BME 174 MD2 Risk Management Plan PDF

Preview

Summary

Mandatory group assignment...

Description

BME 174 Risk Management Plan The LithoVue Flexscope

Group: 10 Revision No.: 5 Last updated: 04/06/2018 Review and Approval Matrix Name

Title/Role

Trevor Cabreros

Author, Reviewer

04/06/2018

Author, Reviewer

04/06/2018

Lucero Sandoval

Author, Reviewer

04/06/2018

Maria Tam Tran

Quality Assurance Manager

04/06/2018

Nam Tran

Author, QA/QC Technician

04/06/2018

Cassandra Villicana

Author, Project Manager

04/06/2018

Netnapit Saengpitayathon

Signature

Date

Table of Contents 1

Scope of the plan 1.1 Description of the Device

BME 174 Risk Management Plan 1

3 3

Rev 5.2

1.2

Description of the Risk Management in the Product Life Cycle

4

2

Safety Characteristics 2.1 Intended Use Statement 2.2 Reasonably Foreseeable Misuse 2.3 Identified safety characteristics of the device. 2.4 Expected Lifetime of the Product

6 6 6 9 13

3

Assignment of responsibilities and authorities

13

4

Requirements for review of risk management activities

14

6

Verification activities

16

7

Method or methods of obtaining relevant post-production information

19

8

Risk Analysis Sources of Available Information

20

9

References

20

1 1.1

Scope of the plan Description of the Device The LithoVue Flexscope is a single-use digital flexible ureteroscope. With the use of optic

BME 174 Risk Management Plan 2

Rev 5.2

fibers and an LED light source, the scope offers a clear visual image of its clinical environment. The visual image can be captured from a range of 2mm to 50mm distance in order to offer clinicians a variable view point[2]. The LithoVue flexscope’s 7.7F (French) tip diameter and 9.5F outer diameter allow its access in ureteros with renal colic (inflammation) making it ideal for therapeutic and diagnostic procedures. It is also built to work in conjunction with many lasers during surgery without causing disruptions or interference. The device offers many key features to help the user control the scope and lasers attached to it (Fig. 1). It includes a user interface that offers the operator a visual of what is inside the patient.

Fig 1: LithoVue Flexscope Schematic

1.2 Description of the Risk Management in the Product Life Cycle

BME 174 Risk Management Plan 3

Rev 5.2

Fig 2 : Waterfall lifecycle model Table 1: Risk Management Activity in the Product Life Cycle Phase

Risk Management Activity

Design Input

The manufacturer will research other ureteroscopes on the market to establish the necessary physical and performance requirements for LithoVue Flexscope. Moreover, the procedures of the LithoVue Flexscope will be regularly maintained and updated to avoid malfunctionee products.

Design Output

Packaging and labeling of the LithoVue Flexscope will be done according to a specific guideline. The guideline will be created by the manufacturing risk management team. The packaging of the LithoVue will be made from appropriate material for the device to avoid any possible damage during the distribution phase. The labeling of the device will be double check by a team to avoid shipment to an incorrect address.

Design Review

Each finished device will undergo a quality test to ensure the safety of the product. Any malfunctioned products will be recorded for future risk assessment activity.

Design Transfer

The manufacture of the LithoVue Flexscope will keep all the records of the procedures of the device for risk assessment. The

BME 174 Risk Management Plan 4

Rev 5.2

risk management team will examine the design of the device before the production begin. Production

The risk management team will complete a monthly risk management process (identify the risk, analyze the risk, evaluate the risk, treat the risk, and review the risk) during the production period.

Distribution

The distribution of the LithoVue Flexscope will be supervised by a qualified personnel such as a quality control manager, nurse, doctor, and/or physician. The distribution of the LithoVue Flexscope will be done by following a guideline created by the risk management team.

Clinical Use

The manufacturer will provide detail manual of the LithoVue Flexscope to the user. The operator of the LithoVue Flexscope is required to complete a proper training in order to avoid possible misuse of the device. The manufacturer will provide training for LithoVue device to a qualified personnel.

Service and Maintenance

The LithoVue Flexscope is a single use device, therefore, no service and maintenance of the device are necessary. Clear instruction will be given to the device to avoid possible risk from the user attempting to perform service or maintenance on the LithoVue Flexscope.

Product end-of-life

The LithoVue Flexscope will be disposed of in a proper manner according to the guideline. The manufacturer will provide a clear instruction/training to the users on the disposal of the device.

The manufacturer will refer to the block diagram of the device throughout the product lifecycle. In addition, the Manufacturer and User Facility Device Experience Database (MAUDE) and Product Life Cycle (TPLC) database will be used to identify hazards and to estimate risks. For the complete list of the available information, see Section 8.

2 2.1

Safety Characteristics Intended Use Statement

The LithoVue Flexscope is intended to be used in conjunction with a visualizing software to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes [1]. It can also be used in conjunction with software-controlled endoscopic accessories to perform various diagnostic and

BME 174 Risk Management Plan 5

Rev 5.2

therapeutic procedures in the urinary tract [1]. It is intended for use within an operating room as it is used in minimally invasive to invasive procedures. Some applications of the system include use involving patients with abnormal growth/narrowing of ureters, UTIs, and hematuria. It is a one-time use ureteroscope; therefore, it can only be used for one operation.

