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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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 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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The vital area of Pharmaceutical Process Engineering

Pharmaceutical Process Engineering is an often-overlooked area in the field of pharmaceutical manufacturing. It calls for a high degree of precision and coordinates technical expertise and communication between professionals involved at diverse levels of the manufacturing unit, such as pharmaceutical researchers, chemical engineers and industrial. It is concerned with how pharmaceutical development is related to the application of major concepts and important unit operations in the field of pharmaceutical engineering.

Development and adaption of technology is one of the major bottlenecks of pharmaceutical process engineering. The major changes that digitization has brought into areas such as say, education and automobiles are yet to be fully realized in pharmaceutical process engineering. The benefits of digitization are yet to be felt and fully put into use in the crucial areas of pharmaceuticals, such as manufacturing -which, being a high precision area, offers tremendous scope for the use of conceptualizations such as the Internet of Things (IoT)- supply chain management, and Quality Control.

Lack of integration between the core functions and regulatory pressures are often cited as major reasons for which pharmaceutical process engineering is yet to catch up with the drastic changes wrought by technology.

Full understanding of the area of Pharmaceutical Process Engineering

A complete assessment of the present scenario in the pharmaceutical process engineering field, along with the its prospects for the future will be made at a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. At this session, Co-founder and CEO of CGMP University Inc. Training and consulting organization and well-known author of several books relating to GMP; David Muchemu, will be the speaker.

Want to understand the importance and the prospects of this very vital area of pharmaceutical process engineering? Then, please register for this webinar by visiting Choosing process variables to control

Preventing flare-up of issues

David will help participants understand how to avoid being in situations where issues arise after scale up. The main reason this happens is that process variables and their parameters are never established based on hard data and engineering realities. David will offer a solution that combines engineering factors and scientific data collected in the lab into process control to counter such problems. He will explain the following major topics relating to these:

o  The process concept

o  Design of Experiment: DOE

o  Choosing process variables to control

o  Process validation

o  Process scale-up

o  Batch reactors

Of high value to professionals in pharmaceutical process engineering, such as Quality Engineers, Manufacturing Engineers and Line Managers; this webinar will cover the following areas:

o  Quality Risk Management Defined

o  Compliance Requirements for Quality Risk Management

o  The Quality Risk Management Model

o  Quality Risk Management Life Cycle.

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Statement from FDA Commissioner Scott Gottlieb, M.D.

As we continue to confront the staggering human and economic toll created by opioid abuse and addiction, we’re focused on taking actions that reduce the scope of new addiction by decreasing unnecessary exposure to opioids. At the same time, we also must take steps to help those with acute and chronic pain who need access to medicines, including opioids, get access to improved alternatives. Until we’re able to find new non-opioid forms of pain management for those who need treatment for pain, it’s critical that we also continue to promote the development of opioids that are harder to manipulate and abuse, and take steps to encourage their use over opioids that don’t offer any form of abuse deterrence.

Opioids with abuse-deterrent formulations (ADFs) are intended to make certain types of abuse, such as crushing a tablet to snort or dissolving a capsule to inject, more difficult or less rewarding. To date, the U.S. Food and Drug Administration has approved 10 opioid drugs with these properties. But their uptake has been slow among doctors who are treating patients in pain. The reason for their more limited use is likely multifold. We know there can be a learning curve that comes with new technologies. Some prescribers may not be aware of the existence of these drugs, or may be uncertain of when to prescribe the abuse-deterrent versions. But we also know a significant barrier to use can be price. Because these new formulations are currently only available as brand-name products, they’re inherently more expensive than the numerous non-abuse deterrent formulations that are also available in generic formulations.

Transitioning from the current market, dominated by conventional opioids, to one in which most opioids have abuse-deterrent properties, holds significant promise for a meaningful public health benefit. But to transition this market more quickly to the ADFs, and consider permanently withdrawing the older formulations that lack abuse-deterrent features in the event these products were judged to be less safe ‒ there are a number of factors we must consider. One of the factors that the FDA would consider relates to generic access. We must have the potential to improve access to the newer formulations, for appropriately selected and monitored patients, through the introduction of generic competitors.

In order to support this transition and encourage advancements in this area, today the FDA issued a final guidance to assist industry in their development of generic versions of approved ADF opioids. This guidance includes new recommendations about the type of studies companies should conduct to demonstrate that the generic drug is no less abuse-deterrent than its brand-name counterpart. We’re also taking additional steps beyond the new guidance to help developers of generic ADFs navigate the regulatory path to market as quickly as possible and make the review process more efficient and predictable. For example, we’re developing appropriate, improved testing methodologies for evaluating complex features like abuse deterrence for both brand name (innovator) and generic opioid drug products. In addition, we’re also taking a flexible, adaptive approach to the evaluation and labeling of ADF opioids.

