HPN in their daily news update on 12/13/07 have reported that the FDA has issued an alert about serious patient injuries, including third degree burns, associated with the use of poorly maintained electric dental handpieces, and to recommend specific actions to prevent or minimize the problem. While this notification is directed to dental health professionals, the following information may be useful to all users of electric handpieces.
Patients have been severely burned when poorly maintained electric dental handpieces were used during dental procedures. Some patients had third degree burns which required plastic surgery. Burns may not be apparent to the operator or the patient until after the tissue damage has been done, because the anesthetized patient cannot feel the tissue burning and the handpiece housing insulates the operator from the heated attachment. Although the reported burns have occurred during cutting of tooth and bone, tooth extraction and other dental surgical procedures, overheating could occur during any dental procedure. Note that this problem is not limited to dentistry. Rotary surgical handpieces can cause patient burns during orthopedic procedures, as reported in the July 2003 edition of FDA Patient Safety News.
Please go to this FDA link for more detailed information on this subject.
http://www.fda.gov/cdrh/psn/show17-burns.html
e premte, 14 dhjetor 2007
e hënë, 26 nëntor 2007
AORN Specialty Assembly for SP/MM News
The AORN Specialty Assembly for SP/MM has released a statement titled "Dancing with the Stars" on their web page concerning how this group interacts with other organizations. Hospital professionals can go to the AORN homepage (www.aorn.org) to view the statementor click on the link below to read the statement.
http://www.cpdguy.net/index.php?s=100&PHPSESSID=a56aee61bcfb545a50adbe75ed709f37
http://www.cpdguy.net/index.php?s=100&PHPSESSID=a56aee61bcfb545a50adbe75ed709f37
e premte, 9 nëntor 2007
FDA and New Requirements for Tracking Medical Devices
Tracking Requirements Relaxed Under FDAAA
Medical devicemakers will be subject to fewer tracking requirements under H.R. 3580, the FDA Amendments Act (FDAAA).
Previously, devicemakers were required to track certain higher-risk devices even if the FDA did not issue a specific order to track a device. Under the new law, tracking will apply only if the FDA issues an order, according to a revised guidance document.
The agency may require tracking for a Class II or III device:
That is a life-sustaining or life-supporting device used outside a device user facility;
That is intended to be implanted in the human body for more than one year; or
Whose failure would be reasonably likely to have serious adverse health consequences.
Tracking methods are subject to FDA inspection, which may include a review of the tracking system and verification of information requirements. Medical device tracking is intended to ensure that manufacturers can promptly identify product distribution information and remove a device from the market in the event of a recall.
This information was posted on the FDA Daily News itmes;Vol.4,No.221,Friday,Nov.9, 2007
http://www.fda.gov
Medical devicemakers will be subject to fewer tracking requirements under H.R. 3580, the FDA Amendments Act (FDAAA).
Previously, devicemakers were required to track certain higher-risk devices even if the FDA did not issue a specific order to track a device. Under the new law, tracking will apply only if the FDA issues an order, according to a revised guidance document.
The agency may require tracking for a Class II or III device:
That is a life-sustaining or life-supporting device used outside a device user facility;
That is intended to be implanted in the human body for more than one year; or
Whose failure would be reasonably likely to have serious adverse health consequences.
Tracking methods are subject to FDA inspection, which may include a review of the tracking system and verification of information requirements. Medical device tracking is intended to ensure that manufacturers can promptly identify product distribution information and remove a device from the market in the event of a recall.
This information was posted on the FDA Daily News itmes;Vol.4,No.221,Friday,Nov.9, 2007
http://www.fda.gov
e martë, 2 tetor 2007
Bush Signs MDUFMA Reauthorization Bill Into Law
President Bush signed the FDA Amendments Act, H.R. 3580, into law Sept. 27, reauthorizing the Medical Device User Fee and Modernization Act (MDUFMA) and granting the FDA additional authority.
FDA Commissioner Andrew von Eschenbach said in an FDA conference call that the timing of the law’s passage is important as it eliminates the possibility of reductions in the agency work force.
Reauthorization of MDUFMA will provide, in addition to appropriated funds, a revenue of $287 million by October 2012, Randall Lutter, the agency’s deputy commissioner for policy, said.
The reauthorization will ensure that the FDA centers have the resources needed to conduct complex and comprehensive reviews of new devices, von Eschenbach said.
FDA Commissioner Andrew von Eschenbach said in an FDA conference call that the timing of the law’s passage is important as it eliminates the possibility of reductions in the agency work force.
Reauthorization of MDUFMA will provide, in addition to appropriated funds, a revenue of $287 million by October 2012, Randall Lutter, the agency’s deputy commissioner for policy, said.
The reauthorization will ensure that the FDA centers have the resources needed to conduct complex and comprehensive reviews of new devices, von Eschenbach said.
e diel, 23 shtator 2007
TWO STERILE PROCESSING INDUSTRY GROUPS
American Society for Healthcare Central Service Professionals and the International Association of Healthcare Central Service and Materiel Management, have merged in order to form a single organization. "The newly unified group will create one organization committed to the education and professional development of CS/SP staff," says Virginia Sylvestri, executive director of ASHCSP. "This is an exciting opportunity for ASHCSP and IAHCSMM to improve upon our current high level of service to our membership." The Certification Board for Sterile Processing & Distribution says this merger in no way affects the CBSPD or personnel certified through the CBSPD.
e mërkurë, 5 shtator 2007
FDA Patient Safety News - Video Available Online and as Podcast
FDA has posted the latest edition of "FDA Patient Safety News," a free Web-based video news program. Aimed primarily at health professionals, the program features information on new drugs, biologics, and medical devices, as well as FDA safety notifications and product recalls.
-- To view video or text version:
http://www.fda.gov/psn
-- To access Podcast: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/podcast.cfm
-- To view video or text version:
http://www.fda.gov/psn
-- To access Podcast: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/podcast.cfm
e mërkurë, 29 gusht 2007
Steris Warned After Reports of Flames and Sparks From Cleaning Units
Steris Corporation’s Amsco Sonic Energy Cleaners are misbranded after an inspection revealed user complaints of product-related fires, the FDA said in a warning letter. For example, one complaint said a user “smelled a strong burning odor and observed flames shooting out the back of the unit,” according to the letter, posted last week to the agency’s website.
The letter documented several other complaints, including: “Visible flame coming from the right side of the unit;” Interior wires melted and caught on fire; A unit was sparking and smoking, smelling like something had burned; A switch was smoking and burning. “Can see flames, but can’t get to plug to unplug it;” “Sonic Cleaner caught fire. No injuries and was under control before the fire department arrived;”
A unit caught on fire and a building was evacuated. This was the second unit to catch on fire within a year; A unit caught fire and was damaged beyond repair; and A unit caught fire while not in use. Steris could not be reached for comment by press time.
The letter can be viewed at www.fda.gov/foi/warning_letters/s6461c.pdf.
The letter documented several other complaints, including: “Visible flame coming from the right side of the unit;” Interior wires melted and caught on fire; A unit was sparking and smoking, smelling like something had burned; A switch was smoking and burning. “Can see flames, but can’t get to plug to unplug it;” “Sonic Cleaner caught fire. No injuries and was under control before the fire department arrived;”
A unit caught on fire and a building was evacuated. This was the second unit to catch on fire within a year; A unit caught fire and was damaged beyond repair; and A unit caught fire while not in use. Steris could not be reached for comment by press time.
The letter can be viewed at www.fda.gov/foi/warning_letters/s6461c.pdf.
e martë, 28 gusht 2007
CDRH Provides Update on Postmarket Transformation
CDRH Provides Update on Postmarket Transformation
Almost a year after the FDA announced its action plan for postmarket transformation at CDRH, the agency is making progress on several “immediate priority actions” identified last November. Don St. Pierre, head of CDRH’s Postmarket Transformation Management Group, said he is receiving updates on these initiatives, some of which will affect devicemakers.
In November 2006, CDRH issued a report recommending work on measures to enhance postmarket surveillance at the center. The report predicted these initiatives would take a number of years to implement. One recommendation was the development of a unique device identification (UDI) system for medical devices, a move that would have “a huge impact on companies,” St. Pierre said.
The agency drafted a concept paper on UDI and held a public meeting on the topic. After collecting comments based on the meeting, the agency has drafted an internal concept paper, which is currently going through internal review. After it completes the review, the FDA will release the concept paper for industry and public comments, he said.
