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Last Updated 02/21/10
   

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In December 1999, the U.S. Federal Government's Institute of Medicine issued a report entitled, "To Err is Human: Building a Safer Health System". This report cited between 44,000 and 98,000 deaths every year due to medical errors. While these numbers are disputed by some, they would make medical errors the 8th leading cause of death, ahead of breast cancer or AIDS.

Dialysis patient safety is a complex issue that involves highly specialized dialysis technology, staff training and turnover, cost pressures, reporting of problems, oversight and regulations, water purification, dialyzer reuse, medication errors, patient compliance, patient education, primary care, prevention, vascular access, infection, location and layout of dialysis units, and the increased age and comorbidities of the ESRD population.

Patient safety and injury prevention are most effective when it involves everyone in the healthcare delivery scheme. Towards that end, RenalWEB has accumulated this list of resources that addresses safety issues from many perspective and at several different levels of complexity.

RenalWEB has a separate resource page for Infection Control.

Warning: Changes should never be made in a patient's treatment or care based solely on the information found here.  All patients have unique healthcare concerns and considerations and these must all be taken into account before any changes can be safely made.  All medical and therapeutic decisions must come from a qualified health care provider.  Read RenalWEB's Legal Disclaimer before proceeding.

  NEWS & LATEST ARTICLES
FDA Finally Unveils Risk Management Plan for ESAs - Article from GoozNews. - February 17, 2010
"The failure to simultaneously force the companies to reeducate the renal physician community was disappointing. There's mounting evidence that high doses of ESAs in renal disease patients is associated with increased risk of heart attacks, strokes and earlier mortality. Many of these patients are poor and unaware of the quality of care they receive at dialysis centers. They, just as much as cancer patients, need to be informed about the risks posed by overuse of ESAs."
Maalox Medication Use Errors - Safety information notice from the FDA. Article from WebMD. - February 17, 2010
Maalox Total Relief is not appropriate for individuals who want to use an antacid, since it contains the active ingredient bismuth subsalicylate which is chemically related to aspirin and may cause serious adverse effects such as bleeding."
Recall: Medcomp 10F Hemodialysis Catheter Insertion Kits Mislabeled - FDA Enforcement Report for 2/17/10. Scroll down 90-95% of page. - February 17, 2010
FDA Approves Plan To Manage ESA Risks; Amgen and J&J Must Educate Oncologists and All Patients - Articles from Reuters, HealthDay, Medscape, and AP. - February 16, 2010
Press release, safety information, and Drug Safety Communication from the FDA.
The guidelines call for all patients treated with Amgen and J&J's anemia drugs to receive a booklet outlining their risks and benefits.
Treatment of severe dialysis reactions with the AN69-ST membrane: biocompatibility does matter - Advance Access abstract from NDT. - February 14, 2010
Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall - Safety information from FDA. - February 9, 2010
China probe into new tainted milk products - Article from AFP. - February 7, 2010
Iron Safety Hits AMAG Pharmaceuticals - Articles from Seeking Alpha and The Street. Shares of AMAG were down nearly 17% due to purported safety concerns regarding Feraheme®. - February 4, 2010
FDA Safety Enforcement Report for February 3, 2010 - The list includes several Class I recalls, catheters, power cords, IV pump sets. (Devices begin approximately 60% of the way down the page.) - February 3, 2010
Class 1 Recall: Edwards Lifesciences Inc., Aquarius Hemodialysis System - Notice from the FDA web site. Baxter International, Inc. is the U.S. distributor of the Aquarius. - February 3, 2010
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death. Earlier this month, Baxter sent an Urgent Device Correction notice (2-page pdf) to peritoneal dialysis clinicians to help reduce or eliminate overfill, also referred to as Increased Intraperitonal Volume (IIPV), associated with HomeChoice/HomeChoice PRO cyclers.
FDA Announces Class I Recall of Certain Infusion Set Needles (Huber) - Notice from the FDA web site concerning Exel/Exelint needles and sets manufactured by Nipro. - February 1, 2010
Salami recalled over salmonella concerns - Article from USA Today. - January 29, 2010
Nipro Medical Corporation Issues a Voluntary Recall of All GlucoPro Insulin Syringes - News release from the FDA. - January 21, 2010
Tylenol, Motrin, Benadryl, St. Joseph Aspirin, Rolaids Recall - Article from WebMD. - January 15, 2010
U.S. taking closer look at bisphenol A in plastics - Article from Reuters. - January 15, 2010
Spire Biomedical Recalls Hemodialysis Catheters - FDA Enforcement Report for Jan. 13, 2009. A total of 55,128 catheters are being recalled due to a possibility that the catheter tubing could separate from the hub/bifurcation of the device. Scroll down the page to see the listing of 48 recallled products (these appear approximately 40% of the way down the page). - January 13, 2010
Rapamune (sirolimus): Drug Monitoring Recommendations - Notice from the FDA MedWatch site. - January 11, 2010
ESA Safety and the New, Transparent FDA - Posting from the IN VIVO blog. - January 10, 2010
FDA Basics Website Explains Agency - News item from AAMI. - January 2010
URGENT RECALL: HomeChoice Automated PD System and HomeChoice PRO Automated PD System (Product Codes 5C4471, 5C4471R, 5C8310, 5C8310R) - 2-page pdf on the Network of New England web site. - January 8, 2010
Baxter recently sent an Urgent Device Correction notice to peritoneal dialysis clinicians to help reduce or eliminate overfill, also referred to as Increased Intraperitonal Volume (IIPV), associated with HomeChoice/HomeChoice PRO cyclers.
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  WEB RESOURCES
ANA Safe Patient Handling web site from the American Nurses Association (ANA)
National Nosocomial Infections Surveillance (NNIS) System Report, data summary from January 1992 through June 2004, issued October 2004 - (pdf format requires Adobe Acrobat Reader) from the National Center for Infectious Diseases (NCID)
ESRD Patient Safety Report (pdf format) - January 31, 2001 - from the Renal Physicians Association web site
Patient safety Network (PSNet) web site
Joint Commission International Center for Patient Safety web site
National Healthcare Safety Network (NHSN) - from the Centers for Disease Control and Prevention web site
2007 National Healthcare Quality & Disparities Reports - from the Agency for Healthcare Research and Quality (AHRQ)
National Patient Safety Agency web site (UK organization)
Keeping Kidney Patients Safe web site
Patient Safety Tools: Improving Safety at the Point of Care from the AHRQ web site
Working Together For Patient Safety - from the APP Pharmaceuticals web site
Using Human Factors Engineering to Improve Patient Safety - Association for Advancement of Medical Instrumentation (AAMI) web site. Cost is $70 for AAMI members / $80 nonmembers.
Promoting ESRD Patient Safety: For Caregivers - (requires Microsoft Word™) document from the ESRD Network 12 web site
Doctor-Robot Service - free online version of Medical Diagnostics Program Symptomat as a way to reduce medical errors
FDA Drug Safety Information for Patients and Health Care Professionals - from the U.S. Food and Drug Administration
FDA Video on Patient Safety Topics: Erythropoietic Agents and Antibody-Mediated Anemias - from the U. S. Food and Drug Administration
FDA Drug Safety Newsletter from the FDA/Center for Drug Evaluation and Research web site
Prevent Dangerous Hemodialysis Catheter Disconnections article from FDA's Medical Device Safety
Electrical Safety Manual, 2008: A Comprehensive Guide to Electrical Safety Standards for Healthcare Facilities - Association for Advancement of Medical Instrumentation (AAMI) web site. Cost is $85 for AAMI members / $135 nonmembers.
Preventing Falls Among Older Adults article from the Centers for Disease Control and Prevention web site
Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigators from the FDA's Regulatory Information
ANA Nursing Practice Information Infrastructure web site

