SPM MEDICARE PVT. LTD that has set-up a state-of-the-art manufacturing facility in the National Capital Region (NCR) of India for manufacturing Disposable Medical Devices and Disposable Apparel Range.
Since the Company's inception in 2015, SPM Medicare has emerged as one of the fastest growing companies in India in the medical sector, and the Company has won laurels for its commitment to Quality and Service in manufacturing and exporting finest products at competitive prices.
We have installed top-of-the-line automatic machines in our facility with a quest to achieve optimized manufacturing processes and to achieve highly safe and quality products. We manufacture all products under Clean Room Areas, and we have in-house ETO Sterilizer and dedicated Quality Lab equipped to meet national and international regulatory requirements. In addition to this, ease in the availability of raw material, experienced and dedicated team, and backing from leading financial institutions helps us to operate smoothly and reliably. We also value the hygiene and safety of our workers and ensure that they wear recommended safety gear during production.
The Company maintains and follows the Quality Management System as per ISO 13485 certified by TUV Rhineland (Germany). Further our products have also received CE certification from TUV Rheinland (Germany) and UKCert (UK). With above Certifications in place from the most stringent quality authorities, we have been able to Market and place our products in more than 20 countries around the world.
We are an organization that follows ethical values and believes in team work and respect for people. We always try to be a step ahead in our Marketing endeavours and believe in regularly adding new products to our portfolio.
Date : 21st Aug. 2019 Edition : Vol. 1, Editorial 1
YAVATMAL/NAGPUR: Fourteen women who underwent caesarean section deliveries at Yavatmal’s Vasantrao Naik Government Medical College and Hospital in April were aﬄicted by Surgical Site Infections (SSI). Instead of being discharged after 10 days, as is usual, some of these 14 patients are still in the gynaecology ward a month later.
Their relatives have alleged that the infection was caused due to the negligence of doctors and staﬀ. Taking cognisance of their complaints, Directorate of Medical Education and Research (DMER) sent a ﬁvemember committee to Yavatmal on Tuesday to record the statements of patients, on-duty oﬃcers, and the dean. The committee will also decide further course of action. Bebitai Kadhav, whose niece Jaishree Babre is one of the 14 patients, said her niece is suﬀering unbearable pain due to the negligence of doctors. “She was complaining of pain right from the day of her delivery on April 21. But doctors ignored her. When we noticed pus and blood oozing out of some stitches, doctors decided to apply fresh stitches. It was even more painful for her. The newborn baby is also suﬀering as she is not getting her mother’s care,” Kadhav said.
Krishna Bondre, whose sister is undergoing treatment since April 18, and Dnyaneshwar Paithankar, whose wife is suﬀering “Against our capacity of 120, we have more than 180 patients any day. More than 80% of our patients come from the rural areas. They hardly have any previous records or undergone sonography. Many expecting mothers are too weak for normal delivery. With HB count as low as 2, they can be easily aﬄicted by infections,” he said.
He added the hospital has conducted 2,871 deliveries by C-section in last one year, and 118 of these cases developed infections. “This is 4% of total cases. The national rate of SSI is nearly 22%. The same in Maharashtra is 7.8%. At our hospital, we have successfully kept it as low as 4%,” he said.
- Reference : GMC TNN I May 15, 2019, IST (THE TIMES OF INDIA)
Date : 29th Aug. 2019 Edition : Vol. 1, Editorial 2
Surgical site infection is one of the major burdens of any surgery; especially in orthopedic surgery, where a prosthetic infection can lead to disastrous consequences. Surgical site infection is the leading nosocomial infection, accounting for approximately 22% of all nosocomial infections.
According to CDC estimates updated this year, 157,000 surgical site infections (SSIs) occur each year. When SSIs occur, they extend patients’ hospital stays by 7.3 days and augment in-hospital costs by more than $20,000 according to latest estimates. SSIs cause the direct death of 3,251 patients and contribute to 9,726 deaths a year. Therefore, an active quest has been underway to reduce the risk of SSI.
One effective strategy against SSI is to adhere to a strict aseptic practice. The use of drapes and a proper surgical gown, an active barrier against bacterial contamination of the surgical field, has a large role to play in the prevention of SSI. While nearly 90% of surgeries in the United States are performed using disposable gowns and drapes, reusable material accounts for half of the materials used during surgical procedures performed in Europe. This has led to comparative research between the two practices, not only based on the patient’s protection against SSI, but also on health workers’ comfort, health care economics and the environmental life cycle.
A surgical gown serves two main purposes: to decrease the transmission of skin flora from health care staff and to protect the staff against the blood-borne pathogens of the patient. The protection should be reproducible and maintained during the whole surgery, even in the event of the gown getting wet with blood, sweat or fluid. Bacterial strike-through is a function of the material used, fluid exposure and pressure applied.
