Sterile Processing News

TASS back in the News

2009-05-12T08:51:00.002-04:00

Outpatient Surgery E-Weekly update of May 12,2009 is reporting that their Instapoll for last week’s question on TASS show that 17% of those responding have Seen TASS

Nine of the 52 readers who answered last week's online poll reported that they'd experienced an outbreak of toxic anterior segment syndrome (TASS) at their facilities. TASS is a post-operative, acute inflammation of the anterior segment of the eye that has been linked to ophthalmic viscoelastic devices, intraocular lenses and irrigation solutions used during eye surgery. Other adverse events happened much less frequently: 1 poll taker reported a case of a retained object and 2 reported wrong-site surgeries. A majority of 69%, however, reported that their facilities had been free of these adverse events.
This is the link to the E-Weekly
http://www.outpatientsurgery.net/newsletter/eweekly/2009/05/12.php#4

VA - Miami - Concern with Hepatitis From Colonoscopies

2009-04-02T14:03:00.002-04:00

April 2,2009 - EndoNurse is reporting that Officials from three Veterans Affairs facilities in the South have issued warnings to thousands of patients in the last few months about infections the patients may face because of equipment mistakes that staff members made.

According to the Miami Herald, a team of doctors and administrators from the U.S. Department of Veterans Affairs is investigating procedures at the Miami Veterans Affairs Hospital to find out what went wrong. Colonoscopies at the facility have been halted.

To read the article, click here

For the EndoNurse link click here.

VA Implementing National Safety “Step-Up”

2009-02-11T11:21:00.001-05:00

2/9/09 - WASHINGTON – The Department of Veterans Affairs (VA) is calling for a special training campaign on safety – called a “Step-Up” – from March 8 to 14 at all medical centers and outpatient clinics to ensure VA staff follow the highest standards for patient safety.
To read the complete letter click on this link.

SYNTHES releases new Sterilization Recommendations

2009-02-03T16:51:00.002-05:00

February 2, 2009 - SYNTHES sends out a letter with new information on the Sterilization recommendations of SYNTHES devices, i.e. implants,instruments,and cases. Click on the link to download the pdf information.
SYNTHES INFORMATION

HHS Issues Action Plan to Prevent Healthcare-Associated Infections

2009-01-06T13:37:00.001-05:00

The U.S. Department of Health and Human Services (HHS) unveiled a plan that establishes a set of five-year national prevention targets to reduce and possibly eliminate healthcare-associated infections (HAIs).

To read the report please click on this link.

Were dirty surgical tools used on patients ?

2009-01-05T12:13:00.002-05:00

The local TV station in Nashville,TN is reporting that there's an investigation under way to determine whether some patients might have been exposed to infection from colonoscopies at the VA Hospital in the area. To read the complete story click on this link.

RFID Tags Found to Interfere With Hospital Equipment

2009-01-05T11:56:00.002-05:00

HospiMedica International is reporting that research done in Amsterdam is suggesting that RFID tags could interfere with some hospital equipment. To read the article click here for the link.

Clinic reports lapses in disinfection for Scopes

2009-01-02T11:19:00.003-05:00

The LAS VEGAS SUN is reporting(1/2/09) that an outpatient surgery center has notified state authorities that it failed to properly disinfect instruments it uses during procedures. To read the complete story click on this link Complete Story .

This is just another reason why medical facilities need to verify their cleaning process. To find products that help you verify your cleaning process click on this link. CLEANING VERIFICATION.

CBSPD Announces Management Course Dates for 2009

2008-11-17T09:40:00.002-05:00

The CBSPD has posted the dates for their Educational meetings for Managers and Supervisors for 2009.

Click on the this link for the PDF

New Research supports the use of the TOSI

2008-11-14T16:05:00.002-05:00

An article that appears in AJIC -2/08-Volume 36,number 1. The study was done by Dr. Michelle Alfa,Nancy Olson and Louise Buelow-Smith in Winnipeg,Manitoba, Canada states" our data supports the value of users evaluating the cleaning efficacy of Washer Disinfectors by...TOSI testing...Washser Disinfectors that do not provide adequate cleaning as determine by these tests should be taken out of service until they are fixed or replaced..."

