Friday, May 31, 2013

Medical Equipment Resources and Consulting Posts New Article about Medical Equipment Inventories

The Newly-Published Article Explains Why it is a Good Idea to Have an Experienced Inventory Team Assess the Amount of Medical Equipment in a Healthcare Facility
Medical Equipment Resources and Consulting (MERC), a group of medical equipment consultants that offers a variety of services including medical equipment appraisals, has just posted a new and informative article to its website. The article, which is titled “Inventory...Do It Yourself?” examines why it is important for healthcare facilities or organizations to arrange for a professional equipment inventory.
While some medical facility owners may contemplate having their own employees do this type of inventory, as the new article points out, it is often a very time-consuming process. This typically leads to overtime, which can be extremely costly for health care facilities to absorb.
“This is where it is beneficial to have an experienced inventory team handle the process,” the new article noted, adding that they can complete the medical equipment valuation and inventory while the hospital and staff function as normal, preventing a time consuming distraction for the facility.
“The length of time to needed complete in-house versus hiring a consultant could be very significant, and the thorough and accurate capture of asset data is vital to results.” Since the day MERC opened for business, they have strived to help save healthcare providers money. For example, inventory services—like the ones described in the newly-published article—can help provide clients with the information they need to more effectively manage their assets. Arranging for a professional medical equipment inventory also helps hospitals and other healthcare facilities to know what replacements are necessary. In turn, this can help them to plan for future purchases and budget accordingly. Another service that MERC provides that can help save their clients money is reconciliation to an asset ledger; this allows healthcare organizations to make better financial decisions. For example, specific serial numbers that are assigned to journal entries will show a more complete picture of the organization’s portfolio and its depreciation. As clients have told the staff at MERC, having a clear understanding of what they have at a facility helps them save money.
Finally, MERC offers both transition services and liquidation, which can help ease the often massive amounts of stress that accompany a facility move. By offering a transition plan that is coordinated with the construction schedule and patient move plan, as well as a host of other details, MERC will take the burden of the move off the medical facility and can also be a “go to” source of help and support for the transition events.
About Medical Equipment Resources and Consulting:
Medical Equipment Resources and Consulting, a division of HLW Enterprises, Inc., is a group of medical equipment consultants helping healthcare providers maximize the value of their medical equipments. Founded in 2007, MERC boasts rich experience in the Healthcare industry that is well beyond its youth as a company. Already with a strong and diverse project portfolio, the company’s medical equipment consultants are experienced and are able to help their clients achieve their facilities’ goals.

Medical Equipment Resources and Consulting Posts New Article about Medical Equipment Inventories

The Newly-Published Article Explains Why it is a Good Idea to Have an Experienced Inventory Team Assess the Amount of Medical Equipment in a Healthcare Facility
Medical Equipment Resources and Consulting (MERC), a group of medical equipment consultants that offers a variety of services including medical equipment appraisals, has just posted a new and informative article to its website. The article, which is titled “Inventory...Do It Yourself?” examines why it is important for healthcare facilities or organizations to arrange for a professional equipment inventory.
While some medical facility owners may contemplate having their own employees do this type of inventory, as the new article points out, it is often a very time-consuming process. This typically leads to overtime, which can be extremely costly for health care facilities to absorb.
“This is where it is beneficial to have an experienced inventory team handle the process,” the new article noted, adding that they can complete the medical equipment valuation and inventory while the hospital and staff function as normal, preventing a time consuming distraction for the facility.
“The length of time to needed complete in-house versus hiring a consultant could be very significant, and the thorough and accurate capture of asset data is vital to results.” Since the day MERC opened for business, they have strived to help save healthcare providers money. For example, inventory services—like the ones described in the newly-published article—can help provide clients with the information they need to more effectively manage their assets. Arranging for a professional medical equipment inventory also helps hospitals and other healthcare facilities to know what replacements are necessary. In turn, this can help them to plan for future purchases and budget accordingly. Another service that MERC provides that can help save their clients money is reconciliation to an asset ledger; this allows healthcare organizations to make better financial decisions. For example, specific serial numbers that are assigned to journal entries will show a more complete picture of the organization’s portfolio and its depreciation. As clients have told the staff at MERC, having a clear understanding of what they have at a facility helps them save money.
Finally, MERC offers both transition services and liquidation, which can help ease the often massive amounts of stress that accompany a facility move. By offering a transition plan that is coordinated with the construction schedule and patient move plan, as well as a host of other details, MERC will take the burden of the move off the medical facility and can also be a “go to” source of help and support for the transition events.
About Medical Equipment Resources and Consulting:
Medical Equipment Resources and Consulting, a division of HLW Enterprises, Inc., is a group of medical equipment consultants helping healthcare providers maximize the value of their medical equipments. Founded in 2007, MERC boasts rich experience in the Healthcare industry that is well beyond its youth as a company. Already with a strong and diverse project portfolio, the company’s medical equipment consultants are experienced and are able to help their clients achieve their facilities’ goals.

Thursday, May 23, 2013

Huawei South Africa supplies training to disabled children

Huawei South Africa has partnered with Khulisani to launch a mobile ICT Training Centre Project to provide computer skills training to schools for underprivileged disabled(disabled products) children in the South of Johannesburg. The ICT Centre aims to provide a firm foundation in terms of computer literacy, focusing specifically on basic desktop training, MS Office and internet access. E-learning initiatives have been introduced and two individuals have been trained and are being developed with the knowledge, skills and experience to provide computer literacy training and e-learning.

