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Transcript of Single Use Devices
The presentation is solely meant for Academic purpose
“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
‘ 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
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
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
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7
8
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
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
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.
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
The issue really is not whether or not to reprocess, but what constitutes safe and appropriate reuse of disposable items.
15
……. 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
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…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
18
Eucomed White Paper - The Reuse of Single Use Devices
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
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
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
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.’
22
WHO Infection Control Guidelines for Transmissible Spongiform
Encephalopathies, WHO/CDS/CSR/APH/2000.3. March 23-26, 1999
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
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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
B A
25
A
B
26
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
A B C
27
Reddish brown contamination observed over the
full length of the third party reprocessed
endoscopic stapling device
28
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.
A B C
29
A) The coil of new, unused biopsy forceps.
B) The coil of reprocessed biopsy forceps
A B
30
Degradation-time curves demonstrating how different polymers degrade over time
…..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
David L. West et al. “Scientific & Regulatory Consideration for the Review and
Approval of Reprocessed Single Use Devices Pre - market Submissions
31
Photograph showing kinks along a reprocessed
single use catheter as a result of previous usage
or reprocessing
When attempting to flush the single use devices a distribution of the contamination rather than cleaning was achieved…..
32
Demonstration of the distribution of contamination rather than
removal as assessed using the radionuclide method of detection
2001, Roth, Heeg, and Reichl
….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 ……
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.
33
Single-use Medical Devices : Implications and Consequences of Reuse
MHRA DB 2006(04) v2.0 December 2011
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
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.
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Single-use Medical Devices : Implications and Consequences of Reuse
MHRA DB 2006(04) v2.0 December 2011
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
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Cost-effectiveness……? We are doing a study
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Potential Risks Examples
Potential for cross infection
Any component of Microbial world esp Blood borne viruses
Inability to clean and decontaminate
Features of a device that make cleaning difficult are: acute angles, coils, long or narrow lumens, spécial surface coatings etc.
Residues from chemical decontamination agents
Disinfectants may be absorbed by plastics and leach out 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
Transmission of CJD, Prions
MHRA DB 2006(04) v2.0 December 2011
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
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.
39
Medical Device Reprocessing
Don Selvey, 2011
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 Implanted infusion pumps
40
Medical Device Reprocessing
Don Selvey, 2011
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
S.U.D Policy: Components
Initial pre-cleaning on site
Cleaning and rinsing
Decontamination
Marking (number of re-uses)
Packaging
Labeling
Sterilization
Documentation
42
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
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
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
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Marking
Should be ensured that marking does not
compromise on the integrity of the device
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
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
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S.U.D. Monitoring
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
Labeling Gun:
Sterilizer number,
Load number,
Batch number,
Date of sterilization
Date of expiry
Sterilization: Validation through Indicators
54
Keeping the track record of that article through appropriate documentation
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:
Clinical Category Device Manufacturer Model(s) Approved Third-Party
Reprocessor
Device Status
Used Open &
Unused Expired
Ambulatory Surgery Center Quality Programme
56
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Any adverse event related to the device should be reported in an incident- form
58
“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
Automated Dialyzer Reprocessing , Minntech 1999
60
$0
$5
$10
$15
$20
$25
1 4 7 10 13 16 19
Co
st
per
treatm
en
t
$0
$5
$10
$15
$20
$25
Reuse Cost Reduction Curve
Cost of Single Use vs. Multiple Use
(Cost per Patient per Year)
$0
$1,000
$2,000
$3,000
$4,000
$5,000
Single Use Multiple Use
Co
st
Dialyzer Cost Reprocessing Cost
Assuming a dialyzer price of $20, costs of
reprocessing of $5, and 15 uses, the cost savings for
one patient are $2,050 every year with reuse
Costs for 50 Patients per Year
(6 Reuses vs. 15 Reuses)
$0
$10,000
$20,000
$30,000
$40,000
$50,000
$60,000
$70,000
6 Reuses 15 Reuses
Co
st
per
year
Reprocessing Cost Dialyzer Cost
61
Daily Checklist For Dialyzer Re-processing System Serial no:____________
Parameters 01.01.20
11 02.01.2011 03.01.11 04.01.11 05.01.11 06.01.11 07.01.11
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
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
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
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
ATP Results of less than 10 RLU are preferred
Capable of detecting 2mg protein / m2
‘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
Green Color-Satisfactory
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
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
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Instrument Single-use device (MRP) (Rs)
Cost per patient when used multiple times
Additional cartridge Cost (Rs)
Saving per patient in multiple use (Rs)
Procedure where device used (Rs)
Harmonic Shear
40,000-50,000
7,000-10,000 approx
Nil 30,000 Advanced and routine Laproscopic surgery
Diagnostic guidewire
1000 250 Nil 750 Interventional Cardiology and radiology imaging
Angioplasty Balloon Catheter
10,000 – 12,000
4,000-5,000 approx
Nil 5,000-6,000 approx
Interventional Cardiology and radiology imaging
Open surgery linear cutter
21,000 – 28,000
4,000-5,000 approx
4,000-6,000 approx
12,000-18,000 Open major abdominal surgery
Endoscopic Linear cutter
22,000 – 36,000
5,000 approx 6,000-8,000 approx
11,000-18,000 Advanced Laproscopic Gastrointestinal Surgery
Mutiload clip applicator
19,700 2,000 per clip applied
Nil 8000 if an average of 6 clips used
Clipping of blood vessels, cystic duct
Skin stapler 734 183 Nil 500 Skin incision approximation
Natl Med J India 2012;25:151–5, Hussain et al
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
……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
71
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.
Single-Use Medical Devices: Little Available Evidence of Harm From Reuse, but Oversight Warranted
(Letter Report, 06/20/2000, GAO/HEHS-00-123)
72
……….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
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
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
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
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
The debate would go on, but the dictum remains….
78
INTEGRITY
STERILITY
79