Project 1 - Device Master File

Introdcution

catheter is a thin tube made from medical grade materials serving a broad range of functions. Catheters are medical devices that can be inserted in the body to treat diseases or perform a surgical procedure. Catheters are manufactured for specific applications, such as cardiovascular, urological, gastrointestinal, neurovascular and ophthalmic procedures. The process of inserting a catheter is catheterization.

Catheters can be inserted into a body cavity, duct, or vessel, brain, skin or adipose tissue. Functionally, they allow drainage, administration of fluids or gases, access by surgical instruments, and also perform a wide variety of other tasks depending on the type of catheter. Special types of catheters, also called probes, are used in preclinical or clinical research for sampling of lipophilic and hydrophilic compounds, protein-bound and unbound drugs, neurotransmitters, peptides and proteins, antibodies, nanoparticles and nanocarriers, enzymes and vesicles.

Types of catheter

INDWELLING URETHRAL CATHETERS

An indwelling urinary catheter is one that is left in the bladder. You may use an indwelling catheter for a short time or a long time.

An indwelling catheter collects urine by attaching to a drainage bag. The bag has a valve that can be opened to allow urine to flow out. Some of these bags can be secured to your leg. This allows you to wear the bag under your clothes. An indwelling catheter may be inserted into the bladder in 2 ways:

• Most often, the catheter is inserted through the urethra. This is the tube that carries urine from the bladder to the outside of the body.
• Sometimes, the provider will insert a catheter into your bladder through a small hole in your belly. This is done at a hospital or provider's office.

An indwelling catheter has a small balloon inflated on the end of it. This prevents the catheter from sliding out of your body. When the catheter needs to be removed, the balloon is deflated.

CONDOM CATHETERS

Condom catheters can be used by men with incontinence. There is no tube placed inside the penis. Instead, a condom-like device is placed over the penis. A tube leads from this device to a drainage bag. The condom catheter must be changed every day.

INTERMITTENT CATHETERS

You would use an intermittent catheter when you only need to use a catheter sometimes or you do not want to wear a bag. You or your caregiver will insert the catheter to drain the bladder and then remove it. This can be done only once or several times a day. The frequency will depend on the reason you need to use this method or how much urine needs to be drained from the bladder.

Usage of Machine and Risk Class

A urinary catheter is usually used when people have difficulty peeing (urinating) naturally. It can also be used to empty the bladder before or after surgery and to help perform certain tests.

Specific reasons a urinary catheter may be used include:

• to allow urine to drain if you have an obstruction in the tube that carries urine out of your bladder (urethra). For example, because of scarring or prostate enlargement
• to allow you to urinate if you have bladder weakness or nerve damage that affects your ability to pee
• to drain your bladder during childbirth if you have an epidural anaesthetic
• to drain your bladder before, during or after some types of surgery
• to deliver medicine directly into the bladder, such as during chemotherapy for bladder cancer
• as a last resort treatment for urinary incontinence when other types of treatment have been unsuccessful.

POSSIBLE COMPLICATIONS

Complications of catheter use include:

• Allergy or sensitivity to latex
• Bladder stones
• Blood infections (septicemia)
• Blood in the urine (hematuria)
• Kidney damage (usually only with long-term, indwelling catheter use)
• Urethral injury
• Urinary tract or kidney infections
• Bladder cancer (only after long-term indwelling catheter)

Features of the machine

A urinary catheter is a hollow, partially flexible tube that collects urine from the bladder and leads to a drainage bag. Urinary catheters come in many sizes and types. They can be made ofTrusted Source:

• rubber
• plastic (PVC)
• silicone

Regulatory Bodies Approvals, Market history and Price Range

the global urinary catheter size is projected to reach USD 2.6 billion by 2025 at a, CAGR 5.5 %. the growing prevalence of urinary incontience, an increasing number of surgical procedure across the globe , high incidence of prostate cancer, and the favourable reimbursement screnio are the major factors driving the growth of urinary catheters market.

So there are several comapnies out there who sell urinary catheters to the customers. Some of the companies who sell catheters are B Braun melsungen (germany ), Boston scientific corpration (US ) , Coloplast(Denmark) , etc. these companies have to follow certain laws in order for their catheters to sell in the market.

with,

ISO 10555-1: Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements

ISO 10555-3: Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters

ISO 10555-4: Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters

ISO 10555-5: Intravascular catheters - Sterile and single-use catheters - Part 5: Over-needle peripheral catheters

ISO 11070: Sterile single-use intravascular catheter introducers.

Safety and Performance Test

The safety and performance test for the catheter is a must since the device is a must since the device needs to make sure that the device is giving out the performance that it has promised to the customer. With the catheter from this company you will not lack on the safety as well as the performace. For the explaination on the safety features refer to Features of this device.

• ASTM F2394-07 for preconditioning of the stent on the deployment system prior to retention testing
• ASTM F623 Standard Performance Specification for Foley Catheter
• ASTM F2081 Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
• ASTM F2394 Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
• ASTM standard F3067 – 14 Guide for Radial Loading of Balloon Expandable and Self Expanding Vascular Stents

As for the performance, this catheter is able to clear the problem in the urinary tract . with utmost precision several times over the procedures. . All of the general safety parameters were alright and passed the test.

Physical Characterstics

classification : II

• Diameter: 0.33 mm

• size : 14 to 16 FR
• baloon size: 30 ml
• materials : silicone , silver, antimicrobial coating, polyethylene,pebax, nylon.

using conditon :

Hospice/comfort care/palliative care. Accurate measurement of urinary output in critically ill patients. Required strict immobilization for trauma or surgery.

Risk Analysis

The main risk of using a urinary catheter is that it can sometimes allow bacteria to enter your body. This can cause an infection in the urethra, bladder or, less commonly, in the kidneys. These types of infection are known as urinary tract infections (UTIs).

It is best to avoid placing urinary catheters. However, when catheters are placed, Leis et al³ describe a pragmatic and innovative approach to help us remove them as expeditiously as possible. By empowering nurses to remove urinary catheters that are no longer needed, they were able to markedly reduce the number of days patient spent with these catheters. This is a promising innovation. We need more team-based interventions that improve patient care and safety.

Risk Management

.

1. Keep the drainage bag below the level of your bladder.
2. Keep your drainage bag off the floor at all times.
3. Keep the catheter secured to your thigh to keep it from moving.
4. Don't lie on your catheter or block the flow of urine in the tubing.
5. Shower daily to keep the catheter clean

Design and Manufacturing Information

The manufacturing of catheters is an end-to-end operation that is being conducted by leading medical manufacturers such as Interplex Medical.

It all begins with the catheter design. Depending upon the medical procedure in which the catheter will be used, catheter designers take into consideration certain characteristics and functions – including a smaller or wider diameter, flexibility, steerability, the ability to handle greater torque or pressure, the need for extra coils, creating an atraumatic tip, modifications to allow for the addition of scopes, lasers, surgical instruments, and other medical devices – in relation to the internal anatomy of the human body part wherein the catheter will be inserted.

Post Market Surveillance

The urinary catheter has been found with minimum complaints from the consumers. The device has been running good and the after sale service respond has been good from the customers. in this market rating increased over 5 years.

Documentations

• User Manuals (BAsic adn technical)

• Service Manual

• Calibration certificate

• All of the accessories and parts price list and part number

• Post market surveillance reports

• AMC and CMC (if taken)