Mercy adopts new blood cell transfusion guidelines

SIOUX CITY | Mercy Medical Center -- Sioux City has stepped up efforts to conserve red blood cells.

All hospitals in the Trinity Health network have applied the new national recommendations developed by The Joint Commission and the American Medical Association -- convened Physician Consortium of Performance Improvement that advise adopting a "more restrictive" practice of red blood cell transfusion to produce better patient outcomes.

"We want to give just what is necessary, one unit at a time," said Dr. Gregg Galloway, a pathologist and vice chair of the Infectious Disease Committee at Mercy. "Give him a unit of blood. It will make him feel better -- that's the old paradigm. We don't believe it anymore."

Mercy has always had guidelines in place instructing staff when to give red blood cell transfusions, but Galloway said those rules have significantly changed and are "more restrictive" than they used to be.

"We're doing it because we do believe it is better quality patient care at all health care institutions and because of the cost of the resources," he said.

The new guidelines were released following a September 2012 national summit that convened representatives from 112 professional organizations and associations in effort to curb overuse of five medical treatments. Transfusion of red blood cells in hospitals was one of them.

A decade of studies, according to Galloway, found that when "more restrictive" red blood cell transfusion practices were used, hospitalized patients had lower mortality rates, fewer complications from infectious diseases, less breathing problems and cardiac events, as well as a reduced chance of developing acute respiratory distress syndrome -- a life-threatening lung condition that prevents enough oxygen from getting to the lungs and into the blood.

Galloway said hospital staff give patients red blood cell transfusions based on their hemoglobin (a protein in red blood cells that carries oxygen) and hermatocrit values (percentage of red blood cells found in whole blood). When their hemoglobin value dropped below 10 grams per deciliter (G/dL), the patients received a transfusion. The "more restrictive" guidelines, he said, don't recommend transfusion until hemoglobin values fall between 7 and 8 G/dL.

"Big difference. You're going to use less red cell and units in the hospital," he said. "We predict that overall we'll have a 15 to 20 percent drop over the next year and a half to two years in our red cells that we'll use in our hospital setting."

Once blood is collected at a donation center, it's processed, placed in a refrigerator and stored. Chemical changes, he said, occur in the hemoglobin, and red blood cells lose their malleability.

"Those red blood cells start to change," he said. "They are no longer like the normal red blood cells you and I have floating around in our body. Banked blood is a tissue transplant. Those are somebody else's red cells."

In addition to the new guidelines, Galloway said, improvements in surgical techniques that reduce the need for red blood cell transfusions in the operating room are also contributing to the downward trend.

Surgeons are encouraged to salvage patients' blood in the operating room, a practice that was once reserved for open heart surgery. Now it's being used in trauma, abdominal aneurism and orthopedic surgeries.

"We're trying to save the patient's own blood. We re-process it in the OR and we give it back to them," Galloway said. "We also have new hemostatic medications that we can give patients that keep them from bleeding as much in OR."

Large hospitals, he said, now have blood management programs that staff nurses who review a patient's clinical situation alongside the guidelines. Some patients seeking elective surgery, he said, may have to wait longer to get into the operating room if they lack enough healthy red blood cells.

The incredible value of blood saving....

Click to enlarge.... Bloodless surgery in US Jehovah's Witnesses results in Heart benefits.

TRALI - further evidence to minimize transfusion

TRALI 

Transfusion-Related Acute Lung Injury (TRALI) is a syndrome characterized by acute respiratory distress following transfusion. All plasma-containing blood products have been implicated including rare reports of IVIG and cryoprecipitate. It is a rare complication of allogeneic blood transfusion but the incidence has not been well established due to difficulty in defining the syndrome and to variable reporting mechanisms worldwide. Various studies have estimated the overall frequency of TRALI to be between 1/1,120 and 1/57,810 units transfused. However, there is wide discrepancy in the literature with the reported frequency is as low as 1/557,000 RBC units and as high as 1/432 platelet units.

TRALI is associated with a high morbidity with the majority of patients requiring ventilatory support. However, the lung injury is generally transient with PO2 levels returning to pretransfusion levels within 48 -96 hours and CXR returning to normal within 96 hours. TRALI is associated with a significant mortality rate, often approximated at 5 to 10%. Given the gains in safety made within the blood component production industry, particularly with respect to transmission of infectious diseases, TRALI is now among the three leading causes of transfusion related fatalities along with ABO incompatibility and bacterial contamination.

Transfusion-related acute lung injury and pulmonary edema in critically ill patients: a retrospective study.

Rana R, Fernández-Pérez ER, Khan SA, Rana S, Winters JL, Lesnick TG, Moore SB, Gajic O.

Source

Division of Pulmonary and Critical Care Medicine, Mayo Clinic College of Medicine, Rochester, Minnesota 55905, USA.

Abstract

BACKGROUND:

Using the recent Consensus Panel recommendations, we sought to describe the incidence of transfusion-related acute lung injury (TRALI) and transfusion-associated circulatory overload (TACO) in critically ill patients.

STUDY DESIGN AND METHODS:

Consecutive patients at four intensive care units (ICUs) who did not require respiratory support at the time of transfusion were identified with custom electronic surveillance system that prospectively tracks the time of transfusion and onset of respiratory support. Respiratory failure was defined as the onset of noninvasive or invasive ventilator support within 6 hours of transfusion. Experts blinded to specific transfusion factors categorized the cases of pulmonary edema as permeability edema (suspected or possible TRALI) or hydrostatic edema (TACO) according to predefined algorithm. In a nested case-control design, transfusion variables and lung injury risk factors were compared between the TRALI cases and controls matched by age, sex, and admission diagnosis.