To read the complete article Click here.

Mystery solved: How bleach kills germs

2008-11-14T15:57:00.001-05:00

Research out of the University of Michigan have just figured out how the cleaner does its dirty work.

It seems that hypochlorous acid, the active ingredient in bleach, attacks proteins in bacteria, causing them to clump up much like an egg that has been boiled, a team at the University of Michigan reported in the journal Cell on 11/14/08.

To read the complete story Click here.

Hospitals use more antibiotics despite concerns

2008-11-14T15:51:00.003-05:00

Reuters has reported that experts worry bacteria will become resistant to existing drugs.

To read the complete story Click here.

Class 6 White Paper now on line

2008-10-31T10:39:00.001-04:00

STERIS Corporation has issued a free white paper to explain the emulating ink technology and capabilities of the first Class 6 steam sterilization chemical indicators cleared for use in US healthcare facilities. Download the paper here.

Doorknobs and TV remotes are germ hotbeds

2008-10-30T15:21:00.002-04:00

The AP is reporting that The University of Virginia has released a report that common areas with in a house harbor germs; some germs stay up to two days. To read the complete article. Please Click on this link.

C.difficile strikes again

2008-09-17T10:35:00.003-04:00

The Toronto paper The Globe and Mail has reported that " Aging hospitals breed deadly outbreaks" . The paper reported that an outbreak of C.difficile at an Ontario hospital between May 2006 and December 2007 killed 91 patients. For the complete story click on this link.

Unreported Changes to Sterilization Wraps Draw FDA Warning

2008-09-17T10:31:00.002-04:00

The FDA Daily email update Vol. 5, No. 181;Tuesday, Sept. 16, 2008 reported the following.

Unreported Changes to Sterilization Wraps Draw FDA Warning
Kimberly-Clark Healthcare failed to obtain marketing clearance before selling 12 models of previously approved sterilization wraps that the FDA considers new products because significant changes were made, according to a warning letter. The FDA says the devices are adulterated and misbranded because the company failed to provide adequate justification for not submitting 510(k)s or PMAs for the updated line. The company claimed the changes made between 1991–1995 were not significant enough to require new 510(k)s.
The GMP Letter

NIOSH brochure offers tips for reducing occupational stress in hospitals

2008-08-21T11:30:00.000-04:00

A new brochure from the National Institute for Occupational Safety and Health examines potential causes and health effects of occupational stress in hospitals, and suggests work practices that can help reduce it. A combination of organizational change and stress management “is often the most successful approach for reducing stress at work,” the authors note.

New Web Page on Understanding Chemical Indicators

2008-08-01T11:38:00.000-04:00

3M Health Care has announced the addition of a new Web site (to its suite of free, objective educational tools offered through 3M Attest Sterile U Online.
Focused on the topic of steam sterilization load and pack control monitoring devices, the new website provides clear answers and facts on the differences and implications of using Biological Indicators, Class 5 Integrating Indicators, and Class 6 Emulating Indicators for monitoring. It also contains guidance on how and when to use the various steam sterilization load and pack control monitoring devices, and offers in depth details on standards and guidelines from various industry associations. To access the site visit click on link.

U.S. News Best Hospitals for 2008 are posted

2008-07-14T12:25:00.002-04:00

The 2008 "Best Hospitals" rankings are out.

For more, click here

The Honor Roll link

Listings by specialty

Where does your hospital rank ?

Printed copy will be on the Newsstands July 14,2008.

Residents Alerted to Improperly Washed Surgical Tools

2008-06-30T15:41:00.002-04:00

Ann Work a reported for the Times Record News in Witchita Falls, Texas has reported that a Health Care System had to inform over 1,800 patients that the instruments used in their surgeries might not have been cleaned properly . The possible source of the concern " the detergent dispenser" . Just another reason why medical facilities should be testing their medical automatic washers.

Clink on the link to read the complete story.

