Assessment of reused catheters.
Demands for health care cost containment have prompted the assessment of recycling medical devices, including catheters. The investigation of catheter reuse for effectiveness and safety began at the University of Ottawa Heart Institute in early 1994. This report provides the preliminary results from this ongoing assessment on the feasibility of catheter reuse. Burst tests were conducted to detect changes in catheter mechanical integrity. Scanning electron microscopy (SEM) was performed to assess surface changes and protein deposition after use and the subsequent cleaning process. Results of burst testing showed no significant difference in burst patterns or burst pressures between single use and unused catheters. Surface differences were observed between used and unused catheters. SEM studies detected physical changes such as scratches, gouges, cuts, and deposits on the used catheters. Unused balloon surfaces appeared to be clean and uniform compared to used ones. Residue and cracking were identified on other used devices. In conclusion, the methods used can assess various effects of recycling. A blind study of large samples of used catheters is planned to establish statistically the level and variance of structural damage to catheters during typical use.
Mussivand
T
T
Cardiovascular Devices Division, University of Ottawa Heart Institute, Ontario, Canada.
Duguay
D G
DG
Valadares
M J
MJ
Rajagopalan
K
K
Mackenzie
A M
AM
Blohon
R
R
Marquis
J F
JF
Beanlands
D S
DS
Keon
W J
WJ
D002404:Catheterization / Q000009:adverse effects / Q000191:economics / Q000295:instrumentation*; D003363:Cost Control; D004868:Equipment Failure; D017743:Equipment Reuse / Q000191:economics; D005027:Ethylene Oxide; D005069:Evaluation Studies as Topic; D006801:Humans; D008855:Microscopy, Electron, Scanning; D013242:Sterilization / Q000379:methods; D013314:Stress, Mechanical; D013499:Surface Properties
D005027:Ethylene Oxide