RESULTS:

There were 8902 units transfused in 1351 patients of whom 94 required new respiratory support within 6 hours of transfusion. Among 49 patients with confirmed acute pulmonary edema, experts identified 7 cases with suspected TRALI, 17 patients with possible TRALI, and 25 cases with TACO. The incidence of suspected TRALI was 1 in 1271 units transfused; possible TRALI, 1 in 534 per unit transfused; and TACO, 1 in 356 per unit transfused. When adjusted for sepsis and fluid balance in a stepwise conditional logistic regression analysis, patients who developed acute lung injury (suspected or possible TRALI) received larger amount of plasma (odds ratio 3.4, 95% confidence interval 1.2-10.2, for each liter infused; p = 0.023).

CONCLUSION:

In the ICU, pulmonary edema frequently occurs after blood transfusion. The association between infusion of plasma and the development of suspected or possible TRALI may have important implications with regards to etiology and prevention of this syndrome.

Link: http://www.ncbi.nlm.nih.gov/pubmed/16965572

Baxter Announces FDA Approval of Expanded Indication for TISSEEL

DEERFIELD, Ill., Jan 30, 2012 (BUSINESS WIRE) -- Baxter International Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved TISSEEL [Fibrin Sealant] to include general hemostasis in surgery when control of bleeding by standard surgical techniques is ineffective or impractical. TISSEEL is effective in heparinized patients. TISSEEL mimics the final stages of the body's own blood clotting cascade, creating a clot that adheres to the wound surface and helps achieve hemostasis.

"The expanded indication for TISSEEL offers more surgeons an effective tool for controlling bleeding across a wider variety of surgical procedures," said Sibu Saha, M.D., Professor of Surgery, University of Kentucky. "This includes patients who have been treated with heparin who may have unique treatment challenges, which was the case for some of the patients involved in Baxter's clinical trials."
A Phase III clinical study assessed the safety and efficacy of TISSEEL in peripheral vascular surgery compared with manual compression, a standard of care, in 140 evaluable patients (70 patients per treatment arm). In the study, TISSEEL was shown to be statistically significantly better than manual compression in achieving hemostasis. These study results complement a clinical data package showing the safety and effectiveness of the use of TISSEEL as an adjunct to hemostasis.
"TISSEEL and its multiple application devices make it well-suited for a variety of surgical situations, such as open and laparoscopic procedures, reinforcing Baxter's commitment to supporting solutions to the surgical community," said Prof. Hartmut J. Ehrlich, M.D., vice president of global research and development in Baxter's BioScience busines

Important Risk Information

For Topical Use Only. Do not inject TISSEEL directly into the circulatory system or into highly vascularized tissue. Intravascular application of TISSEEL can lead to intravascular coagulation, may result in life-threatening thromboembolic events and may increase the likelihood of acute hypersensitivity reactions in susceptible patients. Exercise caution to minimize the risk of intravascular application when using TISSEEL in surgery.

Do not use TISSEEL in individuals with a known hypersensitivity to aprotinin.

Do not use TISSEEL for the treatment of severe or brisk arterial or venous bleeding. In these situations, TISSEEL will be washed away in the flow of blood before hemostasis can be attained.

Hypersensitivity or allergic/anaphylactoid reactions may occur with the use of TISSEEL. Such reactions may especially be seen if TISSEEL is applied repeatedly over time or in the same setting, or if systemic aprotinin has been administered previously.

Aprotonin is known to be associated with anaphylactic reactions. Even in the case of strict local application of aprotinin, there is a risk of anaphylactic reactions to aprotinin, particularly in the case of previous exposure.

Discontinue administration of TISSEEL in the event of hypersensitivity reactions. Remove remaining product from the application site.

Air or gas embolism has occurred when fibrin sealant was administered using pressurized gas. This may occur if a spray device is used at higher than recommended pressures and in close proximity to the tissue surface.

When using the EASYSPRAY device, or an equivalent spray device for open surgical procedures cleared by FDA, TISSEEL must not be sprayed in enclosed body areas and must be sprayed onto only visible application sites.

TISSEEL is denatured when exposing to solutions containing alcohol, iodine or heavy metals. If any of these substances have been used to clean the wound area, the area must be thoroughly rinsed before the application of TISSEEL.

Apply TISSEEL as a thin layer by dripping or spraying using cannula or spray set. Excess clot thickness may negatively interfere with wound healing.

The safety and effectiveness of TISSEEL used alone or in combination with biocompatible carriers in neurosurgical procedures or other surgeries involving confined spaces have not been evaluated; its use in this setting is not FDA approved.

TISSEEL is made from human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Cryolife announce first patients enrolled for BioFoam (Bovine) trial.

ATLANTA, Oct. 24, 2011 /PRNewswire via COMTEX/ -- CryoLife, Inc., CRY +2.52% , a leading tissue processing and medical device Company focused on cardiac and vascular surgery, today announced that it has enrolled the first patient in its U.S. Investigational Device Exemption (IDE) clinical trial for its BioFoam® Surgical Matrix protein hydrogel technology. In connection with the trial, BioFoam will be used as an adjunct to conservative measures of achieving hemostasis on newly resected liver parenchyma.
The approved IDE is for a prospective, multicenter, randomized feasibility study evaluating safety outcomes of BioFoam as compared to a standard topical hemostatic agent. The feasibility investigation will be conducted at up to three investigational sites and will enroll 20 eligible subjects with 10 subjects in each treatment group.
"We are pleased to begin enrolling patients in our IDE study, which is a milestone in our efforts to obtain BioFoam approval for distribution in the U.S.," said Steven G. Anderson, CryoLife president and chief executive officer. BioFoam is based on the same protein hydrogel technology platform from which BioGlue Surgical Adhesive was developed read more HERE.

