Effects of prosthetic materials on the host immune response: evaluation of polymethyl-methacrylate (PMMA), polyethylene (PE), and polystyrene (PS) particles.

The main causes for the long-term prosthetic implants' failure are the body's reaction to the implanted material or mechanical stress on the device resulting in the formation of wear particles. Particulate wear debris attracts macrophages, and depending on the chemical composition of the material and particle size, various levels of inflammatory response may occur. While transient inflammation is common, development of chronic inflammation may have serious consequences, leading to implant failure. Such a process may also cause systemic changes to immune functions and long-term effects on the host immune responses. In this study, we evaluated the effects of polystyrene (PS), polyethylene (PE), and polymethylmethacrylate (PMMA) particles on macrophage function and the generation of T-cell responses. Particles of various diameters were injected intraperitoneally into Balb/c mice, and immune functions were examined at 3, 10, and 21 days after the injection. The intensity of phagocytosis by peritoneal exudate cells (PECs) and the proliferative response of spleen cells from treated mice were evaluated. Enumeration of PECs revealed an increase in the total number of cells. Mice injected with PS or PE particles had a higher percentage of cells containing particles than PMMA-injected mice. Macrophages with PS or PE particles tended to adhere to and/or infiltrate peritoneal fibro-fatty tissues surrounding the spleen and pancreas, while the PMMA-carrying macrophages infiltrated the spleen, resulting in an increase of spleen size and "weight. The spleen cell proliferation assay revealed only mild and transient effects on the mitogen response in both PE and PS particle-injected mice. However, in the PMMA-injected mice we observed a lasting increase of the Con A response and a decrease of the LPS response. In vitro exposure of PECs from untreated mice showed a dose-response pattern in nitric oxide (NO) and TNFalpha production. While exposure to either PMMA or PE induced comparable levels of NO, exposure to PMMA induced a markedly higher production of TNFalpha than exposure to PE. The results indicate that particulate biomaterials may, in addition to the initial activation of phagocytes, significantly affect immune functions and compromise the host response to other antigenic stimuli.

Effects on instruments of the World Health Organization--recommended protocols for decontamination after possible exposure to transmissible spongiform encephalopathy-contaminated tissue.

It has been recommended by the World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC) that rigorous decontamination protocols be used on surgical instruments that have been exposed to tissue possibly contaminated with Creutzfeldt-Jakob disease (CJD). This study was designed to examine the effects of these protocols on various types of surgical instruments. The most important conclusions are: (1) autoclaving in 1N NaOH will cause darkening of some instruments; (2) soaking in 1N NaOH at room temperature damages carbon steel but not stainless steel or titanium; (3) soaking in chlorine bleach will badly corrode gold-plated instruments and will damage some, but not all, stainless-steel instruments, especially welded and soldered joints. Damage became apparent after the first exposure and therefore long tests are not necessary to establish which instruments will be damaged.

Damage of office supply, personal use items, and over-the-counter medical devices after sterilization by ethylene oxide gas, electron beam, and gamma radiation.

After letters containing Bacillus anthracis spores entered the U.S. mail in 2001, a problem emerged regarding how to decontaminate the letters, packages, and personal items in offices that received these letters. The effects of three sterilization methods (i.e. ethylene oxide gas [EO], electron beam [e-beam] radiation, and gamma radiation) were evaluated for a variety of office supply and equipment, personal use items, and over-the-counter medical devices. No single sterilization method was suitable for all items that could be mailed or found in an office. Damage or discoloration was evident for some items by each sterilization method. There were changes in the color of certain items, such as some of the packaging material, some pacifiers, some of the fabrics, and the nylon stockings after e-beam and gamma radiation. Both e-beam and gamma radiation damaged all film samples. Following EO sterilization and normal aeration, there were a number of samples with high (above 250 microg/g) levels of EO and samples with detectable ethylene chlorohydrin levels. The data would suggest that certain items exposed to EO sterilization must be further aerated prior to use, or discarded. Generic descriptions of products (such as plastics) or grouping of items (such as condoms) were not sufficient to predict what is safe in terms of EO residual levels remaining on an item. Successful decontamination of a wide variety of items will require careful selection of different sterilization methods.

Residual ethylene oxide in medical devices and device material.

Ethylene oxide (EO) gas is commonly used to sterilize medical devices. The amount of residual EO remaining in a device depends partly on the type and size of polymeric material. A major concern is the amount of residue that may be available in the body. With the use of the method described by AAMI for headspace analysis of EO residues, different polymers and medical devices subjected to different numbers of sterilization cycles were examined. Next, the effect of various extraction conditions and extraction solutions on these polymers and medical devices was evaluated. The results showed different polymers desorb EO differently. One polyurethane (PU 75D) had much higher EO residue than a different polyurethane (PU 80A). Repeated extraction of the PU 75D was necessary to quantify total EO residue levels. Different extraction solutions influence the amount and reproducibility of EO detected, whereas multiple resterilizations showed no difference in amount of residual EO. Bioavailability of EO was estimated by extracting the devices and polymers in water. Comparison of total EO residues to EO that was bioavailable showed no difference for some polymers and devices, while others had an almost eightfold difference. Some standard biocompatibility tests were run on extracts and devices, but no significant effects were observed.

Use of containment pans and lids for autoclaving caustic solutions.

As a means of decontaminating instruments possibly exposed to Creutzfeldt-Jakob disease, the World Health Organization has recommended immersion and autoclaving in sodium hydroxide. However, this recommendation has raised concerns of possible damage to autoclaves, and hazards to operators as a result of the caustic vapors. A series of experiments has been conducted that demonstrate that there are containment pan-and-lid combinations in which instruments can be autoclaved in sodium hydroxide without risk to the autoclave or the operator.

Effects of different disinfection and sterilization methods on tensile strength of materials used for single-use devices.

Driven by economic and time constraints, some medical centers and third parties are resterilizing single-use devices (SUDs) for reuse. The steam autoclave is quick, but most plastics used in SUDs cannot survive the temperature. Thus, a number of new methods of cleaning, disinfecting, and sterilizing these complex devices are being introduced on the market. The present study investigated the effects of a range of methods on the tensile strength of latex rubber, silicone elastomer, 2 different formulations of polyurethane, nylon, and high-density polyethylene (HDPE) specimens. The methods used were sodium hypochlorite bleach (Clorox), peracetic acid + hydrogen peroxide (Steris), formaldehyde gas (Chemiclave), low-temperature peracetic acid and gas plasma (Plazlyte), and low-temperature hydrogen peroxide gas plasma (Sterrad). The results showed that silicone elastomer was minimally affected, whereas the strengths of nylon, polyethylene, and latex were reduced by some of the methods. Depending on the formulation, the strength of polyurethane either increased or decreased. The data demonstrated that disinfection and sterilization can affect the tensile strength of certain materials used in medical devices.