Project 1 - Device Master File

Introdcution

Infusion Pump is a device that is used to administer dosage of IV fluids at a reguloar time interval.The machine helps in administrating fluids on a set time setting set up by the doctor resposible for the patient. The doctor will put in the fluid bag containing the medicine and set some time for the medicine to be administered to the patient. The device can administer dosage as little as 0.1ml per drip which would be physically impossible for a human being to administer every minute. That is why infusion pumps are used.

Types of infusions

The device has four different infusions based on the doctors preference. All of the infusions are discussed below:

• Continuous infusion usually consists of small pulses of infusion, usually between 500 nanolitres and 10 milliliters, depending on the pump's design, with the rate of these pulses depending on the programmed infusion speed.

• Intermittent infusion has a high infusion rate, alternating with a low programmable infusion rate to keep the cannula open. The timings are programmable. This mode is often used to administer antibiotics, or other drugs that can irritate a blood vessel.

• Patient-controlled is infusion on-demand, usually with a preprogrammed ceiling to avoid intoxication. The rate is controlled by a pressure pad or button that can be activated by the patient. It is the method of choice for patient-controlled analgesia (PCA), in which repeated small doses of opioid analgesics are delivered, with the device coded to stop administration before a dose that may cause hazardous respiratory depression is reached.

• Total parenteral nutrition usually requires an infusion curve similar to normal mealtimes.

Usage of Machine and Risk Class

A clinical usage of an infusion pump is that it infuses fluids, medications or nutrients into a patient's circulatory system. It is generally used intravenously although subcutaneous, arterial and epidural infusions are occasionally used. The risk level under which the MDR classifies infusion pump is Class B since it needs to be invasive for it provide infusion to the patient. The machine is used mostly in NICU and PICU.

Features of the machine

The machine is well made in accordance to the safety protocols set by the MDR. The device is equipped with a alarm system to notify the user as well the attendant if there is any problem that occurs. Now there is LED installed in the machine which lights up as soon as the machine faces any problem. Any critical issue, the LED lights up in red colour and if the issue is moderate and still requires immediate attending, the light colour that comes up is yellow. As for the issues which are not very grave are in colour blue. Also the infusion pump prevents backflow of any liquid, i.e. if the nurse by fault puts the infusion kit in the wrong direction, then the machine will not strt sucking the blood out i.e. will not work in opposite direction rather as soon as the machine feels that something is wrong as picked uo by the sensor, the ionfusion will stop immediately. Plus the arm stays steady and the infusion happens at a steady, programmed

Regulatory Bodies Approvals, Market history and Price Range

So there are several comapnies out there who sell infusion pumps to the customers. Some of the companies who sell infusion pumps are Smiths Medical, Becton etc. these companies have to follow certain laws in order for their infusion ppumps to sell in the market. The certificates that the manufacturers of this medical device should obtain is ISO 13485 and relevant IEC 60601- Part 1 and 2 certificates by the notified bodies. The market cap for this device has been elevating. The market cap for this device in 2020 was USD 4.4 Bn and expected market cap for 2030 is USD 6.6 BN. The CAGR for 202 to 2030 is 5 percent. The products sell for anywhere between 20000 to 1.5 lakh INR. The market of the infusion pump comes mostly from the NICU and PICU departments of the hospitals as well as small nursing homes who house inn sick patients for large hospitals and need to work according to the standards of the hospital

Safety and Performance Test

The safety and performance test for the infusion pump 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 infusion pump 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. As for the performance, the device is able to deliver the medicine with utmost precision several times over the testing of ten rounds. The device accepted the bolous pressure only when the code that is known to the staff was entered and the device bolous worked great 7 out of 10 times in a test. The variation in the liquid for a fraction of nanoliters and the doctors could also administer the minimum dosage of .1nL to the patient. The batteries did not need much frequent charge as it has a battery capacity of 50 hours. The batteries will not need any type of replacement till 1500 charge cycles. The device also showed the least error when an inappropirate tubing was used. The error was only 15 percent. All of the general electrical safety parameters were alright and passed the test.

Technical specifications

• Flow rate programmable range atleast from 0.1 nl/hr to 1000ml/hr.

• Saves last infusion rate even when the AC power is switched off.

• Bolus rate should be programmable to approx, 500ml, with infused volume display.

• Selectable occulusion pressure trigger levels selectable from 300, 500 and 900 mmHg.

• Accuracy of +-2% or better for set parameters.

• Maximum pressure generated 20 psi.

• Pause infusion facility required.

• Self-check carried out on powering on.

• Comprehensive alarm package required including: occlusion alarm, near end of infusion pre-alarm and alarm, volume limit pre-alarm and alarm, low battery pre-alarm and alarm, AC power failure, drive disengaged.

• It should be open system

Physical Characterstics

• Dimensions: NA

• Weight: 150gms

• Configuration: Tamper resistant case made of impact resistant material. Securely mountable on tabletop, IV stand or bed fitting.

• Noise: Noise free

• Mobility: Yes

Energy Source

• Voltage: 220V, 60Hz

• Battery operated: Yes, backup of 50 hours

• Tolerance: +-10%

• Protection: Battery powered alarm for power failure or disconnection

Working condition of the machine and how it should be cleaned

The machine is capable of operating continuously in ambient temperature of 0 to 50 deg C and relative humidity of 15 to 90% ideal circumstances. The machine should be cleaned only with alcohol or chlorine

Risk Analysis

The risk analysis of the machine is done by keeping the machine charging for beyond capability hours. The batteries and PCB are check for short circuiting anf is made sure that both are fire proof and do not cause any internal fire on their own. Also it checked if the PCB will discharge charge onto the person touching the machine while it has been charge continuously. Also it is checked if anything that is used on this machine will harm the patient in any way.

Risk Management

For making sure that the things checked above do not happen, several things have been kept in mind during the designing of the machine. The materials that are used in the machine are electric proof, will prevent the fire from happening and are temperature sensitive and can easily disperse the heating that happens from overcharing the device and also its continuous use. Also sensors are added to the design to make sure the machine does not pull the blood out of the patient if the nurse accidentally puts the infusion set in reverse.

Design and Manufacturing Information

The design of this device has been made to be eco-friendly by not using too many small components to form the device. The device has been casted in from a single cast and then the parts are assembled in them. Also for the assembly, the parts were 3D printed to prevent any carbon footprint in the form of transportation of material and the manufacturing line was made in order to minimise the harmful effects of work on human beings by making them work in coherrence with the machines to lesser the burden on them. Also the batteries were made from recycling the old batteries which were in extremly good condition thus reducing e-waste in the process.

Labelling and Packaging

The device is labelled as Class B since the machine will be using invasing procedure to provide the medicine to the patient. the packaging of the material is made in a way that the package does not get damaged during the delivering procedure. The packaging is made out of 100% recyclable material and several layers are used so that the packaging is quite sturdy when it comes to bumps and slight nudging during the delivering. The shelf-life of the product is quite good since the machine needs to be put on patients for use. The shelf life of the material outlasts the shelf life other products in the market. Also the PCB is sturdy and better at handling heat as well as the components used are of good quality.

Post Market Surveillance

The device 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. The complaints seen generally from the customer side is of the battery backup. The batteries of all the infected pieces has been changed and the devices have been up and running. All of the data regarding it is also attached in the form of booklets.

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)