Reprocessing has emerged as an attempt to control the cost of single-use bipolar and ultrasound diathermy devices despite limited data on defect rates. This study compares the defect rates, as reported by surgical teams, between original equipment manufacturer (OEM) single-use bipolar and ultrasound diathermy devices and reprocessed (RP) devices. Data were retrospectively collected on 3112 devices over a 7-month period for two types of bipolar and ultrasound diathermy devices. There is a significant difference (p < 0.001) in reported bipolar and ultrasound diathermy device defects between OEM and RP. OEM single-use bipolar and ultrasound diathermy devices were reported to be defective more frequently than RP devices based on reports from the surgical team.

References

References
1.
Committee on Gynecologic Practice, The American College of Obstetricians and Gynecologists
,
2012
, “
Committee Opinion No. 537: Reprocessed Single-Use Devices
,”
Obstet. Gynecol.
,
120
(
4
), pp.
974
976
.
2.
U.S. GAO, 2008
, “
Reprocessed Single-Use Medical Devices: FDA Oversight Has Increased, and Available Information Does Not Indicate That Use Presents an Elevated Health Risk
,” U.S. Government Accountability Office, Washington, DC, accessed May 1, 2014, http://www.gao.gov/new.items/d08147.pdf
3.
Blackmore
,
C. C.
,
Bishop
,
R.
,
Luker
,
S.
, and
Williams
,
B. L.
,
2013
, “
Applying Lean Methods to Improve Quality and Safety in Surgical Sterile Instrument Processing
,”
Jt. Comm. J. Qual. Patient Saf.
,
39
(
3
), pp.
99
105
.
4.
Larose
,
E.
,
2013
, “
Legal Implications of Single-Use Medical Device Reprocessing
,”
Healthcare Q.
,
16
(
3
), pp.
48
52
.
5.
Pyrek
,
K. M.
,
2003
, “
Reprocessing of Medical Devices: Government Intensifies Its Scrutiny as Clinicians Debate Patient-Safety Issues. SurgiStrategies
,” Last accessed May 16, 2014, http://www.surgistrategies.com/articles/2003/02/reprocessing-of-medical-devices-116124.aspx
6.
Weld
,
K. J.
,
Dryer
,
S.
,
Hruby
,
G.
,
Ames
,
C. J.
,
Venkatesh
,
R.
,
Matthews
,
B. D.
, and
Landman
,
J.
,
2006
, “
Comparison of Mechanical and In Vivo Performance of New and Reprocessed Harmonic Scalpels
,”
Urology
,
67
(
5
), pp.
898
903
.
7.
FDA, Quality System Regulation
,
2014
, “
Title 21 Part 820 of the Code of Federal Regulations
,” U.S. Food and Drug Administration, Washington, DC, accessed May 15, 2014, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm
8.
Veselov
,
V.
,
Roytman
,
H.
, and
Alquier
,
L.
,
2012
, “
Medical Device Regulations for Process Validation: Review of FDA, GHTF, and GAMP Requirements
,”
J. Validation Technol.
,
18
(
2
), pp.
82
91
.
9.
Federal Register, Unique Device Identification System
,
2013
, “
A Rule by the Food and Drug Administration on 09/24/2013
,”
U.S. Food and Drug Administration
,
Washington, DC
, accessed May 15, 2014, https://www.federalregister.gov/articles/2013/09/24/2013-23059/unique-device-identification-system
10.
Lee
,
J.
,
2013
, “
Repositioning Reprocessing: Hospitals See Big Potential for Savings, But Safety Remains an Issue for Some
,” Modern Healthcare, accessed June 4, 2014, http://www.modernhealthcare.com/article/20130706/MAGAZINE/307069957
You do not currently have access to this content.