AD Syringes were used in immunization projects by UNICEF/PATH even prior to 2000. For curative injections HMD introduced AD Syringes first time in India in the year 2002
Auto Disable syringe is a syringe that cannot be reused. It incorporates a mechanism to automatically break or lock the plunger as the injection is being given to make the syringe inoperable for possibly being used for a second time.
How they are different from similar products available in the market?
Kojak has an involuntary activation of the Auto disabling mechanism, whereas most reuse prevention Syringes manufactured by some of the competitors have a voluntary activated disabling mechanism for reuse prevention.
The role played by HMD to bring the AD Syringes in curative sector?
HMD has been educating Public Healthcare Officers of the need for injection safety via AD Syringes. Field staff of HMD have conducted CME Programmes w.r.t. the usage of Auto disable syringes & importance of AD Syringes for curative purpose in almost all the leading hospitals in India. As far as govt. sector is concerned, HMD has regularly been participating in AD Syringes tenders of State Govt. HMD has been sending communication to the various state Govt. Officials, emphasizing on importance of AD Syringes for curative sector
There exist a large market potential for this product, which is bound to grow thanks to the important role played by Media in enhancing awareness to the general public regarding dangerous effects of reuse of syringes. Before launching the product, we had done clinical evaluations of the product in a few hospitals, in India and in Africa not only for assessing of quality of the product but to get feedback on its relative user friendliness and need for training limited to only introduction of technology.
What made you enter this market? Where does HMD stand in the market?
HMD has played the leadership role in injection drug delivery, whether Glassvan Glass syringe. Dispovan Disposable or now KOJAK AD. HMD has been a key driver in the market development not only in India but worldwide for AD Syringes for Curative Injections. HMD is the currently largest manufacturer world wide of curative AD Syringes technology.
KOJAK's successful usage in international projects such as USA's 'Making Medical Injection Safer' in 10 countries in Africa led to legislative change in countries like Uganda and Nigeria discontinuing the importation of standard disposable syringes and follow a 90: 10 policy. 90% AD Syringes with 10% Reuse Prevention Syringes with/without Needle stick prevention design.
Do you plan to launch more device products in the future and what will so special about those products?
We have recently introduced evacuated Blood Collection Tubes to ensure safe collection of Blood and for enabling accurate and reliable automated testing - this is the future for diagnosis for preventive healthcare
Vision- Role of Regulator is to work with industry in transparent manner, Supervise directly/ through Accrediated and competent Conformity Assessment agencies, Aim to promote public trust in Indian industry, Provide guidance & advice to the Industry for meeting legal obligations. While keeping in mind the, safety of consumers the regulator needs to facilitate the growth of Industry. For stopping Injection Reuse Regulators can be more proactive on suomoto basis as has been the case with Uganda and Nigeria (and soon to be followed by Zambia and Tanzania) in raising the bar of product standard and restricting availability of standard disposable syringes in private sectors like slums and rural areas with clinics run by Quacks.
There are 18-20 Medical Devices under Drugs & Cosmetic Act 1940.
* Controlled & Inspected by Drug Controller General India/ CDSCO, State Drug Controller, Central/State Laboratories.
* License Raj, undergoing review, there is limited knowledge / lack of competencies. There is lack of risk based assessment and proportionately varying degree of regulatory control. As there are no products standards for new products/technologies the regulatory principle of medicine can not be applied to medical devices which depends upon constant innovation and design review for improving patient safety or in assisting medical procedures.
Majority of Indian exporting units comply with ISO 13485 and certificate/registration with GHTF countries.
Top 5 world wide preferred source status has been achieved in :
1) Syringes
2)
Needles
3) I. V Cannulas/Catheters
4)
Contraceptives
5)
Surgical Blades
6)
Gloves
* Upgrade:
1) Manufacturing & testing facilities
2)
Management competencies
3)
Quality management systems
* Get ISO 13485 certification from internationally accredited organizations
* Get registration & certification from a GHTF member country.
* Self regulation / Dialogue with MOH to assist in building the regulatory framework.
What was the obstacles faced by HMD to bring & popularize the AD Syringe in India?
* Exploding the myth of high prices and unaffordability.
* Exploding the myth of lack of adequate availability and capacity
* Exploding the myth of 'Hospital Waste Management' as a substitute for 'AD Syringes Deployment' for ensuring injection safety through non reuse.
* Denial of the problem of Reuse of Syringes in public and private healthcare institutes and of unsafe injection practices.
What is the success gain by HMD during these years?
Leadership in India and the world. HMD is now one of the Top 5 syringe producers in the world and gained respect and credibility with various public healthcare institutes in Africa and also private healthcare institutions in USA and Europe.