Irish Budget cuts mean no CJD screening of donated blood

Ireland - THE MINISTER FOR Health has been advised not to introduce a new technology to screen donated blood for Creutzfeldt-Jakob disease because it would not be cost effective to do so.
Variant Creutzfeldt-Jakob disease (vCJD) is one of a group of rare, progressive fatal non-inflammatory degenerative diseases of the brain affecting humans and animals.
Also known as prion diseases, they are thought to be caused by an abnormal form of a naturally occurring protein in the brain (the prion protein) that has been acquired through infection.
Following a detailed health technology assessment (HTA) carried out by the Health Information and Quality Authority (HIQA), Dr Patricia Harrington, head of assessment with the Authority’s Health Technology Assessment Directorate, said: “The Authority’s HTA found that to filter red cell concentrates as proposed by the blood service would initially cost €11 million per year. It was estimated that such a measure would, over a 10-year period, potentially prevent two deaths from vCJD.”
The origin of vCJD is linked to the outbreak of a bovine form of the disease, bovine spongiform encephalitis (BSE), which occurred in the UK in the 1980s and 1990s.
The incidence of BSE and vCJD peaked in the Britain in 1992-1993 and 2000, respectively, and has been declining since.
However, there is an ongoing risk of vCJD transmission from transfusion of blood or blood products due to donations from carriers of the disease.
Worldwide, there have been five documented cases of transfusion- related vCJD infection, resulting in three deaths from clinical vCJD.
Emphasising HIQA’s increasingly important role as health budgets dwindle, the report states: “Given the likely number of clinical cases and, in the context of a finite healthcare budget, consideration must be given to the existing technologies and services that may need to be displaced should a decision be made to introduce prion filtration, at a cost of up to €11 million per annum.”

Public Increasingly Aware of Meat-Glue in Food - Health Industry Use Certain to be Debated?

As public awareness increases of the use of meat glue (animal derived thrombin) within the food industry, it seems inevitable that the use of similar products in surgery will become a discussion point. Particularly when perfectly viable alternatives are available, it will certainly impact the healthcare sector. Below is an excerpt of a commentary on this practice with further links below. We in the industry are fully aware of the risks associated with bovine thrombin... and this

Not to mention the public belief in regulatory protection

"There was...crap in that stuff. This stuff was manky, it was filthy, it was dirty ... but they still stuck it in the arms of children"

 

Meat what are you getting now?
The commercial meat packing industry and restaurants around the U.S. have found a new way to increase profits by using meat scraps to make filet mignons as well as hot dogs, sausages and stew meat.  Powdered meat glue binds scraps of beef, lamb, chicken or fish, that would normally be thrown out, into solid pieces of meat.  According to its manufacturer, meat glue can be used to produce new kinds of mixed meats (for example combining beef and fish seamlessly).
Meat glue permits restaurants and butchers to sell their meat scraps as premium meat.  Once you cook the glued meat, even a professional butcher or chef can’t tell the difference.
This Franken-food is sold as imitation crabmeat, ham, hot dogs, sausage, fish balls, for making milk, making noodles firmer and making yogurt (water loss) creamier.  It is also used for more expensive products such as filet mignons and veal steaks and products labeled as beef steak, chopped meat, shaped meat, frozen meat, pork or chicken as well as minute steak, formed meat, wafer sliced meat, frozen meat, beef added products, chopped meat, molded meat, cubed or frozen beef, chicken and pork as well as some Hydrolyzed plant protein.
So how do they glue meat together and make it look just like filet mignons?  Super glue?  No!  A new miracle glue from 3M?  No!  The industry uses a pseudo-coagulant called Thrombin or Fibrimex, which were initially banned in Europe but now sold in the EU, Australia, Canada and the U.S.
Thrombin is sold under the brand names Activa RM and Fibrimex.  The products derive from pig or bovine blood.  The active ingredient is called transglutaminase.  When sold in a store, products containing transglutaminase are labeled as “composite meat product”.  However there are no labeling or disclosure requirements placed on restaurants.
But meat glue sold as Thrombin and transglutaminase have a different enzyme makeup.  Transglutaminase is the enzyme that cross-links proteins in “meat glues.”  Thrombin is a different protein, a protease that causes increased transglutaminase activity.  Thrombin can be hazardous to use because if it enters a cut it can cause extensive blood clotting.
Thrombin contains Maltodextrin and sodium caseinate which contain (without disclosure) Ajinomoto’s MSG.  Blood carries bacterias, toxins and viruses causing infections and autoimmune responses in animals as they do in humans.
Factory farms also use growth hormones (steroids) that require daily doses of antibiotics in an effort to control or minimize illnesses.  Animal feed used in CAFOs contains pesticide residues that also contribute to illness.  The use of antibiotics signals an admission that factory farmed animals are sick or become sick.  Why would you give daily doses of antibiotics to an animal or human being unless they were sick?
The infectious agent that leads to mad cow disease can also be passed through animal blood meal.  As a result of mad cow’s disease cases in 2004, the Bush administration’s FDA said it “would ban animal blood in cattle feed, while dietary supplements and cosmetics would be kept free of materials from cattle too sick or hurt to walk.”  Consumer groups said the protections did not go far enough.  Why does the food industry and the USDA think animal blood meal is now safe for human consumption?  What has changed since 2004? 

Links

Full excerpt HERE.

Fibrimex website HERE and Ajinomoto HERE

EU Protocol for the use of CryoLife BioFoam

CryoLife protocol for EU rollout of BioFoam, Click Thumbnail to view.

