Single Use Devices


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Reuse of Single Use Devices - Safe or Sorry

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Single Use Devices

  1. 1. The presentation is solely meant forAcademic purpose
  2. 2. “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
  3. 3. ‘ No stronger condemnation of any hospital or ward could bepronounced from the single fact that zynotic (infectious)disease have originated in it,or that such a disease hasattacked other patients than those brought in with them’ - florence nightingale
  4. 4.  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
  5. 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 6
  6. 6. 7
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  8. 8. 30% of all hospitals reuse one / more SUDsNot all SUDs can be reused / reprocessed50% of hospitals reuse through a third party processor 9
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  10. 10. 2002;7(1):53- 59Conclusions:•No significant overall difference in temperature sensingaccuracy and deflection angle of new and used ablationcatheters.•Nevertheless, individual differences in deflectioncharacteristics between new and used catheters areoccasionally seen and warrant screening of reprocessedcatheters prior to their reuse 11
  11. 11. CONCLUSIONS: Reuse of medical devices labelled "single use only" iscommon in Australian hospitals. Most devices appear to be unsuitable forreuse. Complete cessation of this practice of reusing single-use medicaldevices would stop potential cross-infection, but this would cost andestimated $2.5 million or more per case prevented 12
  12. 12. •Tradition of re-use – reports on re-use of pacemakers areavailable from Europe, North America and Asia (India) with noreported adverse effects•During 1996, in Sweden, 5% of pacemakers were re-useddevices, with no evidence that re-use has increased patient risk.•Re-use of pacemakers may be considered, provided that theirsterility, mechanical and electrical integrity can be ensured andoperating procedures are respected. Re-used pacemakersshould only be given to patients whose life expectancy isestimated to be less than that of the pacemaker. 13
  13. 13. A Randomized Study of the Safety and Efficacy of Reused AngioplastyBalloon CathetersM Zubaid, CS Thomas, H Salman, I Al-Rashdan, N Hayat, A Habashi, MTAbraham, K Varghese, L ThalibDepartment of Cardiology, Chest Diseases Hospital, Kuwait andDepartment of Community Medicine, Faculty of Medicine, KuwaitUniversityConclusions: When performing coronary angioplasty, reused cathetersare as effective (similar angiographic success) and safe (similar clinicalsuccess) as new catheters. (Indian Heart J 2001; 53: 167–171) 14
  14. 14. The issue really is not whether or not to reprocess, butwhat constitutes safe and appropriate reuse of disposableitems. 15
  15. 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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  17. 17.  …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
  18. 18.  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
  19. 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
  20. 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
  21. 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.’ WHO Infection Control Guidelines for Transmissible Spongiform Encephalopathies, WHO/CDS/CSR/APH/2000.3. March 23-26, 1999 22
  22. 22.  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
  23. 23. A BA) 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
  24. 24. BA 25
  25. 25. 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
  26. 26. Reddish brown contamination observed over thefull length of the third party reprocessedendoscopic stapling device 27
  27. 27. 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
  28. 28. A B A) The coil of new, unused biopsy forceps. B) The coil of reprocessed biopsy forceps 29
  29. 29. …..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 timeDavid L. West et al. “Scientific & Regulatory Consideration for the Review andApproval of Reprocessed Single Use Devices Pre - market Submissions 30
  30. 30. Photograph showing kinks along a reprocessedsingle use catheter as a result of previous usageor reprocessing 31
  31. 31. When attempting to flush the single usedevices a distribution of the contaminationrather 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 thehinges and under the isolation coats .This was especially true forharmonic scalpels. These findings indicate that the cleaning agentpenetrates into the device and dilutes the blood but cannot then beflushed out of the device. Therefore, contamination and disinfectionsolution remain in the devices …… 2001, Roth, Heeg, and Reichl 32
  32. 32.  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
  33. 33. 30% of all hospitals reuse one / more SUDsNot all SUDs can be reused / reprocessed50% of hospitals reuse through a third party processorThe cost is reduced by ½ to 1/10 34
  34. 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. Single-use Medical Devices : Implications and Consequences of Reuse MHRA DB 2006(04) v2.0 December 2011 35
  35. 35. 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
  36. 36. Potential Risks ExamplesPotential for cross Any component of Microbial world esp Blood borneinfection virusesInability 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 outdecontamination 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 sterilantsMechanical 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 cathetersReaction 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 2011Transmission of CJD,Prions 37
