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2. Comment Before the Parliamentary Portfolio Committee on HealthEbrahim Jappie: Executive ChairmanAlex Louwrens: Director – Business DevelopmentEdward Krisiunas: Technical Consultant– Infection Control and Waste MattersIntroduction1. Reprocessing2. Maintenance3. Disposal4. Second Hand Market

3. Reprocessinga. Whereas Bill 6 of 2014 and Act 72 of 2008 make provision for assuring compliance with appropriate standards, we wish to emphasise that it is insufficient to merely stipulate such standards for the manufacture, distribution and/ or licensing of medical devices when many of these devices are soiled during use on or in the human body and must necessarily be returned to that state which was approved when granting accreditation or licensing, i.e. as new, before being reused.

4. Reprocessingb. Such a process is referred to as reprocessing which, according to ISO 17664:2004, “includes all the steps performed to make a contaminated reusable or single-use device patient ready. The steps may include cleaning, functional testing, repackaging, relabeling, disinfection or sterilization.“

5. Reprocessingc. Reprocessing is not defined in any Act or Regulation extant or pending.d. It conveys a false sense of security when standards are stipulated for accreditation and licensing purposes pertaining to medical devices but when no legislated provision is made to assure such standards are maintained at all after the very first use.

6. Reprocessinge. We implore the Committee to include appropriate specific provisions in this regard in any new legislation.f. When considering reprocessing, there are two cases that need to be taken into account:i. Devices intended by the manufacturer* to be reused by the user. ii. Devices intended by the manufacturer* for single use (SUD) or single patient use by the user.

7. Reprocessingg. We argue that, in the interests of fairness and reasonableness, a uniform standard should apply in all respects to both categories of devices; it is all too commonly assumed that reusable devices are automatically up to standard when reprocessed by the user, irrespective of actual circumstances, when in fact there are many critical factors to consider before accepting that notion as fact. Factors such as those affecting the actual manner in which the devices are decontaminated or pre-cleaned, usually manually and in a fashion varying in practice significantly between individuals;

8. Reprocessingthose affecting the disassembly of or attachment of accessories for the purpose to the devices being reprocessed; those affecting any equipment and substances used in pre-cleaning or cleaning, whether automated or manual; those likewise affecting any equipment and substances used in disinfection or sterilisation, whether automated or manual;

9. Reprocessingthose affecting the manner in which the devices are handled and stored after reprocessing; and the physical condition of the devices after use, viz. whether they have been stressed or damaged or worn, as well as their condition after reprocessing itself.

10. Reprocessingh. It is, similarly, all too commonly assumed that single-use or single-patient-use devices must be excluded from or subjected to extra stringent criteria in reprocessing because they are somehow fundamentally different to reusable devices; there is, in fact, no specific international standard for reusable devices and another for single-use devices in terms of quality, performance, safety or hygiene – they ought to comply with the same high standards.

11. ReprocessingWe point out that, the decision to release a device as single-use rests with the original equipment manufacturer (OEM) and in most, if not all, cases relates to the OEM not having to develop and demonstrate an acceptable method of reprocessing that a user, with equipment and substances freely available to them, might follow, thus foregoing any cost in this regard and limiting exposure to risk;

12. Reprocessingthe obvious commercial benefits in selling larger volumes of SUDs subject only to out-the-box (OTB) guarantees as opposed to selling small numbers of reusable devices subject to more substantial guarantees and continuing after-sales service are self-evident.

13. Reprocessingi. We note that some OEMs have stated that certain devices cannot be reprocessed due to their delicate or complex or chemically reactive/ susceptible or miniaturised natures and accept that, in some of these specific cases, reprocessing is not commercially or legally feasible;

14. Reprocessingwe argue that should not preclude reprocessing of any and all SUDs per se but we implore the Committee to make specific provision for a reprocessor to accept the responsibility of developing and proving a method(s) of reprocessing said devices that the reprocessor (not necessarily the user) may follow using the methods, equipment, substances and techniques available to that reprocessor.

15. Reprocessingj. We argue, furthermore, that proper records ought to be kept of all reprocessing activities and should be inspected from time to time. This is especially relevant to containing and treating, where possible, outbreaks of highly virulent or resistant diseases. It is also relevant to assigning responsibility and accountability in the event of legal action.

