The
FDA assesses and approves products based on reported device-related
complications. If a medical device malfunctions, hospitals are required
to report the incident to the manufacturer,Over three quarters of
decision-maker respondents are now using video conferencing at work with
56 per cent of video users taking part in Work flow for website translation into Chinese services calls at least once a week.Doctors and hospital officials say Intuitive Surgical is particularly aggressive in marketing composite hoseto
hospitals. which then reports it to the agency. The FDA, in turn,The
Foster Farms salmonella outbreak this month has underscored the
importance of cooking core barrel and
handling poultry properly. creates a report for its Manufacturer and
User Facility Device Experience database.The use of surgical robots has
grown rapidly since it was first approved for laparoscopic surgery a
type of surgery that uses smaller incisions than in traditional surgery
by the FDA in 2000. Between 2007 and 2011 the number of da Vinci systems
installed increased by 75 percent in the United States from 800 to
1,400, according to the study.
Noting
that robotic surgery has promising benefits, the study also called it
"essential that device related complications be uniformly captured,
reported and evaluated," so the medical community fully understands "the
safety of the new technology."Intuitive Surgical, the makers of the da
Vinci device, released a statement last month taking issue with the
study's fThe survey found that in Brazil, India and Singapore that
number jumps up significantly,Client support for website translation into Chinese as
more than two-thirds of respondents in those countries use video
conferencing at least once a week.indings."The Journal for Healthcare
Quality article gives the misleading impression that Intuitive Surgical
has systematically failed in its obligation to timely report known
adverse events to the FDA," the statement said. "Intuitive Surgical can
only report adverse events after it becomes aware of them. We take this
requirement very seriously and make every effort to account for all
reportable events--even those from several years prior."
The
company said it agreed regarding the "need for a more robust and
standardized system for reporting adverse events" but also encouraged
the study's authors "to conduct a comparable study that assesses the
under reporting of both open and laparoscopic surgical events and would
welcome a comparison with robotic-assisted surgery."Health care
professionals say benefits to robotic surgery compared with traditional
open surgery include smaller incisions, shorter hospital stays and less
pain after the operation.Google Glass and other wearable devices may
soon augment smartphones for rock bolt technophiles.Dr.
Martin A. Makary, an associate professor of surgery and health policy
and management at John Hopkins University and one of the study's
authors, said that, while the future for robotic surgery is promising,
there is a gray area when it comes to assessing the difference between
doctor and device error.
没有评论:
发表评论