The EU Attempts to Clarify the Reprocessing of Medical Devices

The EU Attempts to Clarify the Reprocessing of Medical Devices

The long-awaited report on reprocessing of medical devices recently was released by medical device authorities from the European Commission.

Directive 2007/47/EC made steps to explain reprocessing issues, which never had been clarified and always had maintained some degree of uncertainty. To bring some clarity to the topic, Directive 2007/47/EC inserted Article 12a, which mandated that the commission submit a report on the issue of reprocessing of medical devices in the community.

Earlier commission language did little to clarify the issue for manufacturers. For example, Recital 7 of Directive 2007/47/EC provided background, without any legal merit, and subsequently only conveyed the following explanation:

“Particular care should be taken to ensure that the reprocessing of medical devices does not endanger patients’ safety or health … Moreover, the Commission should engage in further analysis in order to see if additional measures are appropriate to ensure a high level of protection for patients.”

Now, several years—and a few surveys—later, the European Commission released a report in August on the reprocessing of medical devices in the European Union in accordance with Article 12a, with the specific goal of addressing “concerns about patient safety … [and which] provides further clarification on the definition of the term ‘single use’ and introduces new requirements for single-use medical devices.”

History of Reprocessing

The report’s introduction outlines the scope of what reprocessing might entail and provides examples of steps that reprocessing could include, such as: “routine maintenance, disassembly, cleaning, disinfection and/or sterilisation [sic] to allow safe reuse.”

Interestingly, the report explores the history of medical devices, namely that they initially were reusable. With the rise of communicable and transmissible disease, however, a shift toward single-use, disposable devices began. To this end, the definition of and requirements for single-use devices were amended by Directive 2007/47/EC and delineated that:

1. A single-use device means a product is intended to be used only once for a single patient;

2. The manufacturer’s indication of single use must be consistent across the community; and

3. If a device bears an indication that it is for single use, information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be reused must be provided in the instruction for use.

Reprocessing of Reusable vs. Single-Use

Accordingly, the report subdivides its discussion into two distinct themes: the reprocessing of reusable medical devices and the reprocessing of single-use medical devices.

For the reprocessing of reusable devices, Section 2 discusses the requirement (which was imposed by Directive 93/42/EEC) for manufacturer validation of the reprocessing process used. This included information on the appropriate process to allow reuse, including cleaning, disinfection and packaging, and—where appropriate—the method of sterilization to be used, along with any restriction on the number of reuses.

The report uses the example of some surgical instruments, many of which may be sterilized and used again, to illustrate this point.

Regarding single-use devices, the report acknowledges the persistent problem, often derived in “the face [of] increasing financial pressures,” of reprocessing devices that were intended to be single use, and thus do not have manufacturer-provided information regarding how they would be safely reprocessed. Often times, according to the report, single-use medical devices, such as needles or angioplasty catheters, are not developed and designed to withstand a reprocessing procedure. This, coupled with the fact that the reprocessing of single-use devices is not regulated by the European Commission, was the impetus for the report, and its clarifications and recommendations.

Single-Use Reprocessing Risks

Section 3.3 outlines the public health considerations on the reprocessing of single-use medical devices. The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) was engaged to assess these issues. Upon review, SCENIHR issued the following conclusions (Section 3.3.2):

• Three major hazards were identified by the SCENIHR—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 sterilization 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.

Ethical and Legal Implications

Other considerations, including ethical and liability issues, are delineated in Section 3.4. A noteworthy comment on liability, states that it is“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.”

Additionally, this section also comments that in order to improve device tracking, which becomes particularly salient after an adverse event has occurred, regulations pertaining to the labeling of devices after they have been reprocessed also must be examined. This concept will be interesting as it relates to Eudamed, the European databank for medical devices, which will become mandatory for Competent Authorities on May 1 next year (refer to this year’s June edition Euro News).

Economic Considerations

As cost-effectiveness almost always is driving force behind decisions, Section 3.5, which addresses economic considerations on the reprocessing of single-use medical devices, is of paramount importance.

The first salient recommendation is: “In the current context of increasing resources constraints and the needs for cost-containment in healthcare, the reprocessing of single-use medical devices has been employed 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).”

The report’s final conclusion on economic issues impacting reprocessing is that the current published literature is inconclusive: “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.”

Section 3.6 examines the environmental considerations of reprocessing single-use medical devices, and recommends the quantitative study of “all the environmental implications of reprocessing … versus discarding those devices.” At their behest, other “elements, such as the environmental impact of transport, resources and energy consumption, as well as the use of chemical disinfectants …” also must be examined.

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The report’s final conclusions draw from all of the concepts delineated above, but primarily call for comprehensive, quantitative studies so that “risk[s] associated with the use of reprocessed single-use medical device[s]” finally can be quantified. Until then, complete clarity on the matter cannot be obtained.

On a more positive note, however, the report has done much to describe many of the concerns and benefits of reprocessing medical devices. As a result of these considerations, it has made progress in clarifying the regulatory implications, which now can be better addressed.

Evangeline Loh, Ph.D., R.A.C., is vice president of regulatory affairs for Emergo Group, an international consulting firm providing regulatory, quality assurance and distribution consulting services. Emergo has offices in the United States, Europe, Japan, China, Canada, Mexico and Australia. Evangeline can be reached at [email protected]. Sage Farrar is a regulatory research associate at the Emergo Group.