How sterile processing plays central role in success
http://www.hpnonline.com/inside/2007-09/0709-CS-BestPractices.html
Central service/sterile processing and distribution professionals may be vital to hospital performance and patient care quality, but their valuable contributions can be overlooked or not taken seriously until an infection outbreak occurs or a surgeon is rankled.
From cleaning, disinfection and sterilization to customer service, kit/pack assembly, loaner implants, maintenance and repair and quality assurance, CS/SPD could be classified as a "hub" of the organization, as one CS department billed itself.
As a result, Healthcare Purchasing News Senior Editor Rick Dana Barlow consulted with a variety of experts on the provider and supplier sides for anecdotes, tips and tools on best practices in sterile processing – on paper and in practice – as well as with some of the recent years’ winners and finalists in HPN’s annual CS/SPD Department of the Year Award.
What they had to say may be old hat for some or helpful reminders for others, but at the very least their words of wisdom should be educational and enlightening, if not inspiring.
Central service/sterile processing and distribution professionals may be vital to hospital performance and patient care quality, but their valuable contributions can be overlooked or not taken seriously until an infection outbreak occurs or a surgeon is rankled.
From cleaning, disinfection and sterilization to customer service, kit/pack assembly, loaner implants, maintenance and repair and quality assurance, CS/SPD could be classified as a "hub" of the organization, as one CS department billed itself.
As a result, Healthcare Purchasing News Senior Editor Rick Dana Barlow consulted with a variety of experts on the provider and supplier sides for anecdotes, tips and tools on best practices in sterile processing – on paper and in practice – as well as with some of the recent years’ winners and finalists in HPN’s annual CS/SPD Department of the Year Award.
What they had to say may be old hat for some or helpful reminders for others, but at the very least their words of wisdom should be educational and enlightening, if not inspiring.
e mërkurë, 22 gusht 2007
Hospital issues warning to surgical outpatients
http://www.hpnonline.com/#22-2
Leader Hospital (Canada) is notifying outpatients who underwent minor surgical procedures that they should be tested for blood-borne infections after being exposed to improperly sterilized medical equipment. “During the period of Jan. 1 to Aug. 13, the procedures for sterilizing medical instruments may not have been effective according to the standards of the health region,” Dr. Khami Chokani, medical health officer for the Cypress Health Region, said in a prepared statement. “While the risk of acquiring an infection from a potentially inadequately sterilized medical instrument is thought to be low particularly given the minimally invasive nature of the procedures, all patients who have had any minor surgical procedures completed during these time frames are being contacted and advised of the issues, and encouraged to be tested for certain illnesses which patients may have been exposed to.”
Leader Hospital (Canada) is notifying outpatients who underwent minor surgical procedures that they should be tested for blood-borne infections after being exposed to improperly sterilized medical equipment. “During the period of Jan. 1 to Aug. 13, the procedures for sterilizing medical instruments may not have been effective according to the standards of the health region,” Dr. Khami Chokani, medical health officer for the Cypress Health Region, said in a prepared statement. “While the risk of acquiring an infection from a potentially inadequately sterilized medical instrument is thought to be low particularly given the minimally invasive nature of the procedures, all patients who have had any minor surgical procedures completed during these time frames are being contacted and advised of the issues, and encouraged to be tested for certain illnesses which patients may have been exposed to.”
e premte, 17 gusht 2007
Plain soap as effective as antibacterial but without the risk
http://www.hpnonline.com/#17-7
Antibacterial soaps show no health benefits over plain soaps and, in fact, may render some common antibiotics less effective, says a University of Michigan public health professor.
In the first known comprehensive analysis of whether antibacterial soaps work better than plain soaps, Allison Aiello of the U-M School of Public Health and her team found that washing hands with an antibacterial soap was no more effective in preventing infectious illness than plain soap. Moreover, antibacterial soaps at formulations sold to the public do not remove any more bacteria from the hands during washing than plain soaps.
Antibacterial soaps show no health benefits over plain soaps and, in fact, may render some common antibiotics less effective, says a University of Michigan public health professor.
In the first known comprehensive analysis of whether antibacterial soaps work better than plain soaps, Allison Aiello of the U-M School of Public Health and her team found that washing hands with an antibacterial soap was no more effective in preventing infectious illness than plain soap. Moreover, antibacterial soaps at formulations sold to the public do not remove any more bacteria from the hands during washing than plain soaps.
e martë, 14 gusht 2007
Global Task Force Issues Guidance on Device Clinical Trials
http://www.ghtf.org/sg5/inventorysg5/sg5_n1r8_2007final.pdf
Two new guidance documents from the Global Harmonization Task Force (GHTF) address basic concepts of clinical evidence and procedures for conducting and documenting clinical evaluations involving medical devices. The final documents — “Clinical Evidence — Key Definitions and Concepts” and “Clinical Evaluation” — are the first issued by Study Group 5, which was established in 2002 to promote harmonization of clinical safety and efficacy requirements for medical devices.
Two new guidance documents from the Global Harmonization Task Force (GHTF) address basic concepts of clinical evidence and procedures for conducting and documenting clinical evaluations involving medical devices. The final documents — “Clinical Evidence — Key Definitions and Concepts” and “Clinical Evaluation” — are the first issued by Study Group 5, which was established in 2002 to promote harmonization of clinical safety and efficacy requirements for medical devices.
Packed House for 4th Annual Oxoid Infection Control Seminar
http://www.rapidmicrobiology.com/news/603h252.php
Oxoid recently hosted the 4th Oxoid Infection Control Seminar Day in the UK. This annual event, which is provided free of charge to microbiologists, laboratory staff and infection control professionals from around the UK, was attended by over 100 delegates who gathered to hear the latest thinking and current opinion on infection control concerns and practices. The morning seminar session started with a presentation by Dr Tom Lewis, Specialist Registrar at Heartlands Hospital, Birmingham, who spoke on the subject of "Cleaning and Setting Standards for Cleanliness". Dr Lewis opened his presentation by commenting that patients now cite fear of hospital-acquired infection as a major cause of concern and that staff morale is often low...
Dr Lewis spoke of the many challenges associated with visual and microbiological assessments, and went on to describe how cleaning protocols can improve outcomes...Conclusions showed that bad cleaning may be worse than no cleaning (ie the organism may actually be spread rather than removed) and that visual inspection does not predict the level of environmental contamination, but that it is possible to devise simple and effective cleaning regimes that will reduce rates of hospital-acquired infection.
Oxoid recently hosted the 4th Oxoid Infection Control Seminar Day in the UK. This annual event, which is provided free of charge to microbiologists, laboratory staff and infection control professionals from around the UK, was attended by over 100 delegates who gathered to hear the latest thinking and current opinion on infection control concerns and practices. The morning seminar session started with a presentation by Dr Tom Lewis, Specialist Registrar at Heartlands Hospital, Birmingham, who spoke on the subject of "Cleaning and Setting Standards for Cleanliness". Dr Lewis opened his presentation by commenting that patients now cite fear of hospital-acquired infection as a major cause of concern and that staff morale is often low...
Dr Lewis spoke of the many challenges associated with visual and microbiological assessments, and went on to describe how cleaning protocols can improve outcomes...Conclusions showed that bad cleaning may be worse than no cleaning (ie the organism may actually be spread rather than removed) and that visual inspection does not predict the level of environmental contamination, but that it is possible to devise simple and effective cleaning regimes that will reduce rates of hospital-acquired infection.
e premte, 10 gusht 2007
Study reports aging population drives medical device packaging
http://www.healthcare-packaging.com/newsletters/hcp-08-10-07.html
"Continuous technological advancements in the medical device market coupled with an aging population provides wide opportunities for growth in the medical device packaging market," according to Urmila Kishore, analyst of the study The North American Medical Device Packaging Market from Frost & Sullivan.
The study shows that the market earned revenues of $569 million last year, with that number predicted to rise to $918.8 million by 2013. Among the report's findings are the following:
- The market for medical device packaging in North America is highly competitive, with a large number of participants vying to establish their presence. Recent times have seen increased demand for surgical and implant devices.
- The market for medical devices is continuously flooded with upgraded and innovative product offerings due to the strong focus on R&D activities within this industry.