ARCHIVE
On 10/27/09, CryoLife (NYSE: CRY) announced that the FDA has granted approval for the company's Investigational Device Exemption (IDE) to conduct a human clinical trial for its BioFoam Surgical Matrix protein hydro-gel technology. BioFoam will be used to help seal liver parenchymal tissue when cessation of bleeding by ligature or other conventional methods is ineffective or impractical. The approved IDE is for a prospective, multicenter, randomized feasibility study evaluating safety outcomes of BioFoam as compared to a standard topical hemo-static agent. The feasibility investigation will be conducted at two investigational sites and will enroll 20 eligible subjects with 10 subjects in each treatment group.
CryoLife now will seek approval from the U.S. Department of Defense (DoD), which will be the final step necessary to begin this trial. CryoLife is currently conducting a 60-patient controlled clinical launch of BioFoam at up to six centers in the United Kingdom, Germany, France and Italy. Upon successful completion of the feasibility study, and subsequent FDA and DoD approvals, a follow-on prospective, multicenter, randomized, controlled pivotal study will be conducted. It is currently anticipated that the pivotal investigation will enroll a total of 164 eligible subjects, 82 subjects in each treatment group across a maximum of 10 investigational sites.

U.S. FDA advisory meeting - TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE

On Oct. 28, the committee will discuss FDA's risk assessment for potential exposure to the variant Creutzfeldt-Jakob disease(vCJD) agent in U.S.-licensed plasma-derived Factor VIII and labeling of blood and blood components and plasma-derived products, including plasma-derived albumin and products containing plasma-derived albumin, to address the possible risk of transmission of vCJD.
On Oct. 29, the committee will hear informational presentations related to FDA's geographic donor deferral policy to reduce the possible risk of transmission of CJD and vCJD by blood and blood products and human cells, and tissue and cellular and tissue based products. The committee also will hear updates on the development of devices to remove transmissible spongiform encephalopathy agents from blood components and chronic wasting disease.

DATE: Oct 28-29, 0830/1230

LOCATION: Holiday Inn, 2 Montgomery Village Ave., Gaithersburg, Md.

CONTACT: Bryan Emery or Rosanna Harvey, 301-827-0314

"There was...crap in that stuff. This stuff was manky, it was filthy, it was dirty ... but they still stuck it in the arms of children"

Patients have called for the inquiry into how people were given infected blood by the Scottish NHS to have a wider remit, as hundreds of pages of evidence were published.
Campaigners hailed the release yesterday of the preliminary report by Lord Penrose, who is chairing the probe, as a milestone.
It included a list of issues that he will investigate during the next year, among them the use of commercial blood products after it was realised internationally that they carried a risk of Aids and the acceptance of blood donations from prisoners.
Hundreds of people in Scotland were given contaminated blood in the 1970s and 1980s either as treatment for blood clotting disorders or through blood transfusions.
The plight of those who caught HIV or hepatitis C as a result is acknowledged in the opening of the preliminary report.
It says: “It would have been impossible for any person involved in this inquiry to have been unaware of and to have remained untouched by the physical, mental and emotional suffering of the individuals and families affected by these serious and potentially fatal diseases.”
Campaign groups including Haemophilia Scotland said that after years of frustration they were pleased to have such a substantial document.
However, they expressed concern that many of the victims and their families who want to be core participants with legal representation when the inquiry progresses to oral hearings will be disappointed.
About 70 patients and their relatives applied to Lord Penrose to be core participants, but so far it is understood about 14 have been accepted.
In addition, Bruce Norval, who has hepatitis C after receiving contaminated blood, complained the inquiry would not explore other infections – in addition to hepatitis C and HIV – to which haemophiliacs given clotting agents may have been exposed.
He said: “One thing that needs to be highlighted is that haemophiliacs are due a public, truthful account of the full toxic potential of the clotting agents we were treated with from childhood. At the moment, the remit would not fully allow for that.
“What we are trying to get is an understanding why this small group of people, which was 500 strong, are now down to half that number, with more dying on a monthly basis.
“There was all kinds of crap in that stuff. This stuff was manky, it was filthy, it was dirty and they knew it, but they still stuck it in the arms of children.”
The inquiry will examine how patients affected were tested for infections and informed about the results. According to the report, almost two-thirds of patient witnesses said they did not know they were being tested for hepatitis C or HIV and a number describe finding out they had hepatitis C years after tests were carried out.
Lord Penrose has been given accounts of doctors dismissing the illness as “nothing to worry about”, while one witness with HIV said the doctor who told his family was “quite blase”.
The report was released after the inquiry team analysed more than 80,000 documents and took more than 100 statements from patients and relatives.
Solicitor Advocate Patrick McGuire, of Thompsons solicitors, the recognised legal representative of families and sufferers, welcomed the report.
He said: “The document … is clearly very well reasoned and therefore a clear measure of the amount of work that has been put in by Lord Penrose and his team and for that I would personally like to thank him.”
He added that it was subject to consultation and he would be discussing some issues with Lord Penrose.
Lord Penrose said: “It is important to emphasise that I have not reached any conclusions on matters of fact or provided any recommendations at this stage and the list of topics that I have included for further investigation at the public hearings is not definitive.
“I am now inviting comments on these topics from interested individuals and organisations by the end of October.”

