“Most recent regulatory developments: Medical Device Single Audit Program (MDSAP) and EU Enforcement of Unannounced Audits”

The first part of the presentation will focus on the most immediate impact on Industry from International Medical Device Regulatory Forum (IMDRF) – the Medical Device Single Audit Program (MDSAP), one audit serving many regulations. Learn about the MDSAP for the US, Canada, Brazil and Australia. Since May 2014, authorities of these countries have been appointing audit organizations for the MDSAP program. In the future, MDSAP certificates will replace regular audits from the named authorities.

The second part of the presentation will focus on new product sampling and testing requirements associated with unannounced audits and offer suggestions for ways manufacturers can prepare and train in advance. In response to the EU Commission Recommendation on 24 September 2013 (2013/473/EU), Notified Bodies must implement unannounced visits to CE-certified manufacturers, sub-contractors and/or crucial suppliers.

Mr. Apur Lathiya
Executive Vice President
Sales and Marketing,
Lubrizol Advanced Materials,
USA

“Tubing- More Than Just Dimensions”

Vesta, a Lubrizol company, is a contract manufacturer of precision thermoplastic extrusion for every catheter component. This presentation will provide an overview of not only the various tubing types and materials but the importance of understanding tubing beyond dimensions including the benefits of understanding the assembly process and the functional use. Tubing types will include balloon tubing; braided tubing, multi-lumen tubing, profile tubing, as well as striped and multi-layer tubing will be covered.

“Henkel Loctite® Innovative Adhesive Solutions For Medical Device Assembly”

The medical market has evolved over the past several years and is facing unprecedented challenges that were unforeseen just a few years ago. Increased government regulation, heavy cost pressures in emerging markets, and increased public pressure to achieve sustainability are challenging companies to drive operational efficiency and revisit material selection in order to succeed in the future global medical marketplace.

To meet the objective, device manufacturers are looking at manufacturing process & exploring opportunities to reduce the overall cost. They are looking at not only input cost (i.e., materials), but also at the manufacturing process and the outputs (i.e., scrap, waste stream, etc.). While improving the quality of the product they currently also have issue of rejection with the use of conventional solvents (drip marks, leaks, etc.), but these are never really measured or looked into closely at because of the low cost of solvents. Device manufactures are looking for a way to replace potentially-toxic solvent bonds to reduce and control worker exposure to toxic and carcinogenic solvents.

“Antimicrobial Strategies for Medical Devices”

The challenges for implantable medical devices coatings are threefold – the coating should protect the device from the body, protect the body from the coated device and importantly without impairing the function of the body or the medical device. This is a very pertinent concept for antimicrobial medical devices.

The clinical problem for implantable medical devices has been known for some time and various methodologies have been used to combat this problem. The price, both in terms of patient life and treatment cost, is having great effect on healthcare providers.

This talk will consider the clinical problems, the strategies employed to overcome medical device infections and will also discuss a new approach developed by BioInteractions Ltd, the AvertPlus™ Surface Enhance Antimicrobial Coating and reveal a new concept to treat medical device infections, Evolve™, this technology combines the advance dual function anti-thrombogenic and anti-platelet moiety with antimicrobial functionality.

“Electrolytic Dissolution Of Stainless Steel For Contamination Free Orthopedic Implants – An Innovative Approach”

Method of electrolytic dissolution of austenitic grades stainless steel for electro-deburring and simultaneously electro-polishing on stainless steels.

‘Corrosion’ as such has always been a dreaded word as it is known to alter the properties of corroded metal which in turn, affects the medium in which the metal is placed. The problem is particularly encountered in the case of orthopedic implants that are used in human body for fixation and positioning of bones. The rusting of these implants can at times even result in toxicity of blood. Also, sometimes the implants that are used are contaminated due to machining operations like, drilling, reaming, milling, turning, polishing, buffing, etc. These operations when carried out on austenitic stainless steel components generate burrs, chips, fine residual particles of iron on the machined surfaces. In the absence of a suitable technology on implants, it may also transmit contaminations, like; iron particles, aluminum oxide, silicon carbide, tungsten carbide and various wax compositions in the implants. When implants with these contaminations are used, they produce harmful effects in the body. It is important for these parts to always remain in hygienic condition in order to meet its purpose. These contamination needs to be removed from the orthopedic implants prior to their fixation in human body.

A suitable electrolyte was, therefore, needed for electro-deburring of implants and other plant and machinery for removal of contaminations. Developed by EDI, this technology of electropolishing by using suitable electrolyte is a boon to the sector. The invention ensures removal of contamination and hence hygienic conditions. As Mr. K.K. Shaw, Inventor of the technology and Faculty - EDI puts it, “In order to produce machines as per international quality norms, it is important for manufacturers to adopt the best of technology that guarantees superior and safe results in hygienic conditions.”

“ETO Sterilisation : Technology, Trends And Developments”

ETO Sterilisation continues to remain the most preferred mode of sterilisation for several decades now. However, it is important to be updated with current industry trends.

Traditional use of spore strip indicators has been replaced by Self Contained Biological Indicators, which are easy to handle, test & retrieve. Direct measurement of humidity is now possible as EtO compatible humidity sensors are readily available. Traditional use of sensors for temperature and humidity mapping using long, rigid cables is replaced by wireless/infrared probes. Dependence on plastic films has reduced. The use of Medical grade paper on one side has become the norm due to its better permeability. Considering toxicity of EtO, it is mandatory to have an exhaustive ‘Risk Analysis” done. EtO gas abatement /scrubbing solutions are available that convert EtO into a non hazardous form. Monitoring of EtO levels in work areas is important to assure worker safety.

In order to meet market demands, sterilisation companies have to constantly keep up with changing technology trends.