Code: Revision:

PGC.7.5-04 04

Scope of application:
QUALITY MANAGEMENT SYSTEM
ISO13485

usMIMA

MOWOOT II

Re-use after returning a used MOWOOT II to

the manufacturer or distributor and Product
Verification every two years
Action Name Position Signature & Date

Technical
Elaborated Marc Benet Pozo
Responsible

Reviewed Markus Wilhelms General Director

Quality
Approved Marc Benet Pozo
Responsible

This document is property of usMIMA. The recipient of the same undertakes not to make any total or partial copy and not to
distribute it to third parties.

usMIMA

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Table of content
1. Introduction.......................................................................................................................................... 4
1.1 Object........................................................................................................................................ 4
1.2 Scope......................................................................................................................................... 4
1.3 References................................................................................................................................ 4
1.4 Definitions.................................................................................................................................. 5
1.5 Responsibilities.......................................................................................................................... 5
2. Protocol............................................................................................................................................... 6
2.1 Overview.................................................................................................................................... 6
2.2 Reprocessing............................................................................................................................. 7
2.3 Re-use Scenarios...................................................................................................................... 8
2.4 Test Description....................................................................................................................... 17
3. Documents and related data.............................................................................................................. 18
4. Records............................................................................................................................................. 18

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Revision History

Revision Date Description Affected Points

01 15-04-19 Newly creation document ----

02 12-06-19 Modifications Complete restructuring of the document

03 05-07-19 Modifications Flowcharts

Name of the document

2.3 Re-use Scenarios

04 29-07-19 Modifications
2.3.2 Flowchart modification

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1. Introduction

1.1 Object
The aim of the procedure is to ensure:

- There are clear lines of accountability for cleanliness and performance verification for medical device
at distributor facilities, health centres, health insurances, etc.,
- All involved staff is correctly trained in cleaning techniques and performance verification regarding
company’s medical devices, tasks and infection prevention and control,
- Clear cleaning specifications and device performance verification are in place and understood by all
levels of staff who are concerned with the cleanliness and device performance verification of medical
device at distributor facilities, health centres, health insurances, etc.,
- Cleaning and device performance verification specifications are appropriately resourced,
- All staff involved with cleanliness and device performance verification of medical device at distributor
facilities, health centres, health insurances, etc. is clear on their individual roles and responsibilities,
- Only clean and verified equipment is stored in the clean equipment area.
o Equipment will not be stored to avoid contamination,
o All equipment that is not clean or cannot be cleaned immediately after use shall be labelled
to indicate that it is ready for reprocessing and placed in the dirty equipment area.
- Only soiled equipment is stored in the soiled or “dirty” area and shall be labelled to indicate that it is
ready for reprocessing.
- All procedure used for cleaning and performance verification of the equipment must be approved by
usMIMA.
- If it is unclear whether the medical device has been cleaned, it must be cleaned before patient use.

1.2 Scope
This procedure applies to medical device distributor facilities, all inpatient units where treatment and non-
invasive procedures are undertaken, and to health insurances protocols.

1.3 References
The following are the regulations, standards and guidelines used in the preparation of the documentation:

 UNE-EN ISO 13485:2016

 Medical Device Directive 93/42/CEE

 Medical Device Regulation 2017/745 (UE)

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1.4 Definitions
1.4.1 Cleaning

Removal of organic and/or inorganic material from objects and surfaces. This is normally accomplished by
using detergents or enzymatic products. Thorough cleaning is necessary before disinfection because organic
and inorganic materials that remain on the surface of medical devices interfere with the effectiveness of the
processes.

1.4.2 Disinfection

Is the use of physical or chemical means to remove, inactivate or destroy microorganisms on a surface or
item, so there are no infectious organisms and the surface or item is rendered safe for handling, use or
disposal. The manufacturer should generally select cleaning equipment, chemicals and exposure time to
prevent damage to the medical devices.

usMIMA’s medical devices are subject to low level disinfection, because they are non-invasive to patients,
and are not in direct contact with the skin.

1.4.3 Reprocessing

Reprocessing of medical devices, which as per their definition should only harbour a low microbial count or
be sterile when put to use, means their cleaning, disinfection and sterilization after use for the purpose of
reuse, including related procedures as well as verification and restoration of functional safety.

