FDA Seeks ‘Remanufacturing’ Feedback from Biomeds

A little more than a month ago, the FDA released the draft guidance “Remanufacturing of Medical Devices” and asked healthcare technology management professionals, original equipment manufacturers, third-party repair organizations and more to submit comments.

United Imaging Goes “All-in” for Nashville

United Imaging makes its debut at HealthTrust University and its in-person debut at AHRA in Nashville over the next two weeks. At both events, the company will focus on several unique aspects of how it solves pervasive pain points in procuring and owning medical imaging equipment.

TechNation Asks Biomeds to Share Right to Repair Issues

TechNation is proud to support and be an advocate for the Right to Repair movement in the healthcare technology management and health care community. A new web form specifically allows biomeds everywhere to report incidents when an original equipment manufacturer...

Delivering precision solutions for a changing world

Change has been the one constant in nuclear medicine from the beginning, with the steady arrival of new radiopharmaceuticals, new technologies and an evolving regulatory environment. Today, as nuclear medicine expands rapidly beyond diagnostics and into novel...

[Sponsored] Company Showcase: Summit Imaging

Summit Imaging is a technology-enabled service organization that repairs and supports ultrasound and mammography imaging equipment in the Healthcare Technology Management (HTM) industry. A unique combination of electronic component level hardware understanding, service software development and an extraordinary team allows the organization to lower total cost of ownership for health care facilities without compromising the safety and performance of the medical devices repaired and supported. Founded in 2006, the organization has grown into an award-winning place to work, according to the ratings given by Seattle Business Magazine. Taking care of its employees and empowering them to focus on caring for the customers has earned Summit Imaging an incredible reputation when it comes to quality and HTM support. What is even more exciting is that the expertise in both software and hardware enables Summit to rapidly expand support to more imaging modalities and give health care facilities an alternative to lower their total cost of ownership and maintain high quality of care for their patients.

How Summit Imaging lowers total cost of ownership for health care facilities

Quality – ISO 13485:2003 and why it matters
The customers of Summit Imaging have shared that the only way to sustainably lower total cost of ownership is through quality products and services. Today, patients are more informed than ever with the ease of access to quality metrics of health care facilities. If patients suffer harm to their health or undergo an unpleasant or unprofessional experience during their health care interactions, the care-giving institution’s rating will go down, potentially depriving it of the patronage of discerning consumers and unnecessarily reduce Medicare and Medicaid revenues.

ISO 13485:2003 is an international standard that specifies the requirements for a quality management system (QMS), where a medical device support organization needs to demonstrate its ability to provide customers with medical devices and related services that consistently meet customer expectations and regulatory requirements applicable to medical devices and related services. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. Summit’s QMS has been ISO 13485:2003 certified for over three years, allowing the organization to scale operations and improve quality as health care facilities continue to grow and consolidate suppliers to optimize their operations.

Summit Imaging has already established new industry standards with a 6-month warranty on all products. This has dramatically reduced the operational risk for customers. It is capable of providing such a generous warranty through methodical execution of its ISO 13485:2003 QMS.

Eliminate unnecessary outsourced service costs
The Technical Support Team at Summit Imaging is available 24 hours a day, seven days a week. The main goal of the organization is simple: to remotely assist HTMs to get equipment up and running in the least amount of time. This remote assistance model supports the on-site HTMs, making them the quickest to respond, diagnose and resolve down equipment by leveraging Summit’s technical expertise. Average diagnosis time is under five minutes, and every call is answered in an average of less than two rings. This relationship with HTM customers eliminates unnecessary outsourced service costs and maximizes equipment uptime.

The organization has deployed an expanded Version 3.0 of Adepto™, a patent-pending software that has a highly useful set of tools, utilities and other valuable functions that work with multiple leading ultrasound system platforms that are otherwise locked down with proprietary passcodes. Functions including system configuration adjustments, retrieving diagnostic error logs and performing calibrations are only a few of the features of this industry-changing software. This software eliminates outsourced service costs and reduces hundreds of downtime hours, thereby increasing revenue potential for health care facilities. HTMs report that 3 to 48 hours of downtime per service call is saved as a result of using Summit’s Technical Support in conjunction with Adepto™.

Effective HTM and user training
Summit aims to partner with its health care facility customers to support their training needs in servicing their own ultrasound and mammography equipment. During each training session, HTMs will be taught the way to accurately diagnose and service ultrasound systems and eliminate unnecessary outsourced service costs. The curriculum formulated by the organization covers additional critical topics HTMs need to know to minimize equipment downtime, including image quality based on image standards decided by the chair of diagnostic ultrasound at Seattle University, a top-ranked diagnostic medical sonography university.

An increasingly popular course has been ultrasound transducer handling. These classes, typically conducted on site, cover topics applicable to a sonographer’s practical use of a transducer and the manner in which the image quality impacts their workflow. Proper care methods and techniques are presented to help prevent unnecessary problems. Attendees will interact with disassembled ultrasound transducer components and learn about the common vulnerabilities of damage, and the relationship of the two to the functionality and the performance of the equipment.

Online video tutorials have been created by the Summit Technical Support Team to aid HTMs in servicing a rapidly growing volume of equipment. These videos have been made available on YouTube and can be viewed for free at any time. Gaining knowledge through the videos has resulted in reduced equipment downtime, as the HTMs are more capable of resolving the problems with the help of a practical and proven approach.

We want to make a positive difference in the HTM industry with education and awareness
The organization has been requested by its health care facility customers to share insights on the many aspects that make Summit unique. Summit continues to work with them to produce YouTube videos that educate and create awareness on topics such as risk mitigation, organizational development, quality standards, image quality and a host of other topics where there is lack of information in the HTM community. YouTube has been an effective platform for the organization to easily articulate and share knowledge and findings with the HTM industry.

Summit’s goal is to improve quality for the industry to best serve patients and provide them the quality of care they expect and deserve. The more the community knows, the more improvements can be made. The YouTube channel of the organization can be found at



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