Areas where the mobile ITC Centre will be active in are Meyerton, Vereeniging, Vanderbijlpark, Sasolburg and the surrounding low-income residential areas and informal settlements in the South of Johannesburg. The five special needs schools that will benefit from the project will be J.N.S school for children with Cerebral palsy, EUREKA school for the mentally disabled(disabled supplies), Handhawer School, Sebokeng Technical High school and Thabavuyo School.

Huawei South Africa supplies training to disabled children

Huawei South Africa has partnered with Khulisani to launch a mobile ICT Training Centre Project to provide computer skills training to schools for underprivileged disabled(disabled products) children in the South of Johannesburg. The ICT Centre aims to provide a firm foundation in terms of computer literacy, focusing specifically on basic desktop training, MS Office and internet access. E-learning initiatives have been introduced and two individuals have been trained and are being developed with the knowledge, skills and experience to provide computer literacy training and e-learning.

Areas where the mobile ITC Centre will be active in are Meyerton, Vereeniging, Vanderbijlpark, Sasolburg and the surrounding low-income residential areas and informal settlements in the South of Johannesburg. The five special needs schools that will benefit from the project will be J.N.S school for children with Cerebral palsy, EUREKA school for the mentally disabled(disabled supplies), Handhawer School, Sebokeng Technical High school and Thabavuyo School.

Tuesday, May 21, 2013

Use of portable ultrasound machines to assist with IV placement growing

I learned I have "difficult" veins when I was a teenager having my wisdom teeth removed.
While trying to insert an intravenous line for anesthesia, a nurse stuck my arm over and over until she found the vein. I left with half a dozen bruises. That wasn't the last time an attempt to find my blood vessels left me black and blue.
So I was intrigued when I heard that Matt Fields, an emergency physician at Thomas Jefferson University Hospital, was using ultrasound to insert IVs more accurately in patients at high risk of multiple needle sticks. His goal -- not yet achieved -- is one stick per patient.
Taking this on, Fields said, is "one of the more gratifying things I can do in the ER. I've had patients call me their hero."
Veins can be difficult because they're small or hard to see. People who've had many needle sticks have scarring in their vessels. Some diseases may also reduce tissue quality.
The use of small, portable ultrasound machines(Ultrasound machines for sale) to assist with IV placement has been growing in recent years, particularly in large teaching hospitals like Jefferson. New emergency medicine residents now learn to use ultrasound as part of their training, and older doctors are catching up.
Experts said the technique was spreading to smaller community hospitals and other units where IVs are inserted. Hospitals are also training nurses and technicians to use the machines to find veins. (Jefferson, which doesn't charge extra for use of the device, plans that training this summer.)
Ultrasound is routinely used for placing bigger central lines in the neck or groin. Where it's becoming more common now is in what doctors call peripheral lines, the ones that usually go in patients' forearms.
"It's a game-changer in terms of how we practice," said Ryan Stanton, an emergency physician in Lexington, Ky., who's a spokesman for the American College of Emergency Physicians.
Having a needle plunged into the arm fewer times is, of course, less painful for patients. But Fields said there were other benefits. Using ultrasound means difficult patients can be treated more quickly, reducing ER waiting times. In research he presented last week at the Society for Academic Emergency Medicine's annual meeting, he found it took an extra 50 minutes to place lines in people with difficult veins. Fields said patients have told him they've delayed going to the hospital because they dreaded the IV placement.
Hamid Shokoohi, an emergency physician at George Washington University Hospital, found that use of central lines, the fallback when the staff can't connect to a peripheral vein, fell by 80 percent after technicians learned how to use ultrasound. That's important because central lines are more expensive and prone to infections.
Shokoohi said 25 percent to 30 percent of GW patients now get ultrasound-guided IV placement.
Physicians said the machine, which Stanton says costs $70,000, is used after nurses or techs try a few times and fail. "If you've done it twice and you can't get it, it's time to call somebody else," Stanton said. "I'm kind of a 'two sticks and you're out' guy."
Fields wants to do better. He asks nurses to seek his help before the first stick if they expect to have trouble. To develop a screening tool, he studied who's at high risk. He found that a quarter of patients in the ER get stuck more than once and 12 percent three or more times.
Key risk factors, he said, are patients with visibly difficult veins or a history of difficult access, diabetes, chronic health problems that needed many blood draws, sickle cell disease, and past IV drug abuse.
He showed me how ultrasound works with a young man who did not want his name used due to his past drug use. Five attempts to insert an IV had failed and he seemed to accept it as punishment for past behavior. "I've done damage to my body over the years," he said. "It's just part of what I have to go through now."
Fields placed the round head of the ultrasound(cheap ultrasound machine) wand near the crook of the patient's elbow. A fuzzy black-and-white picture that would look familiar to any mother emerged on the screen. "When you see the baby, tell me," the patient joked.
What Fields saw was a cross section of the man's arm. Blood vessels appeared as dark-centered circles. There was a good candidate a centimeter below the skin. "There's no way you would be able to feel this vein just by examining him on the surface," Fields said.
He numbed the skin, picked a longer-than-usual needle, and began threading it into the vein. He said it usually takes only three to five minutes to do everything, but this vein, perhaps due to stage fright, was challenging. Fields eventually got the IV in.
For fun, he looked at my arm. I've long joked that I can't get really sick because nurses would soon run out of places for IVs. Fields could see why predecessors had struggled. My veins just don't pop to the surface. With the machine, he saw a good one near the inside of my elbow and another at the back of my arm.
With ultrasound, he said, it would be "very easy" to put in an IV. That's good to know, but I'm hoping he never has to prove it.

