Reuse of Single Use Devices - Safe or Sorry

1. The presentation is solely meant for
Academic purpose

3. “The Guru is none other than the Creator, Lord Brahma;
He verily is Lord Vishnu, the Preserver,
and
He truly is Maheshvara, the Destroyer.
He is the supreme Brahman himself,
To such a Guru I offer my Salutations”
3

4. ‘ No stronger condemnation of any hospital or ward could be
pronounced from the single fact that zynotic (infectious)
disease have originated in it,or that such a disease has
attacked other patients than those brought in with them’
- florence nightingale

5.  Some of the slides an the material are borrowed
and I acknowledge Dr. Gita Nataraj from KEM,
Mumbai and the HISI newsletter on SUDs
reprocessing
 The entire story is borrowed from experiences of
others and self
 I do not claim to be an expert and am as much a
student eager to learn
 I acknowledge the contributions of technical staff
and nursing for implementation of the program
and the entire Infection Control colleagues at
Delhi Apollo, particularly Dr. Leena Mendiratta
5

6.  Original device: “The term ‘original device’ means a new, unused entire
single-use device.”
 Single-use device: “The term ‘single-use device’ means a device that is
intended for one use, or on a single patient during a single procedure.”
 Reprocessed: “The term ‘reprocessed’, with respect to a single-use
device, means an original device that has previously been used on a
patient and has been subjected to additional processing and
manufacturing for the purpose of an additional single use on a patient.
 Critical reprocessed single-use device
 Semi-critical reprocessed single-use device
6

7. 7

8. 8

9. 30% of all hospitals reuse one / more SUDs
Not all SUDs can be reused / reprocessed
50% of hospitals reuse through a third party processor
9

10. 10

11. 2002;7(1):53-
59
Conclusions:
•No significant overall difference in temperature sensing
accuracy and deflection angle of new and used ablation
catheters.
•Nevertheless, individual differences in deflection
characteristics between new and used catheters are
occasionally seen and warrant screening of reprocessed
catheters prior to their reuse
11

12. CONCLUSIONS: Reuse of medical devices labelled "single use only" is
common in Australian hospitals. Most devices appear to be unsuitable for
reuse. Complete cessation of this practice of reusing single-use medical
devices would stop potential cross-infection, but this would cost and
estimated $2.5 million or more per case prevented
12

13. •Tradition of re-use – reports on re-use of pacemakers are
available from Europe, North America and Asia (India) with no
reported adverse effects
•During 1996, in Sweden, 5% of pacemakers were re-used
devices, with no evidence that re-use has increased patient risk.
•Re-use of pacemakers may be considered, provided that their
sterility, mechanical and electrical integrity can be ensured and
operating procedures are respected. Re-used pacemakers
should only be given to patients whose life expectancy is
estimated to be less than that of the pacemaker.
13

14. A Randomized Study of the Safety and Efficacy of Reused Angioplasty
Balloon Catheters
M Zubaid, CS Thomas, H Salman, I Al-Rashdan, N Hayat, A Habashi, MT
Abraham, K Varghese, L Thalib
Department of Cardiology, Chest Diseases Hospital, Kuwait and
Department of Community Medicine, Faculty of Medicine, Kuwait
University
Conclusions: When performing coronary angioplasty, reused catheters
are as effective (similar angiographic success) and safe (similar clinical
success) as new catheters. (Indian Heart J 2001; 53: 167–171)
14

15. The issue really is not whether or not to reprocess, but
what constitutes safe and appropriate reuse of disposable
items.
15

16.  ……. requires that 510(k)s for listed reprocessed SUDs
include “validation data, regarding cleaning and
sterilization, and functional performance demonstrating
that the [SUD] will remain substantially equivalent to a
predicate device after the maximum number of times the
device is reprocessed as intended by the person submitting
the premarket notification.”
 On April 30, 2003, FDA identified in the Federal Register
those critical reprocessed SUDs whose exemption from
510(k) would be terminated.
 On April 13, 2004, FDA identified those semi-critical
reprocessed SUDs whose exemption would be terminated.
 On September 29, 2005, FDA updated and consolidated the
lists of the critical and semi-critical reprocessed SUDs that
would no longer be 510(k) exempt
16

