Disposable Medical Devices Research Articles

Functional properties and performance of new and reprocessed coronary angioplasty balloon catheters

The need of health costs control has prompted the reuse of devices originally manufactured for single use only. To assess reprocessing feasibility of disposable medical devices, hygienic, technical, and functional aspects must be taken into account in addition to economical, ethical, and legal implications. This study aims to characterize coronary angioplasty catheters and to evaluate performance changes induced by reprocessing. Multiple analysis including crossing profile, slipperiness, compliance, mechanical, and burst pressure tests were performed at different steps of the protocol on 25 catheters reprocessed up to two times. The results highlighted that both use and reprocessing can affect the features of angioplasty catheters. Mechanical stress caused by clinical inflation and thermal-chemical stress undergone by polymers during cleaning and sterilization procedures caused partial modifications of material properties, inducing an overall shrinking effect on balloons. Compliance tests reported a maximum variation of 6.2% from nominal values, showing the conformity of reprocessed devices with manufacturers' original specifications (+/-10%). The burst pressure of reprocessed devices was 80% higher than the rated burst pressure certified by manufacturers, thus reducing concerns of breakage during reuse. A strict dependence on device model in the behavior of catheters was found, especially for balloons crossing profile and slipperiness. Main changes occurred after the first reprocessing cycle, while a second cleaning and sterilization did not introduce further significant alterations. On the whole, the magnitude of modifications introduced up to two reprocessing cycles did not compromise catheters performance.

Reprocessing disposable single-use devices: From skepticism to success

ISSUE: The economic pressure to cut healthcare costs is driving facilities to consider reprocessing open but unused medical devices as well as used devices that are expensive. The reuse of disposable medical devices that are labeled “for single-use only” (i.e., single-use devices, or SUDs) raises legal, financial, ethical, and patient safety issues. PROJECT: A SUD reprocessing committee was formed at a university medical center with representation from the following departments: infection control, risk management, accreditation and patient safety, financial management, administration, sterile processing, materials management, procurement services, peri-operative services, radiology, and cardiology. The mission of the SUD reprocessing committee is to establish policies and procedures for the reprocessing of SUDs that will ensure patient safety and quality healthcare. RESULTS: The SUD reprocessing committee established the following policies: 1) Onsite reprocessing is strictly prohibited. 2) Reprocessing may be performed only by FDA-registered third-party reprocessing companies approved by the health system. 3) Each department will determine which SUDs are candidates for reprocessing. 4) Third-party reprocessing must be approved by the SUD reprocessing committee and the hospital infection control committee (HICC). 5) Departmental approval must be obtained for each SUD from the medical director or designated clinical leader based on their expertise in the use of the product. 6) The request to reprocess a SUD must be submitted to the SUD reprocessing committee for approval. 7) The SUD reprocessing committee will submit approved requests to the HICC for final approval. We began reprocessing Category I devices (BP cuffs, SCDs, pulse oximeter sensors, disposable stethoscopes) on June 1, 2003. We began reprocessing Category II devices (bits, burrs, blades, external fixation devices) on April 1, 2004. Beginning in July 2004, fiscal year-to-date savings for both Category I and II devices were $272,565. No patient safety issues related to reprocessing have been identified. LESSONS LEARNED: Successful implementation of reprocessing of SUDs is dependent upon careful analysis of potential risks and benefits. Our SUD reprocessing committee established policies to ensure detailed evaluation prior to approval of reprocessing selected items. SUD reprocessing resulted in substantial cost savings to our health system without compromising the care of patients.

Agents transmissibles non conventionnels

Ophthalmologists must take into account the possible emergence of unconventional transmissible agents in their daily practice. Official recommendations have been circulated; however, their routine application remains difficult, with technical and financial considerations limiting factors in the use of an ideal of one disposable medical device per patient. This review describes how these recommendations are followed and tries to provide insights into improving daily practice with these unconventional transmissible agents.

