Diagnostic Medical Imaging (DI) is part of the broader market of “medical devices”. It has revolutionised healthcare over the years by enabling doctors, specifically radiologists, to diagnose diseases early, and with certainty. Equipment is typically divided into complex high-end machines such as CT and MRI scanners, and technically simpler devices such as ultrasound scanners. These [...]
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 [...]
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, [...]
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 [...]
Independent servicers across the nation have registered with their congressional representatives strong disapproval to the proposed independent servicers legislation. Read more here.
Spending millions on security technology can certainly make an executive feel safe. But the major sources of cyber threats aren’t technological. They’re found in the human brain, in the form of curiosity, ignorance, apathy, and hubris. These human forms of malware can be present in any organization and are every bit as dangerous as threats delivered [...]
Unfortunately, attacking hospital IT systems is just the tip of the iceberg when it comes to cyber vulnerabilities in the health care sector. Hacks of implanted or wearable medical devices are an even more sobering threat. Read more here.
The FDA Medical Device User Fee Amendments (MDUFA IV) package is heading to a Senate committee vote — and it appears not to include any of the House legislative language on independent servicer registration. Read more here.
This market is fueled by the growing use of big data, desire to improve patient outcomes and reduce costs, imbalance between the health care workforce and patients, popularity of personalized medicine, cross-industry partnerships and a significant increase in venture capital investments. Read more here.