17. 17

18.  …simply because they are not designed to be taken apart for
adequate cleaning
 …. or to perform as specified after first use.
 In addition, many of the materials utilized in the various
components of single use medical devices, both plastics,
glues and metals, may not withstand the chemical
environment of the solutions utilized
 Also, the temperatures required for autoclave sterilization
may deform many components and subsequently
compromise their performance and safety
December 15, 2009
Eucomed White Paper - The Reuse of Single Use Devices
18

19.  Canadian Medical Device Technology Companies (MEDEC): the
authors refer to a 2001 review where several reprocessed single
use devices were retrieved from hospitals in the United States and
in Europe.
 In total, 136 devices were obtained from hospitals on both
continents and included clip appliers, clamps, staplers, cautery
devices, tracers and electrophysiology (EP) catheters.
 Examination revealed that at least half of these products had
packaging defects, were contaminated with residual blood or
tissue, and/or experienced functional failures.
19

20.  MEDEC - German report, 2001 (Andreas Beck)
where 727 angiography catheters and guide wires
were studied
 The results showed numerous physical variations
in devices including nicks, kinks, roughness,
erosion, tears and changes in material properties.
 The author concluded that the refurbishment of
devices intended for single use by both healthcare
facilities and third party reprocessors is
inappropriate and a risk to patient safety
20

21.  SGNA believes that patients deserve the same standard of care
regardless of practice setting.
 The reuse of SUDs is a complex issue that must be balanced
with the assurance of patient safety and the delivery of quality
health care. These concerns cannot be overlooked when
evaluating the legal, ethical, financial, and technical aspects of
reusing SUDs.
 In the absence of substantial scientific evidence to prove the
safety and effectiveness of reprocessed critical medical
devices in the endoscopy setting, SGNA maintains the position
that critical medical devices originally manufactured and
labeled for single use should not be reused.
 Adopted by the SGNA Board of Directors, February 1998;
Revised May 2002, October 2005, August 2008.
21

22.  The WHO has stated ‘the safest and most
unambiguous method for ensuring that there
is no risk of residual infectivity on surgical
instruments is to discard and destroy them by
incineration … this strategy should be
universally applied to those devices and
materials that are designed to be disposable.’
WHO Infection Control Guidelines for Transmissible Spongiform
Encephalopathies, WHO/CDS/CSR/APH/2000.3. March 23-26, 1999
22

23.  The use of a reprocessed single use device
provides no direct benefit to the individual
patient or her physician
 …Relies on voluntarily reported adverse
events..
 …Studies on the safety, quality and cost-
effectiveness are needed…..
23

24. A B
A) PTCA balloon catheter refurbished by a third
party and soiled with contrast medium and
blood.
B) A comparison of a PTCA balloon and a
household match demonstrating the small
size of the catheter and how difficult it would
be to ensure effective cleaning of such a
small device
24

25. B
A
25

26. A C
B
A) Proteinaceous contamination on the
inner surface of a guiding catheter.
B) XPS Scan / Spectrum confirming that
the reddish contamination is blood.
C) Scanning electron micrograph (SEM)
photograph to confirm the presence of
a red blood cell
26

27. Reddish brown contamination observed over the
full length of the third party reprocessed
endoscopic stapling device
27

28. A B C
A) Flaking marker on a reprocessed balloon catheter, which
may result in release of particles into the patient’s
bloodstream.
B) Marker of a new balloon catheter.
C) Aluminium contamination in the lumen of a balloon
catheter.
28

29. A B
A) The coil of new, unused biopsy forceps.
B) The coil of reprocessed biopsy forceps
29

30. …..Another challenge when reusing catheters is that it is difficult to predict when a
catheter will degrade to a degree that it will break…..
When and if depends on the type of polymer used and how it is manufactured.
While some plastics degrade over time and show signs of wear others seem to fail
spontaneously
Degradation-time curves demonstrating how different polymers degrade over time
David L. West et al. “Scientific & Regulatory Consideration for the Review and
Approval of Reprocessed Single Use Devices Pre - market Submissions
30

31. Photograph showing kinks along a reprocessed
single use catheter as a result of previous usage
or reprocessing
31

32. When attempting to flush the single use
devices a distribution of the contamination
rather than cleaning was achieved…..
Demonstration of the distribution of contamination rather than
removal as assessed using the radionuclide method of detection
….Most of the inspected devices showed residual contamination in the
hinges and under the isolation coats .This was especially true for
harmonic scalpels. These findings indicate that the cleaning agent
penetrates into the device and dilutes the blood but cannot then be
flushed out of the device. Therefore, contamination and disinfection
solution remain in the devices ……
2001, Roth, Heeg, and Reichl
32