1.5 Responsibilities
1.5.1 Manufacturer

- Reviewing and approving procedures and other documents for compliance with internal standards
and regulations.
- Providing quality assurance and regulatory expertise.
- Developing training material and delivering training on regulations and corporate standards.
- Communicating with regulatory agencies to get the most accurate information on regulations,
guidelines and their interpretations.
- Updating the Distributor on regulations, guidelines and their interpretations.
- supply the distributor and other parties with appropriate reprocessing instructions that comply with
the state of the art.

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1.5.2 Distributor

- Ensuring that all devices are listed in the inventory list and can be traceable.
- Ensuring that all devices are verified according to this procedure.
- Applying reuse protocol according to documented procedures.
- Providing documented evidence that the devices have been verified in a quality assurance
environment.
- Offering services to assist health centres, etc. in specifying, training and verifying the devices.
- Offering support in case the health centre, client, user has a problem with the device.
- Ensuring that reuse protocol is delivered in accordance with agreed specifications, provide advice
and assistance on issues where services are delivered.

2. Protocol

2.1 Overview
Medical devices may not be operated or used if they show defects which could endanger patients,
employees or third parties. As a result, medical devices which pose an infection risk (e.g. by pathogens) may
not be operated nor used.

For medical devices which have already been used on a patient, contamination with multipliable human
pathogenic bacteria must always be assumed and the next patient, user or third party must be protected
from infections, pyrogen-induced, allergic or toxic reactions and altered technical-functional characteristics of
the medical device by relevant handling and conditioning. This applies particularly in the following instances:
 before maintenance and repair procedures;
 after maintenance and repair procedures;
 when a patient has finished using the medical device; and
 before the medical device is used on another patient

The operator is responsible for the conditioning of medical devices. This responsibility cannot be delegated.
Only tasks which arise from this responsibility can be delegated. The operator may only commission those
persons, companies or establishments with the conditioning of medical devices which possess the expertise,
pre-requisites and necessary means for the proper execution of this task.

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2.2 Reprocessing
Conditioning generally comprises the following steps:
 The proper preparation (pre-treatment, collection, pre-cleaning) and, if necessary, the dismantling of
the medical devices used and their rapid, securely packaged and safe transportation to the
conditioning site;
 Cleaning, disinfection and drying;
 Testing for cleanliness and integrity of the surfaces (e.g. corrosion, material properties) and the
identification;
 Maintenance and repair;
 Functional testing;
 Labelling; and
 Packaging and transportation.

The entire reprocessing process and the reprocessed medical device must not pose any danger to the safety
of patients, users or third parties. Reprocessing must ensure that the reprocessed medical device will not
pose any risk of damage to health when subsequently used, in particular such as:
 Infections,
 Pyrogen-mediated reactions,
 Allergic reactions,
 Toxic reactions,
 Risks arising from changes in the functional safety of the medical device.

Cleaning and disinfection procedures must always be conducted in accordance with documented work
instructions and with means and processes checked for effectiveness and tailored to the medical device.

2.2.1 Procedure for Manual Reprocessing

Manual reprocessing is limited to medical devices belonging low risk, and then only following pre-disinfection
(decontamination) in order to protect personnel. Gloves must be worn to minimise contact with disinfectants.
Disinfected items should be dried as quickly as possible and stored in a dry place to avoid recontamination.

Manual disinfection must be performed by following the instructions established by the manufacturer
“REG_CLEAN_MOWOOT_#_Cleaning_&_Disinfecting_Protocol_MOWOOTII”.

To accomplish with reprocessing procedures, and to ensure that the medical devices must not pose any
danger to the safety of patients, users or third parties, it is necessary to perform functional
“REG_FUNC_TEST_#_Function_Test_Instruction_MOWOOTII_ENG” and performance
“REG_PF_TEST_#_Performance_Test_MOWOOTII” testing.

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2.3 Re-use Scenarios

Manufacturer Distributor Health Centres Contractual medical device supplier Health-insurance Patient
of the health insurance (e.g.
SCENARIOS (Hospitals, Doctors,
pharmacy, medical supplies store,
Massager)
home-career)

Manufacturer n.a. n.a. n.a. n.a. n.a. n.a.

Distributor  Sold to n.a. n.a. n.a. n.a. n.a.

Health Centres  Sold to n.a.

(Hospitals, Doctors, n.a.  Sample device to n.a. n.a. n.a.

