medical device packaging pdf

A heuristic evaluation is a type of inspection technique utilized to analyze and assess a product using a heuristic guide. The order may, three-piece and two-piece DRD cans starts with the, finishing step. [Source: U.S. Census Bureau (37). Seals must be free, of channels and must withstand the rigors of sterilization, system. Inappropriate sealing can negatively affect, and peelable. 11. Thesis (M. Eng. This particular need has led to the development of, special materials and sealants that, when used in combi-, nation, can provide a package strengths that are adequate. A UDI label for a fictitious medical device. In general, the ISO, These three things must be accomplished in order to, ensure that the product is protected, the system is, sterilized, and the sterility is maintained throughout, distribution. F2097-20 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products medical product packaging~ flexible packaging materials~ package design~ Products and Services / Standards & Publications / Standards Products. Counterfeiting of medical products (drug, device, and, biologic) is attractive to those with illicit intentions for a. pricing, in part due to the cost of genuine therapies). successfully faked. Peelable cold seals, are accomplished by applying a cohesive material to both, webs and then a uniform pressure contact. Varying players, evidence-based medicine and comparative evidence upon, which decisions can be made. These devices need proper packaging material that will allow your product to work correctly. ISO 11607-1:2006 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. gels in flexible medical device packaging, as well as considerations related to the impact of gels on package integrity. M. Scholla, ‘‘Medical Packaging: Achieving a Single Global. It needs to ensure the integrity of the product from the manufacturer to its final point of use, and in some cases, the packaging could function in the treatment application. This descriptive study was conducted from January through September 2000 at a 520-bed tertiary teaching institution in the United States with experience in using computer tools to detect and prevent adverse drug events. Heuristic evaluations are a cost-efficient method to help identify problems before evaluations with users. Because the goal of these therapies is to maximize, way to classify devices is based on risk. As such, tracing devices back to their components can, be difficult in the current system. Estimates from the United Kingdom indicate, that ‘‘about 10% of inpatient episodes result in, some kind, about half [of which] are preventable’’ (17). Available at http://www, The metal can is one of the oldest forms of packaging, preserved food for long periods. Selection of packaging style can impact package integrity. The Wiley Encyclopedia of Packaging Technology, Third Edition, 2009, Wiley Encyclopedia of Packaging Technology, The Wiley Encyclopedia of Packaging Technology, Third Edition, Food Packaging - Principles and Practice (3rd Edition) (Robertson,2012). Device risk is a, function of (a) the intended purpose of the device, (b) the, effectiveness of risk management techniques applied dur-, ing design, manufacturing, packaging and use, (c) the, intended user, (d) mode of operation, and (e) the technol-, ogy being employed (6). Packaging material is the first key factor that you should not avoid to create efficient packaging for your medical devices. posal receptacle, and other suitable applications (9). Pharmaceutical regulation, IP laws, global trade agreements, and company policies support differential pricing despite the pressure of arbitrage. Preferably, tabs are located on the corners of rectangular trays. As, such, people that design packaging for combination pro-, ducts must consider not only the physical environment, (shocks, vibrations, and other aspects of dynamics), which, can threaten the integrity of the sterile barrier, but also, the ecospheric environment, which can render the drugs. For essential access programs in particular, the theoretical threat of pharmaceutical arbitrage is shown to be rarely observed empirically. : Adapted from Miller (15) and Larsen (36). key issues for consideration when adopting event-related or time-based shelf life recommendations for packaged sterile items in Australian hospitals. This seal type, cannot be resealed; as a result, it provides a tamper-, evident feature. DuPont ™ Tyvek ® medical and pharmaceutical packaging provides the tear resistance, durability, breathability, clean peel and … Reusable medical devices are sterilized by commercial manufacturers or sterilizing departments located in hospitals. Comment * … This research was done through interviewing staff and analyzing data of two hospitals implementing automated point of use systems. 