Duke Settles Hydraulic Fluid Case

2008-06-30T13:36:00.003-04:00

As reported on6/24/2008 in MDSI daily updates.

Duke settles hydraulic fluid case; New lawsuits filed against Cardinal, Steris, and Duke University Health System (Durham, NC) settled claims by patients who in 2004 were operated on at Durham Regional Hospital (Durham, NC) and Duke Health Raleigh Hospital (Raleigh, NC) using surgical instruments mistakenly cleaned with used hydraulic fluid. Details of the settlement were not disclosed. Following the settlement, an additional lawsuit with 67 plaintiffs was filed in Durham County Superior Court against distributor Cardinal Health (Dublin, OH) and Steris Corp (Mentor, OH), which made the sterilization washers used in the hospitals to clean surgical equipment, as well as the detergent and other products used in the process. Cardinal Health employees, several of whom were also named as defendents, allegedly should have been able to tell that the barrels that originally held detergent had been used for another purpose, and should not have returned them to the company for resale.

How do you wipe something clean?

2008-06-19T10:08:00.003-04:00

The actual process of decontamination a surface is the same for both cleaning and disinfection. Due to the effect of biofilms, surface wiping is needed to assist in the removal of surface contamination. Wiping should never be carried out in a circular motion as this causes the wipe in its dirtiest state to be passed over an area which has just been cleaned. This point needs to be reinforced with operators, as a circular wiping pattern is the most comfortable and convenient but not the best practice.

The correct technique is to wipe, towards you, in straight horizontal lines, each time overlapping the previous one by 10-25%. A contaminated wipe should not be passed over an area that has just been wiped, unless it is folded and refolded to provide a clean surface. Usually quarterly folds are recommended but must be validated with each operator concerned, as a quarterly fold can lead to confusion as to which surfaces of the wipe have been used. In this case wipes folded in half should be used. Surface wiping should be carried out from top to bottom, from back to front, and from cleanest to dirtiest. The wipe itself should be constructed from a low particulate material.

The source of this information is Cleaning of Isolators - A Vital Part of a Contamination Control Program By: Karen Rossington; April 2004.

When to Use Alcohol as a Disinfectant

2008-06-19T09:54:00.001-04:00

It has been known for many years that alcohol is an effective disinfectant;studies have shown that it is a better disinfectant when it is neither too weak nor too concentrated.Disinfectant efficacy is optimal at concentrations between 50% and 80%. Many institutions use 70% alcohol blends as standard.

To read more click on this link.

Joint Commission releases 2009 patient safety goals

2008-06-18T10:01:00.002-04:00

The Joint Commission released the 2009 National Patient Safety Goals and related requirements for its accreditation programs.

To review the complete document click on this link.

JCAHO 2009 Patient Safety Goals

More Knee and Hip Surgery Cases

2008-06-13T13:37:00.005-04:00

Central Service departments are going to be doing more knee and hip type surgries in the future according to a report out of The University of Michigan. The number of baby boomers who are opting for knee replacement surgery earlier in life is growing at an exponential rate, says J. David Blaha, M.D., an orthopaedic surgeon at the University of Michigan Health System. Only a few years ago, between 300,000 and 350,000 knee replacement surgeries were being done. Today, that number has risen to a staggering 500,000 and going up each year.

To read more on this story just click on the link.

http://www.newswise.com/articles/view/541310/?sc=rsmn

New Type of Latex Glove Cleared

2008-05-13T08:26:00.001-04:00

On April 23, 2008, the Food and Drug Administration (FDA) cleared for marketing the Yulex Patient Examination Glove. This is the first medical device made from guayule latex, a new form of natural rubber latex.

For more information on this please click on this FDA link.

C. difficile exacts heavy toll at Ontario hospital

2008-05-09T13:20:00.003-04:00

Canada : HPN has reported a story out of Toronto that a deadly outbreak of a highly contagious superbug at an Ontario hospital claimed the lives of one-third of the patients afflicted with the disease, a far greater toll than previously believed. Joseph Brant Memorial Hospital in Burlington announced yesterday that 91 of the 177 patients diagnosed with Clostridium difficile, commonly known as C. difficile, over a 20-month period ending last December died in the institution. It blamed the disease for 62 of the deaths.

