and nutritionists. Be it radio announcements, news coverage or pamphlets, the National Nutrition Week gained entire America’s attention and got upgraded to a month-long program from 1980.

Forward to 1982, India, on a similar intention launched the National Nutrition Week to educate its citizens on Nutrition.

Fast forward 2021: India and Nutrition

Though India’s fight for nutrition began way back in 1982, the rise of obesity, diabetes, polycystic ovary syndrome (PCOS) and other lifestyle diseases in 2021 clearly indicates that we have not reached the mark yet with nutritional choices being the primary culprit. This year’s theme ‘feeding smart right from start’ also highlights that not only us, but our younger generation also requires to make right nutritional choices.  

So how can we contribute?

Cut down on fats and sugar: Eating right involves choosing right. One of the best ways to do so is opting for healthier versions of daily food. Understanding the content of saturated fat is the key as they are responsible for increasing the cholesterol level. 

Stay away from junk food: Junk food does not serve your body’s nutritional requirements, rather hampers your body by causing digestive issues, fluctuation in blood sugar levels, depression, fatigue and weakness. The best idea is to switch to fresh food and leafy vegetables. They not only provide you the right nutrition but also increases your immunity

Drink water: May be your favourite beverage is Coffee, but let’s not forget the importance of drinking water. Water is the ultimate nutritional support. It aids in digestion, normalizes BP, stabilizes the heart beat and what not.

And last but not the least, Exercise.

“Invest in Yourself—Invest in your Nutrition.”

References

  1. eatright.org (2021) National Nutrition Month: A Brief History https://www.eatright.org/~/media/eatright%20files/nationalnutritionmonth/nnmhistory_032006jada.ashx
  2. Dixon, et al. 2007. Social science & medicine, 65(7), pp.1311-1323.
  3. Skerrett, P. J., & Willett, W. C. (2010). Essentials of healthy eating: a guide. 55(6), 492–501.

A SIMPLE GUIDE TO PCOD/PCOS

Health & Fitness, , , , ,

Introduction

Polycystic Ovary Syndrome (PCOS), also known as Polycystic Ovarian Disease (PCOD) is one of common hormonal syndrome that women blame for their weight gain. The cause of PCOS is still unknown, but studies have shown that it may involve a combination of genetic and environmental factors (like lifestyle, pollution). Normally ovaries have follicles which contain eggs, and one or more mature eggs are released during each menstrual cycle. In PCOS, eggs in follicles do not mature and are not released, instead form cysts. The ovaries also produce small amount of male hormones. However, the absence of ovulation in PCOS leads to an imbalance in the sex hormone levels.

The common symptoms PCOS patients present:

Acne, weight gain, irregular periods, extra hair on face and body

If untreated, can lead to:

Infertility (women having regular intercourse, but fail to conceive), heart diseases, breast cancer, endometrial and uterine cancer, diabetes, obesity

Influence of obesity on PCOS:

Obesity aggravates certain manifestations in PCOS and are more likely to have menstrual irregularities. It also increases the risk of infertility, higher probability of hair growth on face and body and complications during pregnancy.

CAN PCOS BE TREATED?

PCOS can be managed by improving insulin levels using metformin, commonly used to treat type 2 diabetes.

Irregular cycles can be treated by Oral Contraceptive Pills (OCPs).

Infertility can be treated by ovulation inducing drugs.

Consult your doctor before taking medicine.

Hair growth on body and face can be treated by laser and non-laser techniques.

However, nutrition and exercise play a major role in the management of PCOS.

Nutrition strategies:

Eating fresh food, wholesome food and eating in peace is important.

Avoid foods that are over-heated or microwave food.

Carbohydrates are extremely important to be included in the diet.

Eating wheat, rice, jowar (whole grains and carbohydrates make slow and steady rise of blood sugar) is very important.

Eating complete proteins is also vital (eggs, pulses, milk, paneer).

Essential fatty acids like ghee, oils, groundnut oil, sesame, sunflower, olive oil should be included in adequate amount.

Alpha-linolenic acid (ALA)-rich food like flax seeds, peas and nuts can also be incorporated in a regular diet.

Calcium-rich foods can help in reducing general fatigue and cramps during periods.

Exercise strategies

Regular workouts are the key to regular periods.

Seven days a month is a good start.

Weight training workouts are must at least twice a week.

Cardio is a great way to burn fat when associated with learning new movements or a skill.

‘Surya namaskar’ along with pelvic opening exercises are among the best.

Sleep strategies

Maintaining sleep-wake cycle with 8 hours of sound sleep.

