Annexes to COM(2010)443 - Report on the issue of the reprocessing of medical devices in the EU, in accordance with Article 12a of Directive 93/42/EEC - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2010)443 - Report on the issue of the reprocessing of medical devices in the EU, in accordance with Article 12a of Directive 93/42/EEC. |
|---|---|
| document | COM(2010)443  |
| date | August 27, 2010 |
Risks and hazards identified by the SCENIHR
For both categories of devices, single-use and reusable medical devices, cleaning, disinfection and/or sterilisation are needed before the device can be reused. For reusable medical devices, the procedures, conditions and number of reuses are already considered at the design stage of the device. The choice of the material and geometry (shape) of the device are also considered at this stage.
Information on the reprocessing procedures to be followed must be provided by the manufacturer of reusable medical devices, and this is not the case for single use medical devices.
The SCENIHR in its opinion identified the main following hazards and risks linked to the reprocessing of single use medical devices.
After use, all medical devices that have been in contact with patients may contain contaminants including pathogenic micro organisms, the elimination of which during the cleaning, disinfection and sterilisation steps may be difficult. If the efficacy of these steps is not properly validated the resulting persistence of the contamination poses a hazard of infection for the next patient on whom the medical device is used. Some simulation studies and a few clinical studies have shown that reprocessing of single use medical devices may result in improper cleaning, disinfection and/or sterilisation leaving a bioburden on the reprocessed single use medical device, which introduces a risk of infection when using the reprocessed single use medical device.
A specific problem pointed out by the SCENIHR is the elimination of prion contamination since only aggressive cleaning methods, not compatible with the commonly used materials, can ensure complete prion inactivation. This issue was further developed in a previous SCENIHR opinion on the safety of human derived products with regard to Variant Creutzfeldt-Jacob Disease[21].
Chemical residues as a result of reprocessing may pose a toxic risk when a device is reused. In addition, changes of the physical and chemical characteristics of the devices may occur which may eventually have an impact on the performance of the reprocessed single use medical device.
It has been shown that a reprocessed single use medical device can be modified in its structure or functionality and may potentially cause some damage to the patient or health-care workers, e.g. mechanical failure of the device.
The risks are related primarily to the use of the device.
Three categories of devices could be identified based on the Spaulding classification, reviewed by Alvarado[22]. This classification is based on the risk linked to the use of the device, depending on the degree of invasiveness, independently from the fact that these devices are intended for single or multiple uses.
1. Non-critical use (in general, for intact skin contact only or no contact with the patient) e.g. basins, thermometers, blood pressure cuffs;
2. Semi-critical use (contact with intact mucous membranes without penetration of tissues) e.g. flexible endoscopes, laryngoscopes, endotracheal tubes;
3. Critical use (surgically invasive medical procedures) e.g. catheters, implants, needles, surgical instruments.
In case of reprocessing, the highest risk occurs when a reprocessed single use medical device is used for invasive medical procedures, while the lowest risk is associated with external (skin contact only) use.
The number of documented incidents is very small, although it can be speculated that the reporting of incidents is incomplete. However, regarding adverse events, there may be a “grey” area for which the recognition and reporting of incidents is difficult, such as a prolonged surgical procedure due to stiffness of a reprocessed single use catheter, and a prolongation of hospital stays. Furthermore, long-term effects may not be identified and attributed to the use of reprocessed medical devices.
Conclusion on public health considerations on the reprocessing of single use medical devices
Three major hazards were identified by the SCENIHR i.e. a remaining contamination, the persistence of chemical substances used during the reprocessing process and the alterations in the performance of the single use medical devices due to the reprocessing.
A specific problem is the elimination of prion contamination, since only relatively aggressive cleaning methods, not compatible with the commonly used materials, can ensure prion inactivation.
In order to identify and reduce potential hazards associated with reprocessing of a specific single use medical device, the whole reprocessing cycle starting with the collection of these single use medical devices after (first) use until the final sterilisation and delivery step, including its functional performance, needs to be evaluated and validated.
Not all single use medical devices are suited for reprocessing in view of their characteristics or the complexity of certain single use medical devices.
The risk is highest when the reprocessed single use medical device is used in a critical procedure, i.e. when used for an invasive medical procedure. In contrast, the risk is much lower for non-critical medical procedures in which reprocessed single use medical devices are used.