Please click on this link for detailed information.

Reprocessing Industry Group Applauds GAO Report Findings

2008-03-12T08:29:00.002-04:00

"Medical device reprocessing, as the GAO again confirms, is stringently regulated by the Food and Drug Administration (FDA),” Vukelich says. “Twice in eight years GAO has looked at the practice of reprocessing ‘single-use’ devices (SUDs) and found no evidence of increased risk to patients.”

To read the complete story pleae click on the link.

How is Your Hospital doing these days ?

2008-02-24T15:07:00.003-05:00

Have you ever wanted to compare hospitals and their care? Now you have a way. The comparisons are posted on a special web site.

The site was launched in 2004 as part of the federal Medicare Prescription Drug, Improvement and Modernization Act of 2003. The U.S. Department of Health & Human Services has created its "Hospital Compare" Web site: www.hospitalcompare.hhs.gov.

Click on these two links to read more about this process and compare your hospital.

Link 1

Link 2

What's Right in Health Care: 365 Stories of Purpose, Worthwhile Work, and Making a Difference.

2008-02-24T15:03:00.004-05:00

A new book has been published dealing with 365 Healthcare stories that have made a difference. Go to this link to read more about this new book. The link is

http://thenewsherald.com/stories/012008/loc_20080120005.shtml

OSHA Offers a New Resource for Medical Facilities

2008-02-19T08:31:00.002-05:00

In the fall of 2007 OSHA released a Web site that provides step-by-step guidance, along with the requirements and educational resources managers need to ensure occupational safety.Please click on the link below for this tool and more information.

http://www.osha.gov/dcsp/compliance_assistance/quickstarts/health_care/index_hc.html

Fingernails and Infection

2008-02-05T08:49:00.000-05:00

Outpatient Surgery E-Weekly (2/5/08) has reported about a study that is published in the January issue of the Journal Infection Control and Hospital Epidemiology that found that although antibiotic gels help increase hand hygiene, they failed to reduce infection rates in two ICUs over a two-year period.

"Hand hygiene may be important, but it's only one ingredient in the overall recipe for preventing infection," says Mark Rupp, MD, professor of infectious diseases at the University of Nebraska Medical Center, medical director of the school's Department of Healthcare Epideminology and the study's principal author.

Exactly why the infection rates did not decrease when hand hygiene compliance increased is unknown, says Dr. Rupp. One theory has to do with fingernail length. They found more, and varied, microbes when the nurses had fingernails more than two millimeters long, wore rings or lacked access to hand gels. According to Dr. Rupp, fingernails are too long for healthcare if you can see them over the skin of your fingers when looking at your palm.

To read more on this topic please go to the link below.

http://www.journals.uchicago.edu/doi/abs/10.1086/524333

FDA Public Health Notification: Unretrieved Device Fragments

2008-01-16T10:34:00.000-05:00

Issued: January 15, 2008

Dear Healthcare Practitioner:

This is to advise you of serious adverse events associated with unretrieved device fragments (UDFs) and provide recommendations to mitigate these events. A UDF is a fragment of a medical device that has separated unintentionally and remains in the patient after a procedure. Patients may not be aware that this has occurred. The Center for Devices and Radiological Health (CDRH) receives nearly 1000 adverse event reports each year related to UDFs. These have included more than 200 different medical devices and numerous medical specialties.

To read the complete report please go to this link :

http://www.fda.gov/cdrh/safety/011508-udf.html

Avoiding Hazards from Using Cleaners and Disinfectants on Electronic Medical Equipment

2008-01-08T13:41:00.000-05:00

FDA, CDC, EPA and OSHA have issued a Public Health Notification on how to avoid hazards when using liquid cleaners and disinfectants on electronic medical equipment. The Notification covers a wide range of equipment, including infusion pumps, ventilators, analgesia pumps, computer workstations and monitoring equipment.