As AD Syringe is primary targeted for public healthcare consumption initially, the growth is dependent upon Government policies. If the Government is smart and willing to invest for the long term benefit in preventive healthcare to reduce noscomial infections they will see the benefits of this technology. Radial tyres are more expensive than Nylon Tyres. They however last much longer so smart consumer buy them as they are more cost effective.
if Government wants to reduce the ALS (Average
Length of Stay) of patients in hospitals and
save money - AD Syringes is good starting
point to bring about change as SPI (Safer
Patient Initiative) .
What is the difference between a two piece & three piece Syringe?
Sterilization of a Syringe in a Ribbon packing is done by passing Ethylene Oxide gas through perforations in the plastic film through the paper ribbon in the packing
The serrations of the film allows E.O. gas to go through the controlled porosity paper ribbon to permit sterilisation.
Plastic film covers the paper ribbon for protection and improving puncture resistance.
Differentiate between Luer Mount & Luer Lock Syringes?
Luer Mount (LM) Syringes are Syringes which permit needle fixation on to Push fit slip tip attachment, while Luer Lock (LL) Syringes are Syringes which permit more secure fixation with Screw on Locking Collar on a Luer Tip. Luer Tip indicates a 6% Taper and is the universally accepted standard for fitment of connectors medical application for ensuring minimal chances of leakages.
Luer Mount
Luer Lock
How is Ribbon packaging better than blister packing?
The plastic lamination of Ribbon packaging has higher puncture & tear resistance than the paper lidding of a blister pack – the sterility assurance factor is therefore relatively superior. Additionally the package doesnot get dusty/dirty/wet in poor handling & transportation, prevalent in underdeveloped / developing nations.
Difference between 1 ml Insulin & Tuberculin Syringe.
1 ml, Insulin Syringe are of two types – U 40 & U-100 Insulin Syringes. Iin U-40 Insulin Syringes markings on the barrel are 5, 10, 15,.............. 40 Units, while in U-100 markings are 10, 20, 30,......................100 Units.
While in case of 1 ml Tuberculin Syringes the markings are in 0.1ml, 0.2ml, 0.3ml,........................ 1 ml.
The above mentioned different markings are based on medication dosage prescribed to the patient.
Gasket is made of natural rubber which has been validated as per ISO: 7886/IS10258 standard for compatibility for wide range of solvents used in medication.
What is the difference between Catheter and Cannula?
Cannula is a short flexible tube which is introduced into a blood vessel, while Catheter is defined as a tube which is substantially longer than Intra Vascular Cannula for peripheral access to body.
Differentiate between cannula & Introducer Needle?
Cannula is Tubing (eg. Poly Tetra Fluro Ethylene ) which remains inside the body, while Introducer Needle is Stainless Steel needle used for inserting the Catheter / Cannula.
2 way I.V.Cannula has integrated side port through which second line of medication is possible, while in 1 way I.V.Cannula only one port is present for drug delivery.
Difference between Teflon, PTFE & FEP Cannula / Catheter tubing.
Teflon â is the brand name of Dupont for its range of Fluro Polymers – PTFE (Poly Tetra Fluro Ethylene) & FEP (Fluorinated Ethylene). PTFE is relatively superior to FEP in having a lower coefficient of friction which is an important factor to minimise trauma to the blood vessel/Tissue for enabling smooth cannulation. FEP is easier to process and form thinner tips of catheter then PTFE , so where you use a little on friction you gain a lot on initial penetration force.
How is Volex Catheter superior than Teflon Catheter ?
Volex catheter is superior then Telflon Catheters which have the inherent limitation of Peel Back on attempts of reinsertion or damage to the tip, leading to reduced indwelling period.
Volex Catheters have below mentioned advantages over Teflon Catheter :-
Ease of insertion without peelback - making second & third reinsertions possible without having to throw away I. V. Cannulas on unsuccessful cannulation.
Extended indwelling period - leading to fewer I. V. Cannulas being consumed.
Fewer Complications - Minimum risk of thrombus generation while reducing medication costs.
Pain Advantage
Minimal trauma - as the penetration force required is only 30% that of PTFE Catheters.
Normally, I.V.Cannula can stay in the body from 24 to 48 hours after insertion, Instances of 48 – 96 hours has also been reported of Cannulation without Thrombophlebitis.
Delivery schedule is usually of 4-6 weeks after receipt of confirmed order for FCL Orders. Specific delivery can be commenced only on receipt of quantity wise query.
On receipt of requirement details, quantity wise/size wise and destination port and mode of transportation, we will send our quotation and prices to you.
How are auto-disable syringes different from other syringes?
Auto Disable Syringe are Syringe that cannot be reused. They incorporate a mechanism to break or lock the plunger when the injection is given to make the syringe inoperable for being used for second time.
Whether it is acceptable to re-use contaminated single-use syringes?
Do not push the plunger forward to avoid activating the Reuse mechanism.
Draw back the plunger only once.
It's not necessary to aspirate when injecting EPI Vaccines.
Which of the following can be used to clean the injection site?
