Medical device market is increasing day by day with billions of dollars profit. Outsourcing medical devices means to seek services of third party companies and organizations. Outsourcing comprises of many services including packaging, validation, testing services, simple as well as complex assembly, and sterilization among many others. The main focus of outsourcing is often balancing quality time and costs to market. Outsourcing of medical devices is involved in fields of Pulmonary, Neurology, Orthopedic, OB/GYN, Biologics, ENT, Spine, and Cardiovascular among many others. The services offered by outsourcing companies for medical devices have various application in surgical Instruments, Bio-fluid Assemblies, Disposable devices, implants, Surgical Kits, Accessory Devices, Pharmaceutical Kits, and Pre-sterile devices. With the dramatic increase in the competition of medical services between several medical companies, it comes as no surprise that companies adopting the cost effective policy tend to find the best solution in outsourcing, as it not only saves them time but , also provide quality at comparatively low price. Rise in population has attributed to the rise in demandof medical supplies and devices.
The demand for quality is increasing day by day by healthcare units. To meet this standard is becoming difficult and outsourcing comes as an easy way. The number of patients is increasing and shortage of medical devices lead to poor health conditions and ill treatment of patient.
Market for medical devices is divided into three categories, Type I, II and III. Different types of medical devices fall in these categories. Type III contains most medical devices which are used in medical procedures.
The market for orthopedic medical devices has seen a rise in the last years due to rise in awareness of playing different sports and accident happening during sports. Some of the major outsourcing include GE Healthcare, Omnica Corp, Medical Systems LLC, Infinity Plastics Group, and Shandong Weigao Co. Ltd.
Many companies are entering the market giving the demand for medical devices is higher now than ever. Many known medical devices manufacturing companies are collaborating with other companies to generate more devices to meet the market demand. Such market collaborations prove to be very healthy between known companies. Established companies are striving hard to provide a one –stop solution for consumer market to cater all their medical needs giving the aggressive market competition between various companies.
Medical devices outsourcing companies such as QTS, LSO, etc. provide various services which not only attract large medical companies but also provide good platform for small vendors. These industries are chosen on the basis of their speed, stellar reputation, and assembly expertise of medical devices. These outsourcing companies also provide additional services including cleaning, inspection, non-sterile as well as sterile kitting, sterilization validation, repackaging, re sterilization, package validation, and package testing services along with special designed services handling more complicated and complex instruments.
According to the various researches conducted, it is seen that there is an increase as much as 13.5% in the implementation of medical devices. In 2013, Class II type medical devices were used rapidly across all platforms.
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Sterilization eliminates transmissible agents including bacteria and harmful spores which helps in killing diseases caused by microorganisms. Different sterilants such as heat and chemicals are used for sterilization of medical equipment.
Clean and dry medical equipment’s are a necessity for keeping the patient health care important. As clean medical tools is necessity for operation, dirty and unhygienic tools leads to spread more infection to the patient instead of curing him. That’s why great care is taken to sterilize the equipment before use. There are several methods available for sterilization, though use of various techniques, most popular are;
1 – Dry Heat Sterilization
This method is used or materials that are in effected or damaged by moist heat for example, petroleum is a product which is not effected by moist heat. There are several reasons to use dry-heat sterilization, the top one is because it is environment friendly and doesn’t harm the environment. It consumes lesser space and is portable enough to adjust is small spaces. Its operating cost is also comparatively low. It is also used for sharp instruments because it is non-corrosive.
Dry heat sterilization includes two types;
I – Static-air
This type is called static air because when in unit’s bottom, coils are heated, hot air rises due to gravity convention into chamber to attain sterilization temperature. This whole process is very slow, it takes a lot of time and non-uniformity of the temperature is unbearable due to which the process is slowed down. It is replaced by more effective and faster Forced-air sterilizer.
II – Forced-air Sterilizer
This type of sterilizer comes with a blower that is driven by motor and it circulates high velocity air throughout the chamber. It allows for a faster and efficient transfer of energy from air onto the instrument for better sterilization. It is faster than static-air sterilizers comparatively.
2 – Chemical Methods
Chemical methods in large numbers are available in market today. Several liquid sterilants such as Ethylene Oxide (ETO), and Chlorine Dioxide (CD) etc. are used in market today. Ethylene Oxide (ETO) is used for preservation of species. They are used to help in sterilizing medical equipment’s which are heat-sensitive and can’t be exposed to heat or else they’ll be damaged. Objects are filled in the sterilizer container to be sterilized. The basic ETO cycle is about 5 stages, and sterilized objects are removed upon completion of all cycles. It stops microbial reproduction. The problem with this is that high temperature sustainability is not present in it and low temperatures provide opportunity for embedded medical devices to be sterilized properly. All of chemicals that use some or other chemical methods are highly inflammable and are sustainable at low temperatures only. They do not provide high temperature sustainability. Care should always be taken in determining the best chemical to sterilize medical devices at hand.
3 – Microwave
This method uses microwaves technology to disinfect soft lenses, milk, dental instruments, and urinary catheters for self-catheterization. As microwaves are radio waves, they must be used with devices which are compatible and durable and do not melt. In an alternating voltage (AC) current they produce water molecules. This produces heat which kills harmful bacteria. Using microwaves at various frequencies not only increase the temperature level but also purifies medical equipment at hand.