North American medical device plastics market continues to rise

According to a report from Business Communications Company, Inc., RP-121U Plastics for Medical Devices, the North American medical plastics market was estimated at slightly over 1 billion kg (2.2 billion pounds) by the end of 2002. It is expected to grow at an AAGR (average annual growth rate) of about 4.3%, consuming almost 1.3 billion kg (2.9 billion pounds) by the year 2008. Disposable medical devices comprise about 60% of the total volume for all years. This is a short news story only. Visit www.addcomp.com for the latest additives and compounding industry news.

Radiation‐induced migration of additives in PVC‐based biomedical disposable devices Part 2. Surface analysis by XPS

AbstractExtruded parts of non‐sterilized and β‐irradiated (25 and 50 kGy) plasticized poly(vinyl chloride) (PVC) used for disposable medical devices have been studied to investigate the effect of sterilization on surface chemical composition. The polymer surfaces were analysed using angle‐resolved x‐ray photoelectron spectroscopy. The inner surface of the blood tubing lines showed a fairly smooth surface both before and after sterilization, so a laterally homogeneous surface can be assumed for XPS analysis. The XPS survey spectra exhibited no signals besides carbon, chlorine, oxygen and calcium. Detailed analysis of the regions showed the C 1s, Cl 2p and O 1s signals to be multi‐component, presenting signals of the PVC, the plasticizer and the other additives. Binding energies remained constant irrespective of β‐radiation dosage, but the amount of chlorine component at 198.4 ± 0.1 eV (associated with modified PVC) decreased with sterilization dosage. Angle‐resolved XPS revealed that this component is located at the outermost surface of the polymer. It can be hypothesized that the production processes themselves (extrusion and/or injection molded) already induce modifications of the polymer surface and also lead to surface segregation of the plasticizer. During the subsequent thermal sterilization of the polymer dehydrochlorination continues but, because of the very short time required by the β‐irradiation technology to sterilize devices, the atmospheric oxygen is unable to diffuse into the irradiated material, thus inhibiting further side‐degradation of the materials, such as thermo‐oxidative degradation. Copyright © 2003 John Wiley & Sons, Ltd.

Recycling and reuse of disposable products in radiology

Legitimacy and appropriateness of recycling and reuse of single-use disposable medical devices is a common issue in many areas of medicine. Advocates of reprocessing claim economic savings and environmental benefits. From the manufacturers' point of view, the single use is a characteristic property of their products. Moreover, they warn that using of recycled instruments makes the procedure more difficult and increases the rate of adverse events. As comparative tests demonstrate, reused products are sometimes inferior to the genuine ones with respect to mechanical properties, but these differences may have relatively little consequence for the performance of the products and the success rate of the interventions. With rigorous cleaning and sterilizing of the instruments, patients do not run an increased risk of infection. Sterile single-use products are subject to the German Medical Products Act (1994) and the German Medical Devices Ordinance (1998). New legal provisions (in force since January 1st 2002) have restricted professional recycling of used devices further. Companies reprocessing medical products for the original users are free from certification liability. CE can no longer be issued for devices newly placed on the market. Lawyers controversially discuss whether patients must be informed about the use of recycled products. In view of the otherwise strict regulations concerning the information given to patients, it seems imperative to obtain a written informed consent when reprocessed devices are used. This might interfere with the confidential relationship of patients and physicians. The combination of increased risk, strict legal regulations, ethical concern and adverse publicity demand to refrain from reprocessing and reusing disposable equipment in diagnostic and interventional radiology.

プラスチック技術の進歩とディスポ製品への応用 (<特集>20世紀の技術進歩と医科器械への応用)

プラスチック技術の進歩とディスポ製品への応用 (<特集>20世紀の技術進歩と医科器械への応用)

Reuse of disposable medical devices: Right or wrong?

Reuse of disposable medical devices: Right or wrong?

