dismiss

Clean Sweep Live Auction on Wed. May 1st. Click to view the full inventory

DOTmed Home MRI Oncology Ultrasound Molecular Imaging X-Ray Cardiology Health IT Business Affairs
News Home Parts & Service Operating Room CT Women's Health Proton Therapy Endoscopy HTMs Pediatrics
SEARCH
当前地点:
>
> This Story

starstarstarstarstar (3)
注册记数器 to rate this News Story
Forward Printable StoryPrint Comment
advertisement

 

advertisement

 

Parts And Service Homepage

GE sued for allegedly 'freezing-out' ISOs in anesthesia equipment maintenance Lawsuit claims monopolistic practices

Varex Imaging and H+P Advanced Technology to build carbon nanotube company Expect to see products come out in two-to-three years

Varex Imaging expands service offering to Europe, releases new tube and detector line at ECR Provide technical and logistical support for installations

Probo Medical acquires Trisonics Now offers an extensive ultrasound service division

MITA's remanufacturing white paper recalls 'Groundhog Day' movie: IAMERS A call for forward thinking and community awareness

MITA proposes framework for defining 'service' versus 'remanufacturing' Also points to the need for quality management systems to be implemented

Is there life after EOL for medical imaging equipment? Ken Hable of Technical Prospects discusses why the concept of 'end of life' is a falsehood

FDA extends deadline for device servicing docket comments One more month for equipment stakeholders to make their voices heard

Merry X-Ray acquires Conquest Imaging Ultrasound repair leader joins growing imaging ISO

New FDA draft guidance on X-ray equipment addresses access to manuals An update to guidances issued 30 years ago

MITA publishes QMS standard for servicing of imaging devices

John R. Fischer , Staff Reporter
The Medical Imaging and Technology Alliance (MITA) and its parent organization, the National Electrical Manufacturers Association (NEMA) have published a voluntary standard outlining minimum quality management system (QMS) requirements for servicing medical imaging devices.

Called NEMA/MITA 2 – Requirements for Servicing of Medical Imaging Equipment, the free-to-download guideline is the first dedicated solely to the servicing of medical imaging equipment.

Story Continues Below Advertisement

Servicing GE Nuclear Medicine equipment with OEM trained engineers

We offer full service contracts, PM contracts, rapid response, time and material,camera relocation. Nuclear medicine equipment service provider since 1975. Click or call now for more information 800 96 NUMED



“Until now, there have not been any QMS Standards developed specifically for servicing of medical imaging devices,” MITA's executive director Patrick Hope and director of policy Peter Weems told HCB News. “MITA saw this as a critical gap that needed to be filled in order to protect patient safety and device integrity.”

The publication of this standard comes as the medical equipment industry awaits FDA guidance for what differentiates servicing from remanufacturing of medical devices.

The decision by the agency to develop the guidance stems from the completion of a two-year investigation last May, which found insufficient evidence that third-party equipment servicers are a public health concern. In that report, the FDA stated that it 'found no evidence that additional formal regulatory action is warranted, based on available information and findings'.

Adoption of the new QMS standard, according to MITA, will enable stakeholders to ensure that their servicing activities do not cross into remanufacturing. The imaging OEM group observed that while remanufacturing is regulated by the FDA, the agency does not currently require third-party medical device servicers to have controls in place to determine if their servicing activities constitute remanufacturing. This lack of oversight poses an increased risk to public health and patient safety, MITA wrote in a statement.

In Februrary, MITA released a white paper outlining a framework for establishing the distinction between the two activities to serve as a resource for the FDA and the broader stakeholder community.

Some industry stakeholders argue that the new standard, as well as the white paper, fail to consider the interests of non-OEM stakeholders, and the value those stakeholders bring to the healthcare ecosystem.
  Pages: 1 - 2 >>

Parts And Service Homepage


(11)

Wayne Moore

MITA Service Standard

March 15, 2019 08:08

Your DOTMED article says that ISO 13485 is only for manufacturers of medical devices; this is simply NOT true. ISO 13485 is designed to be used by all organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes. In short it is designed by ANYONE involved in the above including servicing. Get the facts right before you publish your news releases.

Log inor Register

to rate and post a comment

(3)
(1)

John R. Fischer

re: MITA Service Standard

March 18, 2019 10:31

Hi Wayne,

Thanks for the comment. My article states ISO 13485 is for manufacturers. It does not state it is only for manufacturers. My apologies to anyone who may have been confused - I have revised the article to state "ISO 13485 is a quality system standard for the medical device industry."

Log inor Register

to rate and post a comment

(11)

Wayne Moore

re: re: MITA Service Standard

March 19, 2019 10:26

10-4

Log inor Register

to rate and post a comment

(2)

Stephen Grimes

re: MITA Service Standard

March 28, 2019 09:30

Examine the current 13485 standard and you will it see input was only from OEMs and not from third party servicers. Irrespective of what the what the standard says, it's a dubious claim to make that the standard is appropriate for third party servicers when no 3rd party servicers were involved in its development.

Log inor Register

to rate and post a comment

You Must Be Logged In To Post A Comment

做广告
提升您的品牌知名度
拍卖+私人销售
获得最好的价格
买设备/配件
找到最低价格
每日新闻
阅读最新信息
目录
浏览所有的DOTmed用户
DOTmed上的伦理
查看我们的伦理计划
金子分开供营商节目
接收PH要求
金子服务经销商节目
接收请求
提供保健服务者
查看所有的HCP(简称医疗保健提供商)的工具
工作/训练
查找/申请工作
Parts Hunter +EasyPay
获取配件报价
最近证明
查看最近通过认证的用户
最近额定
查看最近通过认证的用户
出租中央
租用设备优惠
卖设备/配件
得到最划算
服务技术员论坛
查找帮助和建议
简单的征求建议书
获取设备报价
真正商业展览
查找对设备的服务
对这个站点的通入和用途是受期限和条件我们支配 法律公告 & 保密性通知
物产和业主对 DOTmed.com,公司 Copyright ©2001-2019 DOTmed.com, Inc.
版权所有