It must be noted that the World Health Organization identified similar hazards, risks and limitations of reusing single use medical devices in a report titled "Medical device regulations – Global overview and guiding principles"[23].
Ethical and liability considerations on the reprocessing of single use medical devices in the current situation
In addition to public health considerations, the reprocessing of single use medical device may raise ethical and liability concerns.
Ethical considerations
As highlighted in the SCENIHR opinion, the use of a reprocessed single use medical device may pose an additional risk to the patient in comparison with using a new single use device. Therefore, the issue of patient information and prior informed consent before she/he undergoes the medical procedure needs to be considered.
Furthermore, the reprocessing of single use medical devices may create different levels of healthcare provisions and, as a consequence, may create inequalities between patients.
The above mentioned ethical considerations should be however balanced with the potential cost savings generated by the reprocessing practice which, in a context of costs containment for healthcare services, could be seen as a way to facilitate and increase access to innovative technology for the patients.
However, cost savings are very much dependent on the type and level of quality of the reprocessing practice and, to date, there is no clear evidence and data to quantify the cost savings that could create the reprocessing of single use medical devices and to establish to what extent the patient would benefit from these potential cost savings.
The economic aspects of reprocessing single use medical devices are further developed in section 3.5.
Liability considerations
Liability of healthcare professionals
Healthcare professionals may be liable in case of mishandling of a medical device with regard to patients’ health. Since their liability may be engaged, healthcare professionals should be informed in case they are using reprocessed single use devices, in view of the fact that it may have consequences on the handling of the device, for instance in terms of stiffness of a reprocessed catheter, and may constitute an additional risk of medical complications.
Liability of the original manufacturer
The original manufacturer is responsible for the safety and performances of his product when it is used in accordance with its intended purpose.
For reusable devices, the manufacturer shall remain responsible for product related aspects when the device is reused if the hospital or the third party reprocessing service provider has followed the information the manufacturer has provided on the appropriate process to reprocess the device.
Directive 93/42/EC requires for single use medical devices that the instruction for use contains information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be reused[24]. However, the responsibility of the original manufacturer shall be clarified in case of reprocessed single use medical device failure and medical complication due to and only to the reprocessing practice.
Currently, such reprocessed single use medical devices are usually labelled under the name of the original manufacturer. The requirements regarding the labelling of reprocessed single use medical devices products might therefore need to be clarified in order to reflect the liability in case of product failure and ensure the traceability of reprocessed single use medical devices.
Liability of the reprocessing service provider
Where a user or a third party reprocessing service provider develops and validates a procedure for reprocessing single use medical devices, this user or this third party reprocessing service provider shall be responsible for the implications of the reprocessing along the guidelines developed and validated.
Where the reprocessing of single use medical devices is done via a third party reprocessing service provider, the sharing of liability between the user and the reprocessing service provider currently appears unclear.
Conclusion on ethical and liability considerations on the reprocessing of single use medical devices in the current situation
In the current situation, the reprocessing of single use medical devices raises ethical concerns in terms of potential inequalities between patients. In addition, the issue of prior information and consent of patients needs to be considered.
Regarding the liability, it would be necessary to clarify the responsibilities of each stakeholder and to inform healthcare professionals in case they are using reprocessed single use medical devices, as their responsibility may be engaged in case of adverse events.The requirements regarding the labelling of reprocessed single use medical devices shall be clarified, in particular for the purpose of traceability of these devices.
Economic considerations on the reprocessing of single use medical devices
The economic considerations are the main driver in the reprocessing of single use medical devices.
In the current context of increasing resources constraints and the needs for cost-containment in healthcares, the reprocessing of single use medical devices has been used by some hospitals to reduce their expenses. Indeed, new single use medical devices might be expensive and their reuse offers the possibility of dividing their purchasing costs over multiple patients.
However, the reduction of the purchasing cost of a device, even if very visible and not disputable, is only one of the elements needed to assess any potential cost reduction when using reprocessed single use medical devices. Various other costs and considerations need to be taken into account ( e.g. number of reuses, costs for developing and validating a reprocessing process, costs for performing the reprocessing process, costs for logistics and transport, insurance costs, liability costs in case of failure of the reprocessed single use medical device).
