Reusable medical device – WFHSS Guidelines

Reprocessing of reusable medical devices

For the purpose of this guide, a Reusable Medical Device (RMD) means a medical device designated or intended by the manufacturer as suitable for reprocessing. Reprocessing of single-use medical devices are outside the scope of this guide.

RMD’s may be :

Medical or surgical items into contact with skin, mucous, or are inserted into the human body (e.g., surgical instruments, flexible endoscopes, dental instrumentation).
Diagnosis, monitoring and treatment equipment components that may come into contact with a patient.
Items used for conveying body fluids, tissues or preparation for subsequent use in humans (e.g., hemodialysis).

Reprocessing means all operations performed on a used RMD to allow its safe reuse

The European Medical Device Regulation defines reprocessing as a:
“process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilization and related procedures, as well as testing and restoring the technical and functional safety of the used device”.

The US Food and Drug Administration (FDA) defines reprocessing as a:
“validated processes used to render a medical device, which has been previously used or contaminated, fit for a subsequent single use. These processes are designed to remove soil and contaminants by cleaning and to inactivate microorganisms by disinfection or sterilization. Reprocessing of reusable devices encompasses appropriate steps that begin in close proximity to the point of use of the device and, in general, involves the following three steps in sequence: point-of-use processing…., thorough cleaning….. Disinfection or sterilization……”

Reprocessing applies to all sterile RMD’s that were removed from their packaging even if they were not used.

Reprocessing is also performed on:

loaned or deposited RMDs,
RMDs returned from repair. The RMD must also be cleaned and disinfected for the safety of maintenance staff (a reprocessing certificate is provided),
new RMD delivered non-sterile. Specific reprocessing may be recommended by RMD manufacturer to eliminate manufacturing residuals from a new device and/or to sterilize the device before first use.

Reprocessing is performed according to the instructions for reprocessing provided by the medical device manufacturer.

The medical device manufacturer must validated instructions for reprocessing. Informations to be provided to the user are defined by international standards

Before the purchase of a new RMD, the service in charge of reprocessing is consulted to ensure that reprocessing methods specified by the medical device manufacturer are available. If adaptations to RMD manufacturer’s IFU are required they must be justified, risk assessed and documented.

Reprocessing may be performed by the health care facility or shared with an external organization under an outsourcing contract.

Spaulding classification

In the late 1960’s medical devices were categorized by E.H. Spaulding according to the risk of infection for the patient

Critical: An item that contacts sterile tissue or the vascular system. Contamination by any microorganism presents a high risk. A critical device must hence be sterile.
Semi‐critical: An item that contacts mucous membranes or non‐intact skin. Mucous might be an efficient barrier against small quantity of common bacterial spores. However, other organisms such as bacteria, mycobacteria, and viruses. are at risk. Semi-critical items must be at least high-level disinfected (see below).
Non‐critical: An item that contacts intact skin but not mucous membranes. Intact skin acts as an effective barrier to most microorganisms. Non-critical items are disinfected (see below).

Over time, medical devices technologies evolved and as a result, reprocessing practices have been significantly modified

The sophistication of devices and, in particular, those used for minimally invasive surgery shed light on the challenge and importance of cleaning.
Some critical devices are heat sensitive and high-level disinfected instead of being sterilized. This potentially dangerous derogation to Spaulding classification must be limited.
Borders between the Spaulding categories became less clear. For example, flexible endoscope entering non sterile cavities but used for aseptic biopsy may be seen as semi-critical or critical (see flexible endoscopy). The health care facility should proceed according to its own analysis and applicable guidelines.
Prion risk has created a need for specific procedures (see below)
In practice all sterilized items are protected by a packaging. Spaulding classification should hence specify terminal sterilization.
For non-heat sensitive devices, saturated steam sterilization is universally preferred to dry heat. Recommended options for sterilization hence are saturated steam or low temperature sterilization.

	Cleaning	Prion inactivation
Critical An item that contacts sterile tissue or the vascular system Example; surgical instruments	Terminal sterilization Kills all forms of microbial life, including spores Sterility preserved until use by packaging	Per local regulation or guidelines for patients and procedures at risk
	High Level Disinfection Kills all microorganisms except for a small number of bacterial spores
Semi-critical An item that contact mucous membranes or non-intact skin Example: most flexible endoscopes
Non critical An item that contacts intact skin but no mucous membrane Examples: blood pressure cuffs, stethoscopes	Intermediate Level Disinfection Kills most bacteria, viruses, fungi and mycobacteria(tuberculodial) but not spores
	Low Level disinfection Kills some vegetative bacteria, viruses and fungi but not mycobacteria and spores

Prion

Prion is a small proteinaceous infectious unit that appears in a variety of human and animal neurodegenerative diseases, including Creutzfeldt-Jakob disease (CJd), bovine spongiform encephalopathy (BSE, also known as the mad cow disease), and scrapie.