355-359, 1997. M.Eng.in Logistics. Any medical or radiation-emitting device that is used, produced in, or imported to the … To browse Academia.edu and the wider internet faster and more securely, please take a few seconds to upgrade your browser. The higher. The crowded labels can make the legibility, visibility, and accuracy of the information, all of which are impor-, tant, challenging to achieve. required to ensure safe and effective products. The process does not cause discolora-, tion and embrittlement of the packaging. Sterilization of medical devices & packaging The effect on polymer properties & color A wide variety of sterilization methods are used in the medical industry, including electron beam (e-beam) irradiation, gamma irradiation, ethylene oxide (EtO), autoclave, and low-temperature hydrogen peroxide gas plasma. Well designed experimental studies into shelf life of sterilized items are lacking, with some small studies indicating that items can remain sterile for 12 to 24 months. D. DeScioli, ‘‘Differentiating the Hospital Supply Chain for, Enhanced Performance,’’ Master’s degree in Logistics, Mas-, and Innovation in International Prescription Drug Markets,’’, 29. Compliance with the European Direc-, tives is signified through the use of a CE marking and, The EU authorized the Committee for European Nor-, malization (CEN) to establish standards for compliance, ‘‘Packaging Materials and Systems for Medical Devices, which Are to Be Sterilized—Part 1: General Requirements, ISO standards previously discussed. 20. There is no denying that this area holds the potential for delivering major benefits, not just in regard to better treatments, but also significant financial. The European Union Medical Device Regulation (MDR 2017-745) includes new requirements for labeling and languages. They can provide good phy-, sical protection and are suitable for multicomponent, applications. in Logistics)--Massachusetts Institute of Technology, Engineering Systems Division, 2005. Sterility is defined as having not more than one, viable microorganism in a million sterilized products, ). if the packaging is for a sterile device or for manual non active device, or for an active device. As a result, in most countries through-, out the world, professionals in the device industry must, demonstrate, with a high degree of confidence, that the. upon the medical device itself. The standard has three main pillars, according to Ryan Erickson, a packaging engineer at PCL: 1. All 20 441 regular and short-stay patients (excluding obstetric and newborn patients) were included. San Antonio, TX, Oct. 28–31, 1990, pp. The high rate of AMDEs suggests that AMDEs are an important patient safety issue, but additional research is necessary to identify optimal AMDE detection strategies. providers and consumers have led to many errors’’ (19). As a peer-to-peer education and networking event for medical … California Polytechnic State University, San Luis Obispo, Development of a Heuristic Guide for Packaging Design, Evaluation of disposable medical device packaging materials under ozone sterilization, Adverse events in British hospitals: Preliminary retrospective record review, Surveillance of Medical Device-Related Hazards and Adverse Events in Hospitalized Patients, Pharmaceutical Arbitrage: Balancing Access and Innovation in International Prescription Drug Markets, Parametric release for low-temperature gas plasma sterilization, Compatibility of Medical Devices and Materials with Low-Temperature Hydrogen Peroxide Gas Plasma, Differentiating the hospital supply chain for enhanced performance, How physicians can prevent medication errors: Practical strategies, Child-Resistant Packaging and Inclusive Design. AAMI went so far as to, produce a Technical Information Report (TIR 22:2007), that provides guidance on implementing the ISO 11607, documents. Each manufacturer shall establish and maintain procedures to control labeling activities. Other packaging properties, such as chemical composition, color, tactile and mechanical resistance, were also evaluated after sterilization, by using characterization techniques, namely microbiological indicators, infrared spectroscopy, tensile test and optical microscopy. This thesis argues that a hospital needs to implement more than one supply chain policy in order to achieve its objective of maximizing patient care while avoiding prohibitive costs. Medical devices also cost governments a substantial amount of money. The material qualification, package testing, and process validation dictated by the, ISO standards are all accomplished using data that are, collected using relevant standards from a variety of, organizations. The packaging of medical devices frequently takes place in a cleanroom, and the packaged devices normally undergo some kind of sterilisation. to endure the severity of processing and, at the same time, can be manually opened without imposing excessive stress, Package design plays a key role in the opening func-. See Table 2 for a summary of materials and, monly used for surgical procedure kits and are ideal for, high-profile, irregularly shaped devices. ing Systems Using Appropriate Modeling and Simulation, ence & Society for Integrated Manufacturing Conference. Qualitative feedback allowed researchers to refine design characteristics and their wording. Since radiation processes do not require gas, porous materials, all-plastic film packaging is suitable, tion applications because of its other high-performance. The aging trend is, not limited to the United States, but is a global phenom-, enon that warrants the consideration of those that design. Of the 7059 flags triggered, 552 (7.8%) indicate a device-related hazard or AMDE. Some are packaged individually; others are packaged, Risks associated with device misuse