FDA 21 CFR -Part 821 Medical Device Tracking Requirements

The device should be intended to be implanted in the human body for over a year.

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Medical Device Tracking is a very important aspect of the distribution chain of a medical device. This is because it is critical to have a mechanism by which a medical device can be traced and located in its place after it leaves the manufacturer. This system of tracking helps to identify a defective device and ensure that corrective measures are taken immediately. This helps minimize damage, which could range from minor to fatal, depending on the kind of medical device in question.

21cfrPart821MedicalDeviceTrackingRequirementsThe 21 CFR -Part 821 medical device tracking requirements

The FDA’s 21 CFR -Part 821, which became effective in August 1993, is dedicated to medical device tracking requirements. This section requires manufacturers to maintain a system by which they can track the movement of either Class II or Class III devices once they have left the manufacturer’s facility. Tracking is considered the first step for further actions from the FDA, such as mandatory recalls.

Important factors for enforcing 21 CFR -Part 821 medical device tracking requirements 21 CFR -Part 821 medical device tracking requirements have guidelines on the steps that manufacturers must take in order to ensure that they are able to track medical devices after they have left the manufacturer’s facility. These are usually the factors:

  • Failure to track and recall the device should be quite likely to lead to adverse, serious health consequences;
  • The device should be intended to be implanted in the human body for over a year;
  • They should be life-sustaining or life-supporting devices that are put to use in a place outside of a device user facility.

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The Modernization ActThe Modernization Act, which became effective in February 1998, gives the FDA the discretion to decide which manufacturers of certain types of Class II or Class III devices should be part of its program for track their medical devices. By the terms of The Modernization Act, patients whose devices are tracked are not obliged to release details such as their social security number, name, address, or any other identifying information towards tracking.

Duration of tracking is left to the FDAPer 21 CFR -Part 821 medical device tracking requirements, the FDA will decide for how long a manufacturer’s device is being tracked. It will inform the manufacturer when it has decided to stop this activity.

How should manufacturers meet 21 CFR -Part 821 medical device tracking requirements?All manufacturers whose devices are being tracked must establish a written standard operating procedure (SOP). A clearly notified method for tracking the device throughout the distribution channel and a quality assurance program that is inclusive of audit procedures should be part of this undertaking.

Robots may have role in future of elder care

More people live alone these days, and a robot can be a conversation partner for them.

Paro the furry seal cries softly while an elderly woman pets it. Pepper, a humanoid, waves while leading a group of senior citizens in exercises. The upright Tree guides a disabled man taking shaky steps, saying in a gentle feminine voice, “right, left, well done!”

Robots have the run of Tokyo’s Shin-tomi nursing home, which uses 20 different models to care for its residents. The Japanese government hopes it will be a model for harnessing the country’s robotics expertise to help cope with a swelling elderly population and dwindling workforce.

Allowing robots to help care for the elderly – a job typically seen as requiring a human touch – may be a jarring idea in the West. But many Japanese see them positively, largely because they are depicted in popular media as friendly and helpful.

“These robots are wonderful,” said 84-year-old Kazuko Yamada after the exercise session with SoftBank Robotics Corp’s Pepper, which can carry on scripted dialogs. “More people live alone these days, and a robot can be a conversation partner for them. It will make life more fun.”

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Plenty of obstacles may hinder a rapid proliferation of elder care robots: high costs, safety issues and doubts about how useful – and user-friendly – they will be.

The Japanese government has been funding development of elder care robots to help fill a projected shortfall of 380,000 specialized workers by 2025.

Despite steps by Japan to allow foreign workers in for elder care, obstacles to employment in the sector, including exams in Japanese, remain. As of the end of 2017, only 18 foreigners held nursing care visas, a new category created in 2016.

But authorities and companies here are also eyeing a larger prize: a potentially lucrative export industry supplying robots to places such as Germany, China and Italy, which face similar demographic challenges now or in the near future.

“It’s an opportunity for us,” said Atsushi Yasuda, director of the robotic policy office at the Ministry of Economy, Trade and Industry or METI. “Other countries will follow the same trend.”

More than 100 foreign groups have visited Shin-tomi the past year from countries including China, South Korea and the Netherlands.

A few products are trickling out as exports: Panasonic Corp has started shipping its robotic bed, which transforms into a wheelchair, to Taiwan. Paro is used as a “therapy animal” in about 400 Danish senior homes.

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Good Documentation Practices Relating to USP

The General Chapter explains the justification for putting in place Good Documentation Practices in USP and helps the user evaluate and construct GMP activities.

Good Documentation Practices (GDP) is a quintessential part of regulated manufacturing and laboratory environments. GDP has to be adhered to in the regulated industries because it is the only truly authentic method of ensuring that documents are audited and accounted for. GDP is also essential to keep track of and maintain control at all stages of the process and the product. GDP is thus a core requirement of a thoroughly developed Quality System.