Use of portable ultrasound machines to assist with IV placement growing

I learned I have "difficult" veins when I was a teenager having my wisdom teeth removed.
While trying to insert an intravenous line for anesthesia, a nurse stuck my arm over and over until she found the vein. I left with half a dozen bruises. That wasn't the last time an attempt to find my blood vessels left me black and blue.
So I was intrigued when I heard that Matt Fields, an emergency physician at Thomas Jefferson University Hospital, was using ultrasound to insert IVs more accurately in patients at high risk of multiple needle sticks. His goal -- not yet achieved -- is one stick per patient.
Taking this on, Fields said, is "one of the more gratifying things I can do in the ER. I've had patients call me their hero."
Veins can be difficult because they're small or hard to see. People who've had many needle sticks have scarring in their vessels. Some diseases may also reduce tissue quality.
The use of small, portable ultrasound machines(Ultrasound machines for sale) to assist with IV placement has been growing in recent years, particularly in large teaching hospitals like Jefferson. New emergency medicine residents now learn to use ultrasound as part of their training, and older doctors are catching up.
Experts said the technique was spreading to smaller community hospitals and other units where IVs are inserted. Hospitals are also training nurses and technicians to use the machines to find veins. (Jefferson, which doesn't charge extra for use of the device, plans that training this summer.)
Ultrasound is routinely used for placing bigger central lines in the neck or groin. Where it's becoming more common now is in what doctors call peripheral lines, the ones that usually go in patients' forearms.
"It's a game-changer in terms of how we practice," said Ryan Stanton, an emergency physician in Lexington, Ky., who's a spokesman for the American College of Emergency Physicians.
Having a needle plunged into the arm fewer times is, of course, less painful for patients. But Fields said there were other benefits. Using ultrasound means difficult patients can be treated more quickly, reducing ER waiting times. In research he presented last week at the Society for Academic Emergency Medicine's annual meeting, he found it took an extra 50 minutes to place lines in people with difficult veins. Fields said patients have told him they've delayed going to the hospital because they dreaded the IV placement.
Hamid Shokoohi, an emergency physician at George Washington University Hospital, found that use of central lines, the fallback when the staff can't connect to a peripheral vein, fell by 80 percent after technicians learned how to use ultrasound. That's important because central lines are more expensive and prone to infections.
Shokoohi said 25 percent to 30 percent of GW patients now get ultrasound-guided IV placement.
Physicians said the machine, which Stanton says costs $70,000, is used after nurses or techs try a few times and fail. "If you've done it twice and you can't get it, it's time to call somebody else," Stanton said. "I'm kind of a 'two sticks and you're out' guy."
Fields wants to do better. He asks nurses to seek his help before the first stick if they expect to have trouble. To develop a screening tool, he studied who's at high risk. He found that a quarter of patients in the ER get stuck more than once and 12 percent three or more times.
Key risk factors, he said, are patients with visibly difficult veins or a history of difficult access, diabetes, chronic health problems that needed many blood draws, sickle cell disease, and past IV drug abuse.
He showed me how ultrasound works with a young man who did not want his name used due to his past drug use. Five attempts to insert an IV had failed and he seemed to accept it as punishment for past behavior. "I've done damage to my body over the years," he said. "It's just part of what I have to go through now."
Fields placed the round head of the ultrasound(cheap ultrasound machine) wand near the crook of the patient's elbow. A fuzzy black-and-white picture that would look familiar to any mother emerged on the screen. "When you see the baby, tell me," the patient joked.
What Fields saw was a cross section of the man's arm. Blood vessels appeared as dark-centered circles. There was a good candidate a centimeter below the skin. "There's no way you would be able to feel this vein just by examining him on the surface," Fields said.
He numbed the skin, picked a longer-than-usual needle, and began threading it into the vein. He said it usually takes only three to five minutes to do everything, but this vein, perhaps due to stage fright, was challenging. Fields eventually got the IV in.
For fun, he looked at my arm. I've long joked that I can't get really sick because nurses would soon run out of places for IVs. Fields could see why predecessors had struggled. My veins just don't pop to the surface. With the machine, he saw a good one near the inside of my elbow and another at the back of my arm.
With ultrasound, he said, it would be "very easy" to put in an IV. That's good to know, but I'm hoping he never has to prove it.

Monday, May 20, 2013

Huawei South Africa supplies training to disabled children

Huawei South Africa has partnered with Khulisani to launch a mobile ICT Training Centre Project to provide computer skills training to schools for underprivileged disabled(disabled products) children in the South of Johannesburg. The ICT Centre aims to provide a firm foundation in terms of computer literacy, focusing specifically on basic desktop training, MS Office and internet access. E-learning initiatives have been introduced and two individuals have been trained and are being developed with the knowledge, skills and experience to provide computer literacy training and e-learning.

Areas where the mobile ITC Centre will be active in are Meyerton, Vereeniging, Vanderbijlpark, Sasolburg and the surrounding low-income residential areas and informal settlements in the South of Johannesburg. The five special needs schools that will benefit from the project will be J.N.S school for children with Cerebral palsy, EUREKA school for the mentally disabled(disabled supplies), Handhawer School, Sebokeng Technical High school and Thabavuyo School.

Huawei South Africa supplies training to disabled children

Huawei South Africa has partnered with Khulisani to launch a mobile ICT Training Centre Project to provide computer skills training to schools for underprivileged disabled(disabled products) children in the South of Johannesburg. The ICT Centre aims to provide a firm foundation in terms of computer literacy, focusing specifically on basic desktop training, MS Office and internet access. E-learning initiatives have been introduced and two individuals have been trained and are being developed with the knowledge, skills and experience to provide computer literacy training and e-learning.