Prion diseases have always existed but usually very rare. Prion proteins derive from a normal body protein that becomes irreversibly mis-folded. Prion proteins proliferates primarily in the central nervous system (CNS).

In the 1980’s beef became infected by BSE in some Western European countries. A variant of Creutzfeld-Jakob disease spread among humans who had consumed infected beef.

Prions are highly resistant to disinfection and sterilization. Their resistance can be increased by fixative agents.

Some sterilizing, cleaning and disinfecting formulations reinforce the fixation of proteins on RMD surfaces (e.g. dry heat, ethylene oxide, aldehyde based sterilizing and disinfecting agent such as formaldehyde or glutaraldehyde) and alcohol..

Anti-prion regulations or guidelines were implemented by some countries. Strategy is commonly based on patient screening and specific attention to CNS surgeries (brain, spinal cord or posterior of the eye).

Example of measures for at risk patient or surgeries are::

When possible, prefer single use surgery devices.
Extended hold period of an RMD until the absence of risk can be confirmed.
Prescribe the use of protein fixative processes and use processes which experimentally showed an ability to inactivate prion (i.e., destruction of the protein and not only elimination).

Evaluation of prion inactivation is based upon a sequence of in vitro and in vivo tests. Stainless steel wires infected by prion homogenates are treated by the cleaning, disinfecting or sterilizing processes to be evaluated. The processes with good in vitro results enter an in vivo phase. Treated wires are inserted in the Brain of mice or hamsters. The animals are observed during 1 to 2 years (depending on the animal model and prion strain). Criteria for success is that all animals must survive. Example of processes effective on prion are bath of sodium hypochlorite, sodium hydroxide, manual or automated processes with high pH alkaline detergent, some vH₂O₂ low temperature sterilization cycles or a combination of detergent and vH₂O₂cycles_.Steam cycles at 134°C 18 minutes have a high efficacy but fail to achieve complete inactivation.

Medical device vigilance

Medical Device Vigilance Systems reduce the likelihood of reoccurrence of incidents related to the use of a RMD.

Countries with vigilance systems in place collect and analyse incidents report.

There are different vigilance systems in operation in many regions. As an example, in the European Union, the medical device regulations place a legal responsibility on device manufacturers to report adverse incidents and Field Safety Corrective Actions (FSCAs) to EU Competent Authorities.

Users of medical devices can also report incidents to the Competent Authority on their own jurisdiction. These reports contribute to a central database called EUDAMED.

The US food and drug administration (FDA) operate a similar system and have their own database called the Manufacturer and User Facility Device Experience (MAUDE) database which contains all the medical device reports reported to the FDA since Aug 1996.

Other countries such as Canada, Japan and Australia operate similar systems. Many of the regions now co-operate on regulation for medical devices via the International Medical Device Regulators Forum (IMDRF).

RMD reprocessing and quality management

Safe reprocessing is obtained by application of quality management principles by:

RMD manufacturers: They must provide validated instruction for reprocessing.
Manufacturers of reprocessing equipment and consumables:Instruction for use are provided for all equipments, accessories and consumables. Sterilizers, washer-disinfectors and consumablles comply to international standards.
Healthcare facilities: Detailed standard operating procedures (SOP’s) are defined for all reprocessing steps and validated (see process validation, routine controls and maintenance). SOPs are executed by trained operators (see human resources) in the appropriate environment (see facilities, air & water)

WFHSS recommendations for reprocessing of RMD's

Persons in charge of reprocessing are consulted before purchase of a new RMD. It is verified that reprocessing methods recommended by RMD manufacturers are available to the health care facility.
Standard operating procedure for reprocessing follow the instructions for use of the medical device manufacturer. If adaptations to an RMD manufacturer’s IFU are required they are to be justified, risk assessed and documented.
Critical devices are terminally sterilized. Efforts are made to limit exceptions. When doubt exists between Spaulding categories, the highest available is chosen.
Reprocessing procedures take into account applicable prion guidelines or regulation. If medical device or reprocessing deficiencies are detected, they are reported according to applicable medical devices vigilance