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.
e mërkurë, 29 gusht 2007
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.
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