- Packaging forms an integrated and vital component in the medical device market. The North American medical device packaging market is experiencing steady growth. Despite the growth, this market is expected to face stiff competition due to the cost reduction pressure created by device manufacturers.
- The scientific and technological breakthroughs to improve health and lengthen the average life span have accelerated the pace of medical invention, resulting in a plethora of new medical devices with advanced features and superior performance properties. Package manufacturers are encouraged to respond to new product requirements by employing advanced technologies and materials.
- Disposable medical devices including surgical supplies are extremely popular. This market is expected to grow at the rate of 23% through 2011, as increases in the number of surgeries have heightened the concern over postoperative infection," explains Kishore. "The demand for implants is anticipated to encourage the use of rigid packaging materials such as trays, which is likely to boost the revenues of rigid packagers."
e enjte, 2 gusht 2007
New leader set to take The Joint Commission
New leader set to take The Joint Commission reins In a 15-minute teleconference with the media this afternoon The Joint Commission introduced Mark Chassin, M.D., M.P.P., M.P.H., to succeed Dennis O'Leary, M.D., as its next president, effective January 1.O'Leary, who has spent 21 years at the top of the Oakbrook Terrace, IL-based accreditation organization and slides into a president emeritus role next year, praised Chassin's selection as "absolutely a first-rate choice to be the next president of the Joint Commission." Furthermore, O'Leary called him "well- qualified" and "especially well-prepared" for the role, given his building of a nationally recognized quality improvement program at The Mount Sinai Medical Center, New York, where he currently serves as executive vice president for excellence in patient care, and professor of health policy and chairman of the Department of Health Policy at Mount Sinai School of Medicine.
http://www.hpnonline.com/#1-4
http://www.hpnonline.com/#1-4
e mërkurë, 1 gusht 2007
How do you satisfy worst-case requirements in ISO 11607?
http://www.devicelink.com/pmpn/archive/07/07/011.html
ISO 11607:2006, "Packaging for Terminally Sterilized Medical Devices," requires medical device manufacturers to consider the worst case when designing and validating packaging. ISO 11607 addresses "worst case" in three areas, and in each case, it means something slightly different. In order to correctly interpret and apply these clauses dealing with worst case, it is important to understand all the terms that are used.
ISO 11607:2006, "Packaging for Terminally Sterilized Medical Devices," requires medical device manufacturers to consider the worst case when designing and validating packaging. ISO 11607 addresses "worst case" in three areas, and in each case, it means something slightly different. In order to correctly interpret and apply these clauses dealing with worst case, it is important to understand all the terms that are used.
Technological advancements drive medical device packaging in North America, report says
http://www.packagingdigest.com/index.php
The market for medical device packaging in North America is highly competitive with a large number of participants vying to establish their presence. Recent times have seen increase in demand for surgical and implant devices which is consecutively driving this market. The continuous technological advancements in the medical device market coupled with rising aging population provide wide opportunities for growth in this market. New analysis from Frost & Sullivan, North American Medical Device Packaging Market, reveals that the market earned revenues of $569 million in 2006 and is estimated to reach $918.8 million in 2013.
The market for medical device packaging in North America is highly competitive with a large number of participants vying to establish their presence. Recent times have seen increase in demand for surgical and implant devices which is consecutively driving this market. The continuous technological advancements in the medical device market coupled with rising aging population provide wide opportunities for growth in this market. New analysis from Frost & Sullivan, North American Medical Device Packaging Market, reveals that the market earned revenues of $569 million in 2006 and is estimated to reach $918.8 million in 2013.
e martë, 31 korrik 2007
Pa. Gets Tough on Healthcare-acquired Infections
http://www.rxforpa.com/
Pennsylvania's surgery centers and hospitals are on the hook for improving their infection control protocols and will receive financial incentives to do so, thanks to a healthcare reform bill signed into law by Gov. Ed Rendell on July 20.
Under the plan, Pennsylvania's Department of Health must establish best practices for eliminating healthcare-acquired infections and reducing medical errors based on nationally recognized, evidenced-based standards. All of the state's licensed healthcare facilities will be required to adopt those standards, submit a written report of their infection control plan to the department and demonstrate a reduction in healthcare-acquired infections.
Pennsylvania's surgery centers and hospitals are on the hook for improving their infection control protocols and will receive financial incentives to do so, thanks to a healthcare reform bill signed into law by Gov. Ed Rendell on July 20.
Under the plan, Pennsylvania's Department of Health must establish best practices for eliminating healthcare-acquired infections and reducing medical errors based on nationally recognized, evidenced-based standards. All of the state's licensed healthcare facilities will be required to adopt those standards, submit a written report of their infection control plan to the department and demonstrate a reduction in healthcare-acquired infections.
e hënë, 30 korrik 2007
AORN council addresses extended cycle concerns
Many medical facilities are faced with the issue of extended steam sterilization cycles for their surgical instruments (a cycle time longer than the traditional 4 minutes). The Association of periOperative Registered Nurses (AORN) Sterile Processing/Materials Management Specialty Assembly Coordinating Council has released a general statement on extended Cycles:
"Each medical facility needs to make sure that all of their products used for sterilization (peel pouches, wrap, etc.) can withstand theses longer steam sterilization cycles. Each medical facility needs to make sure that the products used in extended cycles are validated for these types of cycles. Many manufactures have tested their products for these longer cycles' times. The manufacture of the products should supply information to the user for their records."
This statement comes from the AORN Sterile Processing/Materials Management Specialty Assembly Coordinating Council: Chair - Rose Seavey, RN, MBA, CNOR, ACSP; Past Chair - Dottie Conroy, RN, BSN; Communication Chair - Wanda Elwell, RN, CNOR; Education Chair - Stephen Kovach; Professional/Practice Issues Chair - Martha Young, BS, MS; AORN CNP Staff Liaison - Ramona Conner, RN, MSN, CNOR; AORN Board Liaison - Deborah Spratt, RN, MPA, CNAA, CNOR; and AORN Staff Consultant - Debbie Stephen.
http://www.aorn.org/docs_assets/55B250E0-9779-5C0D-1DDC8177C9B4C8EB/0972C9ED-F6F7-6E32-CA50251F7599DCDB/Stmnt%20on%20Extended%20Cycles.doc
"Each medical facility needs to make sure that all of their products used for sterilization (peel pouches, wrap, etc.) can withstand theses longer steam sterilization cycles. Each medical facility needs to make sure that the products used in extended cycles are validated for these types of cycles. Many manufactures have tested their products for these longer cycles' times. The manufacture of the products should supply information to the user for their records."
This statement comes from the AORN Sterile Processing/Materials Management Specialty Assembly Coordinating Council: Chair - Rose Seavey, RN, MBA, CNOR, ACSP; Past Chair - Dottie Conroy, RN, BSN; Communication Chair - Wanda Elwell, RN, CNOR; Education Chair - Stephen Kovach; Professional/Practice Issues Chair - Martha Young, BS, MS; AORN CNP Staff Liaison - Ramona Conner, RN, MSN, CNOR; AORN Board Liaison - Deborah Spratt, RN, MPA, CNAA, CNOR; and AORN Staff Consultant - Debbie Stephen.
http://www.aorn.org/docs_assets/55B250E0-9779-5C0D-1DDC8177C9B4C8EB/0972C9ED-F6F7-6E32-CA50251F7599DCDB/Stmnt%20on%20Extended%20Cycles.doc
e premte, 27 korrik 2007
Premier healthcare alliance launches comprehensive project to improve hospital quality, reduce costs
http://www.hpnonline.com/dailyupdates/July_07.html#27-6
The Premier healthcare alliance and a group of healthcare leaders launched a comprehensive project called "QUEST: High Performing Hospitals" to improve patient safety and quality in the nation's hospitals while safely reducing healthcare costs. QUEST is a three-year program through which participating hospitals will report data to Premier on a set of clearly defined performance measures encompassing aspects of quality, efficiency, safety and patient satisfaction. Premier will analyze the data, facilitate sharing of best practices, and provide incentives for top-performing hospitals.