The environmental impact of irradiation plants

The radiation sterilization of disposable medical devices and other medical products brings major benefits to mankind. Furthermore there are potential opportunities to use the irradiation process to significantly improve our environment. Careful examination of the environmental impact of both electron beam and gamma irradiators confirms that these major benefits are not achieved at any significant environmental cost.

Anesthesia and non-conventional transmissible agents (or prion diseases)

The transmissible spongiform encephalopathies (TSE) represent a group of neurodegenerative diseases with lethal outcome. They include Creutzfeldt-Jakob disease (CJD) and kuru, among others in humans, scrapie in sheep and spongiform encephalopathy in cattle (bovine spongiform encephalopathy: BSE). Some are autosomal dominant disorders like CJD, Gerstmann-Straüssler-Scheinker disease (GSS), with point mutation of the prion protein gene. Most of these diseases are idiopathic rather than sporadic, latrogenic CJD could be obtained by central inoculation (neurosurgical instruments or dura mater grafts) or by peripheral inoculation (pituitary hormone therapy). A new variant clinicopathological type of CJD (nvCJD) has been reported. The nvCJD has strain characteristics distinct from other types of CJD, close to those of BSE transmitted (studies with intracerebral inoculation), consistent with BSE being the source of this new disease. All of these spongiform encephalopathies (SE) are characterized by spongiform degeneration of the brain, reactive gliosis in the cortical and subcortical gray matter, neuronal loss and presence of the abnormal isoform of the cellular prion protein (PrPc). In prion disease, PrPc undergoes conformational changes involving a shift from alpha-helix to beta-sheet structure. These neurologic lesions are characterized by major variations from case to case. Neuropathological studies in sporadic CDJ have emphasized phenotypic variations. Clinical presentation with a wide spectrum of manifestations is a rapidly progressive dementia, associated with myoclonus or akinetic mutism and cortical blindness. The clinical course is atypical and when the characteristic triphasic abnormal EEG of CJD is absent, there is an urgent need for a premortem diagnostic test. Histopathological examination of a brain biopsy carries a risk of major morbidity and may miss the site of disease. The 14-3-3 immunoassay of cerebrospinal fluid strongly supports a diagnosis of CJD. Western blot analysis of human tonsil biopsy may allow an early or preclinical diagnosis. It has been suggested that CJD might be transmitted by blood products derived from patients with CJD during the prodromal stage, although CJD linked aetiologically to blood transfusion has not been demonstrated. In animal studies, intracerebral inoculation of infected cells has been associated with development of disease, but never after peripheral inoculation into the blood stream. For the most part of conformational changes of PrPc, the remarkable resistance of the infectious agent (PrP alone or combined) to ordinary sterilising procedures is a major problem. Because of this resistance, current recommendations are to recognize patients at risks and to use disposable medical devices. This is particularly true in anaesthesia during endotracheal intubation, spinal anaesthesia, and to a lesser extent with peripheral nerve blocks. All instruments used for patients with CJD must be destroyed. The economic consequences of these measures have highlighted the essential importance of an early diagnosis.

Radiosterilization of disposable medical devices

The initial contamination and the radiosensitivity of microorganisms isolated from 400 samples of disposable medical devices such as gauzes, eye pads, catguts and chest bottles were determined among which the Bacillus spp. were predominant. For each species the hydrophobicity of spore as measured by BATH method was greater than that of the vegetative form. Hence, it is necessary to reduce Bacillus population in samples using a suitable sterilization process such as ionizing radiation.

A fully integrated 10 MeV electron beam sterilization system

Societal pressure to check rising health care costs has resulted in demands for less expensive and more flexible methods to sterilize medical devices. This has generated renewed interest in electron beam sterilization because it offers fast turn-around time, high efficiency and improved reliability. The combination provides the opportunity for lower sterilization cost. The new Titan electron beam system in Denver, Colorado was designed and is operated as a 100% dedicated medical device sterilization process facility. It combines the electron accelerator, conveyor, safety, documentation and control subsystems into an integrated system used exclusively for the sterilization of disposable medical devices. System specifications and performance features are presented and plans for future development are discussed.

