Did we KNOW that re-use of one-time-use medical devices was common?

More Scrutiny Sought For Reused Devices
House Member Questions FDA's Role
By Alec Klein
Washington Post Staff Writer
Tuesday, December 13, 2005; Page D02


A key member of Congress called yesterday for more rigorous federal oversight of reused medical devices designated as one-time-use instruments.

The Food and Drug Administration has made progress in monitoring the industry -- called reprocessing -- but "significant gaps remain," said Rep. Rosa L. DeLauro (D-Conn.), the ranking Democrat on the House Appropriations subcommittee that oversees the FDA.

Reprocessing is a growing industry that is believed to serve hospitals in all 50 states and the District and at least eight medical facilities in the Washington area.

Device manufacturers say they cannot vouch for the safety of their reconditioned single-use devices, but reprocessors say there is no credible evidence that their refurbished devices are riskier than new ones. They also say no surgery is without risk, and many hospitals cite the practice's safety and cost savings.

DeLauro, however, expressed concerns about the FDA's role. The agency relies on doctors to voluntarily report problems with faulty medical devices, and medical facilities are required to report to the FDA deaths but not device malfunctions....


http://www.washingtonpost.com/wp-dyn/content/article/2005/12/12/AR2005121201469.html

of course we should recycle them. There are safe sterilization techniques that are cost efficient and save everyone money.

that hospitals are making money on the deal, e.g., charging twenty customers for one device at an exorbitant once-only price.

instruments. It's amazing the cost savings that can be realized when you get creative with your recycling efforts.

http://www.chronicle.duke.edu/vnews/display.v/ART/2005/11/14/43787f627944f

Hydraulic fluid? No joke? No, you are joking. Silly me.

fluid with hydraulic fluid and no one knew. Doctors thought there instruments were a little "slippery" but hundreds of patients were operated on with the instruments sterilized by hydraulic fluid...

from Infection Control Today website:

http://www.infectioncontroltoday.com/articles/111feat1.html

Devices that Alliance reprocesses fall into the following general categories:

Open/unused devices and suture
E.P. catheters
DVT compression sleeves
Orthopedic tools
Laparoscopics
GI biopsy forceps
Reprocessable Class I devices include:

Orthopedic chisels
Surgical curettes
Surgical gouges
General use surgical scissors
Non-electric biopsy forceps
Orthopedic knives
Orthopedic saw blades
Chisels
Rasps
Between 65 and 75% of all single-use medical devices are identified as Class II. Class II single-use devices that can be reprocessed include:

Non-ported trocars for endoscopic procedures
Sequential compression devices (compression sleeves)
Most laparoscopic instruments, including: scissors, clamps, dissecters and graspers
Recording and diagnostic EP catheters
Drills and burrs
Flexible snares
Because Class III, single-use medical devices pose greater risk to the patient and now require pre-market approvals (PMA), they are generally not reprocessed. Such Class III devices include:

Transluminal coronary angioplasty catheters
Percutaneous and conduction tissue ablation electrodes
Implanted infusion pumps

Hospitals are losing money on patients left and right (stuff costs more than they're getting reimbursed), so they've got to cut costs everywhere they can. It makes me nervous, but then again, even the first time use stuff straight from the manufacturer can have defects and contaminants.

Here in Michigan, our state constitution says that every single hospital has to be non-profit and take care of the poor, so we don't have quite the nastiness that exists in other states. Even still, hosptial endowments aren't doing as well, investment-wise, and reimbursements are down, so the hospitals are cutting costs everywhere. Frankly, cutting nurses or short-staffing them concerns me much more than reusing one-time-use stuff.