Areas where the mobile ITC Centre will be active in are Meyerton, Vereeniging, Vanderbijlpark, Sasolburg and the surrounding low-income residential areas and informal settlements in the South of Johannesburg. The five special needs schools that will benefit from the project will be J.N.S school for children with Cerebral palsy, EUREKA school for the mentally disabled(disabled supplies), Handhawer School, Sebokeng Technical High school and Thabavuyo School.

Friday, May 17, 2013

Conference of Radiation Control Program Directors


There is one organization that needs to be noted especially with regard to the establishment of regulations by the individual states. This organization is the Conference of Radiation Control Program Directors (CRCPD). In the early 1960s many states were developing radiation control programs. Such programs included, but were not limited to, regulating the use of diagnostic and therapeutic x ray protection, environmental monitoring, and regulating the use of certain radioactive materials including NARM. Simultaneous to the development of these early state and local radiation control programs were similar activities at the federal level. Many of these and varied state, local, and federal programs and activities in radiation control were being developed independent of each other.

A need for uniformity was identified to avoid inconsistencies and conflicts of rules and regulations throughout the country regarding radiation users. As a result, the CRCPD was established in 1968 to serve as a common forum for the many governmental radiation protection agencies to communicate with each other; and promote uniform radiation protection regulations and activities.

To achieve these purposes, the CRCPD developed the Suggested State Regulations (SSR) for radiation control, which it regularly updates as federal or industry changes occur at its website. The SSR address both radioactive materials and radiation machines in medicine(cheap medical equipment) and industry. Although the SSR are only recommendations, their importance is that many states have, and continue to, adopt them as their state regulations giving them the force of law. These suggested rules are discussed in detail below. The primary membership of CRCPD is radiation professionals in state and local government who regulate the use of radiation sources. But it works closely with all relevant federal agencies.

Conference of Radiation Control Program Directors


There is one organization that needs to be noted especially with regard to the establishment of regulations by the individual states. This organization is the Conference of Radiation Control Program Directors (CRCPD). In the early 1960s many states were developing radiation control programs. Such programs included, but were not limited to, regulating the use of diagnostic and therapeutic x ray protection, environmental monitoring, and regulating the use of certain radioactive materials including NARM. Simultaneous to the development of these early state and local radiation control programs were similar activities at the federal level. Many of these and varied state, local, and federal programs and activities in radiation control were being developed independent of each other.

A need for uniformity was identified to avoid inconsistencies and conflicts of rules and regulations throughout the country regarding radiation users. As a result, the CRCPD was established in 1968 to serve as a common forum for the many governmental radiation protection agencies to communicate with each other; and promote uniform radiation protection regulations and activities.

To achieve these purposes, the CRCPD developed the Suggested State Regulations (SSR) for radiation control, which it regularly updates as federal or industry changes occur at its website. The SSR address both radioactive materials and radiation machines in medicine(cheap medical equipment) and industry. Although the SSR are only recommendations, their importance is that many states have, and continue to, adopt them as their state regulations giving them the force of law. These suggested rules are discussed in detail below. The primary membership of CRCPD is radiation professionals in state and local government who regulate the use of radiation sources. But it works closely with all relevant federal agencies.

Wednesday, May 15, 2013

MEDICAL DEVICE RECALLS


Defective medical devices(medical equipment) are subject to recall in the U.S., and the FDA Enforcement Report regularly publishes data on such recalls. For example, a total of 230 medical device-related recalls were made from 1980 to 1982. They were categorized into nine problems areas: defects in material selection and manufacturing, faulty product design, contamination, mislabeling, radiation (X-ray) violations(x ray protection), electrical problems, defective components, misassembly of parts, and no premarket approval and failure to comply with good manufacturing practice.

The first four categories, i.e., defects in material selection and manufacturing, faulty product design, contamination, and mislabeling, accounted for 70% of the recalls. The components of the defects in material selection and manufacturing classification included manufacturing defects, inappropriate materials, and material deterioration.

The subcategories of the faulty product design classification were alarm defects, premature failure, electrical interference, potential for leakage of fluids into electrical components, potential for malfunction, etc. The elements of the contamination category included defective package seals, other package defects and nonsterility. There were four subcategories of the mislabeling category: incomplete labeling, misleading or inaccurate labeling, inadequate labeling, and disparity between label and product. Similar information on other medical device recalls is available from the FDA.

MEDICAL DEVICE RECALLS


Defective medical devices(medical equipment) are subject to recall in the U.S., and the FDA Enforcement Report regularly publishes data on such recalls. For example, a total of 230 medical device-related recalls were made from 1980 to 1982. They were categorized into nine problems areas: defects in material selection and manufacturing, faulty product design, contamination, mislabeling, radiation (X-ray) violations(x ray protection), electrical problems, defective components, misassembly of parts, and no premarket approval and failure to comply with good manufacturing practice.

The first four categories, i.e., defects in material selection and manufacturing, faulty product design, contamination, and mislabeling, accounted for 70% of the recalls. The components of the defects in material selection and manufacturing classification included manufacturing defects, inappropriate materials, and material deterioration.

The subcategories of the faulty product design classification were alarm defects, premature failure, electrical interference, potential for leakage of fluids into electrical components, potential for malfunction, etc. The elements of the contamination category included defective package seals, other package defects and nonsterility. There were four subcategories of the mislabeling category: incomplete labeling, misleading or inaccurate labeling, inadequate labeling, and disparity between label and product. Similar information on other medical device recalls is available from the FDA.

CHOICE OF INSTRUMENTS FOR RADIATION PROTECTION

A radiation field often consists of multiple types of radiation(portable ultrasound machine). Instruments usually must have the capability to detect particular types of radiation and produce relative or absolute measures of their magnitudes, while discriminating against other types of radiation.