We lack a proper consensus on which type of gown to use due to the heterogeneity of materials and production techniques used in making gowns, the type of surgeries and other surgical factors, as well as the lack of a proper method to determine bacterial strike-through and its relationship to SSI. Moreover, the materials used in reusable gowns have undergone a dramatic change, making older literature about these gowns and their protection outdated. Despite these facts, recent published studies still favor disposable gowns as having a more solid, reliable and reproducible bacterial impermeability. With reusable gowns, these properties seem to fade with wetting or repeated wash. While reusable gowns, being more pliable and breathable, may seem more comfortable, this may dispel its concept of being an effective bacterial barrier.
Reusable gowns have been traditionally advocated based on ecoxnomic and environmental basis. However, proper analysis of these aspects is hard to perform due to many factors that should be taken into consideration such as production, transport, storage, disposal, decontamination, sterilization and unexpected loss and damage, especially of reusable gowns. Even if an economic analysis might favor reusable gowns due to their environmental impact and jobs related to their production, one should not lose the sight of their main purpose:to reduce SSIs.
- Reference : Sleiman Haddad, MD (Orthopedics Today, September 2014)
“Currently, single-use disposable linens are commonly used in the perioperative setting. “The benefits of using single use disposable linens include the fact that product quality is consistent. In a recent study comparing single-use and textile products, 56% of the textiles showed serious faults impairing functionality compared to 0 % of the single use products.”
Extract : Pyrek K. Barrier-Protection Properties are key to Surgical
Gown Performance. (Surgi Strategies. 2004 October)
Date : 11th Sept. 2019 Edition : Vol. 1, Editorial 3
The passage of bacteria through surgical drapes is a potential cause of wound infection. Previous studies have shown that liquids and human albumin penetrate certain types of drapes. We studied the passage of bacteria through seven different types of surgical drape and an operating tray. Bacteria easily penetrated all the woven re-usable fabrics within 30 min. The disposable non-woven drapes proved to be impermeable, as did the operating tray. We recommend the use of non-woven disposable drapes or woven drapes with an impermeable operating tray in all surgical cases.
Infection remains a problem despite modem aseptic surgical techniques and the routine use of antibiotics. There is also growing concem over the infection of healthcare workers by patients, particularly those with the hepatitis and human immunodeficiency viruses (HIV). It has been postulated that acquired immunodeficiency syndrome (AIDS) can be acquired by skin contact with HIV-infected blood. Braathen et al. suggested that HIV has an affinity for the Langerhans’ cells of the skin9 and, in 1987, the Centers for Disease Control reported three cases of non- percutaneous transmission of HIV in healthcare workers.
In the operating theatre, infective organisms can be spread either directly by means of instruments, hands and penetration of drapes and gowns, or indirectly through air contamination. Whyte et al. and Hubble et al. have shown that air contamination, caused by shedding of bacteria by theatre personnel, is a significant cause of wound contamination. They suggested special clothing with occlusive cuffs to prevent shedding.
The passage of bacteria through surgical drapes poses a major concern. Mackintosh and Lidwell performed experiments to determine the resistance to penetration by aqueous fluids of certain materials commonly used to make surgical drapes. Untreated woven fabrics are rapidly penetrated; non-woven synthetic materials resisted longer and tightly woven cotton fabrics resisted the longest.Ha'eri and Wlley used human albumin microspheres labelled with Tc as tracer particles to determine the permeability of drapes. The particles penetrated woven drapes, but not non-woven drapes. This study does not take into account the physical and biological differences between albumin and bacteria. These differences may affect rates of penetration.
Using a new method to assess the permeability of fabrics, we performed an experiment to determine the passage of Streptococcus viridans and coagulase-negative Staphylococci spp. (common skin commensals) through various wet surgical drapes.
Materials and Methods
We tested seven types of surgical drapes that are in common use in operating theatres in the Bristol hospitals, as well as a PVC operating tray. Twenty-four round agar plates, with a diameter of 90 mm, were prepared by filling them to the brim with Columbia agar (Becton Dickenson, Oxford, UK) containing 8% whole horse blood (TCS Microbiology). The plates were inoculated with 10 colony forming units of Strep. viridans and coagulase-negative Staphylococcus and incubated in air at 37°C for 18 h. The plates were divided into eight sets of three plates. A set of agar plates was assigned to each type of drape to be tested. A sterile section of drape was placed over each agar plate. Each drape was then wet with 15 ml sterile normal saline placed with a sterile pipette over the centre of each agar plate.
Twenty-four square agar plates, 100 mm x 100 mm in size, were filled to the brim with blood agar. Each of these plates was inverted and placed over a round agar plate. After 30, 60 and 90 min, a square agar plate was removed from each set and incubated for 48 h. All the square plates were inspected for growth of Strep. viridans and coagulase-negative Staphylococci spp. The experiment was then repeated a second time to check for reproducibility.