In the light of the above, to date, there are few and poor quality scientific evidence and economic evaluation to demonstrate that the reprocessing of single use medical devices is globally a cost-saving practice.
According to a systematic literature review on the economic analysis of reprocessing single use medical devices[25] published in 2008, although this practice is used routinely, there is little available evidence of sufficient quality in the published literature. The published evidence on the cost-effectiveness of reprocessing single use medical devices is inconclusive and the authors concluded that their review indicates that the cost-effectiveness of reusing single use medical devices is not established.
Methodology for costs calculation
The methods used for the calculation of the costs are often vague and not well described.
The costs generally do not include several elements like the costs linked to potential adverse events and clinical consequences for patients. In addition, the costs are generally calculated but not really based on a direct observation. Therefore, several elements of the costs could be missing, like the cost of the facilities, the real cost of the consumption of water, energy, etc. The costs can vary a lot between healthcare facilities depending on the existence of a central sterilisation unit in the hospital, the number of medical devices reprocessed per year (scale effect) and the existence of a quality management system for the sterilisation process.
In addition, these studies do not include a validation to ensure that, after the reprocessing, the reprocessed single use medical device presents an acceptable level of safety, in particular, on functionality and on biocontamination aspects. This validation process should include the determination of the number of safe reuses for a type of single use medical device, the verification of the functionality of the reprocessed single use medical device and a quality management system for the reprocessing process ensuring that the complete process was performed with a sufficient level of quality and safety. The cost of this validation process is never included in the published studies.
Economic studies perspective
The studies published on the reprocessing of single use medical devices are always conducted from the hospitals' perspective and do not take into account other costs of the reprocessing practice, like the cost for the insurance systems or the patients in case of clinical consequences or liability.
Level of quality and safety of the reprocessing
A recent study performed in Belgium[26] demonstrates that, in the case where an equivalent level of safety and quality is achieved for reprocessed single use angiography catheters, the cost of these reprocessed devices is higher than the cost of new single use angiography catheters. Such equivalent level of safety and quality would be ensured by following the standards harmonised under Directive 93/42/EEC. In addition, this study demonstrates that without scale benefits (taking into effect the decrease of the costs brought by a scale effect), and taking into account the cost of an estimate rate of adverse event, the reprocessing costs are generally higher than buying single use medical devices.
Prices of single use medical devices
A major parameter in these economic studies is also the prices of single use medical devices. These prices are highly variable between hospitals, countries and medical devices and could evolve a lot during the marketing life of a medical device. Therefore, even if the high price of a new single use medical device could lead to the assumption that the reprocessing is cost-effective, a variation in the price of this device due to an increase in the market competition could reverse completely this assumption.
Conclusion on economic considerations on the reprocessing of single use medical devices
To date, the published economical data do not allow drawing any conclusion on the cost-effectiveness of the reprocessing practice for single use medical devices when performed with a sufficient level of quality and safety. This cost-effectiveness needs to be demonstrated by long-term studies including a large number of patients and clear calculation of the direct and indirect costs.
Environmental considerations on the reprocessing of single use medical devices
Environmental considerations are usually advocated as another argument in favour of reprocessing single use medical devices.
On the one hand, the increasing use of single use medical devices has a negative impact on the environment, due in particular to the resources needed for the raw material production, the manufacturing, the transport of the devices from the manufacturer or the retailer to the user and the management of the waste generated after their use.
It is not disputable that the reprocessing of single use medical devices has the environmental benefit of reducing products' end of life waste management to some extent. However, this environmental impact has some limitations since, according to some data provided by a reprocessing company, only 38% of the highly complex medical devices can be reprocessed[27].
On the other hand, the reprocessing practice presents also some negative environmental impacts that must be taken into consideration.
The reprocessing of single use medical devices requires adequate equipment, specific knowledge, skills and resources, which are likely to be present only in specialised reprocessing companies and therefore would require the collection and the transport of the devices from and to the user, which have an impact on the environment. In addition, the cleaning, disinfection and sterilisation process implies important resources and energy consumption ( e.g. water and electricity), the use of chemical substances and the re-packaging of the reprocessed devices. All those steps have a direct and negative impact on the environment. The environmental impact is also very dependent on the level of quality of reprocessing required and on the scale effect.