Individuals choosing radiation protection instruments for measurements preferably should know about the radiation environment under investigation. Is it predominantly photon radiation, charged particle radiation, neutron radiation, or mixtures thereof? Spectroscopy measurements can determine the types and energy distributions, but often measurements require simpler detection or measurement devices.


The radiation environment may be characterized by the maximum energy of radiation, whether the radiation source is continuous, as with an X-ray unit, rapidly pulsed as with some linear accelerators, or is random decay from a radioisotope. Is the measurement made in the primary direct beam, or in scattered radiation beam filtered by radiation barriers? Choice of instruments depends on why the radiation is being measured.


It is desirable to know the approximate magnitude of radiation, expressed in some appropriate units, and the approximate energy of the radiation. It is then possible to estimate personnel equivalent dose rates in the radiation field. Multiple instruments(cheap ultrasound machine) with different features may be required to properly characterize and measure a radiation environment.

CHOICE OF INSTRUMENTS FOR RADIATION PROTECTION

A radiation field often consists of multiple types of radiation(portable ultrasound machine). Instruments usually must have the capability to detect particular types of radiation and produce relative or absolute measures of their magnitudes, while discriminating against other types of radiation.


Individuals choosing radiation protection instruments for measurements preferably should know about the radiation environment under investigation. Is it predominantly photon radiation, charged particle radiation, neutron radiation, or mixtures thereof? Spectroscopy measurements can determine the types and energy distributions, but often measurements require simpler detection or measurement devices.


The radiation environment may be characterized by the maximum energy of radiation, whether the radiation source is continuous, as with an X-ray unit, rapidly pulsed as with some linear accelerators, or is random decay from a radioisotope. Is the measurement made in the primary direct beam, or in scattered radiation beam filtered by radiation barriers? Choice of instruments depends on why the radiation is being measured.


It is desirable to know the approximate magnitude of radiation, expressed in some appropriate units, and the approximate energy of the radiation. It is then possible to estimate personnel equivalent dose rates in the radiation field. Multiple instruments(cheap ultrasound machine) with different features may be required to properly characterize and measure a radiation environment.

Tuesday, May 14, 2013

FDA GUIDANCE ON ASSESSMENT OF PEDIATRIC MEDICAL DEVICES

As required by the Medical Device User Fee and Modernization Act of 2002 (P.L. 107–250), FDA recently provided guidance on the premarket assessment of pediatric medical devices. The guidance includes a general discussion of developmental considerations and lists a number of factors that should be considered in designing devices or planning clinical studies of devices (FDA, 2004p). The listed factors, which are not mutually exclusive or exhaustive, are
• height and weight;
• growth and development;
• disease or condition;
• hormonal influences;
• anatomical and physiological differences from the adult population;
• activity and maturity level; and
• immune status.
In a further discussion of “unique host characteristics” of pediatric patients, the guidance offers some illustrations of how these characteristics might figure in the assessment of a medical device(cheap medical equipment). For example, in recommending that assessments consider stage of puberty and other developmental milestones, the guidance suggests that clinicians should consider breast bud development in the placement of certain medical devices in infant or young girls (e.g., placement of chest tube in a tiny infant to relieve air or fluid that has collected in the chest, but outside the lungs).

The guidance also summarized the circumstances when clinical data for pediatric populations are appropriate. These circumstances are when • supporting information from sources, such as preclinical bench or animal testing, literature, or adult clinical trials, are inadequate to establish safety and effectiveness for the pediatric indication;
• adult data are inadequate to predict pediatric risks and adverse events;
• pediatric data are needed for validation of design modifications; or
• pediatric data are needed to develop an age-appropriate treatment regimen.
Specific testing requirements will vary depending on the device. FDA, however, stated that its expectations for such tests generally involve the same basic questions and procedures for both adult and pediatric populations.

An article by FDA staff includes additional discussion of pediatric factors as they relate to neurological devices (Pena et al., 2004). With respect to surgical risks, for example, the authors cite concerns about blood loss for patients with small volumes of blood, possible need for sedation for children who cannot control movement during procedures, and repeat surgeries associated with device replacement or growth-associated migration of a device. They note that of 19 high-risk medical devices involving the central and peripheral nervous system that FDA approved between 1994 and 2003,

8 included indications for use in children as well as adults.
In addition to the guidance on premarket assessment, the agency issued guidance on procedures to ensure that advisory panels that review documents such as applications for premarket approval of medical devices appropriately(cheap ultrasound machine) include or consult with pediatric experts. This guidance, which responds to another provision in the Medical Device User Fee and Modernization Act, provides for pediatric expertise to be available (through consultation or inclusion in panel deliberations) in a range of situations. These include when

• there are labeled indications for use that include a pediatric subpopulation or there is a reasonable likelihood that the device would be used in a pediatric subpopulation for the labeled indication;
• there are data in the study that include a pediatric subpopulation;
• there is a reasonable likelihood that the data from the study in the adult population may be used by the applicant to subsequently support a pediatric indication;
• there is a need for advisory panel input on a study design and/or
protocol for use of the device in the pediatric population; or
• there is a reasonable likelihood that the advisory panel may discuss the potential use of the device in the pediatric population.
The next section of this chapter considers how children’s special needs and characteristics may be taken into account in the design and use of medical devices. The descriptive categorizations reflect the committee’s experience and perspectives, reviews of the literature, and information provided during public meetings and other discussions with experts.