33.  A single-use bladder pressure transducer cover
was not changed between patients, resulting in
cross-infection due to Pseudomonas
aeruginosa. One patient developed septicaemia
and died of a sub-arachnoid haemorrhage
 A lithotriptor stone retrieval basket, which was
a single-use device, had been reprocessed and
appeared to be satisfactory for use. During the
procedure,the cable was tightened and
snapped, resulting in the basket remaining in
the patient. Further surgery was required to
retrieve it.
Single-use Medical Devices : Implications and Consequences of Reuse
MHRA DB 2006(04) v2.0 December 2011
33

34. 30% of all hospitals reuse one / more SUDs
Not all SUDs can be reused / reprocessed
50% of hospitals reuse through a third party processor
The cost is reduced by ½ to 1/10
34

35.  The main complication in performing true cost-
benefit calculations in relation to refurbishment
and reuse of single use devices is the challenge
created by the increased patient risk involved.
 How can a price be assigned to increased patient
risk?
 Some studies touch directly upon the problems
associated with creating a true financial cost-
benefit analysis, while others ignore this
complication entirely and therefore reach
questionable financial conclusions
 This does not include the hidden costs related to
the risks of using refurbished single use devices,
such as HAI, complications, litigation, staff injuries
etc.
Single-use Medical Devices : Implications and Consequences of Reuse
MHRA DB 2006(04) v2.0 December 2011
35

36. Cost-effectiveness……? We are doing a study
 Personnel costs: Cost of employing technical and qualified personnel for pre-
cleaning immediately after the point of use, assembly, dismantling and
replacement activities, maintenance and cleaning, repairs, wear and tear,
sterilisation, sterilisation checks (chemical and biological), packaging, etc. In
addition, personnel and/or costs for longer procedure time, re-operation and
infections should be considered.
 Investment costs: Costly apparatus (capital equipment), buildings (designated
for storage/spare parts); centralised sterilisation unit and special apparatus
(autoclaves, machines for washing the devices, ultrasonic baths, means of
cleaning, chemical products, disinfectants, lubricants, etc).
 Administrative costs: Systems used to communicate the results and establish
traceability, managing reserves of spare parts/stock, distribution, transport,
insurance premiums, documentation, validation procedures, auditing third
party refurbishers, recording accidents and injuries involving members of
staff, etc.
 Utility costs: Cost of providing the utilities associated with the sterilisation
process (electricity and water consumption [including drainage]).
 Miscellaneous costs: Overheads, protective clothing (gloves, masks, safety
glasses, double-thickness packaging materials), provision of safety training in
connection with the re-utilisation of instruments, cost of treating post-
operative infections and handling complaints
36

37. Potential Risks Examples
Potential for cross Any component of Microbial world esp Blood borne
infection viruses
Inability to clean and Features of a device that make cleaning difficult are:
decontaminate acute angles, coils, long or narrow lumens, spécial
surface coatings etc.
Residues from chemical Disinfectants may be absorbed by plastics and leach out
decontamination agents during use, resulting in chemical burns or a risk of
sensitization of the patient or user.
Material alteration Plastics may soften, crack or become brittle during
exposure to elevated temperatures or pressure during
the sterilization process or exposure to cleaning agents
and chemical sterilants
Mechanical failure Some devices may experience stress during each cycle of
reuse, leading to fatigue-induced failure and fracturing
e.g. single-use drill, burrs, saw blades, craniotomy
blades catheters
Reaction to endotoxins If the device has a heavy bacterial load after use, which
cannot be adequately removed by cleaning
MHRA DB 2006(04) v2.0 December 2011
Transmission of CJD,
Prions 37

38. 30% of all hospitals reuse one / more SUDs
Not all SUDs can be reused / reprocessed
50% of hospitals reuse through a third party processor
Clinical evidence does not indicate increased risk in controlled
settings
Reuse is not a harmless procedure – Document Integrity and Safety
Continued surveillance for adverse events is required
The procedure has to be regulated
The cost is reduced by ½ to 1/10
38