This action was prompted by reports of fires and other equipment damage, as well as burns to healthcare workers, when these types of liquids were used inappropriately on equipment that has unsealed electrical circuits. In many cases, healthcare workers routinely sprayed the equipment with disinfectants or wrapped the housings with disinfectant-soaked towels, causing damage to the circuitry.

The Notification provides a number of recommendations to reduce the risk. Here are some of the highlights:

• Protect equipment from contamination during use, which can help avoid the need for disinfection.

• If equipment becomes contaminated, remove it from use and be sure it's serviced before returning it to use.

• Clean equipment surfaces according to the instructions from both the equipment manufacturer and the chemical manufacturer.

Additional Information:

FDA MedWatch Safety Alert. Cleaners and Disinfectants: Hazards of Excess Use on Electronic Medical Equipment. November 1, 2007.

http://www.fda.gov/medwatch/safety/2007/safety07.htm#Cleaners

Ireland Issues Guideline on Device Reprocessing

2008-01-07T09:08:00.000-05:00

Ireland Issues Guideline on Device Reprocessing

Ireland’s Health Service Executive has released a practice guideline on decontamination of reusable invasive medical devices (RIMDs).

The new code of practice sets standards and best practices for facilities operating within Ireland’s public health system.

“Decontamination facilities should be designed, constructed, maintained and controlled to provide effective segregation of clean and dirty activities and to provide an environment that minimizes contamination of clean and disinfected RIMD,” the guideline says.

The seven-part guideline includes sections on recommended practices for central decontamination units, endoscopy units and dental services, as well as an audit prototype for evaluating decontamination procedures.

The guideline, “Code of Practice for Decontamination of Reusable Invasive Medical Devices,” can be viewed at:

www.hse.ie/en/Publications/HSEPublicationsNew/AcuteHospitalReportsGuidelines/#d.en.8696.

Patient and User Burns from Rotary Surgical Handpieces

2007-12-14T08:26:00.001-05:00

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

AORN Specialty Assembly for SP/MM News

2007-11-26T12:05:00.000-05:00

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

FDA and New Requirements for Tracking Medical Devices

2007-11-09T08:32:00.000-05:00

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

Bush Signs MDUFMA Reauthorization Bill Into Law

2007-10-02T08:06:00.001-04:00

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.

TWO STERILE PROCESSING INDUSTRY GROUPS

2007-09-23T19:52:00.001-04:00

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.

FDA Patient Safety News - Video Available Online and as Podcast

2007-09-05T08:40:00.000-04:00

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

Steris Warned After Reports of Flames and Sparks From Cleaning Units

2007-08-29T08:34:00.000-04:00

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.

CDRH Provides Update on Postmarket Transformation

2007-08-28T09:08:00.000-04:00

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

2007-08-28T08:43:00.000-04:00

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.

Hospital issues warning to surgical outpatients

2007-08-22T11:10:00.000-04:00

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.”

Plain soap as effective as antibacterial but without the risk

2007-08-17T11:51:00.000-04:00

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.

Global Task Force Issues Guidance on Device Clinical Trials

2007-08-14T08:40:00.000-04:00

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.

Packed House for 4th Annual Oxoid Infection Control Seminar

2007-08-14T08:08:00.000-04:00

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.

Study reports aging population drives medical device packaging

2007-08-10T16:23:00.000-04:00

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."

New leader set to take The Joint Commission

2007-08-02T08:13:00.000-04:00

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

How do you satisfy worst-case requirements in ISO 11607?

2007-08-01T13:57:00.000-04:00

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.

Technological advancements drive medical device packaging in North America, report says

2007-08-01T13:11:00.000-04:00

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.

Pa. Gets Tough on Healthcare-acquired Infections

2007-07-31T10:20:00.000-04:00

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.

AORN council addresses extended cycle concerns

2007-07-30T08:29:00.000-04:00

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

Premier healthcare alliance launches comprehensive project to improve hospital quality, reduce costs

2007-07-27T12:04:00.000-04:00

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.

