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

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

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.

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

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

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

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.

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.

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

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.

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/

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

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.

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

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...

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.

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.

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.

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.

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/

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.