Baxter - Naughty advertisements say FDA

Federal regulators are warning Baxter Healthcare that it is overstating the benefits of Aralast, an emphysema drug, and say they have noticed that the company has a disturbing trend of overstating the effectiveness of its drugs and medical products. On August 3, the FDA sent a warning letter to Baxter CEO

Robert Parkinson, Jr., accusing the company of deceptive advertising in a physician brochure for Aralast NP. The FDA has determined that the brochure misbrands Aralast NP illegally, making overstated claims of efficacy. The FDA warning letter states that the Aralast brochure makes the drug appear to be more effective than has been demonstrated by implying that its alpha1 – antitrypsin levels have a protective effect and clinical benefits that have not actually been clinically proven. In an unusual move, the agency also admonishes the company for its trend toward misleading advertising. “[W]e are very concerned by your continued violative promotion of your products,” the letter states, and then points out that the FDA has cited Baxter for similar violations of overstated efficacy and “unsubstantiated claims of superiority” in letters on April 14, 2009 and July 7, 2008. The April 2009 warning letter cited the company for false and misleading advertising for TISSEEL, a hemostatic surgical tissue glue. Baxter claimed that TISSEEL was 97.5% effective in achieving hemostasis in patients undergoing a cardiopulmonary bypass while on Baxter’s blood thinner, Heparin. The FDA said that claim was unsubstantiated. The July 2008 warning letter chastised the company for also overstating the efficacy of FEIBA VH, a freeze-dried, sterile form of human plasma used to control bleeding in patients with hemophilia in an e-mail. The company claimed that the substance controlled bleeding in 60% of cases within 12 hours of the first infusion. The FDA said that was inconsistent with the prescribing information, which only noted a success rate of 36% with one infusion. The FDA also said the company understated the risk of serious thrombotic events. In its latest warning letter, the FDA has demanded that Baxter not only fix the misleading Aralast information, but is also requiring the company to come up with a plan in writing that will put policies and procedures in place in the company to prevent future misleading advertising problems. If the company fails to comply it could be subject to FDA regulatory action, including seizures and injunctions.

US Military faces challenges from Chinese Knock-offs

As anyone who has served in combat knows, if a buddy is wounded, the first two things you need to do are make sure he can breathe and his bleeding is stopped.
For the past several years, troops serving in Afghanistan and Iraq have used an advanced Combat-Application-Tourniquet (C-A-T) developed by Composite Resources in Rock Hill, S.C. The tourniquet features a nylon strap and a plastic rod to tighten the strap to stop bleeding.
The regulation C-A-T costs about $28. But about two years ago the Army detected cheap knock offs made by a Hong Kong company that had entered the military's supply chain in Afghanistan and Iraq. The imitation sold for about $8.50.
They're accurate looking fakes, right down to the label and national stock number.
But as Col. John Kragh, a doctor at the U.S. Army Institute of Surgical Research at Fort Sam Houston, pointed out in June, the rod on the fake tourniquet "is bendable to a point where it cannot work right. It's like bending Gumby's arm."
He said the fake tourniquet could be fatal because it cannot stop bleeding. Kragh added a decentralized ordering system probably accounts for the presence of the fake tourniquets in the field, with low-level supply personnel ordering the knock offs over the Internet based on price.
The Defense Department issued a warning about the knock-offs in April, Kragh said, and the Food and Drug Administration this month put out a safety alert about the tourniquets, which are also used by civilian first responders.
The lesson here is a good deal isn't always that; it can even be deadly.

Poll Result - Which Geographical Manufacturing Area for Hemostatic Devices Causes Concern?

Controversies

2007 Chinese Export Recall

The 2007 Chinese export recalls were a series of scandals involving tainted food and products exported from China, starting with tainted pet food imported from China to the United States that poisoned pets. The recalls sparked international concern that many products made in China do not meet minimum quality standards. Soon after, the US halted imports of seafood from China after tests detected the presence of drugs unapproved in the US.China has gone on record to admit that nearly a fifth of products made in China do not reach minimum standards. Also, some children's toys made in China were found to contain excessive levels of lead, prompting widespread concern. In 2006, shipments of cough syrup and other medicines, imported from China to Panama and laden with the toxin diethylene glycol, caused mass poisonings and killed 83 people.
On December 19, 2007, The US House of Representatives passed legislation (H.R. 4040) that would significantly amend the current U.S. safety establishment for consumer products imported from China.

2008 Chinese heparin and milk scandals

In March 2008, major recalls of heparin were announced by the U.S. Food and Drug Administration (FDA) due to contamination of the raw heparin stock imported from China.
The raw material for the recalled heparin batches was processed in China from pig's intestines by the American pharmaceutical firm Scientific Protein Laboratories. The U.S. Food and Drug Administration was quoted as stating that at least 81 deaths were believed linked to a raw heparin ingredient imported from the People's Republic of China, and that they had also received 785 reports of serious injuries associated with the drug’s use. According to the New York Times, "Problems with heparin reported to the agency include difficulty breathing, nausea, vomiting, excessive sweating and rapidly falling blood pressure that in some cases led to life-threatening shock."
Upon investigation of these adverse events by the FDA, academic institutions, and the involved pharmaceutical companies, the contaminant was identified as an "over-sulphated" derivative of chondroitin sulfate, a popular shellfish-derived supplement often used as a treatment forarthritis. Since over-sulphated chondroitin is not a naturally occurring molecule, costs a fraction of true heparin starting material, and mimics the in-vitro properties of heparin, the counterfeit was almost certainly intentional as opposed to an accidental lapse in manufacturing. The raw heparin batches were found to have been cut from 2-60% with the counterfeit substance, and motivation for the adulteration was attributed to a combination of cost effectiveness and a shortage of suitable pigs in China.
When the FDA conducted an inspection of Baxter's Chinese Heparin supplier, it found serious deficiencies at the facility which the FDA detailed in a warning letter.
The FDA has stated that it does not have the funds nor bear the responsibility to inspect on a regular basis overseas manufacturers of active pharmaceutical ingredients such as heparin.
In November 2008, the FDA seized eleven lots of heparin from Celsus Laboratories Inc., a manufacturer in Cincinnati, Ohio.