MediSource introduces triple enzyme cleaner

2007-07-24T14:14:00.000-04:00

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.

Expert: FDA Scrutinizes Complaint-Handling Systems

2007-07-19T08:45:00.000-04:00

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 Solutions for Unburdening Instruments

2007-07-19T08:12:00.000-04:00

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

FDA Public Health Notification: Updated Information on Custom Ultrasonics, Inc., Endoscope Washer/Disinfector

2007-07-18T09:01:00.000-04:00

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

Ecolab Hand Hygiene Compliance Monitoring Program Helps Hospitals Reduce

2007-07-13T11:04:00.000-04:00

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.

Innovative Hand Sanitation System Trumps Hospital Acquired Infections

2007-07-13T08:34:00.000-04:00

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."

Soil Particles Found to Boost Prion's Capacity to Infect

2007-07-11T09:02:00.000-04:00

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."

Medical sterilization systems market to reach $2.3 billion by 2010, says new report

2007-07-10T13:50:00.000-04:00

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.

Automation standards benefit pharmaceutical/medical applications

2007-07-09T08:27:00.000-04:00

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.

SPSmedical announces monthly audio seminars for healthcare facility

2007-07-09T08:24:00.000-04:00

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.

CDC network to track HAI

2007-06-29T08:56:00.000-04:00

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

Proactive instrument care contributes to surgical serenity, quality outcomes

2007-06-28T12:13:00.000-04:00

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

CDC Updates Guidelines

2007-06-27T14:00:00.000-04:00

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.

Energy and Commerce Committee Sends MDUFMA to House Floor

2007-06-26T08:32:00.001-04:00

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

APIC conference to focus on 21st century innovations; power of positive deviance among week’s highlights

2007-06-25T13:37:00.000-04:00

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

New European Medical Device Directives Expected This Fall

2007-06-25T08:12:00.000-04:00

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

Medical Device Packagers—Pioneers in Sustainability?

2007-06-21T16:08:00.000-04:00

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.

Study: Hospitals With Joint Commission Approval Safer

2007-06-18T12:18:00.000-04:00

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.

Creating Strong Sterilization Partnerships

2007-06-18T12:13:00.000-04:00

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

Troubleshooting Your Flexible Endoscopes

2007-06-18T12:04:00.000-04:00

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.

RFID in Surgical Sponges

2007-06-13T13:15:00.000-04:00

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/

Where does your State stand when it comes to Quality Healthcare ?

2007-06-12T09:13:00.000-04:00

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

2007-06-12T08:48:00.000-04:00

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

Owens - Illinois Inc. to Sell Plastic Packaging Business

2007-06-12T08:36:00.000-04:00

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.

TASS back in the News

2007-06-11T11:06:00.000-04:00

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

GS1 UK signs up six hospitals for Scan-and-Save

2007-06-07T07:53:00.000-04:00

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...

E. coli, Sensor Developed:

2007-06-05T20:37:00.001-04:00

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

2007-06-05T20:36:00.001-04:00

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

2007-06-05T20:35:00.001-04:00

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.

FDA Answers Questions on Third-Party Inspection Program

2007-06-05T08:16:00.000-04:00

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.

Common Hospital Device Could Lead to Patient Infections

2007-06-03T15:22:00.000-04:00

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.

Scientists develop bioactive paper

2007-06-01T14:10:00.000-04:00

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.

Tetra Pak launches carton recycling campaign in Minnesota

2007-06-01T12:54:00.000-04:00

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

2007-06-01T10:26:00.001-04:00

h ttp://www.theglobeandmail.com/servlet/story/LAC.20070531.HOSPITAL31/TPStory/TPNational/Ontario/

LISA PRIEST

May 31, 2007

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.

2007-05-31T15:07:00.001-04:00

Equipment amongst keys to fighting HAI's

2007-05-31T14:44:00.000-04:00

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.

Duke management of Durham Regional reviewed

2007-05-30T12:48:00.000-04:00

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

2007-05-30T12:40:00.000-04:00

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).