The Premier healthcare alliance and a group of healthcare leaders launched a comprehensive project called "QUEST: High Performing Hospitals" to improve patient safety and quality in the nation's hospitals while safely reducing healthcare costs. QUEST is a three-year program through which participating hospitals will report data to Premier on a set of clearly defined performance measures encompassing aspects of quality, efficiency, safety and patient satisfaction. Premier will analyze the data, facilitate sharing of best practices, and provide incentives for top-performing hospitals.
e martë, 24 korrik 2007
MediSource introduces triple enzyme cleaner
http://www.medisourcemedical.com/JULY_2007.pdf
MediSource Inc (Albany, GA) introduced its new UltiZyme ® Triple Enzyme Cleaner. This new formulation includes increased enzyme activity, higher levels of synergistic surfactants, improved cleaning power, and pleasant fragrance. For additional information, visit www.medisourcemedical.com.
MediSource Inc (Albany, GA) introduced its new UltiZyme ® Triple Enzyme Cleaner. This new formulation includes increased enzyme activity, higher levels of synergistic surfactants, improved cleaning power, and pleasant fragrance. For additional information, visit www.medisourcemedical.com.
e enjte, 19 korrik 2007
Expert: FDA Scrutinizes Complaint-Handling Systems
http://www.fdanews.com/newsletter/article?issueId=10464&articleId=96042
The FDA is increasingly scrutinizing manufacturers’ product complaint systems and procedures, according to David Dills, senior consultant with Parexel Consulting. The FDA has been closely examining records during inspections and evaluating whether firms find root causes of complaints and appropriately close investigation files, Dills said at the recent Center for Business Intelligence 5th Annual Product Complaints for Bio/Pharmaceuticals and Medical Devices conference.
Over the past year, the number of Form 483 observations for product complaints has been at an all-time high, Dills said, as agency field investigators are spending more time examining company complaint sections during inspections. The audits are focusing on documentation and reasons for closure of investigation files. In noting that excessive product complaints are sometimes a sign of product design flaws, Dills said that complaint files, and the reasons behind closing complaint investigations, need to stand up in court. He also said that it is important for firms to not prematurely jump to conclusions regarding the outcomes of investigations. They should wait until investigations are completed.
The FDA is increasingly scrutinizing manufacturers’ product complaint systems and procedures, according to David Dills, senior consultant with Parexel Consulting. The FDA has been closely examining records during inspections and evaluating whether firms find root causes of complaints and appropriately close investigation files, Dills said at the recent Center for Business Intelligence 5th Annual Product Complaints for Bio/Pharmaceuticals and Medical Devices conference.
Over the past year, the number of Form 483 observations for product complaints has been at an all-time high, Dills said, as agency field investigators are spending more time examining company complaint sections during inspections. The audits are focusing on documentation and reasons for closure of investigation files. In noting that excessive product complaints are sometimes a sign of product design flaws, Dills said that complaint files, and the reasons behind closing complaint investigations, need to stand up in court. He also said that it is important for firms to not prematurely jump to conclusions regarding the outcomes of investigations. They should wait until investigations are completed.
The Solutions for Unburdening Instruments
Properly cleaning surgical instruments, that is to say returning them to the level of cleanliness and sterility required for them to be used in another surgical procedure, is a multi-step process. Simply running them through a sterilization cycle is not enough. Prior to sterilization, the instruments must be pre-treated and cleaned to remove harmful and often infectious bioburden. This bioburden (blood, mucous, proteins, fat and other residue), which adheres to use surgical instruments, not only presents the risk of cross-contamination, it can also cause serious damage to the expensive instrumentation itself. continue
e mërkurë, 18 korrik 2007
FDA Public Health Notification: Updated Information on Custom Ultrasonics, Inc., Endoscope Washer/Disinfector
On 7/16/07 the FDA issued a letter to Custom Ultrasonics stating that the firm has now complied with the requirements of the Consent Decree and is permitted to resume manufacturing the System 83 Plus Washer/Disinfector and all accessories. For more information on this topic please go to the FDA link to read their complete statement.
http://www.fda.gov/cdrh/safety/022707-ultrasonics.html
http://www.fda.gov/cdrh/safety/022707-ultrasonics.html
e premte, 13 korrik 2007
Ecolab Hand Hygiene Compliance Monitoring Program Helps Hospitals Reduce
http://biz.yahoo.com/bw/070625/20070625005652.html?.v=1
InfectionMonday June 25, 9:15 am ET
ST. PAUL, Minn.--(BUSINESS WIRE)--Ecolab Inc. announced today a new Hand Hygiene Monitoring Compliance Program for hospitals and healthcare facilities. The program provides a multi-intervention approach that combines effective hand hygiene products, a step-by-step implementation process, patient empowerment education and training materials, ongoing measurement, and benchmarking to increase and sustain hand hygiene compliance. According to the Centers for Disease Control, proper hand hygiene is the single most effective method for preventing healthcare-associated infections (HAIs) in hospitals, which account for an estimated 99,000 deaths annually in the United States.
InfectionMonday June 25, 9:15 am ET
ST. PAUL, Minn.--(BUSINESS WIRE)--Ecolab Inc. announced today a new Hand Hygiene Monitoring Compliance Program for hospitals and healthcare facilities. The program provides a multi-intervention approach that combines effective hand hygiene products, a step-by-step implementation process, patient empowerment education and training materials, ongoing measurement, and benchmarking to increase and sustain hand hygiene compliance. According to the Centers for Disease Control, proper hand hygiene is the single most effective method for preventing healthcare-associated infections (HAIs) in hospitals, which account for an estimated 99,000 deaths annually in the United States.
Innovative Hand Sanitation System Trumps Hospital Acquired Infections
http://www.ereleases.com/pr/20070710002.html
Current infection control practice is bare hand sanitation between patient visits often followed by donning medical exam gloves. However, recontamination of the gloved hand inevitably occurs when room surfaces, healthcare worker's and doctor's clothing, instruments, etc., inevitably covered by pathogens, are touched by the healthcare worker hand during a patient visit and then transferred to the patient during care. We believe that this is the primary and not to be ignored route for transmission of hospital acquired infections. Our patented device, based on ultraviolet (UV-C) exposure of the gloved hand within a small, closed volume, has been designed to allow a system of frequent, fast, and immediately available hand sanitation during patient care, interrupting the infection pathway in a way that infrequent bare hand sanitation cannot. The UV-C is blocked by the exam gloves and no UV-C leaves the device, hence the process is totally safe for the healthcare worker, doctor, and patient."
Current infection control practice is bare hand sanitation between patient visits often followed by donning medical exam gloves. However, recontamination of the gloved hand inevitably occurs when room surfaces, healthcare worker's and doctor's clothing, instruments, etc., inevitably covered by pathogens, are touched by the healthcare worker hand during a patient visit and then transferred to the patient during care. We believe that this is the primary and not to be ignored route for transmission of hospital acquired infections. Our patented device, based on ultraviolet (UV-C) exposure of the gloved hand within a small, closed volume, has been designed to allow a system of frequent, fast, and immediately available hand sanitation during patient care, interrupting the infection pathway in a way that infrequent bare hand sanitation cannot. The UV-C is blocked by the exam gloves and no UV-C leaves the device, hence the process is totally safe for the healthcare worker, doctor, and patient."
e mërkurë, 11 korrik 2007
Soil Particles Found to Boost Prion's Capacity to Infect
http://www.infectioncontroltoday.com/hotnews/77h9655179383.html
The rogue proteins that cause chronic wasting disease (CWD) exhibit a dramatic increase in their infectious nature when bound to common soil particles, according to a new study.
Writing in the journal Public Library of Science (PLoS) Pathogens, a group led by University of Wisconsin-Madison prion expert Judd Aiken reports that prions, the protein agents of a family of fatal brain disorders, bind tightly to a common soil mineral and significantly increase the oral transmissibility of the agent.
Pedersen notes that soils are a complex mixture of organic and inorganic components that vary across the landscape and that scientists are just beginning to tease out factors in soils that may contribute to transmissibility. The new study implies, he says, "that some soils may promote the transmission of the prion agent more readily than others."
The rogue proteins that cause chronic wasting disease (CWD) exhibit a dramatic increase in their infectious nature when bound to common soil particles, according to a new study.
Writing in the journal Public Library of Science (PLoS) Pathogens, a group led by University of Wisconsin-Madison prion expert Judd Aiken reports that prions, the protein agents of a family of fatal brain disorders, bind tightly to a common soil mineral and significantly increase the oral transmissibility of the agent.