2.2

Reasonably Foreseeable Misuse

Use Case A 2.2.1: Normal Operation of LithoVue Single-Use Digital Flexible Ureteroscope to observe urinary tract of patient This use case describes the normal operation of the LithoVue Single-Use Digital Flexible Ureteroscope to observe the urinary tract by the qualified physicians. Related System Goals: G1 Primary Actor: Physician/Doctor Precondition: Patient is under anesthesia and in a correct position for ureteroscopy procedure. New LithoVue Flexscope is connected to the workstation. Post-condition: Ureteroscope is removed from the patient’s body. LithoVue Flexscope is disconnected from the workstation. Patient waits to recover from the anesthesia. Main success scenario: 1. Physician connects LithoVue Flexscope to the workstation. 2. Patient is under the effect of anesthesia and in a position for the procedure. 3. Physician inserts the tip of LithoVue Flexscope into patient’s urethra. 4. Physician releases a sterile solution through the tip of the ureteroscope once it is in the bladder. 5. Physician using the live image on the screen to slowly guides the LithoVue Flexscope into a ureter. 6. Physician observes patient’s urinary tract through the monitor on the workstation. 7. Physician removes ureteroscope from patient. 8. Physician disconnects the LithoVue Flexscope from the workstation and disposes the used ureteroscope according to to the regulation. 9. Patient waits to recover from the anestesia. Use Case A 2.2.2: Normal Operation of LithoVue Single-Use Digital Flexible Ureteroscope to break kidney stones This use case describes the normal operation of the LithoVue Single-Use Digital Flexible

BME 174 Risk Management Plan 6

Rev 5.2

Ureteroscope to break kidney stones by the qualify physicians. Related System Goals: G1 Primary Actor: Physician/Doctor Precondition: Patient is under anesthesia and in a correct position for ureteroscopy procedure. New LithoVue Flexscope is connected to the workstation. Post-condition: Ureteroscope is removed from the patient’s body. LithoVue Flexscope is disconnected from the workstation. Patient waits to recover from the anestesia. Main success scenario: 1. Physician connects LithoVue Flexscope to the workstation. 2. Patient is under the effect of anesthesia and in a position for the procedure. 3. Physician inserts the tip of LithoVue Flexscope into patient’s urethra. 4. Physician releases a sterile solution through the tip of the ureteroscope once it is in the bladder. 5. Physician using the live image on the screen to slowly guides the LithoVue Flexscope into a ureter. 6. Physician observes patient’s urinary tract through the monitor on the workstation. 7. Physician uses the laser tip of the ureteroscope to break up kidney stones into small pieces. 8. Physician removes kidney stones from patient. 9. Physician removes ureteroscope from patient. 10. Physician disconnects the LithoVue Flexscope from the workstation and disposes the used ureteroscope according to to the regulation. 11. Patient waits to recover from the anesthesia.

Table 2 : Possible Foreseeable Misuse of the LithoVue Ureteroscope Use Case

Use Error

Possible Risk

Person who would make the error

A 2.2.1 and A 2.2.2

The LithoVue Flexscope device is inserted without a clear live view of the lumen through which the scope is being advance.

Can cause injury to patient such as perforation, avulsion, hemorrhage, or urothelial damage.

Physician

A 2.2.1 and A 2.2.2

A person looks directly into the light emitted from the

Can cause a serious eye injury.

Patient and/or physician

BME 174 Risk Management Plan 7

Rev 5.2

LithoVue Flexcope. A 2.2.1 and A 2.2.2

An excessive force is used when advancing or withdrawing the scope.

Can cause injury to patient and can damage the LithoVue Flexscope

Physician

A 2.2.1 and A 2.2.2

Failure to remove the LithoVue Flexcope from patient prior to use of a cardiac defibrillator.

Can cause injury to patient and can damage the system

Physician/Doctor

A 2.2.1 and A 2.2.2

The distal tip of the LithoVue Flexcope is forced against sidewall of the ureter or renal pelvis.

Can cause injury to patient such as perforation, avulsion, hemorrhage, or urothelial damage.

Physician

A 2.2.1 and A 2.2.2

The accessories fail to meet the compatibility requirements of LithoVue Flexscope.

Can damage the LithoVue Flexscope and/or damage the system workstation.

Physician

A 2.2.1 and A 2.2.2

The flexible shaft of the articulating section or the LithoVue is excessively bend.

Can break or kink the shaft.

Physician

A 2.2.1 and A 2.2.2

A laser fiber is withdraw back into the ureteroscope while the laser is firing.

Can cause patient injury and/or damage the device.

Physician

A 2.2.1 and A 2.2.2

The distal tip of the LithoVue Flexscope is not straight when inserting and withdrawing accessories.

Can cause patient injury and/or damage the accessory and ureteroscope or malfunction.