Scanty growth was defined as less than 10 colonyforming units. Moderate growth was defined as 10-10 colony-forming units. Heavy growth was defined as >10 colony-forming units. All of the reusable woven drapes allowed penetration by bacteria within 30 min. Drapes made of non- woven synthetic materials were impermeable (Tables 1).
Abstract : Ann R Coll Surg Engl. (2000 Nov; 82(6): 405–407.)
Department of Orthopaedic Surgery, University of Bristol, UK
Date : 20th Sept. 2019 Edition : Vol. 1, Editorial 4
Surgeons have the highest risk of contact with patient’s blood and body fluids. Breaches in gloving material may expose operating room staff to the heinous risk of infections. Today, At SPM, we quote this extract from a highly specialized study conducted at Lady Hardinge Medical College, New Delhi to prove a point.
The aim of the study was to assess the frequency of glove perforation, and subsequent blood or body fluid contact associated with common general surgical operations. For this purpose, a team of specialists used a method known as the spirit wash method on operating surgeons and the first assistant so as to detect the presence of pre and post operative skin abrasions. Perforation and visible skin contamination after surgery was recorded as below :
NO (%) WITH VISIBLE SKIN CONTAMINATION
The presence of visible skin contamination was higher in perforation with the single gloving pattern (42.1%) than with the double gloving pattern (22.7%).
Reference : Thomas S, Agarwal M, Mehta G. Intraoperative glove perforation: Single v. double-
gloving in protection against skin contamination. Postgrad Med J 2001;77(909):458-
Myth1 : Needle sticks and sharp injuries are uncommon events.
- Cuts or needle sticks may occur in as many as 15 percent of operations.
- Up to 16 percent of injuries occur while passing sharp instruments hand-to-hand.
- Suture needles are the most frequent source of injury and are involved in as many as 77 percent of total injuries. Most injuries are self-inflicted, but a notable number, perhaps as many as 24 percent, are inflicted by a co- worker.
-Most, if not all, surgeons have encountered blood on their hands or fingers at the conclusion of a procedure without being aware of an injury or glove barrier breach by any other method (glove puncture tear or failure). The practice of wearing two pairs of gloves offers a high degree of protection from this common event.
Myth2 : The glove failure rate is equally high with double gloves as with single
- Double-gloving reduces the risk of exposure to patient blood by as much as 87 percent when the outer glove is punctured. Volume of blood on a solid suture needle is reduced by as much as 95 percent when passing through two glove layers, thereby reducing viral load in the event of a contaminated percutaneous injury.
- One study conducted a prospective, randomized, trial of 143 procedures involving 284 people and found the glove failure rate (i.e., blood contamination of the fingers) was 51 percent when one glove was worn but only 7 percent with double-gloving.
Reference : Personal Protective, Infection Control Today By Linda McNeilly member of the
Surgical Products team at Cardinal Health
A state-of-the-art manufacturing facility has set up in the heart of the industrial belt of Noida (NCR), designed to incorporate various concepts of ‘Green Building’.
The manufacturing facility has a clean & controlled environment for handling raw material and finished goods.
Further, hygienic ‘ clean room’ environment has been designed for working areas such as gowning-rooms: Molding sections: assembly section: and packing section, meeting international CE and ISO 14644 standards.
Molding Machines manufacture the different plastic parts . This machine has been procured from global leaders in plastics injection molding process.
Fully-automatic Insulin Syringe Assembly machine has been specially designed in South Korea to achieve accuracy, quality, and speed in assembling. The machine is in-built with sensors and checks at regular intervals to reduce manual involvement and maintain consistency in quality.
Quality Test Laboratory is equipped with test machines and instruments to ensure rigorous Quality Control through-out the manufacturing process from raw material entry to in-process testing to finished product testing, ensuring proper safety, sterility, quality, and durability.
ETO Sterilizer Machine has been installed to sterilize the packed finished goods to make it completely safe for use. This machine sterilizes by using Ethylene Oxide (EO) gas.
IV Sets are manufactured and assembled in Clean Room of class 10,000 by highly skilled and trained manpower to ensure quality and accuracy in assembly process.
IV Cannula are assembled in Clean Room of class 10,000 by pneumatic machines of latest technology to provide quality, speed and accuracy in the assembly process.
Medical Disposable apparels are manufactured in controlled environment by highly trained individuals using high speed stitching and cutting machines.
A team of hard-working enthusiastic people who helped this product come to life.
He is an engineer from BITS Pilani. Has more than 10 years of rich technical experience. Prior to venturing in the field of medical devices, he held position of Senior Engineer in Rural Electrification Corporation Ltd., a financial institute under the Ministry of Power, Govt. of India
Has more than 25 years of experience in production and operations of various CE-marked sterile medical disposals such as Insulin Syringe, Other Syringes, IV sets, Surgical Blades, etc. He has served as Production Manager in leading manufacturing units. He has experience in working with the latest generation cutting edge plant and equipment with strong focus on cost control. He also has outstanding people management skills ensuring harmonious working of units with large manpower.