Pedersen notes that soils are a complex mixture of organic and inorganic components that vary across the landscape and that scientists are just beginning to tease out factors in soils that may contribute to transmissibility. The new study implies, he says, "that some soils may promote the transmission of the prion agent more readily than others."
e martë, 10 korrik 2007
Medical sterilization systems market to reach $2.3 billion by 2010, says new report
http://www.hpnonline.com/dailyupdates/July_07.html#10-3
Sterilization methods and techniques continue to evolve towards safer, speedier, and more economic processes. Innovation in sterilization is centered on improving cycle times, reducing cost and safety concerns, and designing affordable systems for in-house use. Shaped by diverse trends, the world medical sterilization systems and equipment market is expected to reach US$2.3 billion by 2010. Steam sterilization continues to be the most important and widely used procedure. Steam sterilization market is stable due to regulatory enforcements imposed on EtO sterilization, a method fraught with higher residuals. Usage of new technologies such as E-beam and X-ray, is also set to register higher growth, widening the scope of options available for sterilization procedures.
Sterilization methods and techniques continue to evolve towards safer, speedier, and more economic processes. Innovation in sterilization is centered on improving cycle times, reducing cost and safety concerns, and designing affordable systems for in-house use. Shaped by diverse trends, the world medical sterilization systems and equipment market is expected to reach US$2.3 billion by 2010. Steam sterilization continues to be the most important and widely used procedure. Steam sterilization market is stable due to regulatory enforcements imposed on EtO sterilization, a method fraught with higher residuals. Usage of new technologies such as E-beam and X-ray, is also set to register higher growth, widening the scope of options available for sterilization procedures.
e hënë, 9 korrik 2007
Automation standards benefit pharmaceutical/medical applications
http://www.healthcare-packaging.com/newsletters/hcp-07-06-07.html
At a biomedical facility in Ireland, machine automation is coming into play in a validated environment that involves 21 CFR Part 11 electronic signatures, integrated robots and vision systems. The application is a real-world example of good automation standards providing real-world benefits.
At a biomedical facility in Ireland, machine automation is coming into play in a validated environment that involves 21 CFR Part 11 electronic signatures, integrated robots and vision systems. The application is a real-world example of good automation standards providing real-world benefits.
SPSmedical announces monthly audio seminars for healthcare facility
http://www.hpnonline.com/dailyupdates/July_07.html#6-2
SPSmedical announces monthly Audio Seminars on a variety of infection prevention and sterilization topics to health care facilities. This new educational service assists health care facilities comply with educational training and provides certified staff with CEUs. Charles Hughes, Lead Educator of SPSmedical provides a one hour CE presentation, pre-approved through both IAHCSMM and CBSPD. Each seminar allows time for Q & A at the end of the presentation. For those unable to attend the live broadcast, a recording will be available for 30 days via the internet. SPSmedical provides handouts prior to each Audio Seminar and a post seminar notification is sent including audio file, certificate of participation and evaluation form. There is no cost to each attendees; however, the health care facility is charged a small fee for each phone connection. For a complete listing of seminar objectives visit: THIS LINK.
SPSmedical announces monthly Audio Seminars on a variety of infection prevention and sterilization topics to health care facilities. This new educational service assists health care facilities comply with educational training and provides certified staff with CEUs. Charles Hughes, Lead Educator of SPSmedical provides a one hour CE presentation, pre-approved through both IAHCSMM and CBSPD. Each seminar allows time for Q & A at the end of the presentation. For those unable to attend the live broadcast, a recording will be available for 30 days via the internet. SPSmedical provides handouts prior to each Audio Seminar and a post seminar notification is sent including audio file, certificate of participation and evaluation form. There is no cost to each attendees; however, the health care facility is charged a small fee for each phone connection. For a complete listing of seminar objectives visit: THIS LINK.
e premte, 29 qershor 2007
CDC network to track HAI
The Centers for Disease Control and Prevention has opened to all U.S. hospitals its Web-based network for tracking healthcare-associated infections. It said the National Healthcare Safety Network has been improved to meet the needs of states with mandatory reporting of HAIs, and that eight states (California, Colorado, New York, Oklahoma, South Carolina, Tennessee, Vermont and Virginia) plan to use the network in implementing mandatory reporting. CDC said the secured network allows hospitals to analyze the data and share it within a facility or with the general public if desired. Denise Cardo, M.D., director of CDC’s Division of Health Care and Quality Promotion, said the agency expects nearly 1,000 hospitals to use the network in coming months to track their progress toward HAI prevention. This information was taken from the AHA News Now update of 6/28/07.Click on link for more information
http://www.cdc.gov/od/oc/media/pressrel/2007/r070627a.htm
http://www.cdc.gov/od/oc/media/pressrel/2007/r070627a.htm
e enjte, 28 qershor 2007
Proactive instrument care contributes to surgical serenity, quality outcomes
Considering the costs and headaches associated with improperly maintained medical instrumentation, it’s clear that the adage, "an ounce of prevention is worth a pound of cure," is aptly suited. If angry surgeons berating the central service department over broken, damaged and poorly functioning devices isn’t enough to make facilities open their eyes to the importance of a well-implemented preventive maintenance program, then consider the risks that malfunctioning devices pose to patients at the receiving end of the instrument.
http://www.hpnonline.com/inside/2007-07/0707-CS-Instruments.html
http://www.hpnonline.com/inside/2007-07/0707-CS-Instruments.html
e mërkurë, 27 qershor 2007
CDC Updates Guidelines
The Centers for Disease Control and Prevention today issued updated guidelines for preventing the spread of infection in health care settings. The document updates and expands guidelines issued for hospitals in 1996 to include new issues such as SARS and avian flu and health care settings other than hospitals. Part I reviews the scientific literature that supports the recommended prevention and control practices. Part II updates information on the basic principles of hand hygiene, barrier precautions, safe work practices and isolation practices, with new emphasis on administrative involvement in developing and supporting infection control programs. It also addresses surveillance of healthcare-associated infections. Part III provides guidance for applying precautions developed by CDC and the Healthcare Infection Control Practices Advisory Committee in various health care settings. This information was taken from the AHA News NOW - Daily Report 6/26/07.
e martë, 26 qershor 2007
Energy and Commerce Committee Sends MDUFMA to House Floor
In a victory for the medical device industry, controversial preemption language was stripped from legislation reauthorizing the Medical Device User Fee and Modernization Act (MDUFMA) that passed the House Committee on Energy and Commerce June 21.
The committee also passed FDA-industry negotiated changes to the third-party inspection program before sending the bill to the full House for consideration, which is expected in July.
The preemption provision, which would have eliminated the FDA’s authority over state laws, threatened industry support of the overall legislation, according to AdvaMed. But the provision was removed after AdvaMed and lawmakers expressed concerns at a hearing earlier this month.
http://fdanews.com/newsletter/article?issueId=10360&articleId=95065
The committee also passed FDA-industry negotiated changes to the third-party inspection program before sending the bill to the full House for consideration, which is expected in July.
The preemption provision, which would have eliminated the FDA’s authority over state laws, threatened industry support of the overall legislation, according to AdvaMed. But the provision was removed after AdvaMed and lawmakers expressed concerns at a hearing earlier this month.
http://fdanews.com/newsletter/article?issueId=10360&articleId=95065
e hënë, 25 qershor 2007
APIC conference to focus on 21st century innovations; power of positive deviance among week’s highlights
Focusing a week-long series of educational sessions tied into its theme of “Innovation in Infection Prevention,” the Association for Professionals in Infection Control and Epidemiology (APIC) will offer “The Power of Positive Deviance: Change from the Inside Out” among its featured presentations during its Annual Conference June 24-28 in San Jose, CA. During that week, the largest gathering of infection prevention and control professionals from around the world will take place when thousands of attendees concentrate on significant research findings and innovations surrounding the field of healthcare-associated infections.
http://www.hpnonline.com/#25-3
http://www.hpnonline.com/#25-3
New European Medical Device Directives Expected This Fall
The new European medical device directives are expected to be adopted this fall, implemented by the end of 2008 and enforced by 2010, Cristiana Spontoni, European partner with Squire, Sanders & Dempsey, said at the recent FDAnews Medical Device Quality Congress.