FDA GUIDANCE ON ASSESSMENT OF PEDIATRIC MEDICAL DEVICES

As required by the Medical Device User Fee and Modernization Act of 2002 (P.L. 107–250), FDA recently provided guidance on the premarket assessment of pediatric medical devices. The guidance includes a general discussion of developmental considerations and lists a number of factors that should be considered in designing devices or planning clinical studies of devices (FDA, 2004p). The listed factors, which are not mutually exclusive or exhaustive, are
• height and weight;
• growth and development;
• disease or condition;
• hormonal influences;
• anatomical and physiological differences from the adult population;
• activity and maturity level; and
• immune status.
In a further discussion of “unique host characteristics” of pediatric patients, the guidance offers some illustrations of how these characteristics might figure in the assessment of a medical device(cheap medical equipment). For example, in recommending that assessments consider stage of puberty and other developmental milestones, the guidance suggests that clinicians should consider breast bud development in the placement of certain medical devices in infant or young girls (e.g., placement of chest tube in a tiny infant to relieve air or fluid that has collected in the chest, but outside the lungs).

The guidance also summarized the circumstances when clinical data for pediatric populations are appropriate. These circumstances are when • supporting information from sources, such as preclinical bench or animal testing, literature, or adult clinical trials, are inadequate to establish safety and effectiveness for the pediatric indication;
• adult data are inadequate to predict pediatric risks and adverse events;
• pediatric data are needed for validation of design modifications; or
• pediatric data are needed to develop an age-appropriate treatment regimen.
Specific testing requirements will vary depending on the device. FDA, however, stated that its expectations for such tests generally involve the same basic questions and procedures for both adult and pediatric populations.

An article by FDA staff includes additional discussion of pediatric factors as they relate to neurological devices (Pena et al., 2004). With respect to surgical risks, for example, the authors cite concerns about blood loss for patients with small volumes of blood, possible need for sedation for children who cannot control movement during procedures, and repeat surgeries associated with device replacement or growth-associated migration of a device. They note that of 19 high-risk medical devices involving the central and peripheral nervous system that FDA approved between 1994 and 2003,

8 included indications for use in children as well as adults.
In addition to the guidance on premarket assessment, the agency issued guidance on procedures to ensure that advisory panels that review documents such as applications for premarket approval of medical devices appropriately(cheap ultrasound machine) include or consult with pediatric experts. This guidance, which responds to another provision in the Medical Device User Fee and Modernization Act, provides for pediatric expertise to be available (through consultation or inclusion in panel deliberations) in a range of situations. These include when

• there are labeled indications for use that include a pediatric subpopulation or there is a reasonable likelihood that the device would be used in a pediatric subpopulation for the labeled indication;
• there are data in the study that include a pediatric subpopulation;
• there is a reasonable likelihood that the data from the study in the adult population may be used by the applicant to subsequently support a pediatric indication;
• there is a need for advisory panel input on a study design and/or
protocol for use of the device in the pediatric population; or
• there is a reasonable likelihood that the advisory panel may discuss the potential use of the device in the pediatric population.
The next section of this chapter considers how children’s special needs and characteristics may be taken into account in the design and use of medical devices. The descriptive categorizations reflect the committee’s experience and perspectives, reviews of the literature, and information provided during public meetings and other discussions with experts.

Sunday, May 12, 2013

ULTRASOUND GENERATION


Physics Sound is produced by anything that moves in an accelerated fashion. Nowadays, most practical materials are piezoelectric, such as quartz (SiO2), polyvinylidene fluoride (PVDF), and lead zirconate titanate (PZT). Piezoelectricity is an effect that is associated with the crystalline structure of the materials. A piezoelectric crystal yields a voltage across its surface when under strain, and the reverse effect facilitates mechanical oscillations of the crystal in response to an alternating current (ac) electric field applied across its surface.

Transducer Construction
Ultrasound transducers(cheap ultrasound machine) are made from piezoelectric materials, as described above. Typically, a layer of material is used to create a surface area for creation and transmission or reception of ultrasonic waves. The thickness of this layer is a function of the material properties and the desired acoustic frequency. As seen in Fig. 3, acoustic waves are reflected by impedance changes. An oscillating layer of piezoelectric material produces mechanical waves that propagate in the oscillation direction. These waves can be either compressional or shear waves. Here, the focus will be on compressional waves. Constructive interference of waves launched or reflected from the front surface and from the back surface of the crystal yield maximum pressure generation. High frequency transducers(cheap medical equipment) are made from very thin crystals due to their short wavelength and low frequency transducers are made from larger thickness crystals. For example, a 4MHz transducer can be made from a 0.55mm thick crystal. Table 2 lists the speed of sound in PZT5A as 4400m_ s_1. The wavelength in PZT5A at 4MHz is 1.1mm. Transducer crystals are typically machined to a thickness of l/2, that is, 0.55mm for 4MHz. The rationale for this thickness is in the constructive interference of acoustic waves inside of the crystal. Figure 5 shows the bottom of the crystal moving up and down. Mechanical waves will launch from this surface and travel to either side of it. Assume that the bottom side of the surface is facing air and that there is no sound transmitted into it. The sound wave traveling toward the top surface will be transmitted beyond that surface into the desired medium (e.g., tissue).
Reflected waves will travel downward and interfere with upward traveling waves. Moreover, reflected waves experience a phase shift of 1808. This is the reason that l/2 is the required thickness and not l.

ULTRASOUND GENERATION


Physics Sound is produced by anything that moves in an accelerated fashion. Nowadays, most practical materials are piezoelectric, such as quartz (SiO2), polyvinylidene fluoride (PVDF), and lead zirconate titanate (PZT). Piezoelectricity is an effect that is associated with the crystalline structure of the materials. A piezoelectric crystal yields a voltage across its surface when under strain, and the reverse effect facilitates mechanical oscillations of the crystal in response to an alternating current (ac) electric field applied across its surface.

