Nationwide hosts IAMERS forum on QMS in advance of FDA report
August 16, 2017
By Robert Kerwin
IAMERS General Counsel
Shortly before the summer congressional recess, the U.S. Senate passed a bipartisan bill to reauthorize the FDA user fee programs. The Senate User Fee bill followed the House bill and was approved 94-1. President Trump’s spokesperson has announced that the president will sign the bill.
The legislation includes a provision important to hospitals and independent servicers. The provision requires the FDA to issue a report within 270 days of enactment on the continued quality, safety and effectiveness of the servicing of medical devices.
The FDA report, which will be posted to its website, will also evaluate comments received from the docket opened by the FDA, as well as the two-day FDA workshop held in October 2016.
The FDA may issue the report in advance of the congressionally-imposed deadline, potentially as soon as next month, according to a reliable industry source who asked not to be named. Since the completion of the two-day workshop, the FDA, principally through a 10-person internal FDA work group, has been hard at work carefully evaluating the comments and testimony received, while also listening to many different stakeholders.
“We appreciate the FDA’s careful consideration of device servicing. We are grateful for their efforts," said IAMERS founder Dave Band, of Advanced Imaging Systems.
ECRI Institute, the American College of Clinical Engineers (ACCE) and other industry observers have noted that, to date, there has been no evidence of systemic servicing issues. Steve Grimes on behalf of ACCE expressed his support for a new quality management system (QMS) standard for service providers. “While we see no evidence of a widespread safety issue to date, ACCE does recognize that service providers could benefit from a QMS standard that will help us ensure a continued high quality of service as we deal with increasingly complex and interconnected medical technology systems.”
IAMERS has been continuing its own efforts to improve independent servicer "best practices".
Last week's meeting
On August 8, Nationwide Imaging Services Inc. hosted a special IAMERS forum on quality management systems. Attending the forum were representatives of AAMI, ACCE, ECRI Institute, AMDSO and the FDA. The FDA attendees included the Director of the Office of Compliance for the Center for Devices and Radiological Health, Robin W. Newman, Consumer Safety Officer Katelyn R. Bittleman, and Electronics Engineer and Scientific Lead Reviewer James Walker. Also attending were several leading servicers including Tim Martin, president of Radon Medical Imaging; Jim Goldner, president of First Source; Hiren Desai, IAMERS ethics chairman; Dave Francoeur, senior director of Brand & Quality for Sodexo; Julie Mardikian, senior compliance auditor for Oxford Instruments Healthcare; and Jimmy Kallam, president of East Coast Medical Systems.
IAMERS President Diana Upton noted: “the QMS forum was conducted so as to explore whether independent servicers and other stakeholders can come to a consensus on the appropriate quality management systems to successfully and safely service diagnostic imaging equipment. We can learn from each other. We are all about patient safety, and encourage all aspects of quality servicing — including manufacturer cooperation.”
Nationwide CEO and founder Rob Manetta welcomed the forum and personally led the attendees on a tour of Nationwide’s impressive facility. Nationwide, established in 1993, provides high quality reconditioned and used medical imaging equipment and servicing to hospitals, imaging centers and private medical practices. Its 117,000 square-foot facility includes warehouse space with a machine shop, spray booths, staging bays, loading bays and even two drive-through Bays. Rob took the time to discuss the steps his team uses to address patient safety, ranging from receipt of the equipment through reconditioning and storage. Of particular importance was the central focus on QMS in Nationwide’s operations.
The formal program began with Jim Goldner, president of First Source, moderating a discussion of the challenges and benefits of independent servicing. Jim’s team has been successfully providing an alternative source for training, technical support and parts to independent service organizations and in-house service groups. Jim also recounted a real-life challenge when, despite growing clients and success, First Source had to move away from servicing certain equipment when the manufacturer declined to provide A.I.A.T. information. First Source moved away from one manufacturer but has enjoyed a successful relationship with other manufacturers, who realized that they could bring more to the bottom line by working with the independent servicer. Jim also spoke of his current successful situation as a distributer of DR systems.
Julie Mardikian, senior compliance auditor for Oxford Instruments Healthcare, and member of the IAMERS Best Practices Committee, spoke about the need for training. “The importance of training within an organization is not only used as a foundation for setting goals or aid in meeting regulatory requirements, it is the integral backbone to provide our customers with the assurance that the personnel performing the services on the product have the reliability to exceed the quality and performance as expected through effective training.” Oxford’ service division specializes in providing reconditioned CT & MRI scanners for the medical industry. It has received ISO 9001 and 13485 certifications.
The afternoon question and answer program was moderated by AAMI Vice President of Emerging Technologies and Health IT Joe Lewelling. While no formal poll was undertaken of those in attendance, it was observed that QMS is necessary and that QMS was enhanced with manufacturer cooperation. Steve Grimes, representing ACCE, spoke of his organization’s commitment to working with any stakeholders that are committed to improving the quality and safety of medical device systems. “We are very active in service and security standards, and have been working to ensure greater collaboration between the medical device and information technology communities in a number of areas, including interoperability and cybersecurity.”
Tim Martin of Radon Medical noted: “we work in rural areas, and hospitals depend on us. We are concerned about safety and traceability. The hospital is always the boss and we try very hard each day to meet their expectations.”
A productive exchange of information did indeed happen throughout the forum, as promised by IAMERS President Diana Upton. The post-meeting comment of Ms. Bittleman of the FDA nicely sums up the general feeling of participants: “it was great to meet with people passionate about their work.”
IAMERS General Counsel
Shortly before the summer congressional recess, the U.S. Senate passed a bipartisan bill to reauthorize the FDA user fee programs. The Senate User Fee bill followed the House bill and was approved 94-1. President Trump’s spokesperson has announced that the president will sign the bill.
The legislation includes a provision important to hospitals and independent servicers. The provision requires the FDA to issue a report within 270 days of enactment on the continued quality, safety and effectiveness of the servicing of medical devices.
The FDA report, which will be posted to its website, will also evaluate comments received from the docket opened by the FDA, as well as the two-day FDA workshop held in October 2016.
The FDA may issue the report in advance of the congressionally-imposed deadline, potentially as soon as next month, according to a reliable industry source who asked not to be named. Since the completion of the two-day workshop, the FDA, principally through a 10-person internal FDA work group, has been hard at work carefully evaluating the comments and testimony received, while also listening to many different stakeholders.
“We appreciate the FDA’s careful consideration of device servicing. We are grateful for their efforts," said IAMERS founder Dave Band, of Advanced Imaging Systems.
ECRI Institute, the American College of Clinical Engineers (ACCE) and other industry observers have noted that, to date, there has been no evidence of systemic servicing issues. Steve Grimes on behalf of ACCE expressed his support for a new quality management system (QMS) standard for service providers. “While we see no evidence of a widespread safety issue to date, ACCE does recognize that service providers could benefit from a QMS standard that will help us ensure a continued high quality of service as we deal with increasingly complex and interconnected medical technology systems.”
IAMERS has been continuing its own efforts to improve independent servicer "best practices".
Last week's meeting
On August 8, Nationwide Imaging Services Inc. hosted a special IAMERS forum on quality management systems. Attending the forum were representatives of AAMI, ACCE, ECRI Institute, AMDSO and the FDA. The FDA attendees included the Director of the Office of Compliance for the Center for Devices and Radiological Health, Robin W. Newman, Consumer Safety Officer Katelyn R. Bittleman, and Electronics Engineer and Scientific Lead Reviewer James Walker. Also attending were several leading servicers including Tim Martin, president of Radon Medical Imaging; Jim Goldner, president of First Source; Hiren Desai, IAMERS ethics chairman; Dave Francoeur, senior director of Brand & Quality for Sodexo; Julie Mardikian, senior compliance auditor for Oxford Instruments Healthcare; and Jimmy Kallam, president of East Coast Medical Systems.
IAMERS President Diana Upton noted: “the QMS forum was conducted so as to explore whether independent servicers and other stakeholders can come to a consensus on the appropriate quality management systems to successfully and safely service diagnostic imaging equipment. We can learn from each other. We are all about patient safety, and encourage all aspects of quality servicing — including manufacturer cooperation.”
Nationwide CEO and founder Rob Manetta welcomed the forum and personally led the attendees on a tour of Nationwide’s impressive facility. Nationwide, established in 1993, provides high quality reconditioned and used medical imaging equipment and servicing to hospitals, imaging centers and private medical practices. Its 117,000 square-foot facility includes warehouse space with a machine shop, spray booths, staging bays, loading bays and even two drive-through Bays. Rob took the time to discuss the steps his team uses to address patient safety, ranging from receipt of the equipment through reconditioning and storage. Of particular importance was the central focus on QMS in Nationwide’s operations.
The formal program began with Jim Goldner, president of First Source, moderating a discussion of the challenges and benefits of independent servicing. Jim’s team has been successfully providing an alternative source for training, technical support and parts to independent service organizations and in-house service groups. Jim also recounted a real-life challenge when, despite growing clients and success, First Source had to move away from servicing certain equipment when the manufacturer declined to provide A.I.A.T. information. First Source moved away from one manufacturer but has enjoyed a successful relationship with other manufacturers, who realized that they could bring more to the bottom line by working with the independent servicer. Jim also spoke of his current successful situation as a distributer of DR systems.
Julie Mardikian, senior compliance auditor for Oxford Instruments Healthcare, and member of the IAMERS Best Practices Committee, spoke about the need for training. “The importance of training within an organization is not only used as a foundation for setting goals or aid in meeting regulatory requirements, it is the integral backbone to provide our customers with the assurance that the personnel performing the services on the product have the reliability to exceed the quality and performance as expected through effective training.” Oxford’ service division specializes in providing reconditioned CT & MRI scanners for the medical industry. It has received ISO 9001 and 13485 certifications.
The afternoon question and answer program was moderated by AAMI Vice President of Emerging Technologies and Health IT Joe Lewelling. While no formal poll was undertaken of those in attendance, it was observed that QMS is necessary and that QMS was enhanced with manufacturer cooperation. Steve Grimes, representing ACCE, spoke of his organization’s commitment to working with any stakeholders that are committed to improving the quality and safety of medical device systems. “We are very active in service and security standards, and have been working to ensure greater collaboration between the medical device and information technology communities in a number of areas, including interoperability and cybersecurity.”
Tim Martin of Radon Medical noted: “we work in rural areas, and hospitals depend on us. We are concerned about safety and traceability. The hospital is always the boss and we try very hard each day to meet their expectations.”
A productive exchange of information did indeed happen throughout the forum, as promised by IAMERS President Diana Upton. The post-meeting comment of Ms. Bittleman of the FDA nicely sums up the general feeling of participants: “it was great to meet with people passionate about their work.”