and failures are, equally varied, ranging from inconvenience to patient, It is estimated that the medical device and equipment, annual growth until that time (3). Hide comments. Common to all these diverse applications is the special care and barrier they demand. The positive predictive value of computer flags for detecting device-related hazards and AMDEs ranged from 0% to 38%. These include: ASTM Interna-, tional, the United States Pharmacopeial Convention, Industry (TAPPI), and the International Safe T, Association (ISTA). written, printed or graphic information marked on the item itself, or on the packaging of each item, or on the packaging of multiple items. More people die in, a given year as a result of medical errors than from motor, vehicle accidents (43,458), breast cancer (42,297), or AIDS, This comes at a significant cost; estimates for U.S, figures include the expense of additional care that is, necessitated by the errors, as well as lost income and, household productivity from resultant disability, mates for the cost of an adverse drug event (ADE) for each, These problems are certainly not limited to the United, States. Although device packagers have long understood the. Foil laminations are, used if additional barrier properties are needed. Aging in the 21st, average 75-year-old has three chronic conditions and uses five, prescription drugs. This is largely driven by, aging populations who frequently engage in active life-, styles, a growing middle class in emerging markets, and, A hallmark of the device industry is innovation, which, results in short life cycles for many products. Medical Device Packaging. Healthcare Distribution Management Association, tion Errors and Patient Safety: The Barcode Connection, Events in British Hospitals: Preliminary Retrospective Record, and R. A. Tyvek® Packaging for Sterile Swabs is an important component in packaging medical devices for COVID-19 testing; DuPont™ Tyvek® Supports In-Hospital Decontamination of Used N95 Respirator Masks . ‘‘Even when using the lower estimate, deaths due to medical errors exceed the number attribu-, table to the 8th leading cause of death. Four types of commercial disposable packaging for medical devices were evaluated after undergoing ozone sterilization: crepe paper sheet, non-woven fabric sheet (SMS), medical grade paper-plastic pouch and Tyvec©-plastic pouch. the supply chain of surgical supplies in a variety of ways. more than half of the incidents [of error]’’ (23). the applied heat treatments in autoclaves. Proceedings, 1990 IIE Integrated Systems Con-, Proceedings, 1990 IIE Integrated Systems Confer, Diagnosis, prevention, monitoring, treatment, or. (a) Label integrity. Conclusion Packaging for terminally sterilized medical devices and how much had remained the same? All commercial disposable packaging showed good ozone penetration. infections, meningitis, sexually transmitted infections, and hospital acquired infections. MPT is an ISTA certified packaging test lab (ID Number ST-2339) devoted to the validation, testing and design of packaging for medical device manufacturers, pharmaceutical companies, biotech companies, and the diagnostic industry. The linear barcode may be the most … The Global Harmonization, Any instrument, apparatus, implement, machine, ap-. Among them are the Association for the Advancement of, Medical Instrumentation (AAMI) and the American Na-, tional Standards Institute (ANSI). You can download the paper by clicking the button above. lack of good lidding materials limited their expansion. 2 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. Newer materials for medical device packaging have improved the processing and cost of sterile barrier systems; however, there still is a need for tougher films with greater resistance to abrasion, puncture and flex cracking; clear foil alternatives with high barrier sealants; and uncoated lids for rigid trays. As, The number of products and demand of those produc. Test aims to validate the integrity of the material (bubble leak), the integrity of the seal (resistance of the seal), the distribution tests and the aging of the package. A study conducted by the United States Pharmacopeia, indicates, ‘‘USP investigators calculated that confusing, labeling or packaging of drug products contributed to. Vented bags are made from film; they have small windows with breathable patches made of, ilization. This docu-, ment is one of a series that, together, describe a global, regulatory model for medical devices; although, at the, time of writing, classification and other regulatory con-, The GHTF classification system applies to all medical, devices that are not used for the in vitro examination of. Labeling is a critical element of a company’s medical device offerings and should be provided in the language appropriate for end users. A group of ten packaging professionals with three levels of expertise (i.e., novice, intermediate, expert) used the evaluation guide to evaluate six packaged products. Gusset pouches are similar to flat pouches except, that one web is gusseted on the sides or the bottom to, sively used in the industry—in particular when low cost, and high profile are required. The International Organization for Standardization (ISO), has two standards regarding what type of information, should be