39.  The FDA classifies single-use medical devices according to the
level and type of control needed to ensure that the devices are
safe and effective.
- Class I devices need the fewest controls
- Class II devices require "special controls."
- Class III is the most stringent regulatory category and
medical devices that fall under this category require a
premarket approval
 Class I and Class II devices are the best candidates for
reprocessing, with some notable exceptions.
Medical Device Reprocessing Don Selvey, 2011
39

40. 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 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
Class III devices include:
 Transluminal coronary angioplasty catheters
 Percutaneous and conduction tissue ablation electrodes
Medical Device Reprocessing
 Implanted infusion pumps
Don Selvey, 2011
40

41. S.U.D Policy: Components
 S.U.D. List (approval of End-Users and Management and
ICC members)
 Specialties using S.U.D.
 Serial Number for each S.U.D
 Number of re-uses specified for each S.U.D
 Protocols on Re-processing of S.U.D.
 Training of Personnel involved (Part of staff Appraisals)
 Functional integrity check to each S.U.D.
 Rejection Criteria of each S.U.D
 Traceability
 Monitoring of S.U.D
 Recall Policy
 Documentation
 Validation by user / third party reprocessor
 Monitoring of Policy
41

42.  Initial pre-cleaning on site
 Cleaning and rinsing
 Decontamination
 Marking (number of re-uses)
 Packaging
 Labeling
 Sterilization
 Documentation
42

43.  For all devices (narrow lumen/balloon) it is necessary to test the
functional integrity before drying.
 The devices shall be inspected for any damage and its functional
integrity verified by the user after the process of cleaning and
decontamination
 Assessment of the functional performance on a worst case basis,
i.e., after the maximum number of times the device is intended to
be reprocessed as specified.
 Simulation of device in reprocessing cycle and this step should be
specified in the summary of the process design and validation.
 The performance tests should be summarized in the process design
and validation documentation
43

44.  Incase the number of usages equals the number of usages
as per Policy, approved for that particular article.
 Any kinks, curves leading to loss of functional integrity
 Blood clots not getting removed
 Loss of Lumen patency
 Incase signals are not being received
 Any leaks
 Incase smooth functioning is absent
 Incase inflation is not taking place
 Incase of breakage
 Incase tip is blunted
 Incase tip is broken
 Incase sharp edge is blunted
44

45.  Ensure drying by either passing dry
compressed air through it or drying in
controlled environment (biosafety) for
devices which are delicate or not able to
withstand air pressure
45

46. Marking
Should be ensured that marking does not
compromise on the integrity of the device
46

48.  Excess air must be removed from packets before
sealing
 Appropriate packaging shall be carried out to
ensure effective sterilisation.
 The packaging shall be compatible to the type of
sterilization being carried out.
 The items shall be wrapped in medical grade
packaging.
48

49.  Appropriate labeling of every packed item is done.
 The Label should include the following:
- Name
- Size
- Manufacturer
- Unique Device No
- Usage no
- Date of Last Usage
- Date of reprocessing
 The Unique Device No includes the following essentially in the
given sequence: Manufacturer / Serial Number of that particular
item- as specified in the approved SUD List / Year of present
usage/ Month of present usage/ no of times that particular type
of item has been opened on that particular day, (eg Ox / 21 /
2008 / 02/ 01)
 These items are then sent for further appropriate sterilization.
49

50. S.U.D. Monitoring
50

51.  The device should be sterilised by an appropriate sterilisation
method for that device e.g. ethylene oxide gas sterilisation
method
 The process of sterilisation should be strictly controlled and as
per the manufacturer’s instructions.
 The cycle shall be monitored with physical,
chemical and biological indicators.
 The device shall not be released till 72 hours
post- Ethylene oxide sterilization
 PCD to be used as simulators
51

52. Labeling Gun:
 Sterilizer number,
 Load number,
 Batch number,
 Date of sterilization
 Date of expiry

53. Sterilization: Validation through Indicators

54. Keeping the track record of that article through appropriate documentation
54

55. SINGLE-USE DEVICE REPROCESSING GUIDE TEMPLATE
The following single-use devices have been approved for reprocessing by the Medical Executive Committee.
No other single-use device may be reprocessed unless written authorization is obtained from the Medical Executive Committee.
Effective Date:
Device Status
Approved Third-Party
Clinical Category Device Manufacturer Model(s) Open &
Reprocessor Used Expired
Unused
Ambulatory Surgery Center Quality Programme
55