Resources: DC Dutta’s textbook of gynecology, Shaw’s textbook of gynecology, The PCOD-thyroid book -book by Rujuta. Diwekar

FDA’s Recent Recalls: Ensuring Patient Safety

Medical Devices, ,

According to the US Food and Drug Administration (FDA), a ‘device recall’ is defined as, “when a manufacturer takes a correction or removal action to address an issue with the medical device that violates the FDA law”1. 

According to the FDA, a recall measure can be classified as1: 

Class I recall type is considered as the most serious type since these devices would result in serious injuries or death. Here, we elucidate this based on some real-life examples.

Some of the Recent Medical Device Recalls

The unique selling property of the Emblem subcutaneous Implantable Cardioverter Defibrillator (S-ICD) electrode (Boston Scientific) was that the lead is implanted just under the skin along the sternum, thus requiring a minimally invasive procedure. In the conventional ICD systems, the leads pass through the large veins from the surgically implanted device into the heart.

Boston Scientific is recalling the Emblem S-ICD electrode as it is associated with increased rate of fractures at a specific point distal to the proximal sensing ring (see image above).  Death can occur due to cardiac arrest as with the fractured device it is impossible to provide therapy for slowing down very fast heartbeats. The FDA reported 27 complaints of electrode body fractures, of which 26 were serious injuries and one death. Thereby, announcing a Class I recall on the Boston Scientific Emblem S-ICD electrode. This measure led to a recall of 19,919 devices that were manufactured and distributed in market between March 2016 to November 2020 2.

In another recent recall case, the manufacturing company (Philips) has voluntarily recalled its ventilator and other breathing devices indicated for patients with sleep apnoea since they posed a significant health risk. These devices were in market since 2009; however, the manufacturing company (Philips) received few complaints about the device around 2020. Further investigations revealed that these complaints rose due to the polyester-based polyurethane (PE-PUR) sound-reducing foam associated to reduce sound and vibration in these devices, which may penetrate to the device’s air pathway and, ultimately find a way to enter the body of the user either via inhalation or ingestion. In addition, the foam tends to off-gas certain chemicals which could be harmful during operation. The manufacturing company has received complaints about instances where presence of black debris/particles were observed in some of these device parts such as outlet, humidifier, tubing, and mask. These instances elevated the risk of particulate exposure in the user which irritates the skin, eye, and respiratory tract leading to headache, asthma, and adverse effects to kidneys and liver as well as possible toxic carcinogenic effects. With respect to off-gassing, the potential risks include headache/dizziness, irritation, hypersensitivity, nausea and vomiting along with possibility of toxic and carcinogenic effects. Although these issues sound serious and could be life-threatening, to date, no death has been reported due to these. The manufacturer eventually decided to recall about 4 million ventilators and breathing machines which were in market between 2009 and April 26, 20213.

Among the two examples, the first one is a typical case of a Class I type recall by FDA since there were reports of serious events and death, whereas the second one showcases that the manufacturing company was alert enough to voluntarily recall their devices on noticing complaints associated with it. Cited here were just the few examples of the recalls that were announced this year. In order to view the detailed list of all the devices that were recalled please check the below link

https://www.fda.gov/medical-devices/medical-device-recalls/2021-medical-device-recalls

How does FDA Ensure Patient Safety?

One of the pivotal roles and responsibilities of FDA include protection of public health by ensuring the safety, efficacy, and security of drugs, biological products, and medical devices. With respect to medical devices, FDA executes a robust program at every stage of a device’s life cycle to evaluate the safety of medical devices 4.

The FDA supervises the adverse event reports and other issues related to medical devices. Since the medical device market is enormous, to monitor all medical devices seamlessly, the devices are classified based on their potential risk as follows4:

Conclusion

To protect and promote public health, FDA’s Center for Devices and Radiological Health (CDRH) improvises its regulatory monitoring strategies now and then, to ensure the best effective use of the medical devices available on the US market without compromising on the quality and safety measures.