16. Reprocessingk. It is possible for reprocessing to be carried out by various categories of persons or parties, to wit:i. The users, which may be either the healthcare practitioner physically using the device on a patient, or the patient, or delegated staff in the employ of the healthcare establishment at which the practitioner practices.

17. Reprocessingii. Delegated staff in the employ of the manufacturers or their appointed distributors.iii. Delegated staff in the employ of third party medical device establishments, either professional reprocessors or professional maintenance service organisations.

18. Reprocessingl. We implore the Committee to make specific provision for reprocessing, of both reusable and single-use devices, by the manufacturers or their agents or the users or professional third party service providers, in respect of medical devices in any legislation.

19. Reprocessingm. We have learned from the MCC management that they construe third party reprocessing as (re)manufacturing. We wish to point out, however, that most users need to carry out reprocessing during the course of their routine duties and many currently reprocess SUDs as well as reusable devices.

20. ReprocessingReferring back to our comments above regarding a fair, reasonable, uniform standard across the spectrum of reusable and single-use devices, this raises issues around users falling under the category of manufacturers.

21. Reprocessingn. We implore the Committee to make special provision for reprocessing as a separate and distinct activity akin to (re)manufacturing but not exactly the same. We concur with the belief that devices should be restored to substantially the same state as new during reprocessing, attaining the same standards as those approved/ accepted when the devices were accredited and licensed.

22. ReprocessingThis notwithstanding, reprocessing is in reality of practice not manufacturing per se. The mere fact that it is believed that the devices should be restored to substantially the same state as the predicate implies in itself recognition of the approved manufacturing process that has already taken place.

23. Reprocessingo. It would appear that treating users as manufactures would give rise to numerous challenges and that requiring reprocessed devices of any type to be (re)licensed without any recognition of the standards and validations/ certifications already attained by the predicate devices would be repetitive and burdensome. We would ask the Committee to carefully consider these posers in any legislation.

24. Maintenancea. As is the case with reprocessing, Bill 6 of 2014 and Act 72 of 2008, whilst making provision for stipulating compliance with standards for manufacturing, distribution and licensing, did not make specific provision for maintaining devices to such standards where applicable.

25. Maintenanceb. In this regard, we mean maintenance to refer to all actions which have the objective of retaining or restoring an item in or to a state in which it can perform its required function. These actions include the combination of all technical and corresponding administrative, managerial, and supervisory actions.

26. Maintenancec. Maintenance, as it pertains to medical devices, is not defined in any Act or Regulation extant or pending.

27. Maintenanced. When considering maintenance activities, there are two cases that need to be taken into account: i. Scheduled or routine or preventative or reliability centred maintenance. ii. Unscheduled or corrective maintenance and repair.

28. Maintenanceiii. Either of the above types of maintenance may be conducted to varying levels of intervention, from superficial/ basic to intricate/ critical, i.e. levels 1 through 4/ 5 respectively. iv. Software or hardware upgrades ought to be included in scheduled maintenance.

29. Maintenancee. It is possible for maintenance to be carried out by various categories of persons or parties, to wit:i. The users, which may be either the healthcare practitioner physically using the device on a patient, or the patient, or delegated staff in the employ of the healthcare establishment at which the practitioner practices. ii. Delegated staff in the employ of the manufacturers or their appointed distributors.

30. Maintenanceiii. Delegated staff in the employ of third party medical device establishments, either professional reprocessors or professional maintenance service organisations.

31. Maintenancef. We argue that all higher order equipment or assemblies, such as processors, generators, engines, machines, computers, large apparatus, etc. as well as the devices used with them, often referred to as accessories or ancillaries or auxiliary equipment or peripheral equipment, ought to be routinely maintained to substantially the same state as new, in terms of all criteria included in the original standards or licensing requirements, as applicable.

32. Maintenanceg. Where a device is rendered unserviceable for whatever reason, such as failure or operation out of limits, owing to wear and tear or improper use or accident or force majeure, it ought to be repaired and returned to substantially the same state as new, in terms of all criteria included in the original standards or licensing requirements, as applicable, prior to reuse or otherwise it ought to be disposed of.