  37. 37. 30% of all hospitals reuse one / more SUDsNot all SUDs can be reused / reprocessed50% of hospitals reuse through a third party processorClinical evidence does not indicate increased risk in controlledsettingsReuse is not a harmless procedure – Document Integrity and SafetyContinued surveillance for adverse events is requiredThe procedure has to be regulatedThe cost is reduced by ½ to 1/10 38
  38. 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. Medical Device Reprocessing Don Selvey, 2011 39
  39. 39. 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
  40. 40. 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
  41. 41.  Initial pre-cleaning on site Cleaning and rinsing Decontamination Marking (number of re-uses) Packaging Labeling Sterilization Documentation 42
  42. 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
  43. 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
  44. 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
  45. 45. Marking Should be ensured that marking does not compromise on the integrity of the device 46
  46. 46.  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
  47. 47.  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
  48. 48. S.U.D. Monitoring 50
  49. 49.  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
  50. 50. Labeling Gun: Sterilizer number, Load number, Batch number, Date of sterilization Date of expiry
  51. 51. Sterilization: Validation through Indicators
  52. 52. Keeping the track record of that article through appropriate documentation 54
  53. 53. 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
  54. 54. 56
  55. 55. 57
  56. 56.  Any adverse event related to the device should be reported in an incident- form 58
  57. 57. “There is no conclusive evidence to substantiatethe notion that either morbidity or mortalityassociated with single use or reuse is different.”National Kidney Foundation Report on Dialyzer Reuse, AJKD 1997
  58. 58. 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 $3,000Cost 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
  59. 59. 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 11CalibrationVerification Volumein ml( 70[+/-]3 ml )Pressure Log:Static Pressure(Ideally: 20 psi to 55psi)Dynamic Pressure(Ideally: 35 psi to 40psi)Exterior Cleaningwith 1% RenalinCaps:30 minutesdisinfection with 1%RenalinSanitizationVERIFICATION 61
  60. 60.  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
  61. 61.  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
  62. 62.  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
  63. 63. ‘Rapid’ monitor that uses bioluminescence to measurethe levels of ATP on a surface. It works throughcollection and quantification of ATP remaining inorganic residues post-cleaning Capable of detecting 2mg protein / m2 ATP Results of less than 10 RLU are preferred Green Color-Satisfactory
  64. 64. VALIDATING SINGLE USE DEVICES•Understanding it’s configuration and application (List of theparts, mantling and dismantling, manufacturersspecifications)•Point of use care (Immediate aspiration, flushing)•Safe transport to re-processing department• Standard operating protocols of reprocessingdepartment•Number of turns, tracking, recall procedure• Back to user•Discard after the last use
  65. 65. Steps Validation ResponsibilityIntegrity & functionality through Visual inspection Device UserPost use pre-cleaning through visual inspection Device UserSafe & covered transport Supervision (Assisting personnel)Disinfection & thorough Microbiological testing Reprocessing Dept.Cleaning & microbiology dept.Inspection, Assembling, Sterility check CSSDPacking, sterilization (No toxic residues left) Pyrogen freeNext turn usability Check by user User departmentUsable life / No. of turns Sterility Assurance & User / reprocessing Adequate working of Microbiology the device, QA dept. headed by I.C.Chief
  66. 66. 68
  67. 67. 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) timesHarmonic 40,000- 7,000- Nil 30,000 Advanced andShear 50,000 10,000 routine Laproscopic approx surgeryDiagnostic 1000 250 Nil 750 Interventionalguidewire Cardiology and radiology imagingAngioplasty 10,000 – 4,000-5,000 Nil 5,000-6,000 InterventionalBalloon 12,000 approx approx Cardiology andCatheter radiology imagingOpen 21,000 – 4,000-5,000 4,000- 12,000-18,000 Open majorsurgery 28,000 approx 6,000 abdominal surgerylinear cutter approxEndoscopic 22,000 – 5,000 approx 6,000- 11,000-18,000 AdvancedLinear cutter 36,000 8,000 Laproscopic approx Gastrointestinal SurgeryMutiload 19,700 2,000 per Nil 8000 if an Clipping of bloodclip clip applied average of 6 vessels, cystic ductapplicator clips usedSkin stapler Natl Med J India 2012;25:151–5, Hussain et al 734 183 Nil 500 Skin incision approximation 69
  68. 68.  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
  69. 69.  ……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
  70. 70. Single-Use Medical Devices: LittleAvailable Evidence of Harm From Reuse,but Oversight Warranted(Letter Report, 06/20/2000, GAO/HEHS- 00-123) 72
  71. 71.  ……….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
  72. 72.  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
  73. 73.  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
  74. 74.  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
  75. 75. SUDs would be reused – need to identify those that canand those that shouldn’tFor the developed nations – reuse is a ‘green option’For resource crunch settings - Reuse is not only costsaving but also life-savingStandards need to be laid down and implemented inhealthcare units/ May be a third party reprocessing unitneeds to step in 77
  76. 76. The debate would go on, but thedictum remains…. STERILITY INTEGRITY 78
  77. 77. 79