If you find our blogs to be interesting and you want to take the next step in advancing your knowledge on EU MDR and CER, consider our CER training class (link for our training class here). Our experts are also available to help you with end-to-end EU CER development and gap analysis please contact us at [email protected]

References

  1. FDA. What is a Medical Device Recall? 2021 [Available from: https://www.fda.gov/medical-devices/medical-device-recalls/what-medical-device-recall.
  2. FDA. Boston Scientific Recalls EMBLEM S-ICD Subcutaneous Electrode (Model 3501) Due to Risk of Fractures 2021 [Available from: https://www.fda.gov/medical-devices/medical-device-recalls/boston-scientific-recalls-emblem-s-icd-subcutaneous-electrode-model-3501-due-risk-fractures.
  3. FDA. Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication 2021 [Available from: https://www.fda.gov/medical-devices/safety-communications/certain-philips-respironics-ventilators-bipap-and-cpap-machines-recalled-due-potential-health-risks.
  4. FDA. Medical Device Safety Action Plan: Protecting Patients and Promoting Public Health  [Available from: https://www.fda.gov/files/about%20fda/published/Medical-Device-Safety-Action-Plan–Protecting-Patients–Promoting-Public-Health-%28PDF%29.pdf.

Diabetes Mellitus & it’s Management

Health & Fitness, , , , ,

Diabetes Mellitus (DM) is an endocrine metabolic disorder, characterized by elevated blood glucose level. DM is sub-classified into following categories.

  1. Type 1 Diabetes mellitus, also called as insulin dependent diabetes mellitus.
  2. Type 2 Diabetes Mellitus, also called as non-insulin dependent diabetes mellitus.

Type 1 DM

In Type 1 DM, there is no secretion of insulin by Beta cells of Islet of Langerhans in the pancreas because of the auto-immune destruction. Hence, there is no proper secretion of insulin. Type 1 DM is mainly treated by insulin replacement therapy. Symptoms of Type 1 DM include excessive thirst and hunger, blurred vision and fatigue. Frequent urination and weight loss occur in short period of time.

Diabetic complications may lead to cardiovascular diseases, retinopathy, and skin problems like foot ulcer.

Diagnosis of Type 1 DM is usually conducted by following procedure:

  1. Fasting blood sugar >126 mg/dl on two separate tests.
  2. Random blood sugar >200 mg/dl.
  3. Haemoglobin, HbA1c> 6.5 on two separate tests.

Management of Type 1 DM:

Good glycaemic control in Type 1 DM requires insulin therapy and oral hypoglycaemic agents like metformin, pioglitazone.

Diet and exercise play a crucial role in the management of DM.

Type 2 DM

In Type 2 DM, body cells not able to respond to insulin which is produce by Beta cells of the pancreas and is not able to produce insulin anymore.

Gestational Diabetes:

Gestational Diabetes is a condition in which sugar level is elevated during pregnancy.

mRNA Vaccine: From Class to Mass

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Coronavirus disease 2019(COVID-19) is giving the world a rollercoaster ride with shoot-up in infection cases globally. With more than 14 crores of infection cases worldwide in 16 months, the world is looking up to a miracle to stop this pandemic. One way of controlling the spread is to get vaccinated. More than 98 crores vaccines have been administered globally till the end of April 2021 and it is still making way to reach people in every corner of the world. India is in its second wave of COVID-19 infection with a tremendous rise in corona infection cases compared to the first wave of infection. But a positive side of this is, the largest vaccination drive of the world is under progress in India and giving positive hope for Indians to overcome this situation.

With COVID-19 a large number of research areas started to work on the war front to explore a possible cure, vaccine, a drug to treat COVID-19. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is the disease-causing virus of COVID-19. The First case of COVID-19 was seen in Wuhan, China in 2019. With the increase in the number of cases globally, the World Health Organization (WHO) declared it as a pandemic. With 13 approved vaccines, more than 150 clinical trials, and pre-clinical trials globally every country is trying its best in exploring safe vaccines for the same. Along with traditional vaccines, new generation mRNA vaccines also jumped in this race. These mRNA vaccines are Messenger Ribonucleic acids vaccines. 

WHAT ARE VACCINES AND WHY ARE THEY NEEDED?

A Vaccine is a product that triggers an immune response in our body and produces antibodies without causing the disease itself. So, when we face a real pathogen (Disease causing organism), our body is trained to produce immune defence against it and make antibodies and protect us from getting the disease. 

Vaccines are developed for decades with traditional methods and few new methods have also emerged with time. The older methods included using the whole organism (Inactivated vaccine, Live attenuated vaccine, viral vector vaccine), a subunit vaccine (only a part of the pathogen is used) and a new method is using Genetic material (DNA or RNA vaccine)

WHAT ARE mRNA VACCINES? AND THE HISTORY BEHIND mRNA VACCINES

mRNA vaccines are new generation vaccines wherein mRNA is used to produce the desired protein. It carries a message to the cell and produces protein. Once the protein is produced, the immune system produces antibodies against it. This feature of using mRNA is not a recent technology, it has been researched for its efficiency for use in therapeutics for the betterment of mankind. So, mRNA has now jumped from classroom studies to the mass population to show its safety and disease controlling ability.