Transducer Construction
Ultrasound transducers(cheap ultrasound machine) are made from piezoelectric materials, as described above. Typically, a layer of material is used to create a surface area for creation and transmission or reception of ultrasonic waves. The thickness of this layer is a function of the material properties and the desired acoustic frequency. As seen in Fig. 3, acoustic waves are reflected by impedance changes. An oscillating layer of piezoelectric material produces mechanical waves that propagate in the oscillation direction. These waves can be either compressional or shear waves. Here, the focus will be on compressional waves. Constructive interference of waves launched or reflected from the front surface and from the back surface of the crystal yield maximum pressure generation. High frequency transducers(cheap medical equipment) are made from very thin crystals due to their short wavelength and low frequency transducers are made from larger thickness crystals. For example, a 4MHz transducer can be made from a 0.55mm thick crystal. Table 2 lists the speed of sound in PZT5A as 4400m_ s_1. The wavelength in PZT5A at 4MHz is 1.1mm. Transducer crystals are typically machined to a thickness of l/2, that is, 0.55mm for 4MHz. The rationale for this thickness is in the constructive interference of acoustic waves inside of the crystal. Figure 5 shows the bottom of the crystal moving up and down. Mechanical waves will launch from this surface and travel to either side of it. Assume that the bottom side of the surface is facing air and that there is no sound transmitted into it. The sound wave traveling toward the top surface will be transmitted beyond that surface into the desired medium (e.g., tissue).
Reflected waves will travel downward and interfere with upward traveling waves. Moreover, reflected waves experience a phase shift of 1808. This is the reason that l/2 is the required thickness and not l.

Wednesday, May 8, 2013

U.S. Divisions Regulating Nonionizing Radiation


The key U.S. government agencies involved in regulating NIR are listed in Table 1. U.S. regulatory guidance specifically addresses some kinds of NIR sources in some spectral regions while omitting direct mention of other sources and spectral regions. For example, Curtis acknowledges that the exposure standards in the OSHA are dated, noting the following weaknesses: the construction industry standard does not include laser classification and controls; the radio frequency exposure limit is from the 1966 ANSI standard (it has no frequency dependence and does not address induced current limits); The RF Safety Program Elements are incomplete. However, the obligation of employers under the General Duty Clause of OSHA to protect workers from recognized hazards compels the control of all potentially harmful NIR hazards(sales lead sheet), whether specifically regulated or not.

Various government agencies also provide a wealth of guidance beyond the requirements specified in the regulations. As noted in Table 1, the FDA regulations apply primarily to manufacturers, so although much FDA guidance clearly pertains to the end users, the FDA typically does not inspect healthcare providers or enforce compliance with FDA guidance by healthcare facilities. However, other organizations that do routinely audit healthcare providers, including in particular the JCAHO, refer to and hold hospitals accountable for compliance with FDA guidance.

Table 2 summarizes the requirements of those states having comprehensive laser safety regulations, adapted and updated from Ref. Many of these states have also passed regulations for the control of other NIR hazards as well. Several nonregulatory organizations have established exposure limits covering the entire NIR spectrum(portable ultrasound machine). The primary industry consensus standard organizations and international standard-setting agencies appear in Table 3. Some of these voluntary standards carry more weight than others, especially internationally. For example, all member countries of the European Union are required to adopt the laser safety standard, IEC/EN 60825-1, of the International Electrotechnical Commission (IEC), which has also been adopted by Japan, Australia, Canada, and nearly every other nation that publishes a laser standard. In addition, the FDA now accepts conformance with the IEC/EN 60825- 1 in lieu of conformance with most (but not all) of the requirements of the U.S. Federal Laser Product Performance Standard. Similarly, the FDA, OSHA, and JCAHO all reference the ANSI Z136 series of standards.

U.S. Divisions Regulating Nonionizing Radiation


The key U.S. government agencies involved in regulating NIR are listed in Table 1. U.S. regulatory guidance specifically addresses some kinds of NIR sources in some spectral regions while omitting direct mention of other sources and spectral regions. For example, Curtis acknowledges that the exposure standards in the OSHA are dated, noting the following weaknesses: the construction industry standard does not include laser classification and controls; the radio frequency exposure limit is from the 1966 ANSI standard (it has no frequency dependence and does not address induced current limits); The RF Safety Program Elements are incomplete. However, the obligation of employers under the General Duty Clause of OSHA to protect workers from recognized hazards compels the control of all potentially harmful NIR hazards(sales lead sheet), whether specifically regulated or not.

Various government agencies also provide a wealth of guidance beyond the requirements specified in the regulations. As noted in Table 1, the FDA regulations apply primarily to manufacturers, so although much FDA guidance clearly pertains to the end users, the FDA typically does not inspect healthcare providers or enforce compliance with FDA guidance by healthcare facilities. However, other organizations that do routinely audit healthcare providers, including in particular the JCAHO, refer to and hold hospitals accountable for compliance with FDA guidance.

Table 2 summarizes the requirements of those states having comprehensive laser safety regulations, adapted and updated from Ref. Many of these states have also passed regulations for the control of other NIR hazards as well. Several nonregulatory organizations have established exposure limits covering the entire NIR spectrum(portable ultrasound machine). The primary industry consensus standard organizations and international standard-setting agencies appear in Table 3. Some of these voluntary standards carry more weight than others, especially internationally. For example, all member countries of the European Union are required to adopt the laser safety standard, IEC/EN 60825-1, of the International Electrotechnical Commission (IEC), which has also been adopted by Japan, Australia, Canada, and nearly every other nation that publishes a laser standard. In addition, the FDA now accepts conformance with the IEC/EN 60825- 1 in lieu of conformance with most (but not all) of the requirements of the U.S. Federal Laser Product Performance Standard. Similarly, the FDA, OSHA, and JCAHO all reference the ANSI Z136 series of standards.