Physician

2.3

Identified safety characteristics of the device.

C.2

Question

Assessment

C.2.1

What is the intended use and how is the medical device to be used?

The LithoVue Flexscope is intended to be used in conjunction with visualizing software to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It is intended for use within an operating room as it is used in minimally invasive to invasive procedures.

C.2.2

Is the medical device intended to be implanted?

No. The device is not designed to be implanted. The device should not stay in the body for an extended period.

BME 174 Risk Management Plan 8

Rev 5.2

C.2.3

Is the medical device intended to be in contact with the patient or other persons?

C.2.4

What materials or Optic fibers and an LED light source and cables are in contact components are utilized with the medical device. in the medical device or are used with, or are in contact with, the medical device?

C.2.5

Is energy delivered to or extracted from the patient?

No, energy is not delivered or extracted to the patient. It is only for visual purposes.

C.2.6

Are substances delivered to or extracted from the patient?

Yes, there will be substances delivered to patient which can include fluids/lubricants.

C.2.7

Are biological materials processed by the medical device for subsequent re-use, transfusion or transplantation?

No, there are no biological materials processed by the medical device for subsequent reuse, transfusion or transplantation.

C.2.8

Is the medical device supplied sterile or intended to be sterilized by the user, or are other microbiological controls applicable?

No, the medical device is not supplied sterile or intended to be sterilized by user because it is a single use device.

C.2.9

Is the medical device intended to be routinely cleaned and disinfected by the user?

No, the LithoVue Flexscope is a single use device. It should be dispose according to guildine after used.

C.2.10

Is the medical device intended to modify the patient environment?

No, the LithoVue Flexscope is not intended to modify the patient environment.

C.2.11

Are measurements taken?

No, its purpose is not to measure.

C.2.12

Is the medical device interpretative?

No, it is just meant as a visual aid.

BME 174 Risk Management Plan 9

Yes, the device is intended to be in contact with the patient. It will be inserted into the patient to to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes.

Rev 5.2

C.2.13

Is the medical device intended for use in conjunction with other medical devices, medicines or other medical technologies?

Yes, it is used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract. It is also need to be connect to a monitor workstation to provide the visual of the urinary tract.

C.2.14

Are there unwanted outputs of energy or substances?

There can be unwanted energy if the device is overheated.

C.2.15

Is the medical device susceptible to environmental influences?

Yes, it is susceptible to environmental influences such as unwanted radiation.

C.2.16

Does the medical device influence the environment?

Yes, it does. It will affect the environment if it is not recycle in the right way.

C.2.17

Are there essential consumables or accessories associated with the medical device?

Yes, it does. It will need the all-in-one touchscreen PC, 7.7F tip diameter, digital CMOS image, light source built into the handle, mobile cart for portability, software DVD and wire cables.

C.2.18

Is maintenance or calibration necessary?

No, since the LithoVue Flexscope is a single use device, it does not require maintenance or calibration.

C.2.19

Does the medical device contain software?

The LithoVue Flexscope does not contain any software. However, it must be connected to the monitor workstation for the live image. The workstation contain an image processing software.

C.2.20

Does the medical device have a restricted shelflife?

No, it doesn't

C.2.21

Are there any delayed or long-term use effects?

Potential complications include but may not be limited to bleeding, avulsion, stenosis, inflammation, laceration, fever, sepsis, renal failure, perforation, hematuria, pain, discomfort, urinoma, infection, ureteral reflux, hematoma, and urothelial damage.

C.2.22

To what mechanical forces will the medical device be subjected?

The ureteroscope is subjected to strain, bending, and shear stresses.

C.2.23

What determines the lifetime of the medical device?

The device must be thrown out after its first use.

BME 174 Risk Management Plan 10

Rev 5.2

C.2.24

Is the medical device intended for single use?

The ureteroscope is a single-use device with no serviceable parts.

C.2.25

Is safe decommissioning or disposal of the medical device necessary?

It is recommended to dispose the device in a biohazard waste container.

C.2.26

Does installation or use of the medical device require special training or special skills?

Yes, only a trained physician who understands all of the risks associated with usage of the device and is able to fully comply with all safety rules should use the device.

C.2.27

How will information for safe use be provided?

The information for safe use will be provided on the labels of the device as well as the user manual.

C.2.28

Will new manufacturing processes need to be established or introduced?

No, new manufacturing processes will not need to be established or introduced.

C.2.29

Is successful application of the medical device critically dependent on human factors such as the user interface?

Yes, since the device must be used by a trained physician, success is critically dependent on user interface.

C.2.29.1

Can the user interface design features contribute to use error?

Yes, the design features contribute to use errors such that wrongful force or noncompliance with usage rules may cause injury to the patient or damage the device.

C.2.29.2

Is the medical device used in an environment where distractions can cause use error?

Yes, the device is used in an environment where distractions can cause use error. Distraction of professionals can cause internal damages by the felxscope to the patient.

C.2.29.3

Does the medical device have connecting parts or accessories?

Yes, the LithoVue Flexscope can be connected to a workstation whi...