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A researcher Katalin Kariko explored the possible uses of mRNA in medical sciences, but she never got a grant for her work and was demoted from her position by a university. But that did not stop her to work. Along with an immunology professor Drew Weissman, she worked to understand immunological benefits by modification of mRNA and published their work through 2005. They modified mRNA to get an entry into the cell, this work was innovative. In 2010, Derrick Rossi and Robert Langer formed the biotech company Moderna, as they saw mRNA’s use for vaccine development and other therapeutic areas. By 2013, one more biotech company BioNTech came into existence looking upon immunotherapies using mRNA work done by Katalin and Weissman. Thus, a new era of pre-clinical testing of mRNA vaccine for various infectious diseases and cancer had already started. HIV, Malaria, Influenza, Rabies were few diseases that were considered to develop mRNA vaccines by preclinical testing in Mice and Non-human primates. But none of these could reach a stage from where it could be used in humans. 

AND CAME THE COVID-19 PANDEMIC

At the end of 2019, when the world was busy planning to welcome 2020 in Wuhan, China people were getting infected by an unknown respiratory disease, which came out to be COVID-19 caused by SARS-CoV-2. This turned out to an outbreak globally in few days.

On 11 January 2020, the first-time genome sequence of SARS-CoV-2 was shared by the Chinese authority. This led to accelerated work by researchers globally for vaccine development. Pfizer/BioNTech vaccine immediately began their vaccine work. Phase I trials were started in April 2020, with required regulatory standards, followed by Phase II/III. On 2 December 2020, UK gave an emergency use approval for this vaccine. MHRA (Medicine and Healthcare products Regulatory Agency) of the UK became the first global medicines regulator to approve an RNA vaccine followed by various other nations also. Vaccine efficacy (is the percentage reduction of disease in a vaccinated group of people compared to an unvaccinated group, using the most favorable conditions)of more than 90% was seen so it was given EUA in many countries. The Pfizer/BioNTech BNT162b2 vaccine was based on the use of nucleoside-modified mRNA (modRNA) which encoded the spike protein found on the surface of the SARS-CoV-2 virus encapsulated in lipid nanoparticles.

A Similar mRNA work approach was seen by Moderna and NIH. Within two days they finalized their sequence for vaccine mRNA-1273.The first participant in the phase I study was dosed within 63 days of the sequence selection. Vaccine efficacy of more than 90% was seen in mRNA-1273. On 18 December 2020 USFDA authorized the Emergency use of the vaccine for individuals 18 years or older. Many countries after the USA, have given emergency use approval (EUA)for mRNA-1273 till today. Moderna vaccine mRNA-1273 is composed of nucleoside-modified mRNA (modRNA) encoding a spike protein of SARS-CoV-2, which is encapsulated in lipid nanoparticles.

FUTURE OF mRNA in VACCINES AND THERAPEUTIC AREA

With emerging variants of Coronavirus mRNA vaccines are showing protection against few new variants. Modified mRNA vaccines according to emerging variants are also being developed and studied by many companies worldwide. 6 more mRNA new vaccines are in pipeline, with one in India by Gennova Biopharmaceuticals Ltd in collaboration with HDT biotech, called HGC019. Animal studies have been done and now they are gearing up for Human Clinical Trials. Other vaccines are CureVac by GSK, MRT5500 by Sanofi and Translate Bio, PTX- COVID19-B by Providence therapeutics, one in under development in Thailand, and Pfizer/BioNTech are developing various modified mRNA vaccines. 

With the development of mRNA vaccines, Science has reached the next level of advancement. But this comes with the pros and cons of the substance. The major con is Storage temperature; it requires very low degree storage and that is causing a problem in many countries for storage or transport globally, wherever it is essential. But with the Indian version HGC019, we are hoping this problem might get solved as it is claimed it is stable at 2-8°C. Pros consisted of short time to design and test mRNA vaccine, rapid and easy manufacturing compared to traditional vaccine.

mRNA is also considered to be used in mRNA-based therapies like protein replacement therapy in cardiology, oncology, pulmonary medicines, etc., and treatment of diseases. Hope this mRNA serves as a boon to the biotechnology industry and a golden substance for humankind.

REFERENCES:

  1. Moderna work 
  2. RAPS Vaccine Information
  3. Pfizer Vaccine 
  4. Moderna Vaccine