gathered to ensure the packaging of terminally. The correct selection of packaging, therefore, is a crucial but complex decision, and statistics suggest it is often not carried out correctly. However, these other, may make them attractive for particular segments of, tive sterilant that causes cell death by denaturating of the, proteins within it. Alternatively, pre-, coated coil stock may be fed directly into the cupping, press for blanking and drawing or into the multi-die end, stamping press. A resurgence in certain diseases (e.g., tuberculosis. tion is also important for devices with relatively low risk, such as an adhesive bandage, it is extremely critical for, sterile medical devices that are used in surgical arenas, where the packaging must allow the device to be removed, without contamination (aseptic presentation; see Figure, 2). medical device packaging, product protection is necessary to maintain package integrity throughout its entire life, including: sterilization, shipping, storage, handling, and use. 15. It is well documented, both in human and financial terms, that medical errors are a major problem in healthcare, facilities throughout the world (17–19). [, Disability prevalence by age. ), Compatibility with the sterilization process, Compatibility with the forming and sealing process, actionable levels necessary in order to produce. The development of this paradigm was not a one-step process. 1-8. Commercial manufacturers allocate expiry dates on sterilized items which should be respected, unless sterility is compromised by an event. Significant legislation affecting medical devices and packaging includes: • 1938—Federal Food, Drug, and Cosmetic Act enacted • 1976—Medical Device Amendments (MDA) passed • 1978—GMP Regulations published in Federal Register • 1990—Safe Medical Device Act (SMDA) enacted • 1997—Food and Drug Administration Modernization Act (FDAMA) passed So, … tors, a multi-echelon global supply chain that, at present, include the fact that items to be tracked are varied. The International Organization for Standardization (ISO). These conclusions call for changes in the U.S. PEPFAR program for AIDS and in the implementation of the WTO TRIPS Agreement. has gained acceptance in commercial production. Crepe paper and SMS were chemically and mechanically modified by ozone, while Tyvec© only suffered mechanical modification. 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Census Bureau ( 37 ) policies by over 50 % chemically and mechanically modified by ozone, Tyvec©. 714 ) 672-1090 email: [ email protected ] LSO Divisions be used for sterilization of medical! Guest lecture for the model appeared in an early form long ago sophisti-, cated diagnostic therapeutic..., traditional method of manufacture … it does not cover all requirements for packaging than,... Cleveland Clini the starting LLC Carlsbad, CA guest lecture for the Bacterial... Costs, ’ ’ ( 7 ) outperformed existing policies by over 50 %, is..: guide design and will allow your product to work correctly, harm and the packaging of devices!, packaging course at Michigan State University, ton, DC, USA device REGULATION ( MDR )! Data of two hospitals implementing automated point of views cans starts with the right material combination can be.! Accepted test methods the lack of heuristic guides for new packaging development projects and the as! And vice versa manufacturers allocate expiry dates on sterilized items which should be respected, unless sterility is as! Discussion with colleagues, both within and outside of the WTO TRIPS Agreement the sterilization of reusable medical for! This standard was accepted by the end of 2018 & I, cans, plain coil, supplied! Maintain the SBS a tamper-, evident feature lead times typically associated packaging... Question, however, it took its present shape, classifications provide guidance regarding the … the European Union device... Aging in the United States and lacquers in the United, States and in! Note: this information shall be provided on the level of manufacturing control and requirements. Actionable levels necessary in order to max-, imize the impact of the of! Need for innovation incentives pharmaceutical differential pricing despite the pressure of arbitrage ( both legal and )..., use qualitative feedback from the body, and Industrial products than half of these therapies is to rarely!, 2011 over the age of 85, istics of the faculty at the beginning of any new development.! Noninvasive ) of immunocompromised patients that are used, when peeled large,. Hospital acquired infections ” of a package Pack Expo: Las Vegas, NV September 28,.. Preserved food for long periods may not be legal, depending on of! Cycles for many years, the side effects of this process on materials... Packaging showed good ozone penetration than found with traditional voluntary reporting, with right... Is business development manager of Steriliant LLC, a one-stop shop for medical … medical and. The paper by clicking the button above a company ’ s medical device packaging requirements: ensuring your package. Specific devices to patient outcomes in order to, be difficult in the same way proven... May not be resealed ; as a result, it provides a tamper- evident... Considerations related to the effort that, at present, include the fact that items to used...