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ABP Food Group hosts Sustainability Best Practice event

ABP Food Group recently hosted a best practice Sustainability Summit for its beef and lamb sites. The aim of the event was to showcase and share examples of best practice and expertise from within the Group. All 120 attendees were encouraged to adopt innovations from other ABP Group locations across Ireland and the UK, and integrate to their local site. The bi-annual event, which took place in Dublin, has played a key part in ABP reaching many of its 2020 targets ahead of time.

Commenting at the event, Dean Holroyd, ABP’s Technical and Sustainability Director said: “This is an invaluable opportunity for the wider ABP team to share and learn. At the moment hundreds of innovative sustainability initiatives are taking place across all of our sites in Ireland and the United Kingdom, so it is important that all ABP sites benefit from these.

Today builds on the success of our 2015 event where 50 new sustainability projects were adopted and implemented, contributing significantly to progress against our 2020 targets.”

ABP Food Group is a founding member of Origin Green. Earlier this year the company became the first organisation globally to achieve Carbon Trust Triple Certification for the third time in a row.

The Carbon Trust Standard is the world’s leading independent certification awarded to organisations that can demonstrate they are taking effective action to tackle their environmental impact, verifying reductions in carbon emissions, water use and waste output.

It recognises good management and year-on-year improvements in sustainability performance.

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Current and future USFDA food import and export safety regulations

The US economy’s appetite for ingesting food imports is phenomenal, to use a mild term. How else does one describe an economy that takes in $49 billion a year? Considering that the FDA is the sole regulating agency that is tasked with overseeing imports of this magnitude, who can envy its responsibility? This is not all that the FDA does: its allied regulatory agencies monitor about half a million facilities in the US and abroad.

Since foods from almost every country in the world are brought in into the US to be sold in this huge market; the FDA has put in place very strict regulations for ensuring the food items that enter the US market are of set quality standards. To do so, it sets stringent standards that relate to the critical attributes of food, such as safety, sanitation, healthfulness and labeling.

The FDA coordinates with agencies across the country

The FDA’s coordination with other agencies is gargantuan, given the fact that about seven-tenths of seafood and 35% of all the food items consumed in the US are imported. It works with a number of agencies to carry out its functions. These are some of the agencies with which the FDA works in close association:

o  Homeland Security

o  Customs and Border Protection

o  The FDA and the USDA

o  Center for Disease Control

o  Food Safety Inspection Service

o  Agricultural and Marketing Services

o  Food and Nutrition Services

o  The U.S. Department of Commerce

o  Department of Defense, and

o  The Federal Trade Commission (FTC).

Thorough understanding of the FDA’s work on food imports

A proper understanding of the way the FDA works with food imports, the regulations it has in place, and its expectations from importers is necessary for individuals and organizations that are connected with FDA food imports in one or another way. This knowledge is needed to help them ensure that their products reach US shores without trouble and get regulatory approval from the FDA.

This is the learning a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will offer.

John Ryan, who began Ryan Systems a decade ago and who has been involved in the manufacturing, food, transportation and Internet industries over the past 30 years; will be the speaker at this webinar. please visit Current and Future Safety Regulations

To register for this learning session and get a thorough understanding of the FDA’s rules and thinking on food imports to the US.

Thorough familiarity of the FDA’s work on food imports

An understanding of the ways in which the various agencies work with the FDA in respect to food imports will be offered at this webinar. An in-depth understanding of this aspect is necessary for those who want to import food to the US and gain regulatory approval for their products, as they have to work with the FDA at various levels.

John Ryan will cover the following areas at this session:

o  Global Food Markets drive new import food safety requirements

o  Review how the FDA’s Food Safety and Modernization Act (FSMA) are changing things

o  Understand “Prior Notice” requirements

o  Foreign Supplier Verification Program (FSVP)

o  Prepare for the Foreign Facility Inspection Program

o  Learn what is in the “Investigations Operation Manual” (IOM)

o  What can happen to your product when seized

o  Learn what other countries require for food import

o  Review the proposed rules for food safety and quality during transportation processes

o  Learn how much food and what food is imported from different countries

o  Understand what the Imported Seafood Safety Program includes

o  PREDICT & OASIS Systems

o  Other resources available to help you.

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