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US Pharmacopeia (USP) has laid out a series of GDP’s. One of the major new updates is contained in the newly proposed USP-NF General Chapter <1029>.

Basis for GDP in USPGDP for USP is also formulated on the same principle and rationale on which any GDP is built: proper, accurate and comprehensive records are the backbone to proper documentation, which is the basis for all major and minor procedures and operation.

GDP for USP has guidelines in the General Chapter 1029. These guidelines are given with the intention of helping build a foundation for the Quality Systems, apart from also ensuring the integrity and control of documents.

These GDP’s are meant for use in the production and control of the following:

  • Active pharmaceutical ingredients (APIs)
  • Medical devices
  • Excipients
  • Pharmaceutical products
  • Dietary supplements
  • Food ingredients

The General Chapter explains the justification for putting in place Good Documentation Practices in USP and helps the user evaluate and construct GMP activities.

In what areas are GDP’s listed out in Chapter 1029?GDP’s for USP are mentioned in relation to electronic and paper records, which include reports, raw data, protocol, and procedures concerning analytical data and manufacturing controls, and has recommendations on the kind of information that should be recorded for different kinds of documents that require GMP. A prominent amendment brought into the new chapter 1029 is that there is no longer a distinction between instructions and records, and all records and instructions are broadly merged into “records”.

Some broad requirements of GDP as set out in Chapter 1029USP Good Documentation Practices spell out a number of principles. Some of these include:

  • There should be clarity, accuracy, conciseness and legality of records
  • Every time an action is performed, there should be a documentation
  • Anyone dealing with documents should not backdate or postdate any action
  • The initial of the person who carried out a change should attest her initials and offer an explanation whenever an amendment is made

Electronic or manual records should go by the following GDP’s:

  • Any data entry should be traced back to the person who did the entry
  • Shorthand notations are not allowed
  • Controls should be put in place to ensure integrity of the record
  • When a thermal paper is used, a verified copy of its accuracy should be retained, and the user should initial it with the date

Food Production Is A Modern Agricultural Miracle So Why Is It Under Attack

The study concluded that people of today’s developed nations eat better than the kings of old.

Agriculture is under attack. Environmentalists label modern farming as unsustainable, blaming farming for polluting the planet and destroying the climate. But today’s food is abundant and nutritious—a modern agricultural miracle.

From 1961 to 2013, world population more than doubled from 3.1 to 7.2 billion. But agricultural output more than tripled over the same period, according to data from the United Nations. We are slowly winning the battle against world hunger. The percentage of chronically undernourished people has fallen from 30 percent of world population in 1950 to about 11 percent today.

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Not only the quantity, but the quality and variety of food are much better than in past ages. A 2015 study at Stockholm University compared modern food to recipes from the chef of King Richard II of England in the 1300s. The study concluded that people of today’s developed nations eat better than the kings of old.

In the 1300s, King Richard did not have pepper, cinnamon, cloves and nutmeg, which came to Europe from the Far East in the 1400s. He did not have coffee, which was first brewed in Arabia in the 1400s. He did not have oranges, corn, or pineapple, which arrived in Europe from Asia and North America during the 1400s and 1500s. Today we enjoy dozens of varieties of fruits, vegetables, and meats that were not available in past ages.

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Today’s foods are a product of thousands of years of efforts to cultivate more abundant and more nutritious crops. Cross-pollination of plants, cross-breeding of animals, and now genetic engineering of plants and animals continues to deliver rising farm output with better food quality and variety. Grains, fruits, vegetables, meats, dairy products, and even seafood continue to improve due to advanced farming techniques.

But environmental groups attack modern farming methods as unsustainable, scorning the farmer’s use of water, land, pesticides and energy. A 2010 UN Environmental Programme document states:

Agricultural production accounts for a staggering 70% of global freshwater consumption, 38% of the total land use, and 14% of the world’s greenhouse gas emissions…The use of agrochemicals is related to ecotoxicity, eutrophication and depletion of phosphorus stocks. Intensive agriculture is related to substantial energy use. The loss of soil and biomass carbon can contribute to climate change.

The attacks on agriculture are too numerous to address in a single article, but one aspect of modern agriculture is not well known. Farmers are now giving land back to nature.

According to UN data, land used for farming is now declining. Total world agricultural area, the sum of crop land and pasture land, peaked in 2000 at 4.95 billion hectares and declined about one-half percent through 2013. Over the same period, world agricultural production increased 37 percent. The recent decline in total farm land use occurred despite 41.3 million hectares added for biofuel production, an area larger than Germany.