56. 56

57. 57

58.  Any adverse event related to the device
should be reported in an incident- form
58

59. “There is no conclusive evidence to substantiate
the notion that either morbidity or mortality
associated with single use or reuse is different.”
National Kidney Foundation Report on Dialyzer Reuse, AJKD 1997

60. Assuming a dialyzer price of $20, costs of
Reuse Cost Reduction Curve
reprocessing of $5, and 15 uses, the cost savings for
one patient are $2,050 every year with reuse
Cost of Single Use vs. Multiple Use $25 $25
(Cost per Patient per Year)
$20 $20
$5,000
Cost per treatment
$15 $15
$4,000
$10 $10
$3,000
Cost
Costs for 50 Patients per Year $5 $5
(6 Reuses vs. 15 Reuses)
$2,000
$0 $0
$70,000 1 4 7 10 13 16 19
$1,000 $60,000
Cost per year
$50,000
$0
Single Use Multiple Use $40,000
$30,000
Dialyzer Cost Reprocessing Cost $20,000
$10,000
$0
6 Reuses 15 Reuses
Reprocessing Cost Dialyzer Cost
Automated Dialyzer Reprocessing , Minntech 1999
60

61. Daily Checklist For Dialyzer Re-processing System Serial no:____________
01.01.20
Parameters 02.01.2011 03.01.11 04.01.11 05.01.11 06.01.11 07.01.11
11
Calibration
Verification Volume
in ml
( 70[+/-]3 ml )
Pressure Log:
Static Pressure
(Ideally: 20 psi to 55
psi)
Dynamic Pressure
(Ideally: 35 psi to 40
psi)
Exterior Cleaning
with 1% Renalin
Caps:
30 minutes
disinfection with 1%
Renalin
Sanitization
VERIFICATION
61

62.  If required, a S.U.D. maybe recalled, if decided
so by the Infection Control Committee, incase
of repetitive incidents if any, or if any such
notification from the Manufacturer
62

63.  Appropriate Personal Protective Equipment (gown, gloves, eye-
protection, etc) to be worn while cleaning and decontamination
 Care should be taken in the direct handling of intricate or sharp-
edged devices to avoid injury to the handler or damage to the
device.
 For devices with lumen special care should be taken while
injecting the cleaning solution into the lumen so as not to cause
damage
63

64.  Cleaning, sterilization, and functional performance
validation of reprocessed SUDs include aspects of
both:
(i) design validation
(ii) and process validation.
 Design validation, in this case, should incorporate
both the design of the product and the design of the
processes to be used in reprocessing the device.
64

65. ‘Rapid’ monitor that uses bioluminescence to measure
the levels of ATP on a surface. It works through
collection and quantification of ATP remaining in
organic residues post-cleaning
Capable of detecting 2mg protein / m2
ATP Results of less than 10 RLU are preferred
Green Color-Satisfactory

66. VALIDATING SINGLE USE DEVICES
•Understanding it’s configuration and application (List of the
parts, mantling and dismantling, manufacturers
specifications)
•Point of use care (Immediate aspiration, flushing)
•Safe transport to re-processing department
• Standard operating protocols of reprocessing
department
•Number of turns, tracking, recall procedure
• Back to user
•Discard after the last use

67. Steps Validation Responsibility
Integrity & functionality through Visual inspection Device User
Post use pre-cleaning through visual inspection Device User
Safe & covered transport Supervision (Assisting personnel)
Disinfection & thorough Microbiological testing Reprocessing Dept.
Cleaning & microbiology dept.
Inspection, Assembling, Sterility check CSSD
Packing, sterilization (No toxic residues left)
Pyrogen free
Next turn usability Check by user User department
Usable life / No. of turns Sterility Assurance & User / reprocessing
Adequate working of Microbiology
the device, QA dept. headed by
I.C.Chief