Massager)
 Temporary
replacement device to

Contractual medical  Sold to n.a.

device supplier of the
n.a.  Sample device to n.a. n.a. n.a.
health insurance (e.g.
pharmacy, medical
supplies store, home-
carer)

Health-insurance n.a. n.a. n.a.  Sold to n.a. n.a.

Patient  Sold to  Sample device to  Used on  Sold to when patient has no  Gives to
insurance
 Temporary n.a.
replacement device to

* Note: All devices sold, sampled or temporary replaced could/will come back to the distributor.
*Note: All the devices which come back to the distributor have to be cleaned and tested by the performance test before sending it back to the user who had a complaint or sending it to
another user.

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Depending on the scenario, the different parts of the medical device could be reusable or not:

Manufacturer Direct Sales Distributor sell to: Distributor sell to: Distributor sell to:

(B2C / B2B) Health Centres Contractual medical device Home Carer, etc. for use in
supplier of the health insurance patients’ household

Pneumatic Console Reusable Reusable Reusable Reusable

Pneumatic Console - (Sample, Reusable Reusable Reusable Reusable

testing or replacement unit)

Exoperistaltic Belt Reusable Reusable Non-Reusable Reusable

Exoperistaltic Belt - (Sample, Reusable Reusable Reusable Reusable

testing or replacement unit)

Power Supply Reusable Reusable Reusable Reusable

Block Connector Reusable Reusable Reusable Reusable

Packaging Non-Reusable Non-Reusable Non-Reusable Non-Reusable

Instructions for Use Non-Reusable Non-Reusable Non-Reusable Non-Reusable

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2.3.1 Manufacturer · Reuse Protocol

This scenario shows the process that the legal manufacturer of medical devices must follow, once receives
the products from distributors, health centres, users/clients, etc.

The procedure is the following:

1. the first step must be placing the devices in the received quarantine area of the warehouse,
2. Then, apply the cleaning and disinfection protocol,
3. Once cleaned and disinfected, the devices will be placed in the released quarantine area of the
warehouse,
4. Next, the performance test procedure will be applied to verify the efficiency of the treatment of the
received devices:
a. Test Passed  Devices will be placed in the area of released sample products, ready to be
used again, or send back to the client the devices.
b. Test Failed  The devices will be placed in the area of NC products, the quality manager
will apply the NC product procedure, open a corrective action and send the relevant claims
to the critical suppliers responsible for the manufacturing of the defective devices.

The legal manufacturer will perform every 2 years, a performance verification of the sample devices that are
in the warehouse.

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2.3.2 Hospitals · Continuous Daily Use Protocol

This scenario establishes the process to be followed by hospitals that use one or more MOWOOT medical
devices in one or more patients simultaneously, and the relationships of hospitals with distributors and the
legal manufacturer.

The procedure is the following:

1. The flow begins with the purchase order of the distributor to the legal manufacturer,
2. Once the distributor receives the order, the received products must be stored in the area of released
products of the warehouse.
3. Then, when the distributor receives an order from a hospital, it will send the medical devices, and the
distributor personnel or authorised representative will perform the functional test of each medical
device.
a. Test Passed  The product is ready to be stored in the hospital facilities and its
subsequent use in their patients.

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 b. Test Failed  Hospital will send the defective medical devices back to the distributor.
4. Check section 2.3.4 of this document to see how the distributor shall proceed.
5. If the test is passed, the medical device is sent back to the hospital for storage and subsequent use
with patients.
6. Once the patient of the hospital is already using the medical device, it can occur different situations:
a. Device operation error (internal failure, misuse, etc.),
b. Product Return.
7. If there is no device malfunction, the hospital must only apply the cleaning and disinfection protocol,
then the product is ready to be stored in the hospital facilities and its subsequent use in their
patients.
8. In case of device malfunction, the hospital must apply the following protocols and tests, respecting
the following order:
a. Cleaning and disinfection protocol,
b. Function Test.
i. Test Passed  The product is ready to be stored in the hospital facilities and its
subsequent use in their patients.
ii. Test Failed  Hospital will send the defective medical devices back to the
distributor.
9. Again, check section 2.3.4 of this document to see how the distributor shall proceed.
a. Test Passed  The medical device is sent back to the hospital for storage and subsequent
use with patients.
b. Test Failed  Defective medical devices will be placed in the nonconforming product area
of the warehouse and the complaint will be reported to the legal manufacturer.