The European Parliament recently approved the amendments to the directives. The amendments narrow the definition of a single-use device and obligate the European Commission to further study the practice of reprocessing single-use devices, according to Spontoni.
http://www.fdanews.com/newsletter/article?issueId=10357&articleId=95035
The European Parliament recently approved the amendments to the directives. The amendments narrow the definition of a single-use device and obligate the European Commission to further study the practice of reprocessing single-use devices, according to Spontoni.
http://www.fdanews.com/newsletter/article?issueId=10357&articleId=95035
e enjte, 21 qershor 2007
Medical Device Packagers—Pioneers in Sustainability?
http://www.devicelink.com/pmpn/
At last week’s Medical Design & Manufacturing East and EastPack shows, sustainability was discussed more often than I expected in healthcare packaging. After all, points out Curt Larsen, a consultant with Dupont Medical Packaging and a member of PMP News’s Editorial Advisory Board, ISO 11607 demands traceability for sterile medical packaging. And traceability is hard to achieve when using recycled content. Nonetheless, more than a few exhibitors and attendees at the East show reported that their healthcare product customers are asking about sustainability.
At last week’s Medical Design & Manufacturing East and EastPack shows, sustainability was discussed more often than I expected in healthcare packaging. After all, points out Curt Larsen, a consultant with Dupont Medical Packaging and a member of PMP News’s Editorial Advisory Board, ISO 11607 demands traceability for sterile medical packaging. And traceability is hard to achieve when using recycled content. Nonetheless, more than a few exhibitors and attendees at the East show reported that their healthcare product customers are asking about sustainability.
e hënë, 18 qershor 2007
Study: Hospitals With Joint Commission Approval Safer
Study: Hospitals With Joint Commission Approval Safer
Hospitals accredited by the Joint Commission are more likely to have implemented systems to promote patient safety, according to a study published in the May/June 2007 issue of the Journal of Healthcare Management.
Further, accreditation was found to be the most significant factor, even though researchers also considered hospital size, management (such as for-profit or non-profit) and location (such as rural or urban).
"Accreditation status was the only organizational characteristic that consistently emerged in identifying which hospitals have more extensively implemented patient safety systems," the authors write.
Patient safety initiatives undertaken by the hospitals include computerized physician order entry systems, computerized test results, assessment of adverse events, use of data in patient safety programs, specific patient safety policies, handling adverse event/error reporting, root cause analysis and medication management.
Hospitals accredited by the Joint Commission are more likely to have implemented systems to promote patient safety, according to a study published in the May/June 2007 issue of the Journal of Healthcare Management.
Further, accreditation was found to be the most significant factor, even though researchers also considered hospital size, management (such as for-profit or non-profit) and location (such as rural or urban).
"Accreditation status was the only organizational characteristic that consistently emerged in identifying which hospitals have more extensively implemented patient safety systems," the authors write.
Patient safety initiatives undertaken by the hospitals include computerized physician order entry systems, computerized test results, assessment of adverse events, use of data in patient safety programs, specific patient safety policies, handling adverse event/error reporting, root cause analysis and medication management.
Creating Strong Sterilization Partnerships
Suppliers Explain How Their Business Model Has Changed as the Device Industry Evolves
by Jennifer Whitney
n early April, the FDA and US marshals dramatically seized products at Union, NJ-based Shelhigh, a manufacturer of implantable cardiothoracic surgical products. Prior to the seizure, which resulted in national headlines, the company received FDA warning letters citing concern with its sterilization (among other issues). For the device industry, there's a clear takeaway message from the Shelhigh debacle: Never forget the importance of ensuring product sterility.
The FDA seems to be on a roll, given additional warnings related to sterilization procedures that were sent in April. Clark Research and Development, Inc., a Folsom, LA-based manufacturer of Biocompatible Hyperfusion Cartridges, was another company recently cited for problems within its sterilization procedures. In April, the FDA sent a warning letter stating that the company’s validation studies for sterilization were inadequate. Specifically, the agency cited numerous problems with Clark's documented summary of an autoclaving process used for its devices
by Jennifer Whitney
n early April, the FDA and US marshals dramatically seized products at Union, NJ-based Shelhigh, a manufacturer of implantable cardiothoracic surgical products. Prior to the seizure, which resulted in national headlines, the company received FDA warning letters citing concern with its sterilization (among other issues). For the device industry, there's a clear takeaway message from the Shelhigh debacle: Never forget the importance of ensuring product sterility.
The FDA seems to be on a roll, given additional warnings related to sterilization procedures that were sent in April. Clark Research and Development, Inc., a Folsom, LA-based manufacturer of Biocompatible Hyperfusion Cartridges, was another company recently cited for problems within its sterilization procedures. In April, the FDA sent a warning letter stating that the company’s validation studies for sterilization were inadequate. Specifically, the agency cited numerous problems with Clark's documented summary of an autoclaving process used for its devices
Troubleshooting Your Flexible Endoscopes
http://www.outpatientsurgery.net/2007/os06/troubleshooting_your_flexible_endoscopes.php
Can You Successfully Channel Your Flexible Endoscope Reprocessing Technique Building Toward Consensus in GI Endoscope Reprocessing Maintain High Flexible Scope Reprocessing Standards
Troubleshooting Your Flexible Endoscopes. Four tips to save on repairs and keep your scopes functioning optimally.
Randy Markham
markhamr@ohsu.edu
When you work in endoscopy, you know being down even one scope is a huge problem. We have more than 150 endoscopes here at Oregon Health and Science University because we never want to be caught short-handed. And despite our best efforts, there are times when we need a loaner or two. If you can count the number of scopes you have on two hands, the situtation is even more urgent. Here are four tips to keep your scopes functioning optimally and save on repairs.
Can You Successfully Channel Your Flexible Endoscope Reprocessing Technique Building Toward Consensus in GI Endoscope Reprocessing Maintain High Flexible Scope Reprocessing Standards
Troubleshooting Your Flexible Endoscopes. Four tips to save on repairs and keep your scopes functioning optimally.
Randy Markham
markhamr@ohsu.edu
When you work in endoscopy, you know being down even one scope is a huge problem. We have more than 150 endoscopes here at Oregon Health and Science University because we never want to be caught short-handed. And despite our best efforts, there are times when we need a loaner or two. If you can count the number of scopes you have on two hands, the situtation is even more urgent. Here are four tips to keep your scopes functioning optimally and save on repairs.
e mërkurë, 13 qershor 2007
RFID in Surgical Sponges
ClearCount Medical Solutions (Pittsburgh, PA) announced that its patented SmartSponge™ System based on radio frequency identification (RFID) received U.S. Food and Drug Administration (FDA) (Rockville, MD) 510(k) clearance. It uses Texas Instruments Inc's (Dallas, TX) Tag-it™ HF-I portfolio of high-frequency products to automate the process of managing surgical sponges during surgery. The sponges are permanently affixed with passive RFID tags smaller than a dime. ClearCount expects to make available a commercial solution that fully integrates into the current workflow of the operating room by the end of this year.
Click on link to find more information. http://dailenews.mdsi.org/
Click on link to find more information. http://dailenews.mdsi.org/
e martë, 12 qershor 2007
Where does your State stand when it comes to Quality Healthcare ?
The Agency for Healthcare Research and Quality updated its State Snapshots Web tool based on data from its 2006 National Healthcare Quality Report. The data draws on 129 quality measures from various sources, and includes state rankings for a subset of 15 measures chosen to represent a broad range of common diseases. The snapshots provide summaries by type of care, care setting and clinical area, and users can view whether a state has improved in a particular area and how it compares to other states. The tool includes a section on diabetes care and a table containing all the measures for every state. Just click on the link for more information. http://statesnapshots.ahrq.gov/statesnapshots/index.jsp
FDA patient Safety News Video Available Online as a Podcast
FDA Patient Safety News Video Available Online and as Podcast
FDA has posted the latest edition of "FDA Patient Safety News," a free Web-based video news program. Aimed primarily at health professionals, the program features information on new drugs, biologics, and medical devices, as well as FDA safety notifications and product recalls.
To view video or text version: http://www.fda.gov/psn
To access Podcast: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/podcast.cfm
FDA has posted the latest edition of "FDA Patient Safety News," a free Web-based video news program. Aimed primarily at health professionals, the program features information on new drugs, biologics, and medical devices, as well as FDA safety notifications and product recalls.
