|Intense and rising focus among regulators, hospitals and consumers to protect patients from harm, particularly from HAIs, is putting healthcare device makers under tremendous pressure to enhance their products with antimicrobial properties and other safety attributes. Several material manufacturers are offering more robust, nuanced and scientific alternatives. Several technologies and materials are being offered to enable healthcare products and services, medical device OEMs address existing safety concerns or proactively add value to differentiate their products in the marketplace.
SABIC Innovative Plastics offers customized antimicrobial compounds to help device OEMs combat healthcare associated infections (HAIs). Its line of LNP specialty compounds for medical devices, contribute to other important aspects of patient and clinician safety, from X-ray shielding to static dissipation in the presence of oxygen. Safeguards for patients and staff extend far beyond avoiding HAIs. SABIC compounds for medical devices can help address other top safety issues:
� Shielding against radiation and electromagnetic/radio-frequency interference (EMI/RFI): SABIC LNP Thermocomp HSG (high specific gravity) compound can replace lead in radiation shielding applications, enabling medical imaging device manufacturers to meet the European Union�s (EU) Restriction of Hazardous Substances (RoHS) directive. LNP Faradex compound combines Lexan EXL resin with proprietary fillers and additives to provide EMI/RFI shielding solutions with superior toughness, flame retardance and process ability.
� Detecting lost device parts: LNP Thermocomp compound can help to make a surgical device detectable via X-ray imaging. This safeguard allows the fragments to be located and retrieved before concluding the procedure.
� Decreasing �slip-stick�: LNP Lubricomp and Lubriloy compounds help to decrease the chance that a surgical device will slip or stick due to wear and friction. The inherent lubrication properties of these materials help ensure that the device performs consistently, thus avoiding errors and accidents.
Avoiding fire hazards: LNP Stat-Kon compound combines base resins with electrically conductive fillers or reinforcing agents to produce conductive and dissipative materials. LNP Stat-Kon compound helps protect devices and components against static build-up and electrostatic discharge (ESD), which present potential fire hazards in operating rooms and other locations where oxygen is used.
� Ensuring consistent drug delivery: LNP Stat-Loy compound provides permanent anti-static properties. This is important in drug delivery systems to prevent the medication from adhering to device walls and resulting in inconsistent dosages.
Bayer MaterialScience has introduced a specialty grade of resin designed for use in diagnostic imaging equipment, such as CT, MRI and PET scanners, workstations and kiosks. Bayblend M303 FR is a non reinforced, flame-retardant, amorphous, thermoplastic polymer blend of polycarbonate and acrylonitrile butadiene styrene copolymer (PC/ABS) for extrusion, blow molding and thermoforming. It can be used in surface device applications contacting intact skin. Bayblend M303 FR PC/ABS meets the requirements of ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization) guidelines. The blend can be utilized in surface device applications that contacts undamaged skin. The medical applications include kiosks, workstations and positron emission tomography (PET), magnetic resonance imaging (MRI) and computed tomography (CT) scanning devices. Main features of the medical-grade PC/ABS blend are exceptional deep draw for thermoforming, melt strength for extrusion and high hydrolysis and chemical resistance. The material is naturally opaque and is also offered in custom colors. Bayblend M303 FR plastic meets the specifications of ISO 10993-10 for sensitization and irritation and ISO 10993-5 for cytotoxicity. The material has good chemical and hydrolysis resistance, excellent melt strength for extrusion and deep draw for thermoforming. Naturally opaque, this PC/ABS blend is also available in custom colors.
Evonik Industries� �Care� line of plastics that includes a wide range of high performance polymers for medical applications. �Vestamid Care� and �Trogamid Care� products have undergone comprehensive biocompatibility tests by independent testing institutes and meet USP (US Pharmacopoeia) Class VI requirements. A range of customized products for medical devices, whether flexible or rigid, transparent or translucent can now be provided by the company. Existing medical applications include catheters for vascular treatment, surgical instruments and selector valves for infusion equipment. The biocompatibility of these Product Lines, that meet USP Class VI requirements, has been proven in comprehensive tests by independent testing institutes, A range of customized product solutions can be offered depending on the technical requirements for the medical device, whether flexible or rigid, transparent or translucent.
To address specific challenges facing the healthcare device value chain, The Dow Chemical Company�s portfolio of high performance polyolefin includes a strong commitment to service, production quality and regulatory compliance. Products in the portfolio of HEALTH+™ Polymers include specific grades of DOW� High Density Polyethylene, CONTINUUM™ High Density Polyethylene, and DOW� LDPE. Medical device brand owners and pharmaceutical packaging manufacturers selecting these polymers receive a strong service standard which includes a Notification of Change in specifications, product composition, sourcing location and discontinuation of product, and assurance the products are produced according to stringent specifications. Dow�s resins for the healthcare device market segment and pharmaceutical packaging industry may be utilized for injection molding, blow-fill-seal, injection blow molding and extrusion blow molding applications. These resins are fully supported by a dedicated team of technical service, research and development and marketing professionals and are backed by DOW HEALTH+.
DMDA-8007 HEALTH+™ High Density Polyethylene: Resin with excellent stiffness, low warpage, good toughness and good mold ability; suitable for certain injection-molded medical devices such as IV kit components and respiratory care as well as caps and closures for pharmaceutical packaging. Dow is aligning a wide range of resins utilized in the healthcare and medical device industry under its new Polymers umbrella. The HEALTH+ Polymers designation immediately offers customers these long-sought assurances:
� Product Quality - Manufactured to stringent specifications, allowing lot-to-lot consistency and quality.
� Regulatory Compliance - All medical application uses of these polymers must be approved by Dow pursuant to its Medical Policy. Each HEALTH+ Polymer has been certified in accordance with requirements for some healthcare applications. It is the responsibility of the medical device or pharmaceutical manufacturer to determine that the Dow product is safe, lawful, and technically suitable for the intended use.
� Commitment - These Polymers come with a Notification of Change in specifications, product composition, sourcing location, and discontinuation of product.
Radel® polyphenylsulfone (PPSU) resin from Solvay Specialty Polymers finds application in surgical sterilization units. The new product made of Radel PPSU is more chemically resistant than those made of acetal while also boasting reduced maintenance and extended service life. Radel PPSU is a super-tough thermoplastic with high heat resistance, exceptional hydrolytic stability and excellent chemical resistance. It can withstand over 1000 cycles of steam sterilization without significant loss of properties. It is inherently flame retardant and is resistant to bases and other chemicals. This material is also compliant with ISO 10993-1 for limited exposure, non-implantable applications. PPSU's broad processing window ability to be molded to tight tolerances. This resin can also be colored to provide users with an identification method to insure proper product connections. It�s high heat resistance and excellent hydrolytic stability make it an excellent choice for hot water fittings and medical devices requiring repeated steam sterilization. Radel R-7000 Series products are specially formulated for use in aircraft interiors and are in compliance with stringent FAA regulations requiring low heat release, low smoke generation and low toxic gas emissions. Acudel® modified PPSU offers cost advantages for applications with less demanding requirements. Typical Applications include sterilization cases and trays, dental and surgical instruments, medical devices, aircraft interiors, airline catering trolleys, hot water fittings, plumbing manifolds, food service trays
� High HDT of 207°C (405°F)
� Superior toughness and impact strength
� Exceptional long-term hydrolytic stability
� Better chemical resistance than PSU and PEI
� Withstands over 1,000 cycles of steam sterilization without any significant loss of properties
� Inherently flame retardant