Conclusion on environmental considerations on the reprocessing of single use medical devices
To date, no comprehensive study balances quantitatively all the environmental implications of reprocessing single use medical devices versus discarding those devices.
Available data very much focus only on the waste reduction that the reprocessing of single use medical devices creates to some extent. Various elements, such as the environmental impact of transport, resources and energy consumption, as well as the use of chemical disinfectants, must be taken into consideration.
CONCLUSION
In the absence of quantitative data, it is not possible to quantify the risk associated with the use of reprocessed single use medical device. The number of documented incidents is very small, although it can be speculated that the reporting of incidents is incomplete. Regarding adverse events there may be a “grey” area for which the recognition and reporting of incidents is difficult. In addition, long-term effects may not be identified and attributed to the use of reprocessed medical devices.
Three major hazards were however identified by the SCENIHR i.e. a remaining contamination, the persistence of chemical substances used during the reprocessing process and the alterations in the performance of the single use medical devices due to the reprocessing.
In addition, not all single use medical devices are suited for reprocessing in view of the characteristics ( e.g. material used, geometry), their complexity and their intended use (non critical, semi-critical, critical). In order to identify and reduce potential hazards associated with the reprocessing of a specific single use medical device, the whole reprocessing cycle starting with the collection of these single use medical devices after (first) use until the final sterilisation and delivery step, including its functional performance, needs to be evaluated and validated.
It must be noted that the SCENIHR expressed specific concern about the potential contamination with transmissible agents such as prions, for which elimination and inactivation is not possible, or the procedure is not compatible with the materials generally used for a single use medical device.
It is not disputable that reprocessing single use medical devices leads to a waste reduction to some extent and offers the possibility of dividing the purchasing costs of these devices over multiple patients. However, to date, no comprehensive study clearly demonstrates that reprocessing single use medical devices is globally a cost effectiveness and environmental friendly practice when done under high quality standards.
In the light of the above, taking into account the potential hazards and risks identified by the SCENIHR in terms of the remaining contamination, persistence of chemical residues and alteration of the functionality, the Commission will assess which are the appropriate measures to be put forward in the context of the Recast of the Medical Devices Directives with regards to the reprocessing of single use medical devices in order to ensure a high level of protection for patients. This assessment will also take into account potential economic, social and environmental consequences that any envisaged measure may have.
ANNEX
SCENIHR answers to the terms of reference
Does the use of reprocessed single use medical devices constitute a hazard for human health (patients, users and, where applicable, other persons) causing, for example, infection/cross contamination and/or injury?
Inadequate cleaning, disinfection, and/or sterilisation during the reprocessing of single use medical devices introduces the hazard of persistence of a bioburden resulting in a risk of infection during subsequent use of the reprocessed single use medical device for patients and users, as a single use medical device is not designed to be reprocessed. This hazard which also occurs with devices designed for reprocessing and reuse, is characterised by the presence of contaminants of biological origin on the used single use medical device including proteins and micro-organisms such as bacteria and viruses. In addition, residues of chemicals used for cleaning, disinfection or sterilisation pose a hazard of toxic reactions. Furthermore, alterations in the performance of the device due to reprocessing may pose a hazard such as device failure during subsequent medical procedures. Of special concern is the potential contamination with transmissible agents such as prions, for which elimination and inactivation is not possible, or the procedure is not compatible with the materials generally used for a single use medical device.
If yes, please characterise the risk for human health.
In the absence of quantitative data related to the eventual residual biological and chemical contamination after reprocessing, it is not possible to quantify the risk associated with the use of reprocessed single use medical devices.
Some experimental laboratory simulation studies have demonstrated the risk of both microbiological and chemical residues occurring after reprocessing. The number of documented incidents is very small, although it may be speculated that the reporting of incidents is incomplete. In the existing inventory in the United States[28], no evidence of an increased risk was noted for patients from reprocessed devices. This apparent lack of an increased risk may be associated in part with the limitations that the United States impose on the reuse of reprocessed medical devices.
If yes, under which conditions or uses does the reprocessing of single use medical devices pose a risk? Please consider in particular, the following:
- Intended use of the device;
- Reprocessing method used: cleaning, sterilisation and/or disinfection (depending generally on the material of the device) and lack of instruction on the reprocessing method to be used; and
- Other characteristics such as functionality, handling, raw material or design of the device.
