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To help manufacturers produce safer reusable devices, the FDA is issuing a draft guidance that, when final, will provide greater clarity on how to scientifically validate the reprocessing instructions that are part of the device labeling.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:5/1/2015)... Following yesterday,s release of Center for Medicaid and Medicare services ... need to know: ... programs. , As ... of Medicare and other government programs because it relies on ... drug benefits to enrollees. , Competition and rebates have ...
(Date:5/1/2015)... --Research and Markets ( http://www.researchandmarkets.com/research/pjbxjd/us_aco_it ) has ... Spending Outlook 2018" report to their offering. ... by ACO would grow at a CAGR of 22% ... spending has been studied on three main grounds viz. ... services. Our research provides current market estimation and forecast ...
(Date:5/1/2015)... May 1, 2015 At the American Association ... Washington D.C. , Elekta will highlight ... enables clinicians to leverage the enormous amount of data ... conducted each year – to advance clinical research and ... is a cloud-based solution that allows practitioners to store, ...
Breaking Medicine Technology:5 Things to Know About the CMS Part D Data Release 25 Things to Know About the CMS Part D Data Release 3United States ACO IT Spending Outlook 2014-2018 2Elekta to showcase Leksell Gamma Knife Registry at AANS Annual Meeting 2Elekta to showcase Leksell Gamma Knife Registry at AANS Annual Meeting 3
... Reportlinker.com announces that a new market research report is ... Neurology Devices Market Outlook to 2016 ... Market Outlook to 2016 Summary ... Market Outlook to 2016" provides key market data on ...
... Reportlinker.com announces that a new market research report ... Europe Hospital Supplies Market Outlook to 2016 ... Hospital Supplies Market Outlook to 2016 ... Outlook to 2016" provides key market data on ...
Cached Medicine Technology:Reportlinker Adds North America Neurology Devices Market Outlook to 2016 2Reportlinker Adds North America Neurology Devices Market Outlook to 2016 3Reportlinker Adds North America Neurology Devices Market Outlook to 2016 4Reportlinker Adds North America Neurology Devices Market Outlook to 2016 5Reportlinker Adds North America Neurology Devices Market Outlook to 2016 6Reportlinker Adds North America Neurology Devices Market Outlook to 2016 7Reportlinker Adds North America Neurology Devices Market Outlook to 2016 8Reportlinker Adds North America Neurology Devices Market Outlook to 2016 9Reportlinker Adds North America Neurology Devices Market Outlook to 2016 10Reportlinker Adds North America Neurology Devices Market Outlook to 2016 11Reportlinker Adds North America Neurology Devices Market Outlook to 2016 12Reportlinker Adds North America Neurology Devices Market Outlook to 2016 13Reportlinker Adds North America Neurology Devices Market Outlook to 2016 14Reportlinker Adds Europe Hospital Supplies Market Outlook to 2016 2Reportlinker Adds Europe Hospital Supplies Market Outlook to 2016 3Reportlinker Adds Europe Hospital Supplies Market Outlook to 2016 4Reportlinker Adds Europe Hospital Supplies Market Outlook to 2016 5Reportlinker Adds Europe Hospital Supplies Market Outlook to 2016 6Reportlinker Adds Europe Hospital Supplies Market Outlook to 2016 7Reportlinker Adds Europe Hospital Supplies Market Outlook to 2016 8Reportlinker Adds Europe Hospital Supplies Market Outlook to 2016 9Reportlinker Adds Europe Hospital Supplies Market Outlook to 2016 10Reportlinker Adds Europe Hospital Supplies Market Outlook to 2016 11Reportlinker Adds Europe Hospital Supplies Market Outlook to 2016 12Reportlinker Adds Europe Hospital Supplies Market Outlook to 2016 13Reportlinker Adds Europe Hospital Supplies Market Outlook to 2016 14Reportlinker Adds Europe Hospital Supplies Market Outlook to 2016 15Reportlinker Adds Europe Hospital Supplies Market Outlook to 2016 16Reportlinker Adds Europe Hospital Supplies Market Outlook to 2016 17
(Date:5/2/2015)... 2015 Vancouver fencing company, QS Fencing, has ... advice to prospective clients related to their questions on railings ... railings around their decks and patios. While that seems like ... up once the person rolls up their sleeve to start ... railing in finding a gate that matches it. , Instead ...
