Materials vigilance and traceability

This chapter outlines the regulation of medical devices in Australia, China, India, Japan, the United States, and the European Union, focusing on classification systems, regulatory procedures, and oversight mechanisms. It covers Australia’s framework that is governed by the Therapeutic Goods Act 1989 and administered by the Therapeutic Goods Administration (TGA). It also details China’s three-tier approval system under the State Food and Drug Administration (SFDA), India’s evolving legal structure under the Drugs and Cosmetics Act, and Japan’s Ministry of Health, Labour and Welfare’s categorisation into Highly Advanced Controlled Medical Devices, Controlled Medical Devices, and General Medical Devices. The chapter examines the United States’ approach under the Federal Food, Drug, and Cosmetic Act, which introduced pre-market review and risk-based classification. It highlights the EU’s reliance on the Active Implantable Devices Directive, Medical Devices Directive, and IVD Medical Devices Directive, which is enforced through national competent authorities, notified bodies, and CE marking.

Cybersecurity vulnerabilities of cardiac implantable electronic devices: Communication strategies for clinicians—Proceedings of the Heart Rhythm Society's Leadership Summit

ImportanceStrengthening premarket and postmarket surveillance of medical devices has long been an area of focus for health policy makers. The recent class I recall (the most serious of the US Food and Drug Administration [FDA] recalls) of reperfusion catheters manufactured by Penumbra, a US-based medical device company, illustrates issues of device safety and oversight that mandate attention.ObjectivesTo review the regulatory history and clinical evidence of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7) and use the device recall as a case study of the challenges associated with clinical evaluation, transparency, and oversight of medical devices in the US.EvidenceRegulatory history and clinical evidence for the Penumbra medical devices were analyzed through a qualitative review of decision letters in the Access FDA database for medical devices and medical device reports in the Manufacturer and User Facility Device Experience database and a review of market data (eg, earnings calls, company communications) and clinical literature.FindingsThe JET 7 device was subjected to a class I recall following more than 200 adverse event reports, 14 of which involved patient deaths. Regulatory analysis indicated that each of the Penumbra reperfusion catheters was cleared under the 510(k) pathway (which allows devices to be authorized with limited to no clinical evidence), with limited submission of either new clinical or animal data. Clinical evidence for Penumbra devices was generated from nonrandomized, single-arm trials with small sample sizes. The regulatory issues raised by JET 7 are reflective of broader challenges for medical device regulation. Opportunities for reform include strengthening premarket evidence requirements, requiring safety reporting with unique device identifiers, and mandating active methods of postmarket surveillance.Conclusions and RelevanceThe case study of JET 7 highlights the long-standing gaps in medical device oversight and renews the impetus to build on the Institute of Medicine recommendations and reform FDA medical device regulation to protect public health.

<p>Although great strides have been made to tackle hospital-acquired pressure ulcers (HAPUs), there is a need for greater recognition of device-related pressure ulcers (DRPUs), including their causes, management and prevention. This consensus statement, an updated second edition, aims to continue raising awareness of these largely preventable injuries and, crucially, to stimulate action. DRPUs are relatively common and account for a growing proportion of HAPUs. Updated information on the incidence of DRPUs is described in chapter 1. Although it is recognised that DRPUs increase the financial burden of healthcare, there is little formal analysis of their economic impact. This needs to be addressed; robust evidence on the burden of DRPUs and the value that can be released by adopting prevention strategies is needed to help drive action. Our understanding of the pathophysiology of DRPUs has improved significantly over the past few years; this is described in chapter 2. One crucial difference between PUs and DRPUs is that body-weight forces are less significant in DRPUs, with the force being exerted from a device that is typically strapped or taped onto the body. Devices and their securement may generate high stress concentrations in tissues, leading to cell and tissue-damage pathways associated with sustained deformation. As more evidence is published on DRPUs, recurring themes are emerging, as outlined in chapter 3: The most vulnerable patients are bearing the brunt of DRPUs; paediatric and neonatal patients, and all those needing critical care are particularly susceptible. During the COVID-19 pandemic, a new high-risk population (people with severe COVID-19 infection) emerged. They are at increased risk of DRPUs because of their need for prolonged ventilatory support, especially when 'proning' Devices associated with DRPUs are often used to perform essential, life-saving functions. They include continuous positive airway pressure (CPAP) masks or endotracheal tubes. Minimising their use is clearly not an option, so practice innovation is needed Although the most common locations for DRPUs are the face, ears, lower legs and heels, any location where a device comes into close contact with the skin can be at risk. In the same vein, any device, whether needed for a medical purpose or not, has the capacity to cause injury if its use is not properly managed. Vigilance is needed for all patients. What can be done? The importance of routine risk assessment is covered in chapter 4. Although use of a validated risk assessment tool is the vital first step, this will not be enough on its own. Several steps can be taken to ensure the safe use of devices. These are described in chapter 5 and include device repositioning, cushioning with prophylactic dressings and moisture control (only where possible and clinically appropriate). Of key importance is the development of an institutional protocol and champions to ensure all necessary steps are adopted. For any of these changes to be put into practice, awareness of DRPUs needs to increase. A number of proposals are outlined in chapter 6. A change of focus among health professionals and policy makers, along with more investment in education and training, are needed. All patients being managed with a medical device must be considered as at high risk. The pandemic introduced the world to the problem of DRPUs in health professionals caused by the extended wear of personal protective equipment. Health professionals also have a right to expect institutional protocols and provision of devices that protect them from DRPUs. Cutting-edge ideas and technologies that may be available in the future are described in chapter 7. When designing new products, manufacturers of medical devices have a duty of care to investigate the risks of DRPUs associated with their products and mitigate them, wherever possible. Our developing understanding of how the design, structure and materials used in medical devices contribute to DRPUs will help us develop new solutions for tomorrow. The first step is for everyone involved to ask themselves, 'what can I do to help?' There is work to be done-your journey to reduce DRPUs starts here!.</p>

The Medical Device Regulation (EU) 745/2017 (MDR) has replaced the medical device directives which were in place since the early 1990s. MDR introduces a number of changes of relevance to biomedical engineers who work in healthcare institutions or with medical devices. This includes changes relating to devices produced in healthcare institutions, custom-made devices, single use devices, devices without an intended medical purpose, clinical investigations and device traceability. There are also challenges in implementation of the MDR, with a shortage of available notified bodies needed to conduct conformity assessment, with a consequent risk of product unavailability. Understanding these changes is important as implementing new requirements in practice may require additional resources or the introduction of new processes or systems.

Defibrillators are medical devices (MDs) used in the most critical situations, hence their performance must be ensured at all times. This requires defibrillators to be subjected to regular performance assessments after they have been placed on the market. The new Medical Device Regulation (MDR) defines medical device post-market surveillance (PMS) as performed by independent, third-party, notified bodies more strategically in hope to improve traceability of device performance. However, there is still an apparent gap in terms of standardised conformity assessment testing methods. This paper proposes a novel evidence-based method for conformity assessment testing of defibrillators. The proposed method is developed in accordance with the International Organisation of Legal Metrology (OIML) guidelines and is intended to be used for conformity assessment testing of defibrillators for post-market surveillance purposes. The developed method was validated from 2018 to 2021 in healthcare institutions of all levels. The results obtained during validation suggest that conformity assessment testing of defibrillators as a method used during PMS contributes to significant improvement in devices' accuracy and reliability. A standardized approach in conformity assessment testing of defibrillators during PMS, besides increasing reliability of the devices, is the first step in the digital transformation of the management of these devices in healthcare institutions opening possibility for use of artificial intelligence.

Recent safety issues involving non-active implantable medical devices (NAIMDs) have highlighted the need for better pre-market and post-market evaluation. Some stakeholders have argued that certain features of medicine safety evaluation should also be applied to medical devices. Our objectives were to compare the current processes and methodologies for the assessment of NAIMD safety profiles with those for medicines, identify potential gaps, and make recommendations for the adoption of new methodologies for the ongoing benefit–risk monitoring of these devices throughout their entire life cycle. A literature review served to examine the current tools for the safety evaluation of NAIMDs and those for medicines. We searched MEDLINE using these two categories. We supplemented this search with Google searches using the same key terms used in the MEDLINE search. Using a comparative approach, we summarized the new product design, development cycle (preclinical and clinical phases), and post-market phases for NAIMDs and drugs. We also evaluated and compared the respective processes to integrate and assess safety data during the life cycle of the products, including signal detection, signal management, and subsequent potential regulatory actions. The search identified a gap in NAIMD safety signal generation: no global program exists that collects and analyzes adverse events and product quality issues. Data sources in real-world settings, such as electronic health records, need to be effectively identified and explored as additional sources of safety information, particularly in some areas such as the EU and USA where there are plans to implement the unique device identifier (UDI). The UDI and other initiatives will enable more robust follow-up and assessment of long-term patient outcomes. The safety evaluation system for NAIMDs differs in many ways from those for drugs, but both systems face analogous challenges with respect to monitoring real-world usage. Certain features of the drug safety evaluation process could, if adopted and adapted for NAIMDs, lead to better and more systematic evaluations of the latter.

On September 24, 2023, the US Food and Drug Administration (FDA) and other stakeholders marked the 10-year anniversary of the publication of the FDA Unique Device Identifier (UDI) Final Rule. The infrastructure for the UDI system is in place—UDI is on the label of medical devices for which UDI requirements apply, unless an exception or alternative applies, and key device identification information, including the device identifier portion of the UDI, is available in the Global Unique Device Identification Database. The focus now is on adoption and implementation of UDI throughout the healthcare ecosystem to realize the intent of the UDI Rule, which is to enhance patient safety through accurate device identification. To that end, this article provides an example of the utility of the UDI for evaluating device performance as a device evolves over time. The example demonstrates that UDI can facilitate identification of the specific version or model of a device that has malfunctioned and/or contributed to an adverse event by enabling more accurate data aggregation compared with other identifying information, potentially leading to key safety insights.

The European Union (EU) Medical Device Regulation increased regulatory scrutiny to improve the safety and performance of new medical devices. An equally important goal is providing timely access to innovative devices to benefit patient care. The European Society of Cardiology strongly advocates for the evolution of the Medical Device Regulation system to facilitate priority access for innovative devices for unmet needs and orphan cardiovascular (CV) medical devices in EU countries. Although device approval is currently executed by Notified Bodies in the EU, it will be advantageous in the mid-term to consider a single EU regulatory agency for devices. In the short term, steps can be taken to transform the current system into a more efficient, predictable, cost-effective, and user-friendly service. Key strategies include the following: enhancing predictability of the approval process through use of early scientific advice from regulators; establishing unique regulatory pathways for CV orphan, paediatric, and innovative devices; promoting more efficient (re)certification of essential legacy CV devices; improving transparency of sponsor interactions with Notified Bodies; expanding the roles of the Expert Panels to assist in the approval of CV devices; promoting global regulatory harmonization, considering streamlined authorization of CV medical technologies across selected jurisdictions; developing an efficient system to monitor device safety; and ensuring funding for data collection platforms. Some strategies that could help include considering a pilot programme for joint approval processes of selected devices in partnership with other regions (i.e. US Food and Drug Administration); developing priority pathways for accelerated access to innovative or orphan devices; and increasing recognition of the importance of early feasibility studies in the EU.

PMD138 - IMPACTS OF NEW EU MDR&IVDR REGULATIONS FOR TURKEY

Accurate identification and management of medical devices is of particular importance to ensure patient safety and regulatory compliance within healthcare systems. This paper presents a comprehensive exploration of medical device data retrieval, focusing on the integration of web scraping and API technologies. The utilization of Unique Device Identifiers (UDIs) and the Global Medical Device Nomenclature (GMDN) system is emphasized to enhance device authentication, attribute verification, and accurate categorization. This paper introduces a state-of-the-art code implementation that combines web scraping techniques and API integration to address the challenges of retrieving and verifying device information. The code facilitates both access to data and for healthcare professionals and stakeholders to make informed decisions based on reliable and up-to-date information. This is a significant and defining advance in the field, offering a powerful solution that is innovative as well as vital. The paper concludes by discussing the potential impact of these developments on patient safety, regulatory compliance, and the overall advancement of healthcare technology. In addition, the importance of accurate device identification, the role of UDIs and GMDN, and the significance of the provided cutting-edge code are highlighted, providing valuable insights into the field of medical device data retrieval.

This article deals with the situation of reimbursement and application for reimbursement of diabetes medical devices by statutory sickness funds in Germany, who represent more than 90% of the market. The bases are both the SGB (Social Code), which regulates a sufficient, comprehensive, necessary, and economic social security, and the MPG (Medical Devices Code), which regulates the conditions under which a product may qualify to become a medical device, jurisdictions (BSG case B3KR25/05R and B3KR21/99R), and other sources that can be found in the abbreviations section. There are a total of more than 400 000 different products summarized under “medical devices.” They all have in common—different from pharmaceuticals—that they mainly have a “physical mode of action,” that is, they do not have a pharmacological effect and will not be absorbed and used up by the body. Medical devices are designed for diagnosing, preventing, screening, and treating diseases. They can be pacemakers, ultrasound equipment, insulin pump catheters, surgical dressings, software, and disposable prefilled syringes. A product qualifies as a medical device pursuant to the MPG when the manufacturer offers it for the use of patients and the handicapped. Thus, qualification is based only on the purpose defined and given by the manufacturer. The product has to be certified (CE certification) and must fulfill the conditions of the MPG, ensuring the quality of the product and the safety of patients and users. Through a defined procedure the manufacturer has to prove that the product fulfils all these conditions. Medical devices that under EU law can be legally sold in 1 member state consequently can be sold in all member states. However, this certification is not about the medical benefit of the product. Proof of functionality, safety, and medical benefit of a product through the manufacturer is the prerequisite for the listing of the product as a therapeutic appliance in the list of medical devices of the GKV Spitzenverband. The listing again is the prerequisite for a product to be reimbursed by the statutory sickness funds. Although this list is not binding, it has a steering effect, meaning also that a product may achieve reimbursement by the single decision of an independent sickness fund. However, the list provides overall information about the reimbursement duty of a sickness fund and the quality and variety of products in the market. The manufacturer applies at the GKV Spitzenverband for the listing (see § 139 of SGB V), who can involve the MDK in the decision-making process, for instance, to check Functionality and safety of the product (fulfilled by CE certification) The proven medical benefit Indication- or use-related conditions User manuals in German to ensure safe handling of the product Weather additional services must be provided by the sickness funds accompanying the use of the product In case of a positive decision, which can take up to 6 months after filing, the product will receive a so-called medical device number, which shows it classification into the 33 different product groups, (eg, aids for application, surgical dressings, aids for inhalation, and systems to measure body functions). Each product group contains definitions with advice about medical indications that justify a respective use and reimbursement. In addition, minimum quality and conditions under which the product can be provided are fixed to ensure a necessary, high-quality, and reliable social security. The statutory sickness funds provide their services under a binding principle regulated in section 12 of SGB V: The services have to be sufficient, reasonable, and economic and may not exceed necessity. Services that are not necessary or economic cannot be demanded by the insured and may not be provided by sickness funds.

The aim was to identify the experiences of Notified Bodies (NBs) in Europe in applying restrictions or limitations to certificates for high-risk medical devices. A survey examining NB practices regarding restrictions or limitations applied to Class III and IIb implantable medical devices was conducted as part of the CORE-MD Horizon 2020 project. Thirteen NBs responded; three had issued certificates of conformity with restrictions or limitations. NBs reported challenges in collecting and providing data on conditional certification, which would likely increase their workload. Enhancing clarity of regulatory standards, improving data transparency, fostering stakeholders' collaboration, and providing targeted training are essential to ensure uniform and homogeneous application of conditional certifications across the EU.

The US Food and Drug Administration (FDA) is building a national postmarketing surveillance system for medical devices, moving to a "total product life cycle" approach whereby more limited premarketing data are balanced with postmarketing surveillance to capture rare adverse events and long-term safety issues. To assess the methodological requirements and feasibility of postmarketing device surveillance using endovascular aneurysm repair devices (EVARs), which have been the subject of safety concerns, using clinical data from a large health care system. This retrospective cohort study included patients with electronic health record (EHR) data in the Veterans Affairs Corporate Data Warehouse. Implantation of an AFX Endovascular AAA System (AFX) device (any of 3 iterations) or a non-AFX comparator EVAR device from January 1, 2011, to December 21, 2021. The primary outcomes were rates of type III endoleaks and all-cause mortality; and rates of these outcomes associated with AFX devices compared with non-AFX devices, assessed using Cox proportional hazards regression models and doubly robust causal modeling. Information on type III endoleaks was available only as free-text mentions in clinical notes, while all-cause mortality data could be extracted using structured data. Device-specific information required by the FDA is ascertained using unique device identifiers (UDIs), which include factors such as model numbers, catalog numbers, and manufacturer-specific product codes. The availability of UDIs in EHRs was assessed. In total, 13 941 patients (mean [SD] age, 71.8 [7.4] years) received 1 of the devices of interest (AFX with Strata [AFX-S]: 718 patients [5.2%]; AFX with Duraply [AFX-D]: 404 patients [2.9%]; or AFX2: 682 patients [4.9%]), and 12 137 (87.1%) received non-AFX devices. The UDIs were not recorded in the EHR for any patient with an AFX device, and partial UDIs were available for 19 patients (0.1%) with a non-AFX device. This necessitated the development of advanced natural language processing tools to define the cohort of patients for analysis. The study identified a significantly higher risk of type III endoleaks at 5 years among patients receiving any of the AFX device iterations, including the most recent version, AFX2 (11.6%; 95% CI, 8.1%-15.1%) compared with that among patients with non-AFX devices (5.7%; 95% CI, 2.2%-9.2%; absolute risk difference, 5.9%; 95% CI, 2.3%-9.4%). However, there was no significantly higher all-cause mortality for any of the AFX device iterations, including for AFX2 (19.0%; 95% CI, 16.0%-22.0%) compared with non-AFX devices (18.0%; 95% CI, 15.0%-21.0%; absolute risk difference, 1.0%; 95% CI, -2.1% to 4.1%). The findings of this cohort study suggest that clinical data can be used for the postmarketing device surveillance required by the FDA. The study also highlights ongoing challenges to performing larger-scale surveillance, including lack of consistent use of UDIs and insufficient relevant structured data to efficiently capture certain outcomes of interest.

Caregiving is an inherently difficult role, replete with the emotional strains of watching a loved one deteriorate physically or mentally while trying to balance work and home responsibilities, and finding needed services with little or no guidance. These challenges are compounded by extreme stress, emotional overload, and a sense of isolation. Family caregiving is a lifespan issue, encompassing those with chronic conditions, disabilities, disease or the frailties of old age. Caregiving embraces a wide spectrum, ranging from the families of children with special needs to adult children caring for parents with Alzheimer's disease. Many family caregivers interact with medical devices in home settings.Advances in medical technology have allowed care recipients to remain ambulatory and independent. Because care recipients expect to be able to stay independent, mobile or active, the term “home use” extends beyond the home to encompass all environments in which a person plans to use his or her medical device to continue or enhance the quality of daily life.1For medical equipment designed for longterm use in the home, labeling will often not be with the device. In such cases, the home healthcare provider must develop his or her own basic instructions for use, maintenance, and cleaning. Through the MedWatch adverse event reporting system, the Food and Drug Administration (FDA) receives medical device reports of problems that stem from missing, absent or inadequate labeling, or misinterpretations of the information in labeling and instructions for use (IFU).The FDA also receives anecdotal information from consumers, healthcare practitioners (HCPs), healthcare organizations and device manufacturers suggesting interest in enhancing medical device equipment labeling content and format. Consumers and HCPs are particularly interested in having a searchable website containing medical device labeling and instructions for products intended for home use.This study was conducted to help the FDA better understand device labeling-related challenges that family caregivers face when care is provided in the home environment. Study respondents are members of the Caregiver Action Network (CAN), formerly the National Family Caregivers Association (NFCA), which educates, supports, empowers, and advocates for the more than 65 million Americans who care for loved ones with a chronic illness or disability or the frailties of old age,2 advocating for the needs of family caregivers, including their desires and need for instruction in the safe and effective use of medical devices in the home. These findings will assist in guiding the FDA's future efforts to characterize information pertinent to medical device labeling and provide online access in order to facilitate safe medical device use at home.A web-based survey contained multiple choice questions with pre-coded responses offering CAN respondents the opportunity to provide free-text responses and comments. The questionnaires were developed collaboratively by CAN, FDA/CDRH, and contractor to the FDA Social and Scientific Systems (SSS). Questions for both methods were based around the following topics:The survey questionnaire was administered via e-mail to a random sample of CAN members who met selection criteria (n=557; See Appendix 1 in online version of this article). The email provided background information about the FDA and the purpose of the study.The web-based survey was conducted October 5, 2011 through January 6, 2012. Reminders were sent four times over the course of the study, in October, November, and two in December. After the survey closed, results were collated and de-identified to maintain respondent confidentiality and then analyzed by the authors.One hundred twenty-seven respondents completed the web-based survey, a 22% response rate. Ninety-five percent of all respondents care for adult family members (over 21 years old). Forty-nine percent and 45% of these respondents care for a family member 65 years or over (n=63) or a family member between the ages 21–64 years (n=58), respectively.Of these 127 respondents, 77% care for their family member in their own home (n=99) and 59% of all respondents have cared for their family member more than five years (n=76). Forty-four percent of all respondents care for their spouse/partner (n=56).The majority of respondents indicated that they have been using their medical equipment for two or more years for chronic conditions, including heart disease, lung disease, and diabetes, or conditions related to stroke and cancer. Free text responses also included conditions, such as dementia and Alzheimer's disease.The survey determined that the home medical equipment respondents most commonly used in the care of family members included wheelchairs, specialty hospital beds, blood glucose monitors, patient lifts, nebulizers, and assistive equipment, such as canes, walkers, and bathroom handrails. Survey questions allowed respondents to share their experiences using the aforementioned medical products, specifically their experiences with the labeling and instructions that accompany the products they use.Respondents indicated that their medical equipment is most often delivered to their homes from the manufacturer or received from a pharmacy or drug store. From the free-text responses, respondents indicated that their equipment was handed down from friends or family after previous use. Respondents specified that it was ‘somewhat easy to very easy' to learn how to use their medical equipment, and most received training prior to use. Equipment use training was most often provided from the medical supply company representative.Other responses indicated that no training was received; or that training had been provided by the home health provider, rehabilitation staff, or hospital staff. Other methods besides training that helped respondents learn how to use their medical equipment included trial and error, following written (paper) instructions from the manufacturer, Internet instructions, verbal instruction, or observation and return demonstration.