One year later, the 2008 Chinese milk scandal refers to a food safety incident in mainland People's Republic of China involving milk and infant formula which had been adulterated with melamine, an organic base combined with formaldehyde to form plastic. The result was catastrophic - By 22 September, nearly 53,000 illnesses, over 12,800 hospitalizations, and four infant deaths had been reported, caused by kidney stones and other renal failure.The chemical appeared to have been added to milk in order to cause it to appear to have a higher protein content. The same chemical was also involved in a series of pet food recalls in 2007. In November 2009, two individuals were executed for endangering public safety and producing and selling toxic food.

2009 Made in India scandal

In June 2009, the Nigerian Government Drug Regulatory Authority (NAFDAC) reported about the detention of a large consignment of fake anti-malarial generic pharmaceuticals labeled Made in India but produced in China. The Laboratory analysis conducted by NAFDAC revealed the drugs to be fake and had it not been intercepted, about 64,200 adults would have been affected. The consignment containing Maloxine and Amalar tablets, used for the treatment of Malaria, were valued at 32.1 million Naira and were produced, packed and shipped from China. After Indian Authorities took up the matter, The State Food and Drug Administration (SFDA) of China was asked to investigate the matter[10]. In December 2009, 6 chinese traders were sentenced to death for their involvement.
In July 2009, customs officials in the South Indian port city of Chennai seized spurious cosmetics and mobile phone batteries worth Rs. 30 million, imported into India from Scheko in China. The 40 foot container was held up at the port for more than 75 days and opened on 13th July when the importer did not file a bill of entry. It was reported to contain over 187,000 batteries with Nokia holograms and stickers, and 126,000 cosmetic items including face packs, lipsticks and hair gels.

Further Reading - "These are not isolated cases," Han Yi, director of the administration's quality control and inspection department, told the state media. Underlining his concerns, officials said hundreds of bottles of fake human blood protein were found in hospitals......

Also - Federal drug regulators, in announcing Wednesday that the mystery contaminant in heparin was an inexpensive, unapproved ingredient altered to mimic the real thing, moved closer to concluding that Americans might be the latest victims of lethal Chinese drug counterfeiting.

And - There also seems to be agreement that our regulatory agencies can’t rely on China to police its own factories. The Chinese have lurched between vows of reform and disregard for American concerns about the quality of the country’s products.

Cutting back on blood use could halt infections, illness — and even death

SEATTLE — As a doctor and a patient, Dale Reisner knows the value of donated blood. But when the Seattle obstetrician had to have heart surgery four years ago, she did everything possible not to get a single drop.
“I don’t have any religious problems with it. If I was near death, I definitely would have taken blood, no question,” said Reisner, who is fine now at age 62. “But if I could avoid a transfusion by better pre-op preparation, then I was interested.”
Dr. Dale Reisner actively avoided a blood transfusion during surgery to repair a mitral valve in her heart.
Long dominated by Jehovah’s Witnesses — whose faith forbids blood transfusions — bloodless surgeries and blood conservation programs are now attracting mainstream patients worried about what some experts say are clear risks, including more infections, longer recuperation, increased illness and even death.
"The best blood is in your own veins,” said Dr. Lori Heller, medical director of the blood management program at Swedish Medical Center in Seattle, where Reisner had her surgery — without any transfusion. “We want to think before we transfuse.”
Decades of experience with Jehovah’s Witness patients, including 1.5 million members in the United States, has helped propel the new emphasis on blood management, said Sherri Ozawa, clinical director of the Institute for Patient Blood Management at Englewood Hospital and Medical Center in New Jersey.
“In the early days, it was, ‘We have Witness patients, what in the world do we do with them?’” she recalled. “Now we believe it should be the standard of care.”
More doctors, from cardiac surgeons to orthopedists, are offering patients ways to conserve their own blood and avoid transfusions. From drugs that boost blood levels before surgery to cell salvage and blood diversion techniques during operations and lower thresholds for giving blood at all, the techniques are a sea change in the attitude that more blood is always better.

Egypt - Nearly 7 out of every 1,000 Egyptians acquire HCV infections every year, suggesting intense ongoing transmission

The Arab Republic of Egypt has the highest rates of new hepatitis C virus (HCV) infection in the world, according to a new study published today in the prestigious Proceedings of the National Academy of Sciences. The study also estimates more than 500,000 new HCV infections occur in Egypt every year, likely signaling an epidemic in a country of more than 77 million people. This high rate of HCV transmission may be due to the lack of sufficient standard safety precautions in medical and dental facilities, the authors suggest. “Nearly 7 out of every 1,000 Egyptians acquire HCV infections every year, suggesting intense ongoing transmission. This is the highest level of HCV transmission ever recorded at a national level for a blood borne infectious disease transmitted parenterally, that is, by use of non-sterile medical instruments,” said Dr. F. DeWolfe Miller, lead author of this study and professor of epidemiology at the Department of Tropical Medicine and Medical Microbiology and Pharmacology at the University of Hawaii.Although the high prevalence of hepatitis C in Egypt has been well established for many years, and linked in part to limited safety measures during anti-bilharzia campaigns, published estimates of prevalence from different Egyptian communities failed to provide a nationwide picture of the magnitude of ongoing HCV infection transmission.

To estimate the rate of new HCV cases of infection in Egypt, the authors of the study performed epidemiologic modeling of data from a range of studies, including a 2008 national HCV survey with a representative sample and well-documented study design.“The study opened our eyes to a disease burden similar in scale and challenge to the HIV problem in sub-Saharan Africa: Millions of cases of an infection for which there is no vaccine, no effective treatment, and where case management is so expensive that it is beyond the reach of most patients,” said Dr. Laith J. Abu-Raddad, co-author of the study and assistant professor of public health at the Infectious Disease Epidemiology Group at the Weill Cornell Medical College–Qatar.

