Alquest launches support system
Alquest (Minneapolis), a device contract research organization, has launched a new support service aimed at helping medical device manufacturers anticipate, prepare for and respond to new and unpublished FDA standards being applied to biomedical research monitoring inspections and audits.
Clinical standards and practices that medical device manufacturers believed to be true and reliable as recently as a year ago are significantly outdated, said Alquest president Ann Quinlan-Smith.
Alquest's rigor and thoroughness in investigational site monitoring, record keeping and data management were validated following a recent week-long FDA sponsor audit at the firm's Minneapolis location.
“We also have participated in six BIMO field inspections by FDA in the last six months and we've found that scrutiny by FDA's Office of Compliance is significantly different and more thorough than before,“ said Quinlan-Smith. “Many manufacturers are being blindsided by these requirements. In essence, 2009 regulatory wisdom is largely useless today.“
GuildNet makes AMAC's MedSmart available
GuildNet (New York), a managed long-term care program that offers a community-based alternative to facility-based long-term care, said that after a three-month evaluation period, it has decided to make American Medical Alert's (AMAC; Oceanside, New York) MedSmart Medication Management system available to its members. Wanda Figueroa-Kilroy, GuildNet's executive VP, said “our members and their families report a great deal of satisfaction with the device and we saw evidence that the reminders helped to ensure medication compliance.“
The MedSmart system organizes, reminds and dispenses the correct pills at the correct time from 1 to 6 times per day ensuring safe and appropriate medication use. Using a two-way communication modem, MedSmart uploads device and dispensing information on a daily basis to a secure, web portal for access by authorized individuals. If a dose is missed or medications are low, the system will promptly notify designated caregivers via text, voice or email message, allowing for early intervention and timely tray refill.
GuildNet, a subsidiary of The Jewish Guild for the Blind, is a managed care program designed to keep visually impaired, blind, multi-disabled and chronically ill persons in their communities. AMAC is a healthcare communications company.
St. Joseph's to expand orthopedic services
St. Joseph's Hospital (Tampa, Florida) reported the initiation of a $35 million project that aims to serve more critical care patients and expand orthopedic services in a spacious and comfortable setting. This week the hospital welcomed its first patients to the new wing that includes 52 private patient rooms, including a brand-new intensive care unit.
Each of the private rooms features an identical floor plan that allows the care team to work more efficiently with each patient. The sink near the door allows visitors to take part in one of the most important patient safety practices: washing their hands while entering and exiting the room. Decentralized nursing stations decrease walking distance for nurses, allowing them to spend more time at the patient's bedside. Placement of medication, supplies and nutrition rooms are organized around the process of care delivery to keep resources close to nursing staff.