(The distributor will send these products to the legal manufacturer, who will be in charge of applying the appropriate corrective
measures)

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2.3.3 Hospitals · Product Verification

This scenario focuses solely on describing the process that hospitals must follow, every two years with every
MOWOOT II medical device, to verify the effectiveness of the treatment.

The procedure is the following:

1. Every 2 years, the hospital database shall require a Performance Functional Verification of each
medical device.
2. The hospital staff will segregate, from the normal flow of the hospital, the medical devices subject to
such verification.
3. The cleaning and disinfection protocol will be applied (in case it is not already applied, or in the case
it is not clear whether it has already been applied or not).
4. The performance test will be carried out:
a. Test Passed  The product is ready to be stored in the hospital facilities and its
subsequent use in their patients.
b. Test Failed  Proceed to its disposal, as it has already fulfilled its life span.

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2.3.4 Distributor · Reuse Protocol

This scenario describes the process that medical device distributors must follow, once receive the products
from hospitals, health centres, users/customers, health insurance, etc.

The procedure is the following:

1. The first step must be placing the devices in the received quarantine area of the warehouse,
2. Then, apply the cleaning and disinfection protocol,
3. Then, the devices will be placed in the warehouse released quarantine area.
4. The performance test will be carried out to verify the efficiency of the treatment of the received
devices:
a. Test Passed  Devices will be placed in the area of released sample products, ready for
re-use/distribution.
b. Test Failed  Defective medical devices will be placed in the nonconforming product area
of the warehouse and the complaint will be reported to the legal manufacturer.
5. The distributor must verify that the non-compliant devices are within the warranty period:
a. In Warranty  The distributor will send the products to the legal manufacturer, who will be
in charge of applying the appropriate corrective measures (to see if it is possible to be
repaired), and at the same time, the distributor may have to replace the defective unit by a
new one.

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 b. Expired Warranty  The distributor will ask to the client what he wants to do with the
device. (p.e. remove the medical device from the market proceeding to its disposal, as it has
already fulfilled its life span).

2.3.5 Contractual Medical Device Supplier to Health Insurance· Reuse Protocol

This scenario describes the process that contractual medical device suppliers, that provide Health-insurance
with MOWOOT II devices, will follow when using medical devices on one or more patients simultaneously.

The procedure is the following:

1. When the distributor receives an order from a contractual medical device supplier, it will send the
medical devices, and the distributor personnel or authorised representative will perform the
functional test of each medical device.
a. Test Passed  The product is ready to be stored in the contractual medical device supplier
facilities and its subsequent delivery to Health-insurance companies.
b. Test Failed  Contractual medical device supplier will send the defective medical devices
back to the distributor.
2. Check section 2.3.4 of this document to see how the distributor shall proceed.
3. If the test is passed, the medical device is sent back to the contractual medical device supplier for
storage and subsequent delivery to Health-insurance companies.

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 4. Once the Health-insurance company has provided the MOWOOT II device to a patient, it can occur
different situations:
a. Device operation error (internal failure, misuse, etc.),
b. Product Return.
5. In both situations, the Health Insurance company must apply the following protocols and tests,
respecting the following order:
a. Belt Disposal,
b. Desktop Device Cleaning and disinfection protocol,
c. Desktop Device Performance Test:
i. Test Passed  The desktop device is ready to be stored and its subsequent use
with their clients.
ii. Test Failed  Health Insurance company will send the defective desktop devices
units back to the contractual medical device supplier.
6. The contractual medical device supplier will send the defective desktop devices units back to the
distributor.
7. Check section 2.3.4 of this document to see how the distributor shall proceed.
8. If the test is passed, the medical device is sent back to the contractual medical device supplier for its
storage and subsequent delivery to Health-insurance companies.
9. If the test is failed, Defective desktop devices will be reported to the legal manufacturer.

(The distributor will send these products to the legal manufacturer, who will be in charge of applying the appropriate corrective
measures)

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2.3.6 Contractual Medical Device Supplier to Patient · Reuse Protocol

This scenario describes the process that contractual medical device suppliers will follow when using medical
devices on one or more patients (who has no insurance) simultaneously.

