Final rule to amend medical device Quality System regulation
https://content.govdelivery.com/accounts/USFDA/bulletins/387b23eUPDATE: Change in Reprocessing Methods with Certain Karl Storz Urological Endoscopes – Letter to Health Care Providers
https://www.fda.gov/medical-devices/letters-health-care-providers/update-change-reprocessing-methods-certain-karl-storz-urological-endoscopes-letter-health-care?utm_medium=email&utm_source=govdeliveryUse Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication
https://www.fda.gov/medical-devices/safety-communications/use-duodenoscopes-innovative-designs-enhance-safety-fda-safety-communication?utm_medium=email&utm_source=govdeliveryASCA Calls for Continued Access to Care During COVID-19
The surgery center association lobbies Congress for support of patients who need elective surgery and the providers who can deliver it.
http://www.outpatientsurgery.net/outpatient-surgery-news-and-trends/general-surgical-news-and-reports/asca-calls-for-continued-access-to-care-during-covid-19--07-09-20
http://www.outpatientsurgery.net/outpatient-surgery-news-and-trends/general-surgical-news-and-reports/asca-calls-for-continued-access-to-care-during-covid-19--07-09-20
New member of the AMDSO – ENDOMOBIL GmbH
The Association of Medical Device Service Organizations (AMDSO) welcomes ENDOMOBIL, an ISO 13485:2016 certified company that has one of the largest endoscopy repair facilities in all of Europe. They are based in Germany and specialize in maintenance as well as repair of pre-owned flexible and rigid endoscopes from Olympus, Pentax and Fujinon. Their expertise also includes, endosonic probes, TEE probes, ultrasound probes, gastroscopes, colonoscopes, bronchoscopes and duodenoscopes, as well as associated medical/technical peripheral devices.
A member of AMDSO since September 2019, ENDOMOBIL’S entire staff is committed to quality, safety and efficiency of service and repairs to reusable medical devices. “Our commitment can be more easily attained and fully realized through group action rather than through individual action” said Thorsten Peters, the CEO of ENDOMOBIL. “We are proud to be part of AMDSO and are looking forward to working with the group to achieve and support its goals and commitments. https://www.endomobil.de
A member of AMDSO since September 2019, ENDOMOBIL’S entire staff is committed to quality, safety and efficiency of service and repairs to reusable medical devices. “Our commitment can be more easily attained and fully realized through group action rather than through individual action” said Thorsten Peters, the CEO of ENDOMOBIL. “We are proud to be part of AMDSO and are looking forward to working with the group to achieve and support its goals and commitments. https://www.endomobil.de
Infection Control Today - AMDSO Opinion Pages
Endoscopy Specialists Announcement
On August 1, 2018, Endoscopy Specialists, Inc. (ESI) joined the Association of Medical Device Service Organizations (AMDSO) as a new member. “We are excited to join AMDSO,” said ESI President, Mike Mason. He added that “ESI supports the drive for quality systems principles, maintaining a competitive open market place for independent service providers, and preservation of hospital choice.”
Medical Device service and repair continues to be a hot topic of discussion and companies are joining AMDSO to help bring clarity to questions of quality, safety and effectiveness. AMDSO provides an organized approach to elevate quality of service, repair and education in establishing value metrics and industry indicators. By means of a clear unified message regarding Independent Service Organizations (ISOs) capabilities, healthcare providers will be able to align their service needs and expectations with supplier proficiencies.
ESI provides endoscopy service, specializing in repair and resale of endoscopy equipment, fiberoptic and video scopes. Providing excellent customer service is ESI’s main focus and number one priority. For more information about ESI, please visit www.endoscopyspecialists.com
AMDSO is a non-profit trade association representing members who service and repair of reusable medical devices. AMDSO is leading efforts to elevate the quality of service, repair and education, while increasing value to health systems and preserving patient safety.