(Date:5/2/2015)... Peachtree Audio ” was featured on NewsWatch as part ... and coolest technology products available to consumers. Scott Steinberg, ... the review and shared with viewers how this is ... important part of people’s lives – and as such, ... Peachtree Audio does just that with high-end audio equipment ...
(Date:5/2/2015)... With the success that Veatch Dental Consulting has had over ... and Alex Shields to the team. With Neida and Alex ... combined experience working with dentists to ensure their success. , ... years. She was certified as dental assistant from Texas ... and showing the importance of oral hygiene to patients, Neida ...
(Date:5/1/2015)... Royal River Natural Foods, a locally-owned ... a new study that found two natural nutrients, glucosamine ... physical function as well as standard drug treatment after ... knee. , The report is part of the May ... ,” which Royal River Natural Foods publishes for free ...
(Date:5/1/2015)... (PRWEB) May 01, 2015 Ernst & ... Dr. Joshua Rosenthal, Co-Founder & CSO, and Burak Sezen, ... for the EY Entrepreneur Of The Year® 2015 ... & Young is a global leader in assurance, ... to be one of the top audit companies in ...
Breaking Medicine News(10 mins):Health News:Professional Staff at QS Fencing Company Now Provides Advice on Railings and Gates 2Health News:Affordable High-End Audio Equipment was Featured on NewsWatch Television 2Health News:Veatch Dental Consulting Services Welcomes New Team Members 2Health News:New Study Finds Nutrients Ease Arthritis Pain, Retailer Reports 2Health News:RowdMap, Inc. Named as a Ernst & Young Entrepreneur Of The Year® 2015 Award Finalist 2
... (October 6, 2008) Asthmatic children whose parents have ... less likely to have symptoms than other children dealing ... also are more likely to use asthma controller medications ... and if their parents clearly understand how well symptoms ...
... that reading is beneficial. But can it help kids lose ... of literature on obese adolescents, researchers at Duke Children,s Hospital ... a difference. , The Duke researchers asked obese females ages ... loss program to read an age-appropriate novel called Lake Rescue ...
... Magazine recently included,Connolly Consulting in its annual ranking ... The list is the most comprehensive look,at the ... entrepreneurs. Taken as a whole, these companies,represent the ... http://www.newscom.com/cgi-bin/prnh/20081003/NY36880LOGO ), Connolly Consulting,s consistent and ...
... to Visit Harrisburg to Rally Residents to Eat Right, Move More and ... ... be defined,by the ups and downs of different fad diets -- which seem ... success has been,slim. Two out of three Americans -- including 27 percent of ...
... income impact. , ... Alpharetta, GA (Vocus) October 3, ... and the presidential campaign, Americans still view healthcare reform as a ... But how do U.S. surgeons view the issue? , , , ...
... Cynthia Haines has been,named Chief Medical Officer of ... Dr. Haines, who is also managing editor of ... company,s physician-directed,content division, which provides a variety of ... reviewed and created by,board-certified physicians., Other Chief ...
Cached Medicine News:Health News:Children's asthma affected by parental expectations 2Health News:Duke researchers show reading can help obese kids lose weight 2Health News:Connolly Consulting Makes the 2008 Inc. Magazine's List of America's 5000 Fastest Growing Companies 2Health News:Message to Pennsylvania Residents: Forgo Fad Dieting and Join the Campaign for Healthy Weight 2Health News:Message to Pennsylvania Residents: Forgo Fad Dieting and Join the Campaign for Healthy Weight 3Health News:LocumTenens.com Reaps Mixed Reviews on Universal Healthcare 2Health News:LocumTenens.com Reaps Mixed Reviews on Universal Healthcare 3Health News:Dr. Cynthia Haines Named Chief Medical Officer of HealthDay News 2
... Vision, Quality of Vision and Contrast ... target illumination and glare luminance levels ... Day/Night testing with/without glare and background ... all ANSI standards. All Light Levels ...
Contrast Sensitivity is Recognized as a Valuable Tool for Measuring Functional Vision Loss Caused by Early Eye Disease. Distance Test S.W.C.T. 201: Size 27in x 37 in (68.58cm x 93.98cm),Can be Wal...
Vectograms are the standard for vision training. They are available in fixed or variable,styles to accommodate unlimited base-in and base-out training. Each vectogram,includes one pair,of standard 3-...
Adult: Letter Monocular Acuity, Binocular Astigmatism, Acuity Balance, Supression, Binocular Acuity, Fixation Desparity, Muscle Balance, Stereopsis...
Medicine Products: