◦ Medical suction equipment- part 3

◦ IOS- international organisation for standardisation worldwide

federation of national standards. The work of preparing international standards is
normally carried out through IOS technical committee.
◦ This document specify basic safety and performance requirements for
medical suction equipment powered from a vacuum or positive pressure gas source
generating Venturi suction.
◦ It applies to suction equipment connected to medical gas pipeline
systems or cylinders and ventri attachment and can be standalone or part of an
integrated system.

Medical suction equipment- part 4(general requirements)

◦ The established risk management process shall be applied to the
suctions equipment. This process includes following elements .
◦ Risk analysis, risk evaluation , risk
control,production or post production information
◦ The manufacturer shall apply the usability engineering process to
access mitigate any risks caused by usability problems associated with correct use
◦ Clinical studies
◦ Material-natural rubber latex-for any material manufactured needs to
give justification
◦ Cleaning disinfection and sterilisation
◦ Environmental conditions for transport and storage
◦ Noise
◦ Air leakages
◦ Accuracy
◦ Symbols and marking
◦ Connectors
◦ Strength
◦ Usability
◦ Pressed protection
◦ Accuracy

Medical device 1
◦ To do list how should we design the medical device

Medical device -application of risk management to medical devices

◦ This document specifies terminology principles and a process for risk
management of medical devices

Checklist

◦ The 510(k) regulatory pathway is a submission process that medical

device manufacturers use to get clearance from the FDA to market an eligible
product in the U.S.

Vacuum-assisted closure of a wound

◦ Vacuum-assisted closure of a wound is a type of therapy to help wounds

heal. It’s also known as wound VAC. During the treatment, a device decreases air
pressure on the wound. This can help the wound heal more quickly.

VAC-IROX

◦ Vacuum-assisted closure is a treatment that applies gentle suction to a

wound to help it heal. It's also called wound VAC or negative pressure wound
therapy (NPWT).
 ◦ VAC IROX offers wound care with instillation and oxygen therapy to
hospitalized patients to facilitate painless recovery of wounds at moderate premium
price.
◦ During the treatment, a device decreases air pressure on the wound.
This can help the wound heal more quickly.
◦ Therapy achieved an 82% success rate compared with 33% for wounds
present for >6 months prior to V.A.C. Therapy. V.A.C. Therapy is a feasible and
effective treatment for surgical and traumatic wounds in home care patients with
over 70% of patients treated in this sample achieving pre-defined treatment goals.
Types of wound healing

Here are some different types of wound healing machines commonly used in clinical
settings:
◦ Negative Pressure Wound Therapy (NPWT) Devices: NPWT devices, also
known as vacuum-assisted closure (VAC) systems, apply negative pressure to the
wound bed through a sealed dressing. This promotes wound healing by removing excess
fluid, reducing swelling, and increasing blood flow to the area.
◦ Ultrasound Therapy Devices: Ultrasound therapy devices utilize low-
frequency sound waves to promote wound healing. The sound waves penetrate the
tissue, stimulating cellular activity, increasing circulation, and promoting the
production of collagen, which is essential for wound repair.
◦ Hyperbaric Oxygen Therapy (HBOT) Chambers: HBOT involves exposing the
patient to 100% oxygen at a pressure higher than atmospheric pressure. This
increased oxygen concentration and pressure promote wound healing by enhancing
tissue oxygenation, increasing blood vessel formation, and fighting off certain
infections.
◦ Electro stimulation Devices: Electrostimulation devices use electrical
currents to promote wound healing. These devices deliver controlled electrical
impulses to the wound, which can help improve blood circulation, stimulate cell
growth, and accelerate tissue repair.
◦ Laser Therapy Devices: Laser therapy devices utilize focused light
energy to stimulate wound healing. The laser energy is absorbed by the cells,
promoting cellular activity, collagen synthesis, and blood flow, leading to faster
wound healing.
◦ Pulsed Electromagnetic Field (PEMF) Therapy

Companies

Smith & Nephew

KCI (Acelity)

Mölnlycke Health Care

ConvaTec

Medela

Talley Group Limited

Cardinal Health

Systagenix (now part of Acelity)