Biocompatibility testing and evaluations for medical devices

Biocompatibility testing and evaluations for medical devices is a vital component of patient safety, for it is the only effective means to ensuring that a medical device or any related material, when it happens to come into contact with the patient’s body has to not only perform its intended purpose and function; it should also not result in adverse reactions for the patient.

When medical devices and/or materials come into contact with the patient’s body, they can cause problems or what may be termed adverse effects that can be either short-term or long-term adverse effects to the body. These effects, called acute to chronic, can result in mutagenic effects. It is to prevent the occurrence of such events that biocompatibility testing and evaluations for medical devices has to be carried out.

These evaluations for biocompatibility of medical devices are done to evaluate the interaction between a device and anything it comes into contact with within the patient’s body, such as cells, tissue or body fluids. Essentially, device biocompatibility is assessed to prevent biological risks from happening to the patient.

ISO standard for biocompatibility testing and evaluations for medical devices

The International Standards Organization (ISO) has a specific standard for carrying out and ensuring biocompatibility testing and evaluations for medical devices. It is called ISO 10993-1: 2009, and makes biological evaluation part of a structured biological evaluation program that comes under a risk management process. All these are carried out in accordance with ISO 14971.

ISO 10993-1, Biological Evaluation of Medical Devices – Part 1 The basis for biocompatibility testing and evaluations for medical devices is the Risk Management Process. This is the most prevalent standard for assessing biocompatibility testing and making evaluations for medical devices. In requiring biocompatibility testing and evaluations for medical devices to be conducted in compliance with Principles of Good Laboratory Practice (GLP) and/or ISO/IEC 17025 and requiring the consideration of evaluation of local and systemic risk factors; the ISO 10993-1 is considered the basis for determining the subsequent, necessary biocompatibility testing and evaluations for medical devices.

What factors are tested? In line with the principles set out in ISO 10993-1: 2009 on biocompatibility testing and evaluations for medical devices, specific testing is prescribed based on two factors: a) the type and the intended use of a medical device or related material, and b) the kind, tenure and extent of contact the medical device makes with the body.

ISO 10993-1: 2009 on biocompatibility testing and evaluations for medical devices requires assessment to be made for the following among others:

  • Cytotoxicity
  • Genotoxicity
  • Sub chronic toxicity
  • Sensitization
  • Irritation or intra-cutaneous reactivity
  • Implantation
  • Haemocompatibility
  • Systemic toxicity, etc.
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Antibiotics sales for use in U.S. farm animals dropped in 2016: FDA

CHICAGO (Reuters) – The sale and distribution of antibiotics approved for use in food-producing animals in the United States decreased by 10 percent from 2015 to 2016, a U.S. Food and Drug Administration (FDA) report said on Thursday.

It was the first decline in year-to-year sales since the FDA began collecting the data in 2009, according to food and consumer health groups.

For years scientists have warned that the regular use of antibiotics to promote growth and prevent illness in healthy farm animals fuels dangerous, antibiotic-resistant “superbug” infections in people.Major U.S. food companies including McDonald’s and Tyson Foods have stepped up efforts to curtail, and in some cases eliminate, antibiotics in their products.

“Actions speak louder than words, and the most action we’ve seen on antibiotics has come from food companies,” said Matthew Wellington, Antibiotics Program Director of public interest campaigning group U.S. PIRG. “We’re cheering this good news.”

Last month, the World Health Organization urged farmers to completely stop using antibiotics to enhance growth and prevent disease in healthy animals.

An estimated 70 percent of the kinds of antibiotics that are also used to fight human infections and in surgery are sold in the United States for use in meat production.

In 2016, sales and distribution of those medically important antibiotics for food production fell 14 percent, the FDA said.

Medically important antimicrobials accounted for 60 percent of the domestic sales of all antimicrobials approved for use in farm animals in 2016, the agency said.

The FDA’s data show chicken accounting for 6 percent of medically important antibiotic sales, with swine at 37 percent and cattle at 43 percent.