* Respondents noted that the best time to receive written instructions was upon delivery of equipment at home and the worst time was at the hospital.When manufacturer instructions came with their medical equipment, respondents indicated that it was ‘somewhat easy' to follow. Instructions were typically provided in a manual, booklet, or information sheet format. Respondents specify that the table of contents was most helpful in finding the information they need to use their equipment. When seeking information to troubleshoot their product, respondents believed they could ‘quickly and easily' find the information in the manufacturer's instructions.In free-text responses, respondents indicated that they would make use of the 1-800 helpline, or ask a nurse or company representative when they need information about using their product in general or for information about troubleshooting. Free-text comments indicated that a DVD would be helpful for these purposes.In addition to manufacturer's instructions, respondents indicated that they obtained information from medical supply companies, home health agencies, and hospitals, in the same format as the manufacturer's instructions. Interestingly, even when manufacturer's instructions are provided, information from additional sources is obtained in order to simplify and clarify the manufacturer's instructions.Respondents did not always use the instructions, because they felt the training they received was enough. The survey results indicated that most respondents commonly used their instructions when they were first learning to use their equipment; until they felt comfortable using it; and for information about cleaning.Respondents often referred back to their instructions when there was a problem, to find a phone number, or to refresh their memory and ensure they were using their equipment correctly. When respondents referred back to their instructions, they found what they needed to know. However, respondents specified that the information they needed was not always contained in the manufacturer's instructions. Instead, this information could come from other sources, such as from friends.Respondents who keep their instructions often file them with other medical information for as long as they own the equipment, which allows for easy access if needed. However, not all respondents have the instructions for their equipment. Whether this is because they never received it, or because they lost it requires further exploration.Most instructions include pictures and diagrams; however, whether respondents find them helpful is unclear. Interestingly, free-text responses indicated that pictures, diagrams, and other visuals are indeed useful and suggest that these be included in the instructions. Respondents report that the information they need to have to use their medical equipment, in the order of importance, includes the following:Respondents indicate that they most prefer to find information via paper instructions, such as a manual, brochure, or quick-start guide affixed to the equipment itself. In addition, respondents will also seek information online and find it helpful to obtain instructional information by phone with a company representative or home health nurse. To that end, respondents commonly turn to these sources, in addition to seeking advice from friends or others with the same condition or equipment.Respondents specify that a short version or quick-start guide would be helpful, especially if it includes the following:Sixty-five percent of all respondents are very comfortable with using computers (n=83), and 70% of respondents indicate they would welcome and make use of an FDA ‘searchable website that contained instructions for medical equipment used in the home' (n=90). Respondents noted that if the FDA created a searchable website, it should include videos to supplement the written instructions, diagrams, and pictures, all of which should be easy to print, and parallel the instruction preferences discussed above.Individuals likely to use medical products in the home setting may be elderly, chronically ill patients of any age, pregnant women, high-risk infants, and rehabilitation patients. These individuals vary significantly in their ability to operate and maintain devices. Complex instructions with multiple steps could confuse the user's ability to understand or adequately operate the device. To that end, instructions and information written in simple language should accompany any home use device product. Photographs, diagrams or other graphical representations may be used to provide clarity, as evidenced by respondent preferences.Survey results about medical equipment training portray an interesting situation: More complex devices used in the home environment are designed to be used by trained healthcare professionals in an acute care facility, rather than in a nonclinical setting. Furthermore, care recipients may not be able to choose the devices that they will ultimately use, as the device may be pre-selected by their insurance, for example.For these reasons, care recipients may not receive devices that are optimal for their comprehension level or that of a family caregiver. Therefore, it is imperative that home care recipients are properly trained on how to use their device as well as provided with instructional information that is readily accessible, easily understood and in a format that meets the users' needs.While this study generated important feedback on medical device labeling and use instructions, not all respondents (n=127) answered every question. Toward the end of the survey, there was attrition, evidenced by the dwindling number of responses to all remaining questions. This is likely due to the fact that respondents were requested to answer questions related to three pieces of medical equipment, which, in hindsight, is a large time commitment. While the free-text responses presented respondents with an opportunity to elaborate on their responses, many free-text reactions include ‘gripes' about the specific equipment(s) they use. Future studies like this one should consider responses of this nature during survey question development.Social desirability respondent bias was also present in this study. When comparing responses to questions with pre-coded selections with responses to questions that offered free text, there was a tendency for respondents to select favorable pre-coded responses to downplay the difficulties they experience, especially with regard to learning, following instructions, and using medical equipment.The pre-coded responses do not always match free-text feedback, which many times express frustration and confusion with regard to following medical device labeling and instructions. Furthermore, many free-text responses indicate that respondents do not recall receiving or did not receive instructions upon receipt of their medical equipment, which may also skew the results.Many study respondents are comfortable using computers, and often refer to information sources online and using a website that contains instructions for medical equipment used in the home. This finding, however, cannot be generalized to the entire population. Clearly there is selection bias at play: Respondents taking a web-based survey are likely to be more comfortable with computers, which could impact their ability to accurately respond to these questions.Another limitation to this study is that CAN respondent educational levels were not captured, nor were they included as part of the selection criteria eligibility. Authors suggest that in future studies of this nature, a question to obtain respondents' educational levels be included to determine whether there are relationships between education and labeling comprehension ease.