Sterilization and reprocessing of materials and medical devices--reusability.

Problems associated with reprocessing of disposable medical devices such as hemodialysers with resterilization for reuse and changes in material properties with resterilization of polymeric (PVC, polypropylene, polyester, polycarbonate) materials intended for development of disposable devices are reviewed. Reprocessing of hospital supplies, polystyrene microtiter plate and angiographic catheter for reuse is also discussed.

The advantages of contract sterilization.

The concept of utilizing contract sterilization of medical devices. The advantages and disadvantages of utilizing contractors for the sterilization of disposable medical devices are presented, including the use of cobalt-60 gamma, electron beam, and ethylene oxide. A general update on the scope, activities, and capabilities of the contract sterilizer is included.

Molecular assessment of the membrane menaquinones of irradiated micrococcus on disposable medical devices with high performance liquid chromatography (HPLC)

The genus of micrococcus and its main species like; M. Roseus, M. Nishinomiyansis consist of upto 10% of microbial contamination of disposable medical devices. Chemical alteration of Menuquinones Mainly [MK-7-(H2), MK-8(H2),…] from some Irradiated species of the micrococcus at different doses (500 Gy to 25 kGy; the sterilization dose) are quantitatively evaluated by HPLC.

Technical and regulatory requirements for radiation sterilization facilities using electron beam accelerators

Various technical and regulatory considerations must be addressed in order to sterilize disposable medical devices by ionizing radiation. Current practices specific to electron beam-based sterilization events are discussed and include material compatibility testing, dose setting, dose mapping, process validation and process control associated with the accelerator/conveyor system. Projected trends in regulatory guideline development are made relative to the appearance and implementation of reliable high power machine-generated sources of electrons operating in the energy range of 0.3–12 MeV.

The strategic human resource management process in practice

Becton Dickinson (BD) is a $2.5 billion medical technology company. Our primary product lines are disposable medical devices such as syringes, needles and scalpels. The other half of the business is diagnostic instruments and systems, ranging from one‐step pregnancy tests to large instrument systems. Fifty‐five percent of our sales are in the U.S., although our international segment is growing much faster than our domestic operations.

Packing and Sterilization Methods for Disposable Sterile Medical Devices

Packing and Sterilization Methods for Disposable Sterile Medical Devices

Adaptation of the centers for disease control guidelines for the prevention of nosocomial infection in a pediatric intensive care unit in Jakarta, Indonesia

We attempted to implement a nosocomial infection control program based on the Centers for Disease Control (CDC) guidelines in an urban Indonesian public hospital at the request of Project Hope. Adoption of unmodified CDC guidelines was impeded by a substandard physical plant, absence of an infection control infrastructure, limited sterilization capabilities, lack of clinical microbiologic laboratory support, and the expense of single use medical devices. After on-site evaluations, CDC guidelines were extensively modified so that they were appropriate for local conditions and culture. Strategies included inexpensive architectural modifications, addition of sinks and a commode, introduction of disinfection procedures for reuse of disposable medical devices, and adaptation of available supplies for maintenance of aseptic technique. On subsequent site visits, many physical changes had been accomplished, and handling of reusable and disposable medical devises had improved considerably but adoption of clinical practice policies was incomplete. We conclude that it may be difficult to implement and sustain improvements in clinical practice in the absence of an infection control infrastructure and a strong commitment by hospital clinicians and administrators. Additional research is needed to refine flexible methods for rapidly assessing the specific infection control needs of institutions with widely disparate resources, patient populations, environments, and cultures.

Bioburden Control for Manufacture of Disposable Medical Devices

Bioburden Control for Manufacture of Disposable Medical Devices