The risk is highest when the reprocessed single use medical device is used in a critical procedure, i.e. when used for an invasive medical procedure. In contrast, the risk is much lower for non-critical medical procedures in which reprocessed single use medical devices are used.
The design and choice of material of the single use medical devices is very important for the outcome of cleaning, disinfection, and/or sterilisation and the risk of persistence of a bioburden.
The choice of the method of cleaning, disinfection, and/or sterilisation must depend on the chemical composition and nature of the single use medical device. Inappropriate methods may lead to the introduction of chemical contaminants with adverse biological effects.
Possible changes in the physico-chemical characteristics ( e.g. stiffness, brittleness, and surface characteristics) of the material of a reprocessed single use medical device may pose a risk in terms of performance of the device. Material deterioration resulting in device failure may occur with repeated reprocessing cycles.
Additional critical issues in using reprocessed single use medical devices may be the identification and traceability of the reprocessed medical device, and for more sophisticated and complex medical devices, the continued availability of documentation needed for proper use of the medical device.
SCENIHR recommendation
Not all single use medical devices are suited for reprocessing in view of their characteristics or the complexity of certain single use medical devices. The possibility for reprocessing is dependent on the material used and the geometry of the medical device. In order to identify and reduce potential hazards associated with reprocessing of a specific single use medical device, the whole reprocessing cycle starting with the collection of these single use medical devices after (first) use until the final sterilisation and delivery step, including its functional performance, needs to be evaluated and validated.
[1] OJ L 169, 12.7.1993, p. 1
[2] OJ L 189, 20.7.1990, p. 17
[3] OJ L 331, 7.12.1998, p. 1
[4] Annex I section 13(3)(f) of Directive 93/42/EEC
[5] Annex I section 13(6)(h) of Directive 93/42/EEC
[6] OJ L 247, 21.9.2007, p. 21
[7] Article 1(2)(n) of Directive 93/42/EEC
[8] Annex I section 13(3)(f) of Directive 93/42/EEC
[9] Annex I section 13(6)(h) of Directive 93/42/EEC
[10] http://ec.europa.eu/transparency/regexpert/detail.cfm?ref=1574&l=M
[11] http://ec.europa.eu/consumers/sectors/medical-devices/files/guide-stds-directives/synthesis_en.pdf
[12] http://ec.europa.eu/enterprise/newsroom/cf/itemshortdetail.cfm?item_id=3280
[13] http://ec.europa.eu/consumers/sectors/medical-devices/files/pdfdocs/summary_5_12_2008_workshop_en.pdf
[14] http://ec.europa.eu/health/ph_risk/committees/04_scenihr/04_scenihr_en.htm
[15] Annex I section 13(6)(h) of Directive 93/42/EEC
[16] National Institute for public Health and environment – "Reprocessing of medical devices, Possibilities and limiting factors"
[17] http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofSingle-UseDevices/default.htm
[18] http://www.tga.gov.au
[19] Article 222(5), Ministerial Ordinance on Pharmaceutical Affairs Law
Notification by Director-General, Pharmaceutical and Food Safety Affairs Bureau, Yakusyokuhatsu #0310003, March 10, 2005
[20] http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_027.pdf
[21] http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_004.pdf
[22] Alvarado CJ. Revisiting the Spaulding classification scheme. In: Rutala WA, editor. Chemical germicides in healthcare. Washington DC: APIC; 1994. p. 203-8
[23] http://www.who.int/medical_devices/publications/en/MD_Regulations.pdf
[24] Annex I, section 13(6)(h) of Directive 93/42/EEC
[25] Jacobs.P and al. Economic analysis of reprocessing single use medical devices: a systematic literature review. Infect Control Hosp Epidemiol 2008;29:297-301
[26] The impact of reprocessing single use devices in Belgium - An economic study - Larmuseau David, Siok Swan Tan - Erasmus MC University Medical Center, Institute for Medical Technology Assessment, Rotterdam, Netherlands – April 2008
[27] Dr. Matthias Tschoerner, Reprocessing of highly complex medical devices, accessed on 22/04/2010 at http://www.eamdr.com/mm/Matthias_Tschoerner.pdf
[28] http://www.gao.gov/new.items/d08147.pdf