68. 68

69. Instrument Single-use Cost per Additional Saving per patient Procedure where device
device patient when cartridge in multiple use (Rs) used (Rs)
(MRP) (Rs) used multiple Cost (Rs)
times
Harmonic 40,000- 7,000- Nil 30,000 Advanced and
Shear 50,000 10,000 routine Laproscopic
approx surgery
Diagnostic 1000 250 Nil 750 Interventional
guidewire Cardiology and
radiology imaging
Angioplasty 10,000 – 4,000-5,000 Nil 5,000-6,000 Interventional
Balloon 12,000 approx approx Cardiology and
Catheter radiology imaging
Open 21,000 – 4,000-5,000 4,000- 12,000-18,000 Open major
surgery 28,000 approx 6,000 abdominal surgery
linear cutter approx
Endoscopic 22,000 – 5,000 approx 6,000- 11,000-18,000 Advanced
Linear cutter 36,000 8,000 Laproscopic
approx Gastrointestinal
Surgery
Mutiload 19,700 2,000 per Nil 8000 if an Clipping of blood
clip clip applied average of 6 vessels, cystic duct
applicator clips used
Skin stapler Natl Med J India 2012;25:151–5, Hussain et al
734 183 Nil 500 Skin incision
approximation
69

70.  Is it moral or ethical to treat a patient with a
refurbished medical device of unknown and
potentially lower (i)quality, (ii)performance or
(iii)cleanliness than when it was used on the
previous patient?
 Informed Consent from Patient…?
 Is the treating Physician fully aware……?
70

71.  ……But before medical devices can be reprocessed and reused, a third-
party or hospital reprocessor must comply with the same requirements
that apply to original equipment manufacturers, including:
 Submitting documents for premarket notification or approval
 Registering reprocessing firms and listing all products
 Submitting adverse event reports
 Tracking devices whose failure could have serious outcomes
 Correcting or removing from the market unsafe devices
 Meeting manufacturing and labeling requirements
DEADLINES: Manufacturers of reprocessed single-use laparoscopic
and endoscopic electrosurgical accessories who already have 510(k)
clearance for these devices were required to submit supplemental
validation data for the devices by June 29, 2006, or their devices were
no longer legally marketed.
71

72. Single-Use Medical Devices: Little
Available Evidence of Harm From Reuse,
but Oversight Warranted
(Letter Report, 06/20/2000, GAO/HEHS-
00-123)
72

73.  ……….while the agency reviews all adverse event reports, it places
the highest priority on reports involving pediatric deaths, multiple
deaths or serious injuries from a single device, fires, burns, or
highly unusual events such as radiation exposure, over- or
underdosing of radiation, radiation being delivered to the wrong
site, and severe allergic reactions (anaphylaxis)
 While FDA has made changes to its data collection process
regarding reprocessed SUD-related adverse events, the data are
not suitable for a rigorous comparison of the safety of
reprocessed SUDs compared to similar original SUDs
 Rigorous Safety Comparisons Not Possible through Current or
Planned Adverse Event Reporting
 Neither existing FDA data nor studies performed by others are
sufficient to draw definitive conclusions about the safety of
reprocessed SUDs compared to similar original devices.
 FDA Oversight Has Increased, and Available Information Does Not
Indicate That Use Presents an Elevated Health Risk
73

74.  Potential for cost saving
- Health care establishment
- Patients
 Dependable supply
 Reduction of waste
 Ecofriendly - pollution reduction, less
incineration and less use of landfills and dump
sites
74

75.  Who should be allowed to reprocess?
 Who will provide the guidelines, standards and
protocols ?
 Who will cross check the quality of the
reprocessing and regulatory oversight?
 Who will pay for failures?
 What if we do away with reprocessing- who
would bear the cost?
75

76.  If a device cannot be cleaned, it cannot be re-
processed and re-used
 If the sterility of a post-processed device cannot be
demonstrated, the device cannot be re-processed
and re-used
 If the integrity and functionality of a re-processed
SUD cannot be demonstrated and documented as
safe for patient care and or equal to the original
device specifications, the device cannot be re-
processed and re-used.
 If anything sterile is opened, it needs to be
decontaminated before re-processing
 Validation and documentation of processes and
outcomes is mandtory
76

77. SUDs would be reused – need to identify those that can
and those that shouldn’t
For the developed nations – reuse is a ‘green option’
For resource crunch settings - Reuse is not only cost
saving but also life-saving
Standards need to be laid down and implemented in
healthcare units/ May be a third party reprocessing unit
needs to step in
77

78. The debate would go on, but the
dictum remains….
STERILITY
INTEGRITY
78

79. 79