33. Maintenanceh. Proper records of all maintenance ought to be kept and inspected from time to time. This is especially relevant to assessing chains of causality in adverse events or incidents and taking appropriate corrective steps, including recalling affected devices or issuing revised directives for use. It is also relevant to assigning responsibility and accountability in the event of legal action.

34. Maintenancei. We implore the Committee to make specific provision for maintenance, of both routine/ preventative and corrective natures, by the manufacturers or their agents or the users or professional third party service providers, to the relevant levels, in respect of medical devices in any legislation.

35. Disposala. Bill 6 of 2014 and Act 72 of 2008, as well as the draft Medical Devices Regulations, whilst making provision for disposal as it pertains to the final act of destroying any device either totally or substantially such that it may not be recovered and used again as a medical device, it stopped short of stipulating exactly at which point or under which circumstances disposal is mandatory;

36. Disposalit did not make specific provision for various activities that are not in conflict with the spirit of legislation, that may add substantial value to the medical devices market and that are in harmony with South African National Waste Management Strategy, viz.:

37. Disposal i. Reprocessing of used single-use devices (reuse). ii. Recycling of used medical devices.

38. Disposalb. We have discussed the case for reprocessing above. Both single-use and reusable devices need to be disposed of at some time, when they are damaged or worn or degraded beyond repair, thus “unfit for use”, however it would be wasteful in the extreme to have SUDs destroyed by default immediately after use or after being opened but not used when most can safely be reprocessed and used again.

39. DisposalHaving said that, it is impossible to guarantee that a used SUD will pass quality assurance inspection/ testing to be reprocessed and it may be routed again into the waste stream. It follows then, that from amongst any given set of used SUDs, some will be fit for reprocessing and some fit for disposal. The question then arises when does the clause concerning disposal become mandatory?

40. Disposalc. We implore the Committee to make provision for reprocessing SUDs in this respect and to qualify clearly at which point a device must be destroyed, for example, when it is no longer possible to restore the device to substantially the same state as that when it was accredited and/ or licensed, i.e. when new. This will also ensure that devices that are worn or damaged beyond limits such that function or performance is impaired but not necessarily blatantly so are also disposed of without latitude for interpretation of being “unfit for use”.

41. Disposald. We wish to point out that many medical devices contain many valuable substances such as gold, titanium, platinum, tungsten, high grade stainless steel or fluorinated polymers, amongst others. Many devices, such as processors or generators or machines do not contact human bodies but function much like their counterparts in general industry, such as computers, appliances and power tools.

42. DisposalWe would argue that it would be wasteful in the extreme to destroy by default these devices using indiscriminate, resource (power, water, carbon) hungry methods that do not yield economically recoverable products.

43. Disposale. We implore the Committee to qualify which devices must be destroyed, for example, those that come into contact with human bodies, and to make special provision for recycling of valuable materials prior to them being absolutely destroyed or denatured in the disposal process, yet without allowing retrieval of the device per se or a substantial form/ part thereof.

44. Second Hand Marketa. In situations where devices are still serviceable after an unspecified period of time and the owner wishes to replace said device with a newer or different version, it is conceivable and understandable that the owner would seek to sell the device either to another user or to the OEM/ distributor, perhaps as a “trade-in” on a new device.

45. Second Hand MarketIn such instances, the seller is not necessarily the OEM, or the appointed distributor or a wholesaler/ retailer and would conceivably not be licensed as any one of these. The purchaser would also not be purchasing the device from one of these.

46. Second Hand Marketb. This scenario is not accommodated in the proposed legislation but is, on the contrary, prohibited.

47. Second Hand Marketc. The prohibition of such transactions would negatively impact the medical devices market in terms of not creating space for new devices whilst not satisfying the needs of those that do not need or want new, more expensive devices and immediately renders any device almost valueless as an asset once purchased, since no value can be realised by its sale as a functional device; this will have a severe impact on financing models available to users when purchasing devices new.

48. Second Hand Marketd. We accordingly implore the Committee to make provision for the resale of used devices by persons not specifically licensed to sell devices to persons who are not licensed as wholesalers or retailers.