AAMI is partnering with the International Association of Medical Equipment Remarketers and Servicers (IAMERS) to work with the association’s members to adopt new or improve their existing quality management systems.
AAMI President and CEO Robert Jensen said the agreement with IAMERS underscored AAMI’s commitment to forge partnerships that advance safety in healthcare technology and promote the sharing of valuable information and best practices that ultimately benefit the patients.
“We can learn from one another and support professionals in the field with this agreement,” Jensen said. “In the end, innovation and safety are advanced when organizations collaborate on solutions to the shared challenges we face in healthcare technology.”
AAMI has developed a number of education programs related to quality management systems that it will now offer to IAMERS members on a discounted basis under the terms of this agreement.
According to IAMERS, all of its members are expected to employ quality management in their organizational structure, policies, procedures, processes, and resources. In May 2017, IAMERS members unanimously approved recommendations related to complaint management, identification and traceability, competence, awareness and training, inspection of equipment, and data management.
“IAMERS members are striving to achieve the best solutions for their clients, and of course, continuing to address patient safety,” said IAMERS President Diana Upton. “We know engaging with AAMI will greatly help us with these efforts. We are delighted to enter into this understanding with AAMI. We hope we too will bring important insights about our member businesses.”
AAMI and IAMERS will also provide opportunities for representatives from the other organization to participate in specific committees and conferences to reinforce information sharing and open discourse relevant to both groups’ missions.
AAMI (www.aami.org) is a nonprofit organization founded in 1967. It is a diverse community of approximately 7,000 healthcare technology professionals united by one important mission—supporting the healthcare community in the development, management, and use of safe and effective healthcare technology.
George Mills, Director of Engineering for the accrediting organization, The Joint Commission, announced yesterday at the American College of Clinical Engineers (ACCE) meeting a new element of performance expected which essentially requires healthcare organizations to have on hand service manuals and technical bulletins:
EP 3 provides “The organization has a library of information regarding inspection, testing, and maintenance of its equipment and systems. Note: This library includes manuals, procedures provided by manufacturers, technical bulletins and other information.”
In other news, our general counsel Robert Kerwin, also spoke to the ACCE on the amendment to the MDUFA IV legislation passed this week by the House Energy and Commerce Committee which requires the FDA, if enacted, to provide a report to Congress on its assessment of the need for further legislation/regulation of servicing by any person other than manufacturers. Mr Kerwin had previously testified before the Subcommittee on Health in opposition to Servicing Legislation and welcomed the House Committee’s compromise decision to await the FDA report. “Independent services are essential to the healthcare ecosystem and if it’s truly about patient safety, why should some manufacturers withhold manuals all the while claiming further regulation is necessary to address uneven levels of servicer performance.”
On June 7, 2017, the U.S. House of Representatives Energy and Commerce Committee approved an amendment to the FDA Reauthorization Act of 2017 which will require the FDA to submit to the House and Senate Committees a report on how the FDA intends to ensure the quality and continued effectiveness of devices with respect to servicing “performed by any entity engaged in servicing other than the manufacturer of the device. The amendment, if passed by the full House and Senate will require the FDA to report within 6 months on: (i) the specific activities performed on a device by the manufacturer of the device or other entities; (ii) a description of the legal authority of the FDA used to oversee and regulate servicing conducted with respect to the device; (iii) detail how the FDA intends to protect public health by ensuring consistent quality, safety and continued effectiveness of the devices;(iv) provide information on how the FDA can better understand the device servicing industry including the size, scope, location and composition of entities performing such servicing and the rate of adverse events related to such servicing; (v) address the current regulation by states, the Joint Commission or other regulatory bodies of servicing with respect to devices by all entities including manufacturers, third party entities and hospitals.