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How a new technology is changing the lives of people who cannot speak

They’d take an MRI to make sure there wasn’t any serious inward growth, and then schedule the surgery.

Last November, Joe Morris, a 31-year-old film-maker from London, noticed a sore spot on his tongue. He figured he’d bitten himself in his sleep and thought nothing more about it until halfway through the winter holidays, when he realised the sore was still with him. He Googled “cut on tongue won’t heal” and, after sifting through pages of medical information on oral cancer, he decided to call his doctor.

The cut was nothing, Joe was sure: he was a non-smoker with no family history of cancer. But he’d make an appointment, just in case.

I’m sure it’s nothing, the doctor said. You’re not a smoker, and you’re 31 years old. But see a specialist, just in case.

I’m sure it’s nothing, the specialist said, you don’t check any of the boxes, but we’ll do a biopsy, just in case.

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When the biopsy results came back positive for cancerous cells, the specialist said that the lab must have made a mistake. The second time Joe’s biopsy results came back positive, the specialist was startled. Now Joe was transferred to Guy’s hospital, which has one of the best oral cancer teams in Britain.

The oncologists at Guy’s reassured Joe again: the cancerous spot was small, and cancer of the tongue typically starts on the surface and grows inward. This tiny sore could likely be nipped out without much damage to the rest of his tongue. They’d take an MRI to make sure there wasn’t any serious inward growth, and then schedule the surgery.

The image revealed a tumour like an iceberg. It was rooted deep in the base of Joe’s tongue, mounding upward and out, its tip breaking the surface just where the telltale sore was located. “When the doctor told me the news, there was a work email that was bugging me and I still had that on my mind,” Joe wrote to me last summer. “As he was explaining to me that I was going to lose my tongue, I was redrafting a reply in my head.”

“You’re going to lose two-thirds of your tongue,” the doctor was telling him. “This is going to seriously affect your ability to eat. And your speech.”

Joe wanted to know how the surgery would affect his speaking. Would he have a lisp?

The doctor hesitated, and then looked at his hands. “Your family will still be able to understand you.”

A week before the surgery, Joe started to panic: he realised that he might never speak again. Even if he did, he would no longer sound like himself. Knowing that he was about to lose a huge part of his identity, Joe asked a friend to film an interview with him so that he would have a permanent record of his voice.

In the video, Joe’s speech is already beginning to falter: he has a bit of a lisp, and he has to sip water frequently and take breaks to withstand the strain of talking. He is dressed in a black knitted V-neck sweater, and seated near a window through which you can see the London skyline at dusk. He is pale, with sunken, blue eyes, dark, shaggy hair and three days of stubble. He looks a little unwell, a little sad, and a little rueful, as if he’s unsure about being the centre of attention. He keeps ducking his head and looking away, or making jokes. When asked to state the date, he smirks and says, with wry formality, “The date is, I believe, the 24th of February, the year of our Lord 2017.”

Speaking to the camera, Joe struggles genially to articulate what it feels like to contemplate losing his voice for ever. “I’m not what you’d call a vain man,” he says, quietly. “Usually it’s very far into the day before I’ve looked in the mirror. I don’t care about any of that.” He takes a moment. “But I am human. And the idea that I’m going to not look like me or sound like me … terrifying.” He swallows. “And also my job, my life, is all about communication, all about talking. I love talking,” he says feelingly, with a little smile. “I’ve got a few things to say.”

Shortly before this video was taken, the friend behind the camera had come to Joe with some news. He had found a company outside Boston called Vocal ID, which creates custom digitised voices for people who use devices to help them speak. The company could use recordings of Joe speaking to recreate his own voice on a computer for him to keep and use for ever.

When they contacted Vocal ID’s founder, a speech pathologist named Rupal Patel, she explained that it would be possible to digitally reconstruct Joe’s voice if, before his surgery, he was able to “bank” his voice. This meant recording the few thousand sentences that Vocal ID has developed to capture all the phonemes in the English language.

Joe agreed to try. He recorded several hundred sentences and then, realising the magnitude of the task, stopped for several days. “This was my last week of freedom and I had a lot of stuff to do, people to see, life to live (and steaks to eat),” he wrote to me. Two days before the surgery, he started again. Banking his voice was slow and painful – by then, it was excruciating to talk, and he was trying to be at his most eloquent. On the final day, he recorded late into the night.

The next morning, Joe went back to hospital and had his tongue cut out, joining the ranks of those who cannot, in any traditional sense, speak.

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Biocompatibility testing and evaluations for medical devices

It is to prevent the occurrence of such events that biocompatibility testing and evaluations for medical devices has to be carried out.

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.

Potentially deadly drugs stolen in Perth vet break in

Alfaxan are used for general anaesthetic and can be dangerous for human consumption.

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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