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FDA’s program to speed up drug approval shaved nearly a year off the process

Speeding the pace at which potentially lifesaving drugs are brought to market was a rallying cry for Donald Trump as a candidate, and is a stated priority of his Food and Drug Administration commissioner, Dr. Scott Gottlieb. But a new study finds that programs already in place were routinely shortening the drug development process by close to a year, and sometimes much more.

Shorter drug-development timelines hold the promise of getting new medications to suffering patients more quickly. But when it comes to getting a drug candidate through clinical trials and FDA review, time is also money. Faster approval means drug companies can begin profiting more quickly from their discoveries. And that may (or may not, according to whom you talk to) result in lower drug prices.

In a Research Letter published Tuesday in the journal JAMA, a trio of health economists from Brigham and Women’s Hospital in Boston set out to test whether and how four FDA programs shortened the length time it took for proposed prescription drugs to get from their earliest clinical trials to market approval.

Of 174 drugs and biologic therapies approved between January 2012 and December 2016, 105 (or 60%) traversed the FDA evaluation process with one of four designations aimed at speeding the path to approval. The 69 candidate medications that had no such hurry-up designations took between 6.5 and 10 years to proceed from the start of human trials to FDA approval, with a midpoint of eight years.

Candidate medications evaluated under one of the four accelerated programs took between 5.1 and 10.1 years to cover the same ground, with a midpoint of 7.1 years.

Those faster speeds were largely attributable to two programs.

One, instituted in 2012, compresses clinical trials, dedicates FDA personnel to provide advice, and streamlines the FDA evaluation process for experimental drugs that may provide “breakthrough” therapy for a disease. Half of the drug candidates that got the breakthrough designation sprinted from the start of human clinical trials to FDA approval in 4.8 years or less, compared with a median start-to-finish time of eight years for drug candidates with no expedited designation.

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3D Printing: FDA Finalizes Guidance for Medical Devices

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The US Food and Drug Administration (FDA) on Monday finalized guidance on medical device additive manufacturing, also known as 3D printing.

The guidance finalizes the draft version from May 2016 and largely keeps intact the recommendations and considerations laid out in the draft.

FDA Commissioner Scott Gottlieb said Monday that the guidance “will help manufacturers bring their innovations to market more efficiently by providing a transparent process for future submissions and [ensures] our regulatory approach is properly tailored to the unique opportunities and challenges posed by this new technology.”

Gottlieb also said that FDA has now reviewed more than 100 3D printed medical device applications, including knee replacements and implants used for facial reconstruction, up from the 85 reviewed at the time the draft was released.

FDA describes the guidance as a “leap-frog” guidance in that it is meant to provide manufacturers about its initial thinking on manufacturing 3D-printed devices and how to characterize and validate such devices. The final guidance also emphasizes that the recommendations made will not be applicable to all 3D-printed devices due to the wide array of available additive manufacturing technologies and materials.

Some changes in the final guidance include new considerations for handling complex design files and cybersecurity considerations for patient-matched devices.

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Potentially deadly drugs stolen in Perth vet break in

A thief who broke into a Perth veterinary hospital may not know one of the drugs they stole is used to euthanise pets, WA Police have warned.

The Forrestdale veterinary hospital was broken into at around 2.15am on Monday morning, and a large quantity of drugs were stolen.

The thief made away with Lethabarb, Apomorphine, Propofol, Alfaxan, Diazepam, Zoletil, Antisedan, Dozadine and ACP.

While a number of drugs the thief took are used as general anaesthetic or sedatives, WA Police warned the thief against taking anything they had stolen.

“The person(s) who stole the drugs may not fully appreciate the dangers associated with veterinary drugs,” police spokeswoman Susan Usher said.

Diazepam is a type of valium while Profpol and Alfaxan are used for general anaesthetic and can be dangerous for human consumption.

Apomorphine also has a peculiar effect on humans, including induced vomiting and potentially causing an erection in males.

However, police are most concerned about the thief taking Lethabarb from the hospital.