The study necessitates not only further analysis of HCV transmission in Egypt but also justifies the immediate increase of resources to strengthen public health measures aimed at reducing the transmission of HCV in clinical and non-clinical settings, according to the authors. Failure to address this problem will result in a massive disease burden in the nation in terms of HCV infection complications, including active liver disease, liver failure, or liver cancer.
“There is only one way to deal with the HCV challenge in this country: HCV prevention,” warned Dr. Miller. “Effective and stronger HCV prevention programs are urgently needed in Egypt. Failure to act could swamp the public health system over the coming decades with millions of cases of HCV disease complications with an economic and social cost that this nation does not have the means to confront.”
Key scientific findings of the study
• Nearly 7 out of each 1,000 Egyptians acquire HCV infection every year for a total of 537,000 new HCV infections every year. This is by far the largest ever recorded rate of occurrence of HCV at a national level of all countries in the world.
• One in every 10 Egyptians is a carrier of the HCV infection, which means that there are at least 4,459,000 persons infected with HCV who are infectious to others. This is the largest reservoir of HCV infection in the world.
• Contrary to the widely-held perception that this rate of occurrence reflects merely the limited safety measures during anti-bilharzia campaigns, HCV incidence likely continues at alarming levels due to limitations in the implementation and enforcement of stringent standard precautions in public and private medical and dental facilities.

Tests aim to settle if fresher blood works better

WASHINGTON — Facing surgery? You could receive blood that's been stored for a week, or three weeks, or nearly six — and there's growing concern that people who get the older blood might not fare as well.
It's a question with big implications for the nation's already tight blood supply.
Blood is rotated almost like milk on the grocery shelf: The Food and Drug Administration allows red blood cells to be stored for 42 days, and hospitals almost always use the oldest in their refrigerators first to ensure none expires. How old the blood you receive is depends on how much the hospital has of your type that day. The average age of transfused blood is just over 16 days.
This summer, hospitals around the country are launching major new research to try to settle if fresher blood really is better for at least some patients. And if so, they're hunting ways to turn back the clock for older blood — like the University of Miami's work to wash away some cellular debris — and offset any deterioration.
Donated blood "saves lives every day. We certainly do not want to run out of it," says Dr. Simone Glynn of the National Institutes of Health, which is spearheading the multimillion-dollar studies.
But if shelf life is proven to make a difference, then "how can we have the safest product possible?" asks Glynn, transfusion medicine chief at NIH's National Heart, Lung and Blood Institute.
Those attempts range from trying to improve the oxygen-carrying capacity of stored blood to ridding it of so-called microparticles, cell fragments that gradually build up in storage.
"It's very challenging to find out what's causing this," Miami's Dr. Wenche Jy, who's leading the microparticle work, says of the age-of-blood debate.
About one in every seven hospitalized patients requires a transfusion, a staggering 15 million bags administered in the U.S. each year — with few donations to spare. Every year, parts of the country experience spot shortages.
Scientists have long known that blood breaks down the longer it's stored, but not whether those changes were enough to trigger side effects.
Several years ago, a number of small studies began suggesting that blood well under the FDA's 42-day storage limit may increase the risk of complications like blood clots, infections, or organ dysfunction.
Then the Cleveland Clinic examined records of 6,000 of its past heart surgery patients — and found those who received blood that was more than two weeks old were slightly more likely to die, required a ventilator longer and had higher rates of infection and kidney failure than those who got fresher blood.
Earlier this year, Connecticut researchers reported similar findings in a study of 200 trauma patients.
But that's far from proof. Maybe the sickest patients just got the oldest blood, a flaw these kinds of look-backs can't overcome. Complicating the controversy, other similarly performed studies concluded age of blood doesn't matter, finding no differences between patients who got older or fresher transfusions.
Enter the more stringent research to find out:
_In the largest NIH-backed study, 15 hospitals will recruit 1,800 patients about to have heart surgery who agree to be randomly assigned to get blood more than 20 days old or less than 11 days old, and then track how they fare. (Patients who don't participate would get older blood anyway, per standard hospital policy.)
_In Canada, researchers are enrolling 2,500 patients in critical-care units into a similar study that defines "fresh" as no older than a week. Separately, they're also studying the question in several hundred premature infants who need blood.
_The Cleveland Clinic has enrolled about 1,000 heart-surgery patients and counting into another comparison, this one defining fresh as no older than two weeks.
At the same time, the NIH is funding eight additional projects to tease apart just what happens to stored blood that might trigger side effects. One leading theory is that stored blood gradually loses its ability to get oxygen to tissues, largely through loss of a blood vessel dilator called nitric oxide.
And Jy's team has found those microparticles play a role in blood clotting and inflammation, and that they start accumulating inside blood bags around day 10. Next up is a study of 500 heart surgery patients to test if washing two- or three-week-old blood in special machines that filter out the microparticles can make a difference.
However the debate turns out, it already may be spurring hospitals to be more conservative with blood.
"We actively seek to avoid transfusions whenever possible," says the Cleveland Clinic's Dr. Colleen Koch, through such steps as using devices that capture and recycle a patient's own blood during surgery.

