Navigation Links
FDA Looks to Improve Design and Cleaning Instructions for Reusable Medical Devices
Date:4/29/2011

sable medical device is the endoscope, used in over 10 million medical procedures per year. Endoscopes are long thin tubes with a camera or a light that are threaded into the lungs, the blood vessels or other cavities to visualize areas within the body.  

In a review of adverse event reports on endoscopes filed with the agency from Jan. 1, 2007 to May 11, 2010, the FDA identified 80 reports of inadequate reprocessing and 28 reports of infection that may have occurred from inadequate reprocessing.

The FDA believes that the risk of acquiring an infection from a reprocessed device is relatively low and that the benefits of these important devices outweigh their risks. The agency does not recommend that patients cancel or delay procedures that involve such devices.

To help manufacturers produce safer reusable devices, the FDA is issuing a draft guidance that, when final, will provide greater clarity on how to scientifically validate the reprocessing instructions that are part of the device labeling.

The FDA also is working with standards-setting groups, such as ASTM International and the Association for the Advancement of Medical Instrumentation, in the development of standards and Technical Information Reports that update processes, materials, test methods, design, and acceptance criteria for cleaning reusable medical devices.

In addition, the FDA developed a webpage of useful resources for use by health care facilities seeking to implement their reprocessing quality assurance programs. Included are links to guidelines, self-audit tools, education and training materials, and safety communications from other government agencies and professional organizations.

For more information:

FDA: Medical Devices

http://www.fda.gov/MedicalDevices/default.htm

FDA: Reprocessing Reusable Devices


SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Forecast Looks Good for India Pharma Shows
2. Study Suggests High-Dose Fish Oil May Significantly Improve Behavior in Children with ADHD
3. Nexavar Significantly Improved Overall Survival in Phase 3 Asia-Pacific Liver Cancer Trial
4. Experimental Drug Ketasyn(TM) Improves Memory in Age-Associated Memory Impairment Study
5. Study Shows Combination Therapy Incorporating AVODART(R) and Tamsulosin Provides Continuous Symptom Improvement Over 2 Years
6. First Osteoporosis Study in Hip Fracture Patients Finds Once-Yearly Reclast(R) Prevents Additional Fractures and Improves Survival
7. One Year Study of Exenatide Treatment Showed Improved Beta-Cell Function
8. One Year Study of Exenatide Treatment Showed Improved Beta-Cell Function
9. Promising Phase 3 Trial Results Show Novel Biologic Therapy Ustekinumab (CNTO 1275) Significantly Improved Psoriasis
10. Surgeons Find That Laparoscopic Banding Procedure Helps Overweight Adolescents Lose Weight and Improve Health
11. KineMed Presents Preclinical Data for Investigational Agent Demonstrating Neurogenesis and Confirming Improvements in Behavioral Model
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/28/2014)... N.J. , July 28, 2014   ... $520,000 settlement of off-label marketing and fraud claims ... and Vascular Solutions, Inc. ("VSI").  The settlement covers ... medical devices for endovenous laser ablation of varicose ... Magnanini, a firm with a history of representing ...
(Date:7/28/2014)... -- June 28 th , 2014 – Oncolab, the ... cancer test, is making its AACC debut (booth #4051) at ... is a serum-based in vitro immunoassay, has been run for ... in the fight against cancer recurrence. Photo - ... million cancer survivors in the US alone, the race is ...
(Date:7/28/2014)... 2014 Reportlinker.com announces that a new ... Portugal Pharmaceuticals and Healthcare Report ... Includes 3 FREE quarterly ... growth last quarter has led us to revise ... forecast previously, BMI expects Portugal,s ...
Breaking Medicine Technology:Stone & Magnanini LLP Announces $520,000 Department of Justice False Claims Act Settlement With Vascular Solutions, Inc. 2Stone & Magnanini LLP Announces $520,000 Department of Justice False Claims Act Settlement With Vascular Solutions, Inc. 3Oncolab, Inc. Exhibits Pioneering AMAS Cancer Test at AACC 2Portugal Pharmaceuticals and Healthcare Report Q3 2014 2Portugal Pharmaceuticals and Healthcare Report Q3 2014 3Portugal Pharmaceuticals and Healthcare Report Q3 2014 4
... Prostate Conditions Education Council (PCEC) – a ... in prostate cancer screening – today announced it strongly ... Services Task Force (USPSTF). The draft guidance recommends against ... PCEC believes that until a more accurate and ...
... 10, 2011 PDI, Inc. (Nasdaq: ... R. Melillo, Jr. as senior vice president of Business ... drive PDI,s commercial outsource services and contract sales business. ... officer. Melillo was most recently general manager ...
Cached Medicine Technology:Prostate Conditions Education Council Opposes U.S. Preventative Services Task Force Recommendation 2Prostate Conditions Education Council Opposes U.S. Preventative Services Task Force Recommendation 3PDI Appoints Gerald R. Melillo, Jr. As SVP of Business Development 2
(Date:7/28/2014)... that they monopolize large amounts of sugar. More recently, ... characterized by a series of features such as mobility ... are calling this behavior "mesenchymal," and they suspect it ... was able to demonstrate that the two observations ... the same mechanism, at least in "non-small cell lung ...
(Date:7/28/2014)... 29, 2014 The “Tissue ... Hybridization, Digital pathology & Workflow, Special Staining), ... Cancer, Non Small Cell Lung Cancer and ... Pharmaceutical companies, Research Laboratories, Contract Research Organizations ... Europe, BRIC, Japan & RoW) - Trends ...
(Date:7/28/2014)... TX (PRWEB) July 28, 2014 A lush ... family playtime during the summer. However, the summer heat, lack ... lawn to become brown, weak and unhealthy. The Grounds Guys ... It Grow, Mow a lawn once a week and set ... than normal. This protects the grass roots from heat and ...
(Date:7/28/2014)... UHY LLP, a member of the ... UHY International Business – Issue 29. This bi-annual publication ... most current business challenges and key issues faced by ... the following topics:, , Key industry ... over the next five years? Where are growth opportunities ...
(Date:7/28/2014)... 2014 Dawn Echols’ professional background ... and music. This experience has honed her people ... psychology. Her professional counseling ( http://dawningphoenix.com ) work ... for offenders in domestic violence. , As ... she enjoys counseling individuals and groups for a ...
Breaking Medicine News(10 mins):Health News:Cancer: Tumors absorb sugar for mobility 2Health News:Advanced Cancer Diagnostics Market Worth $3,924.01 Million by 2018 - New Report by MarketsandMarkets 2Health News:Advanced Cancer Diagnostics Market Worth $3,924.01 Million by 2018 - New Report by MarketsandMarkets 3Health News:Advanced Cancer Diagnostics Market Worth $3,924.01 Million by 2018 - New Report by MarketsandMarkets 4Health News:Advanced Cancer Diagnostics Market Worth $3,924.01 Million by 2018 - New Report by MarketsandMarkets 5Health News:Nurturing Lawns in the Summer Heat: The Grounds Guys® Offers Tips on Caring for Lawns This Summer 2Health News:Uhy International Business Issue 29 Now Available 2Health News:Uhy International Business Issue 29 Now Available 3Health News:Dawn M. Echols, M.S., LPC of Dawning Phoenix Speaks at Newly Formed Task Force 2
... Perot Systems,Corporation (NYSE: PER ) ... received the #1 ranking in the KLAS ... implementation services(1). Known throughout,the Healthcare industry for ... informed technology decisions by independently,monitoring vendor performance ...
... LA JOLLA, CA Diabetic individuals have a ... the molecular connection between the two remains unexplained. ... Studies identified the probable molecular basis for the ... published in the current online issue of Neurobiology ...
... How Drugs Actually Work in Real ... ... free,patient-driven online healthcare community, announced the launch of an,innovative new tool that ... taking prescription drugs, and eight out of,ten surfing the web for their ...
... Hillenbrand, Inc.,(NYSE: HI ) today announced that ... a publicly traded company of $0.1825 per share,on the ... 2008 to,shareholders of record at the close of business ... board to approve this inaugural dividend is based,on the ...
... Pet Week, May,4-10, celebrates the relationships formed between ... emphasize the caretaking actions we can take for ... recommended by,your veterinarian; giving them plenty of attention, ... pets safe and pleasant., "Being a responsible ...
... Tex. April 30, 2008 - Despite the general ... critically ill heart failure patients, implantation of these devices ... high-volume blood transfusions during and immediately after surgery. A ... that the incidence of these complications may be significantly ...
Cached Medicine News:Health News:Perot Systems Ranked #1 for Clinical Implementation Services By KLAS 2Health News:Perot Systems Ranked #1 for Clinical Implementation Services By KLAS 3Health News:Salk study links diabetes and Alzheimer's disease 2Health News:Salk study links diabetes and Alzheimer's disease 3Health News:iGuard.org Alters the Face of E-Health: New Web Service Draws 10,000 New Patients Weekly 2Health News:iGuard.org Alters the Face of E-Health: New Web Service Draws 10,000 New Patients Weekly 3Health News:Hillenbrand, Inc. Declares First Quarterly Dividend As a New Publicly Traded Company 2Health News:California Veterinarians Recognize National Pet Week With Tips to Keep Your Animal in a Safe Environment 2Health News:California Veterinarians Recognize National Pet Week With Tips to Keep Your Animal in a Safe Environment 3
The Calcitonin ELISA is intended for the quantitative determination of Calcitonin in human serum....
... nm and 940 nm) laser system is ... solid-state laser quickly and effectively treats vascular ... offers the clinical versatility to precisely target ... vessels in a convenient, affordable package. , ...
... PREMIUM SURGICLIP™ clip applier consists of an applier ... 15 or 20 titanium clips. , ,The ... or other tubular structure. As the handles of ... closed around the vessel or structure. As the ...
The LIGACLIP ERCA Endoscopic Rotating Multiple Clip Applier is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated. The tissue being ligated should be consis...
Medicine Products: