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.
Read the AAMI article here.
MITA continues to omit in its proposed Servicing Standard device manufacturer responsibility to provide appropriate documentation for technical descriptions, instructions for use and preventive and corrective maintenance and repair procedures, despite ANSI/AAMI EQ56: 2013.
IAMERS after receiving a copy of the latest version of MITA’s servicing standard, notified MITA that the Standard continues to impose on ISOs installation, preventive maintenance, complaint and control of design change provisions while omitting concurrent manufacturer responsibilities to provide information necessary to carry out these responsibilities if the standard was to be imposed.
See the May 31, 2017 letter from IAMERS General Counsel below.
Our last annual meeting was the best yet. And we’re not the only ones who think so.
“I felt the information was invaluable to my company and the ISO industry”
–Effie Fryer, Conquest Imaging
“I don’t know that this one can be topped. Quality of speakers was top notch and very relevant. This was the best meeting content yet.”
–Carolyn Shaw, Northeast Electronics
“This was the best meeting I have attended.”
–Kevin McGehee, Marquis Medical
“I really liked having Dr. Maisel [FDA] present for our programs. I believe it was very positive showing of who we [IAMERS] are.”
–Jimmy Kallam, East Coast Medical Systems
Diana Upton, our President, does an excellent job putting the agenda and presentations together for an informative and quality meeting for all.
–Julie Mardikian, Oxford Healthcare
We want to thank you all for one of the best meetings that we have attended. The agenda was very relevant for our industry today and the professionalism displayed by the members was exceptional. The guest speakers on the agenda were well chosen for covering the present challenges for the industry today.
Being a new member, IAMERS is the organization to be associated with. As an ISO that has relied on its training and reputation for 36 years to support its customers, the professionalism and concern for customer service by the other members is a breath of fresh air. The proposed Best Practices Manual that has been approved by the members will be a great starting point for EPRS to ensure continued quality support of our customers
We at EP Radiological Services look forward to our continuing association of IAMERS.
–Rick Flannery, EP Radiological Services Inc.