Victim of blood products sues for hep C relief

OITA (Kyodo) A 61-year-old man filed a suit Friday seeking state relief and damages for being infected with hepatitis C from tainted blood products, which are not covered under a 2008 law on blanket relief for people with the infectious disease.
The plaintiff lodged the suit with the Oita District Court seeking the law to be applied to him and ¥2 million in damages.
In Tokyo, the Health, Labor and Welfare Ministry said this was the first lawsuit filed by a patient with hepatitis C who was given tainted blood products not covered by the relief law.
According to the suit, the man underwent heart surgery at Kurume University Hospital in Kurume, Fukuoka Prefecture, in 1976, and was administered the blood products globulin and albumin.
He developed symptoms of acute hepatitis, including jaundice, two weeks later. He was confirmed to be infected with hepatitis C, according to the legal document.
The plaintiff was found suffering from cirrhosis of the liver in 2007 and was confirmed in 2010 to have developed liver cancer, the document says.
The plaintiff's counsel said there were no other chances for the plaintiff to have contracted hepatitis C except when he was administered the blood products.
The relief law, which was enacted in January 2008, offers blanket relief to people with hepatitis C caused by tainted blood products such as fibrinogen. Globulin and albumin are not covered by the law.
Under the law, people who contracted hepatitis C from contaminated blood products such as fibrinogen will receive compensation ranging from ¥12 to ¥40 million per person depending on the severity of the case.
Hepatitis C is a liver disease mainly transmitted by blood.

Animal Products

Following on from the Bleeding Calf Syndrome posting available HERE and other postings available Here regarding risks of animal sourced products.

I have provided further info above provided by DEFRA. To the best of my knowledge only the UK and Scotland are acting to investigate?

You can follow this link for further details also 'This intriguing disease captures the imagination. The VLA will be working with others to help discover the cause.'

I expect manufacturers will focus efforts on recombinant, plant-based technologies.

While our industry battles achieving financial success in the market with the ideal of creating an agent that is:

• of minimized risk
• efficaious
• cost effective,
• easily deliverable
• and applicable to multiple surgeries

The removal of King Pharmaceuticals crown as leader in the multi- $million Thrombin market by Zymogenetics is

a sure indicator as to market preference and acceptance of these benefits. J&J have a human sourced Thrombin following theirpurchase of Omrix.

Certainly reconstituted animal based technologies are facing severe threats currently as the link between zoonotic diseases (animal/human transfer) become more widely known. While BNP (Bleeding Calf Syndrome) transmission is far from clear it should be of concern. The lack of reporting and individual Government action highlight the inadequacies of public protection even with a cursory investigation.

While Bleeding Calf Syndrome may not pose infection risks via medical devices it exemplifies the public vulnerabilities to weak protection measures from their Governments. This is weak response and is exactly the response delivered that saw vCJD, and Prion borne infections escalate. Harvesting Bovine Materials HERE

Cow Products - Why ?

Bovine Neonatal Pancytopaenia (BNP) is a newly emerging disease syndrome of calves less than one-month-old which has recently been reported in Britain and Europe.
It is often referred to as calf haemorrhagic disease, haemorrhagic diathesis, bleeding calf syndrome or blood sweating disease.
The first cases of the condition were reported in Germany in 2007.Since then, reports of confirmed cases have slowly risen in a number of European countries while the first confirmed case was recently diagnosed in Ireland and there have been four cases confirmed in Northern Ireland to date.

Typically, the clinical signs in young calves can include excessive bleeding from small abrasions of the skin, or even from injection sites, and the passing of large clots of blood in the dung.

Temperature

Calves affected with the condition normally have a high temperature and become rapidly depressed. In the majority of cases, death follows within 24 to 48 hours (mortality of about 90% is commonly reported), with aggressive veterinary treatment, including blood transfusions, normally providing only a temporary respite for the animal.

The disease syndrome tends to affect single calves in a herd although multiple calves have been affected in some herds in Britain and Germany.

Affected calves tend to be found in larger well-managed herds with a large proportion of affected farms also keeping sheep as well as cattle.

Within countries that have identified cases, a geographical pattern to the occurrence of the disease has not been identified nor has any breed or gender association been established.

On post mortem examination of affected calves, significant damage to the bone marrow has been consistently reported.

The bone marrow is responsible for producing the blood cells. Red blood cells are responsible for transporting oxygen, while white blood cells play a role protecting against infection. Platelets are responsible for blood clotting.

Of these three, the platelets are most severely affected, giving rise to the typical clinical signs of poor clotting and widespread bleeding in the calf.

While the cause of the condition is unknown, there is no evidence that the condition is infectious or that it gives rise to food safety concerns.

The fact that apparently normal calves at birth can develop clinical signs rapidly after consuming colostrum has focused the attention of researchers on colostrum. It is possible that colostrum acts as a vehicle for the introduction into the calf of the agent which damages the bone marrow.

During the 24 hours that follow the birth of an animal, the intestine allows antibodies (a form of defence against disease) which are contained in the colostrum to pass from the gut into the blood stream. This is an important step in the transfer of immunity from the mother to her offspring and plays a vital role in preventing disease in the newborn calf.

It is possible that, in a very small percentage of calves, some of these antibodies target the bone marrow cells, leading to the clinical signs of the disease. Indeed, a similar mechanism is known to cause destruction of blood cells in some newborn foals and piglets. Researchers wish to ascertain whether this is the case in affected calves and, if so, to determine what has changed in the cow or her environment which has led to the occurrence of the condition.

The Department of Agriculture, Fisheries and Food's regional veterinary laboratories are available to assist herdowners and veterinary practitioners with laboratory diagnosis and investigation of any suspicious cases.

The Department has offered to provide free post mortem examinations of any young calf with clinical signs typical of the condition.

While the condition is rare, with minimal losses to date, the Department is always vigilant to the occurrence of novel diseases or novel presentations of existing diseases. Herd owners are asked to notify their veterinary practitioner of any young calves with apparent clotting difficulties.