In Europe, where they don't just take the reprocessors word that a product is sterile, they have banned reprocessing. We're talking about countries who have socialized healthcare and are known to be cheap when it comes to medical devices and THEY DON'T use reprocessed devices.
(Global Perspectives: Europe) Latest News Regarding the Reprocessing of Single-Use Medical Devices in the EU
By: René Clément, Co-Chairman, MediMark Europe
René Clément
Today, a few countries in the EU allow the reprocessing of single-use medical devices and have developed corresponding guidelines (e.g., Germany), while some countries completely prohibit this practice (e.g., France).
The new Article 12a of the Directive 93/42/EEC such as amended by Directive 2007/47/EC requested the European Commission (EC) to submit, no later than September 5, 2010, a report to the European Parliament and the Council on the issue of the reprocessing of medical devices in the European Community.
This report was published at the end of August and represents an assessment of the issues regarding public health, ethical, legal, economic, and environmental factors. It includes the scientific opinion of the Committee on Emerging and Newly Identified Health Risks (SCENIHR) concerning the safety of reprocessed medical devices marketed for single use. The main findings from the report include the following:
Risks and hazards identified by SCENIHR. Remaining contamination, remnants of chemical substances used during the reprocessing process, and alterations in the performance of the single-use medical devices due to the reprocessing represent the three major hazards that pose a specific problem regarding the elimination of prion contamination, since only relatively aggressive cleaning methods that are not compatible with commonly used materials can ensure prion inactivation. The risk is highest when the reprocessed single-use medical device is used in a critical procedure (i.e., 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.
Ethical and liability considerations. Ethical concerns are raised in terms of potential inequalities among patients, and the consent of patients needs to be considered. Patients with poor insurance coverage would be more likely to accept secondhand devices. Regarding liability, it would be necessary to clarify the responsibilities of each stakeholder, such as the responsibility of the original manufacturer in case of failures and medical complications due to the reprocessing practice. The requirements regarding the labeling of reprocessed single-use medical devices shall be clarified, in particular for the purpose of the traceability of these devices.
Economic considerations. The economic considerations are the main driver in the reprocessing of single-use medical devices. To date, most of the published economic data do not draw any conclusions on the cost effectiveness of the reprocessing of single-use medical devices because indirect costs are not included and the reprocessing is not performed with a sufficiently equivalent level of quality and safety. However, a recent study performed in Belgium demonstrates that, in a case in which an equivalent level of safety and quality was achieved for reprocessed single-use angiography catheters, the cost of these reprocessed devices was higher than the cost of new single-use angiography catheters.
Environmental considerations. Environmental considerations are usually advocated as another argument in favor of reprocessing single-use medical devices. 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, and the management of the waste generated after their use. However, the reprocessing practice also has a negative environmental impact that must be taken into consideration (e.g., the use of chemical substances).
The EC is currently assessing the appropriate measures to be put forward in the context of the Recast of the Medical Devices Directives. We believe that reprocessing of single-use devices will be permitted only for devices that are not used in surgically invasive medical procedures and with a validated reprocessing procedure for each device. Since hospitals will not be able to validate their reprocessing processes, only third-party reprocessing companies will be able to comply with any corresponding standards or guidelines.
The full EC commission report can be downloaded at ec.europa.eu/consumers/sectors/medical-devices/files/pdfdocs/reprocessing_report_en.pdf.
This is a report published by the EC on reprocessing but it is not a formal banning of reprocessing. It is a report based on their findings from research:
"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."
- Here the EC states the known fact that reprocessed devices contain bioburden. However, there are no numbers or statistics provided that support an increased infection rate after adoption of reprocessed devices. Rather, the EC chooses to identify that the whole reprocessing cycle must be evaluated and validated to help identify and reduce potential hazards of reprocessing.
- The FDA requires reprocessors to receive 510(k) validation prior to allowing reprocessing of a device. The 510(k) validation directly addresses the reprocessing process and validates that there are no hazards to the process.
"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."
- I've already noted the ethical and moral implications with using reprocessed devices. Our system chose to make a statement that both new and reprocessed are viewed as "like new" in our hospitals. It is not the perfect answer, but it is ours. I've already raised the point of needing to identify when other like products could be used in place of other products in procedures.
"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 costeffectiveness
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."
- The EC states that there is no published economical data on the savings from using reprocessed devices. They recommend that a long-term study of a large number of patients is needed to prove cost-effectiveness.
- My hospital system has tracked savings on reprocessing down to the line item, purchase order level for 2+ years now. We have shown savings and executive leadership has supported this initiative since it's inception.
"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."
- My argument for the EC is that, aren't the various elements common between reprocessed devices and new? When both items become waste and must be discarded, transportation is the same. The EC argues that resources, energy consumption and chemical disinfectants are environmental aspects of reprocessing that may make this an environmentally detrimental activity. My point is that, each time we use a reprocessed device, we save that much waste from going to our landfills. As part of our $2.5million in cost savings, we diverted 56,237 lbs of waste from the landfills by re-using the devices. At the end of the reprocessing cycle, the reprocessed breakdown and recycle the component parts of the device, something that few if any hospital systems will do.
In the end, this document was intended as guidance for hospital systems choosing to use reprocessing. The EC points out concerns with reprocessing but few of the points in the document are clear, conclusive evidence against using reprocessed devices. Item 3.2 clearly points out some of the countries with views on reprocessing. Most have no oversight on the reprocessing industry and those that do have guidelines and regulations to follow for third party reprocessors.
If the article had actually been read rather than just copied and pasted, it's clear this is more of an editorial and commentary on reprocessing rather than an edict. Are there countries that have banned reprocessing? Absolutely. Are there some still using and allowing it? Absolutely. Within the US alone there are hospitals that don't use reprocessed devices and have banned it and others that use it regularly. I don't think that the commentary from a governmental body outside of the US is evidence for or against reprocessing. I don't even want to get into the differences between their healthcare industry and ours. Socialized healthcare and our healthcare system? Worlds apart.
I think the views of other countries can be noted but should not be used to govern what we choose to do and what is discussed in the on-going commentary on this board.
