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.
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.
IAMERS Letter to MITA
EXCERPTED MITA SERVICING STANDARD