The procedure is the following:

1. When the distributor receives an order from a contractual medical device supplier, it will send the
medical devices, and the distributor personnel or authorised representative will perform the
functional test of each medical device.
a. Test Passed  The product is ready to be stored in the contractual medical device supplier
facilities and its subsequent delivery to patients.
b. Test Failed  Contractual medical device supplier will send the defective medical devices
back to the distributor.
i. Check section 2.3.4 of this document to see how the distributor shall proceed.

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 ii. If the test is passed, the medical device is sent back to the contractual medical
device supplier for storage and subsequent delivery patients.
2. Once the contractual medical device supplier has provided the MOWOOT II device to a patient, it
can occur different situations:
a. Device operation error (internal failure, misuse, etc.),
b. Product Return.
3. If there is no device malfunction, the contractual medical device supplier must only apply the
cleaning and disinfection protocol, then the product is ready to be stored in their facilities and its
subsequent use in patients.
4. In case of device malfunction, the contractual medical device supplier must apply the following
protocols and tests, respecting the following order:
a. Cleaning and disinfection protocol,
b. Function Test.
i. Test Passed  The product is ready to be stored in the contractual medical device
supplier facilities and its subsequent use in their patients.
ii. Test Failed  contractual medical device supplier will send the defective medical
devices back to the distributor.
c. Again, check section 2.3.4 of this document to see how the distributor shall proceed.
d. Test Passed  The medical device is sent back to the contractual medical device supplier
for storage and subsequent use with patients.
e. Test Failed  Defective medical devices will be placed in the nonconforming product area
of the warehouse and the complaint will be reported to the legal manufacturer.

(The distributor will send these products to the legal manufacturer, who will be in charge of applying the appropriate corrective
measures)

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2.4 Test Description
Depending on the scenario, the different parties involved must perform different tests on medical devices. This section will describe what tests should be performed,
who should perform those tests and, most importantly, when such tests should be performed.

TEST Cleaning & Disinfection Function Test + Data Record Performance Test Product Verification

Manufacturer · First step that must be applied when · Apply the test after performing
devices are received: the cleaning protocol, to verify the
n.a. n.a.
efficiency of the treatment of the
(sold, sampled, testing or replaced).
received devices.

Distributor · First step that must be applied when
devices are received:
(sold, sampled, testing or replaced).
· Apply when sending the devices to
Hospitals, for the first time.
· Apply the test after performing
the cleaning protocol, to verify the
n.a.
efficiency of the treatment of the
received devices.

Health Centres · Apply the cleaning & disinfection · Apply when devices are received. · Apply as the 2nd step of the Apply the Product Verification
protocol in case of device Product Verification. protocol once every 2 years
· Apply when a device malfunction
return/malfunction. (cleaning protocol +
occurs.
Performance Test).
· Apply the cleaning & disinfection
protocol as the 1st step of the Product
Verification.

Contractual medical · Apply the cleaning & disinfection · Apply when devices are received. n.a. n.a.
device supplier of protocol in case of device
· Apply when a product is returned,
Health-insurance return/malfunction.
or a device malfunction occurs.

Health-insurance · Apply the cleaning & disinfection n.a. · Apply the test after performing n.a.
protocol of desktop devices, in case of the cleaning protocol, to verify the
return or malfunction. efficiency of the treatment of the
received desktop devices.

Notes:
Function Test: With Reading Data,
Performance Test: Function Test + Reading Data + Pressure Test + Frequency Test,

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Product Verification: Function Test + Reading Data + Pressure Test + Frequency Test + Electrical Test (Power Supply).

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3. Documents and related data
 PGC.7.5-05 – Identificacion y Trazabilidad
 PGC.7.5-06 – Preservacion del Producto
 PGC.8.3-01 – Control de Producto No Conforme
 PGC.8.5-01 – Tratamiento Reclamaciones
 PGC.8.5-02 – Accion Correctiva y Preventiva
 INS-M2DATA-001_#_Reading_data_from_Mowoot2

4. Records
 REG_CLEAN_MOWOOT_#_Cleaning_&_Disinfecting_Protocol_MOWOOTII.
 REG_FUNC_TEST_#_Function_Test_Instruction_MOWOOTII
 REG_PF_TEST_#_Performance_Test_MOWOOTII
 REG_PV_TEST_#_Product_Verification_MOWOOTII

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