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How the Future of Finance Gives You Total Control

In the world of commerce, internet is king as it never sleeps and continues to take transactions long after you and I have laid to rest for the night. With the evolution of finance and online transactions the internet world has taken large steps to make it easier for the consumer and investor to feel more safe and secure with the funds which are being processed.

Remember when Paypal came on the scene? “E-commerce”? It was still like a toddler – wobbling across the room and making the grown-ups feel just a little nervous. Now it’s just commerce. People latched onto this new way of transacting and now it is one of the biggest modes of payment.

Future

Like Paypal, cryptocurrency has big potential. In 2009, Bitcoin launched onto this transactional scene and today, hot on its heels, enters Zen Protocol, a blockchain which is built for finance and completely erases the need for bankers and brokers.

What does this mean for you as a consumer or financial investor, and how does Zen Protocol make a good product even greater? I’m glad you asked. Let me give you the three tips why ZP is one of the hottest reasons you should get involved.

#1 – Safety and Security are Key

When you press the “BUY” button on your favorite clothing line do you pause and hope your financial information won’t be stolen?

I would wager the answer to that question is a “No”. You trust them. You’ve purchased from them before or know someone who has. Besides, their site has that little “s” at the beginning of the URL.

All joking aside, when it comes to cryptocurrency, security and safety is no joke with these guys. You may or may not have heard, but a few weeks ago over $150 million were permanently frozen on the Ethereum blockchain by what seems to have been a mistake. The cause: an Ethereum contract called “Parity multisig”, used by numerous individuals and organizations to store their funds, contained a simple bug.

Believe it or not, this was the second critical bug for this contract. Back in May, when the first flaw was discovered, some “white hat” hackers saved most of the tokens and returned them to their owners. Not this time.

Zen Protocol takes steps to solve the security and safety issue by making it easy to ensure the code actually works for you. It works with a language designed to prove what contracts do – a method called “formal verification”. It also makes simple transactions – like multisig – easy to do, without using special contracts.

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How to free Indians from the medical poverty trap

India is the largest supplier of generic drugs in the world, and Indian pharmaceutical companies have famously succeeded in pushing down the cost of medication in many countries across the world. Yet, too many Indian citizens do not get access to medicines owing to high costs. The preferred solution of the government right now—price control—is suboptimal.

The problem starts with the thin insurance cover that leads to most patients paying for medical expenses out of their pockets after they have been diagnosed with an ailment. The latest National Sample Survey Office (NSSO) survey on healthcare, in 2014, shows that 86% of the rural population and 82% of the urban population were not covered under any scheme of health expenditure support, and that medicines are a major component of total health expenses—72% in rural areas and 68% in urban areas. Healthcare costs pushed 60 million Indians below the poverty line in 2011. Therefore, even a modest drop in drug prices will free hundreds of households from the widespread phenomenon of a medical poverty trap.

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The government is aware of the problem, which is why it has been fixing the prices of “essential medicines” for some time, and even medical devices such as stents and knee replacement caps from this year. As this newspaper has argued, price controls have their costs. First, investment in price-controlled medicines has fallen vis-a-vis non-price-controlled ones. Second, while stent manufacturers like Abbott have been denied permission to withdraw their high-end stents from the market, it is also unlikely that high-end, innovative products will be introduced in the market if they’re commercially unviable.

Generic medicines are affordable versions of the drug, introduced after a company loses patent over a medicine. These medicines are sold either by their salt-name or by a brand (called branded generics). For example, Crocin is a branded generic whose active ingredient is paracetamol. A study by the Indian Journal Of Pharmacology in 2011 revealed that the price to the retailer for the branded product of cetirizine was 11 times the price of branded generics by the same company—the price of the generic was Rs2.24 per strip of 10 tablets and that of the branded medicine, Rs27.16. These costs reveal the markup that companies charge for the research, reputation and marketing costs of branded medicines. However, doctors continue to prescribe branded medicines for rational reasons.

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