To view video or text version: http://www.fda.gov/psn
To access Podcast: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/podcast.cfm
Owens - Illinois Inc. to Sell Plastic Packaging Business
O-I to sell plastics packaging business to Rexam PLC for approx $1.8 billion
Owens-Illinois Inc (Perrysburg, OH) announced that the Company concluded the strategic review process of its plastics portfolio and has entered into a definitive agreement with Rexam PLC (London) to sell its plastics packaging business. Total consideration for the business (including tax basis step-up) will be approximately $1.825 billion, to be paid in cash at closing. The transaction, which has been approved by the board of directors of both Rexam and O-I, is expected to close early in the third quarter, subject to regulatory approvals and Rexam shareholder approval. For more information, visit www.o-i.com.
Owens-Illinois Inc (Perrysburg, OH) announced that the Company concluded the strategic review process of its plastics portfolio and has entered into a definitive agreement with Rexam PLC (London) to sell its plastics packaging business. Total consideration for the business (including tax basis step-up) will be approximately $1.825 billion, to be paid in cash at closing. The transaction, which has been approved by the board of directors of both Rexam and O-I, is expected to close early in the third quarter, subject to regulatory approvals and Rexam shareholder approval. For more information, visit www.o-i.com.
e hënë, 11 qershor 2007
TASS back in the News
The problem with Toxic Anterior Segment Syndrome is that there are more questions than answers when it comes to understanding the hows and whys. Here’s what’s known: TASS is a non-sterile, post-op inflammation occurring predominantly in cataract patients, typically within 24 hours of surgery. New recommendations can help you avoid a debilitating outbreak at your facility. Outpatient Surgery has just posted the latest recommendations. Just click on the link and read about the latest recommendations.
http://www.outpatientsurgery.net/2007/os05/kicking_TASS.php
http://www.outpatientsurgery.net/2007/os05/kicking_TASS.php
e enjte, 7 qershor 2007
GS1 UK signs up six hospitals for Scan-and-Save
http://www.itpro.co.uk/information-management/news/114223/six-hospitals-sign-up-to-scan-and-save-initiative.html
GS1 UK, an independent supply chain data standards body, has announced that six hospitals have signed up to use its "scan and save" initiative to automatically track and trace their sterile surgical instruments.
Six NHS hospitals in England have already registered to apply the GS1 system of standards to accurately track and trace their sterile surgical instrument. Threats of transferable diseases, such as MRSA, CJD, and cross contamination of surgical instruments as well as major safety concerns raised by the Patients Association have been the main...
GS1 UK, an independent supply chain data standards body, has announced that six hospitals have signed up to use its "scan and save" initiative to automatically track and trace their sterile surgical instruments.
Six NHS hospitals in England have already registered to apply the GS1 system of standards to accurately track and trace their sterile surgical instrument. Threats of transferable diseases, such as MRSA, CJD, and cross contamination of surgical instruments as well as major safety concerns raised by the Patients Association have been the main...
e martë, 5 qershor 2007
E. coli, Sensor Developed:
E. coli, Sensor Developed 6/4/2007 Source of Article: http://www.freshplaza.com/news_detail.asp?id=2290 A Drexel University engineering professor has developed a millimeter-size cantilever biosensor that can detect cells and proteins in trace samples and in only minutes. The sensor could have wide applications in medical diagnostic testing (prostate cancer), detecting contamination in food products (E. coli bacteria) and monitoring for biothreat agents (anthrax). In medical testing, the sensor can be used to analyze the four most widely tested fluids: blood, urine, sputum and spinal fluid.
Virus linked to drinking water
Source of Article: http://www.sciencedaily.com/OSLO, Norway, May 30 (UPI) -- Health officials in Norway say drinking water may be to blame for a stomach virus that sickened scores of Coastal Voyage passengers. Three of the Coastal Voyage ships that cruise the west coast of Norway have been hit by the virus, the Aftenposten newspaper said Wednesday About 200 passengers and crew have fallen ill on board the vessels Midnattsol, Finnmarken and Nordlys in the past two weeks. "Tests we have taken on board Midnattsol and Finnmarken indicate that systems meant to cleanse the water of virus and parasites function poorly," Tom Arne Hanssen of the government's food safety authority told Aftenposten. Cruise line officials say they have worked closely with food and health authorities and done major disinfection work on board the ships.
AORN Develops Correct Site Surgery Kit
http://new.reillycomm.com/acuity/makingheadlines.php?id=1620
June 4, 2007 — The Association of Perioperative Registered Nurses (AORN) has developed a Correct Site Surgery Tool Kit to assist healthcare providers in implementing the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) Universal Protocol as part of National Time Out Day.Wrong-site surgery and other preventable mistakes still occur frequently in U.S. operating rooms. That's why the American College of Surgeons (ACS) and The Joint Commission are both partnering with AORN on its annual National Time Out Day observance on June 20.
June 4, 2007 — The Association of Perioperative Registered Nurses (AORN) has developed a Correct Site Surgery Tool Kit to assist healthcare providers in implementing the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) Universal Protocol as part of National Time Out Day.Wrong-site surgery and other preventable mistakes still occur frequently in U.S. operating rooms. That's why the American College of Surgeons (ACS) and The Joint Commission are both partnering with AORN on its annual National Time Out Day observance on June 20.
FDA Answers Questions on Third-Party Inspection Program
http://www.fdanews.com/newsletter/article?issueId=10260&articleId=94117
The FDA recently released a list of questions and answers for device manufacturers interested in the Pilot Multipurpose Audit Program (PMAP), a joint effort by the FDA and Health Canada toward a third-party inspection system satisfying both agencies’ requirements.
Under the PMAP, the two agencies will evaluate the effectiveness of third-party inspections that would meet the regulatory requirements of both Canada and the U.S. The agencies anticipate this will reduce inspection-related manufacturing interruptions and result in cost savings for devicemakers.
“Although the inspections/audits would still encompass two separate but similar sets of requirements, we believe the downtime for a manufacturer will be minimized as a result of one auditing organization conducting the inspections/audits simultaneously,” a 2005 FDA letter to manufacturers said.
The FDA recently released a list of questions and answers for device manufacturers interested in the Pilot Multipurpose Audit Program (PMAP), a joint effort by the FDA and Health Canada toward a third-party inspection system satisfying both agencies’ requirements.
Under the PMAP, the two agencies will evaluate the effectiveness of third-party inspections that would meet the regulatory requirements of both Canada and the U.S. The agencies anticipate this will reduce inspection-related manufacturing interruptions and result in cost savings for devicemakers.
“Although the inspections/audits would still encompass two separate but similar sets of requirements, we believe the downtime for a manufacturer will be minimized as a result of one auditing organization conducting the inspections/audits simultaneously,” a 2005 FDA letter to manufacturers said.
e diel, 3 qershor 2007
Common Hospital Device Could Lead to Patient Infections
http://www.newswise.com/articles/view/530464/
Newswise — Patients might be at greater risk for developing bloodstream infections due to a common device used in hospitals around the country, according to a research team at the University of Nebraska Medical Center (UNMC) in Omaha, Nebraska.
The device is a needle-less intravascular catheter connector valve, commonly used for hospital patients with a vascular catheter in place. Vascular catheters are widely used in many types of patients for the infusion of medications, blood products or fluids, and the connector valve is the small piece of equipment that connects the catheter to the IV tubing.
The first generation of needle-less devices was introduced into medical care over a decade ago in order to prevent needlestick injuries and bloodborne pathogen exposure in health care workers. More recently, mechanical valves have been incorporated into the devices in an attempt to minimize the risk of catheter occlusion. Unfortunately, some of these devices may be putting patients in harm’s way, said Mark Rupp, M.D.
Dr. Rupp said the valves have a shallow depression and rim. “It’s possible that microbes and debris could collect in this depression, making them relatively resistant to cleansing or disinfectants,” he said. “They also are opaque, making it more difficult for health care workers to observe if blood or infusion products are collecting within the valve.”
Once the higher rate of bloodstream infections was determined, Dr. Rupp said the hospital immediately stopped using the mechanical needle-less connector valves and went back to using the older version.
Newswise — Patients might be at greater risk for developing bloodstream infections due to a common device used in hospitals around the country, according to a research team at the University of Nebraska Medical Center (UNMC) in Omaha, Nebraska.
The device is a needle-less intravascular catheter connector valve, commonly used for hospital patients with a vascular catheter in place. Vascular catheters are widely used in many types of patients for the infusion of medications, blood products or fluids, and the connector valve is the small piece of equipment that connects the catheter to the IV tubing.