Research and Markets: Medical Equipment Monthly Deals Analysis: March 2013- M&A and Investment Trends

DUBLIN -- Research and Markets (medical_equipment) has announced the addition of the "Medical Equipment Monthly Deals Analysis: March 2013- M&A and Investment Trends" report to their offering.
Medical Equipment Monthly Deals Analysis: March 2013- M&A and Investment Trends report is an essential source of data and trend analysis on the mergers and acquisitions (M&As) and financings in the medical equipment industry. The report provides detailed information on M&As, equity/debt offerings, private equity, venture financing and partnership transactions registered in the medical equipment industry in March 2013.
The report portrays detailed comparative data on the number of deals and their value in the last six months, subdivided by deal types, segments and geographies. Additionally, the report provides information on the top financial advisory firms in the medical equipment industry.

Scope
- Analyze market trends for the medical equipment/medical devices market in the global arena
- Review of deal trends in anesthesia and respiratory devices, cardiovascular devices, dental devices, diabetes care devices, diagnostic imaging, drug delivery devices, endoscopy devices, ENT devices, healthcare IT, hospital supplies, in vitro diagnostics, nephrology and urology devices, neurology devices, opthalmic devices, patient monitoring, surgical equipment, and wound care management segments
- Analysis of M&A, Equity/Debt Offerings, Private Equity, Venture Financing and Partnerships in the medical equipment market
- Summary of medical equipment deals globally in the last six months
- Information on the top deals that took place in the medical equipment market
- Geographies covered include - North America, Europe, Asia Pacific, South & Central America, and Middle East & Africa
- League Tables of financial advisors in M&A and equity/debt offerings. This includes key advisors such as Morgan Stanley, Credit Suisse, and Goldman Sachs
- Review the financial metrics, such as operating profit ratio, P/E ratio, and EV/EBITDA on mergers and acquisitions
For more information visit http:
medical_equipment(cheap medical equipment
About Research and Markets
Research and Markets is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Research and Markets: Medical Equipment Monthly Deals Analysis: March 2013- M&A and Investment Trends

DUBLIN -- Research and Markets (medical_equipment) has announced the addition of the "Medical Equipment Monthly Deals Analysis: March 2013- M&A and Investment Trends" report to their offering.
Medical Equipment Monthly Deals Analysis: March 2013- M&A and Investment Trends report is an essential source of data and trend analysis on the mergers and acquisitions (M&As) and financings in the medical equipment industry. The report provides detailed information on M&As, equity/debt offerings, private equity, venture financing and partnership transactions registered in the medical equipment industry in March 2013.
The report portrays detailed comparative data on the number of deals and their value in the last six months, subdivided by deal types, segments and geographies. Additionally, the report provides information on the top financial advisory firms in the medical equipment industry.

Scope
- Analyze market trends for the medical equipment/medical devices market in the global arena
- Review of deal trends in anesthesia and respiratory devices, cardiovascular devices, dental devices, diabetes care devices, diagnostic imaging, drug delivery devices, endoscopy devices, ENT devices, healthcare IT, hospital supplies, in vitro diagnostics, nephrology and urology devices, neurology devices, opthalmic devices, patient monitoring, surgical equipment, and wound care management segments
- Analysis of M&A, Equity/Debt Offerings, Private Equity, Venture Financing and Partnerships in the medical equipment market
- Summary of medical equipment deals globally in the last six months
- Information on the top deals that took place in the medical equipment market
- Geographies covered include - North America, Europe, Asia Pacific, South & Central America, and Middle East & Africa
- League Tables of financial advisors in M&A and equity/debt offerings. This includes key advisors such as Morgan Stanley, Credit Suisse, and Goldman Sachs
- Review the financial metrics, such as operating profit ratio, P/E ratio, and EV/EBITDA on mergers and acquisitions
For more information visit http:
medical_equipment(cheap medical equipment
About Research and Markets
Research and Markets is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Monday, May 6, 2013

Historical development of medical device

The history of the use of medical devices(sales lead sheet) may be traced back to the ancient times. For example when the ancient Egyptians and Etruscans used dental devices. Today, in many countries, health care expenditures are among the largest social costs, and over the past three decades they have increased quite rapidly. 
In 1980, Organization for Economic Cooperation and Development (OECD) countries on average spent 4.2% of their gross domestic product (GDP) on health care, and by 1984 the figure increased to almost 8% of GDP. In 1958, sales of medical devices in the U.S. totaled less than $1 billion, and grew to more than $17 billion in 1983. Furthermore, in 1988, the U.S. medical equipment production reached around $22 billion. It means the production of medical devices/equipment is an important sector in the U.S. industry. 
The history of the reliability field may be traced back to the 1930s and 1940s, when the probability concepts were applied to electric power generation related problems and Germans applied the basic reliability concepts to improve reliability of their V1 and V2 rockets. Ever since those days, many new developments have taken place, and the field has branched out into many specialized areas: software reliability, human reliability, mechanical reliability, power system reliability , structural reliability, etc. 
Comprehensive lists of publications on almost all of the reliability areas are given in references 11 and 12. The real beginning of the medical device reliability field may be regarded as the latter part of the 1960s. During this period, several publications on the subject Medical Device Reliability and Associated Areas appeared. An article 18 published in 1980 listed most of the publications on the subject, and in 1983 a text on reliability devoted a chapter to medical device/equipment reliability(cheap medical equipment) . Nowadays, the medical device reliability field has become an important component of the general field. This chapter presents some introductory aspects of the medical device reliability field.