Medical Device service and repair continues to be a hot topic of discussion and companies are joining AMDSO to help bring clarity to questions of quality, safety and effectiveness. AMDSO provides an organized approach to elevate quality of service, repair and education in establishing value metrics and industry indicators. By means of a clear unified message regarding Independent Service Organizations (ISOs) capabilities, healthcare providers will be able to align their service needs and expectations with supplier proficiencies.
ESI provides endoscopy service, specializing in repair and resale of endoscopy equipment, fiberoptic and video scopes. Providing excellent customer service is ESI’s main focus and number one priority. For more information about ESI, please visit www.endoscopyspecialists.com
AMDSO is a non-profit trade association representing members who service and repair of reusable medical devices. AMDSO is leading efforts to elevate the quality of service, repair and education, while increasing value to health systems and preserving patient safety.
IEC joins AMDSO
Innovative Endoscopy Components, LLC (IEC) joins the Association of Medical Device Service Organizations (AMDSO) as a new member. "Becoming part of AMDSO will keep IEC on the forefront of good business practices and a valuable member of our medical device/service community". [said IEC Managing Director, Gerald Goigitzer]
Medical Device service and repair continues to be a hot topic of discussion and companies are joining AMDSO to help bring clarity to questions of quality, safety and effectiveness. AMDSO provides an organized approach to elevate quality of service, repair and education in establishing value metrics and industry indicators. By means of a clear unified message regarding Independent Service Organizations (ISOs) capabilities, healthcare providers will be able to align their service needs and expectations with supplier proficiencies.
IEC has been an ISO13485/ISO9001 Certified vendor of choice to hundreds of endoscope service facilities and dealers worldwide, for over 20 years.
IEC product range and services are constantly growing with international demand. Rapid prototyping, optical assemblies, injection molding, and CNC machined parts are offered just like OEM endoscope and equipment labeling as well as CCD' repair and multilingual repair training and consulting. For more information about IEC go to www.IECendoscopy.com
AMDSO is a non-profit trade association representing members who provide service and repair of reusable medical devices. AMDSO is leading efforts to elevate the quality of service, repair and education, while increasing value to health systems and preserving patient safety.
Medical Device service and repair continues to be a hot topic of discussion and companies are joining AMDSO to help bring clarity to questions of quality, safety and effectiveness. AMDSO provides an organized approach to elevate quality of service, repair and education in establishing value metrics and industry indicators. By means of a clear unified message regarding Independent Service Organizations (ISOs) capabilities, healthcare providers will be able to align their service needs and expectations with supplier proficiencies.
IEC has been an ISO13485/ISO9001 Certified vendor of choice to hundreds of endoscope service facilities and dealers worldwide, for over 20 years.
IEC product range and services are constantly growing with international demand. Rapid prototyping, optical assemblies, injection molding, and CNC machined parts are offered just like OEM endoscope and equipment labeling as well as CCD' repair and multilingual repair training and consulting. For more information about IEC go to www.IECendoscopy.com
AMDSO is a non-profit trade association representing members who provide service and repair of reusable medical devices. AMDSO is leading efforts to elevate the quality of service, repair and education, while increasing value to health systems and preserving patient safety.
FDA concludes that evidence indicates many third party independent service providers deliver safe and effective medical devices
Click here to find out moreDavid Anbari, AMDSO Chairman, speaks with Beyond Clean
This week on Beyond Clean we speak with David Anbari, Chief Executive Officer of Mobile Instrument Service and Repair, a national provider of repair and maintenance services for reusable surgical equipment. David brings a diverse background in industries outside health care to Mobile. He blends his background in finance, technology, and operations to bring innovative solutions to enable providers to maximize their investment in surgical equipment. Recently, David has been a vocal advocate for the independent medical service industry including multiple speaking engagements as well as presenting at the FDA’s workshop on the issue. He serves as chairman of AMDSO (Association of Medical Device Service Organizations) which is a trade association advocating for the right to repair and for strong quality systems for the servicing industry. Though David did not grow up in health care, he brings a practical business focused perspective to the industry’s challenge
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