Safe Practices for Better Healthcare - 2009 Update A Consensus Report 12-page (pdf) public version of the report from the National Quality Forum web site

Safe Staffing Saves Lives web site from the American Nurses Association (ANA)
Dialysis Collection of AAMI Dialysis Standards and Guidance Documents Revised for 2003 - Association for Advancement of Medical Instrumentation (AAMI) web site. Cost is $195 for AAMI members / $275 nonmembers.
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  ESSENTIALS AND CLASSICS
FDA Patient Safety News - video from the U. S. Food and Drug Administration - July 2006
Advances in Patient Safety: From Research to Implementation from the Agency for Healthcare Research and Quality (AHRQ) web site
First in a series of publications from the Institute of Medicine's Quality of Health Care in America project. To Err Is Human: Building a Safer Health System - on line book by Linda T. Kohn, Janet M. Corrigan, and Molla S. Donaldson, Editors; Committee on Quality of Health Care in America, Institute of Medicine; Copyright © 2000.
Safe Patient Handling and Movement - from the U.S. Dept. of Veterans Affairs web site

Second in a series of publications from the Institute of Medicine's Quality of Health Care in America project. Crossing the Quality Chasm: A New Health System for the 21st Century. Overview from the Renal Physicians Association web site

Workbook for Designing, Implementing, and Evaluating a Sharps Injury Prevention Program - from the Centers for Disease Control and Prevention web site
Internal Bleeding: the Truth Behind America's Terrifying Epidemic of Medical Mistakes by Robert M. Wachter, MD and Kaveh G. Shojania, MD (Rugged Land Books, 2004)
ASHHRA Disaster Planning Guide - ($259 members/$329 nonmembers) from the American Society for Healthcare Human Resources Administration web site
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  PUBMED SEARCHES
PubMed Search Tool of the National Library Of Medicine's MEDLINE Database. These links allows you to search through over 11 million indexed articles. Due to copyright laws, only the abstracts (summaries) of the articles are usually listed. Some articles appear in full text on the publishers' web sites that are linked to PubMed. This page provides an Overview of PubMed. All these search results links are continually updated by the Library of Congress.
biocompatibility and dialysis
pyrogen and dialysis
equipment malfunction and dialysis
hemolysis and hemodialysis
chloramines and hemodialysis
disequilibrium syndrome and dialysis
dialysis dementia or dialysis encephalopathy
air embolism and dialysis
medical error and dialysis
patient safety and dialysis
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  DISCUSSION FORUM
General Dialysis Nursing Issues and Questions (No dedicated RenalWEB forum)
Dialysis Technical Forum  
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  RELATED TOPICS
AIDS (auto immune deficiency syndrome) and dialysis - PubMed search
VRE (vancomycin-resistant enterococci) and dialysis - PubMed search
MRSA (methicillin-resistant Staphylococcus aureus) and dialysis - PubMed search
Guidelines & Recommendations for Immunizations - infection control practices from the Centers for Disease Control and Prevention (CDC)
hepatitis AND dialysis - PubMed search - Continually Updated!
hepatitis B - PubMed search - Continually Updated!
hepatitis C - PubMed search - Continually Updated!
hepatitis AND vaccine - PubMed search - Continually Updated!
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  UPCOMING EVENTS
Listing of National Patient Safety Foundation Seminars
Listing of The American Health Quality Association Events Calendar
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  PRODUCTS
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  INPUT / SUGGESTIONS
E-mail to RenalWEB on the Hepatitis Topic
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