The first generation of needle-less devices was introduced into medical care over a decade ago in order to prevent needlestick injuries and bloodborne pathogen exposure in health care workers. More recently, mechanical valves have been incorporated into the devices in an attempt to minimize the risk of catheter occlusion. Unfortunately, some of these devices may be putting patients in harm’s way, said Mark Rupp, M.D.
Dr. Rupp said the valves have a shallow depression and rim. “It’s possible that microbes and debris could collect in this depression, making them relatively resistant to cleansing or disinfectants,” he said. “They also are opaque, making it more difficult for health care workers to observe if blood or infusion products are collecting within the valve.”
Once the higher rate of bloodstream infections was determined, Dr. Rupp said the hospital immediately stopped using the mechanical needle-less connector valves and went back to using the older version.
e premte, 1 qershor 2007
Scientists develop bioactive paper
Source of Article: http://www.sciencedaily.com
HAMILTON, Ontario, May 29 (UPI) -- Canadian researchers have developed bioactive paper to detect and deactivate life-threatening bacteria and viruses, such as E.coli and salmonella.
Researchers from 10 Canadian universities, nine industrial partners, and federal and provincial government agencies formed a research consortium named the SENTINEL Bioactive Paper Network to develop low-cost and easy-to-use paper-based products with biologically active chemicals that can protect the public against increasing incidents of food-, water- and air-borne illnesses.
"What bioactive paper will offer are immediacy, portability and low-cost in detecting and repelling or deactivating harmful pathogens," said McMaster University Professor Robert Pelton, scientific director of SENTINEL. "Right now, it can take days or weeks to get samples to a lab, diagnose the problem and get the remedy into the field."
But George Rosenberg, managing director of SENTINEL said the development of bioactive paper also holds potential benefits for the paper products industry as well. "It provides our industrial partners with the opportunity to develop innovative, high value-added paper and packaging products" such as food wrappings and hospital masks, said Rosenberg.
Canada's Natural Sciences and Engineering Research Council has provided $7.5 million in funding for the project through 2010.
HAMILTON, Ontario, May 29 (UPI) -- Canadian researchers have developed bioactive paper to detect and deactivate life-threatening bacteria and viruses, such as E.coli and salmonella.
Researchers from 10 Canadian universities, nine industrial partners, and federal and provincial government agencies formed a research consortium named the SENTINEL Bioactive Paper Network to develop low-cost and easy-to-use paper-based products with biologically active chemicals that can protect the public against increasing incidents of food-, water- and air-borne illnesses.
"What bioactive paper will offer are immediacy, portability and low-cost in detecting and repelling or deactivating harmful pathogens," said McMaster University Professor Robert Pelton, scientific director of SENTINEL. "Right now, it can take days or weeks to get samples to a lab, diagnose the problem and get the remedy into the field."
But George Rosenberg, managing director of SENTINEL said the development of bioactive paper also holds potential benefits for the paper products industry as well. "It provides our industrial partners with the opportunity to develop innovative, high value-added paper and packaging products" such as food wrappings and hospital masks, said Rosenberg.
Canada's Natural Sciences and Engineering Research Council has provided $7.5 million in funding for the project through 2010.
Tetra Pak launches carton recycling campaign in Minnesota
With growing consumer interest in sustainable packaging comes greater demand for recycling empty cartons. Tetra Pak Inc., Eureka Recycling and the city of Saint Paul, MN launched a public education campaign about the addition of aseptic packaging to its curbside recycling program. Saint Paul Mayor Chris Coleman challenged residents to start adding both milk cartons (known by the industry as gable top packages) and juice boxes (aseptic carton packages) to their recycling. "We want Saint Paul to continue to be a model of recycling for other cities throughout the nation," he said.
Neonatal unit shut down after infection kills baby
http://www.theglobeandmail.com/servlet/story/LAC.20070531.HOSPITAL31/TPStory/TPNational/Ontario/
TORONTO -- A highly feared bacterial infection has killed a premature baby at a downtown Toronto hospital, sparking special hygiene measures and the closing of a neonatal intensive care unit.
The infant died of bacteremia, commonly known as blood poisoning, at Mount Sinai Hospital after acquiring serratia, a particularly harmful pathogen that can cause severe infections in babies, Allison McGeer, the hospital's director of infection control, confirmed in a telephone interview yesterday....
Crucial to minimizing serratia infections is hand hygiene, facility design and adequate space, he said. Though serratia is "not the most common infection, it is the most feared outbreak in neonatal units," Dr. Zoutman said, adding that when it sweeps through neonatal intensive care units, it can cause pneumonia, meningitis and bacteremia, such as in this most recent case.
e enjte, 31 maj 2007
Equipment amongst keys to fighting HAI's
http://www.hospitalinfection.org/press/052007lhj.html
CAN A HOSPITAL STAY MAKE YOU SICKER?
Each year 2 million patient get hospital-based infections, and 90,000 die as a result. Seventy percent of bacterial infections are resistant to at least one antimicrobial drug, and the numbers are rising. Some doctors say infections are inevitable given patients' weakened immune systems. Also, devices such as prosthetic joints are potent germ portals. "The kinds of heroic care physicians offer today involve invading skin and tissue - proven opportunities for staph bacteria to infect them," says Robert Daum, M.D., professor of pediatrics at the University of Chicago. Others blame hygiene. "The real issue is the meticulous cleaning of hands and very careful cleaning of equipment between patient use," says Betsy McCaughey, Ph.D., chair of the Committee to Reduce Infection Deaths (RID), in New York City. The University of Pittsburgh Medical Center cut MRS in its ICU 90 percent by isolating patients who tested positive for staph infections and having medical personnel use disposable gowns when treating them. Reaportedly the costs of doing so came to $35,000, but the hospital saved $800,000.
CAN A HOSPITAL STAY MAKE YOU SICKER?
Each year 2 million patient get hospital-based infections, and 90,000 die as a result. Seventy percent of bacterial infections are resistant to at least one antimicrobial drug, and the numbers are rising. Some doctors say infections are inevitable given patients' weakened immune systems. Also, devices such as prosthetic joints are potent germ portals. "The kinds of heroic care physicians offer today involve invading skin and tissue - proven opportunities for staph bacteria to infect them," says Robert Daum, M.D., professor of pediatrics at the University of Chicago. Others blame hygiene. "The real issue is the meticulous cleaning of hands and very careful cleaning of equipment between patient use," says Betsy McCaughey, Ph.D., chair of the Committee to Reduce Infection Deaths (RID), in New York City. The University of Pittsburgh Medical Center cut MRS in its ICU 90 percent by isolating patients who tested positive for staph infections and having medical personnel use disposable gowns when treating them. Reaportedly the costs of doing so came to $35,000, but the hospital saved $800,000.
e mërkurë, 30 maj 2007
Duke management of Durham Regional reviewed
The board of trustees of Durham County Hospital Corp (Durnam, NC) retained Noblis Inc (Falls Church, VA) to review the first 10 years of Duke University Health System's (Durham, NC) 20-year management contract with Durham Regional Hospital (Durham, NC). The board wishes to determine whether Durham Regional has maintained its position among the state's top tertiary care community hospitals. A three-year to five-year "strategic plan" will result that will address whether to extend the lease or seek another manager. Although financial results are improving after several years of major losses, services such as inpatient pediatrics and cardiovascular care have been reduced or eliminated. Speculation has arisen that the board may consider Novant Health (Winston-Salem, NC) to replace Duke. In 2006, the Durham County Board of Commissioners initiated a separate study to examine whether Duke's upkeep of the Durham Regional facilities had met expectations. That study recommended improvements, including timely completion of a $10 million ICU renovation and the conversion of its inpatient beds from semi-private to private.
WHO and UN issue new HIV guidelines for health facilities
WHO and UNAIDS issue new guidance on HIV testing and counselling in health facilities
New recommendations aim for wider knowledge of HIV status and greatly increased access to HIV treatment and prevention
30 MAY 2007 | LONDON -- WHO and UNAIDS today issued new guidance on informed, voluntary HIV testing and counselling in the world's health facilities, with a view to significantly increasing access to needed HIV treatment, care, support and prevention services. The new guidance focuses on provider-initiated HIV testing and counselling (recommended by health care providers in health facilities).
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