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MedSun: Discussions with Healthcare Providers

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Discussions with Healthcare Providers

Here you will find information healthcare professionals have shared with MedSun about the safety and effectiveness of a variety of medical devices.

Discussions with Healthcare Providers

Medical Device Quality: Small Sample Survey Summary

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Survey Topic: Medical Device Quality - Survey Final Report
Year Conducted: 2014

Introduction

In 2011, FDA launched the “Case for Quality” program to promote improvements in medical device quality. Health care providers who work in hospitals or hospital systems and who are involved in making decisions about purchasing medical products for their organizations are key stakeholders in this effort. As medical devices and use environments become more complex, the costs of devices increase, and differences in quality continue among competitor products, decision-making for these stakeholders becomes more challenging and critical to obtaining and providing safe, effective and high quality medical products for patients.

FDA conducted a small sample survey to speak with hospital representatives and other health care providers responsible for key product decisions in their organizations. The survey purpose was to enhance FDA's knowledge about the decision-making process and criteria used for evaluating and purchasing medical devices in real-world clinical settings. Feedback and insight about what healthcare providers do to assess and procure medical devices for their patients helps FDA better understand the needs of the clinical community and the criteria that help users evaluate device quality. This information will assist FDA in promoting the manufacturing of higher quality devices that would be less likely to be the subject of device recalls and preventable adverse events.

Methodology
A small sample of health care providers from hospitals that participate in FDA’s Medical Product Safety Network (MedSun) were queried to obtain detailed and in-depth perspectives about processes for selecting and purchasing medical products. Respondents from seven different hospitals (located in the West, Midwest, Mountain, Mid-Atlantic, and Southern regions of the U.S.) participated in the voluntary survey.

Two of the hospitals have approximately 250 beds, three have about 500 beds, and one hospital has over 900 beds. Additionally, corporate staff from a large system of hospitals were also part of the respondent sample. Two of the seven facilities that participated are pediatric hospitals.

The respondent sample included health care providers representing biomedical and clinical engineering, materials management, risk management, nursing, medicine, product safety and recall management, knowledge management, clinical technology, environmental services, purchasing, value analysis, and supply chain management.

All respondents’ organizations have a group of individuals responsible for evaluating medical devices and making key product decisions. However, the structure, management, roles and responsibilities, and numbers of individuals involved vary among institutions. Different names are used for committees and groups and differences exist in how they function. For purposes of clarity and consistency in this report, the word “team” is used and refers to the group of individuals in each organization who are involved in the decision-making and purchasing of medical devices.

Overview of Responses to the Survey

Roles and Responsibilities of the Value Analysis Team (VAT)
There are many different names that respondents’ hospitals use for their committees responsible for the evaluation and approval to purchase medical devices. Four hospitals use the name Value Analysis Team and the other hospitals use various titles for their teams such as, Supply, Nursing, New Technology, and Product Review for the individuals involved in this effort.

All of the teams employ a multidisciplinary approach and have representation from management in several clinical specialty or functional areas. For example, a team may include managers in nursing, nursing education, infection control and prevention, biomedical engineering, laboratory, risk management, quality management, physical therapy, respiratory therapy, operating room (OR), emergency room, environmental services, materials management, information technology (IT), and supply chain and purchasing departments. Other ancillary departments are included as needed depending on the product being evaluated such as the pharmacy, wound care specialists, etc. Some hospitals have specific cardiology, critical care and surgical value analysis teams that focus only on the needs or issues for their respective clinical areas. Four institutions’ teams include physicians and in one facility with two primary teams, one team is physician-led and focuses on implants or medical devices primarily used by physicians. This particular hospital emphasizes the importance of keeping physicians engaged in the process. Additionally, one hospital team includes the Chief Financial Officer (CFO) and the Chief Operating Officer (COO). One hospital system has multiple teams for different clinical product categories such as, cardiology, medical imaging, internal medicine, and laboratory, who are responsible for following standard processes for evaluating quality and desirability of medical products. This particular organization has a system-wide product council that includes clinicians and other support staff from biomedical engineering, IT, supply chain, contracting, legal, etc. that provides oversight of processes used by the smaller clinical product teams. All survey respondents report that there is some crossover among teams when products are assessed that will have an impact on several different types of clinical users.

Additionally, two respondents mention having technology assessment or new technology teams that are also involved in purchasing decisions. One respondent says distinctions are made between new devices and devices that reach a threshold in cost (e.g., over $100,000 per year in a single acquisition or a cumulative acquisition during the course of a year). The second respondent explains that their new technology team is a recommending board that is responsible for reviewing information when there are questions about bringing in a new device to the hospital. However, this particular respondent adds that sometimes it’s difficult to determine what is really “new” technology and says they define it as technology that is new to the marketplace and they don’t currently have in their institution. The respondent further explains that other items that may go to their new technology team are devices where the practice or use of the device has changed. For example, ultrasound is not a new technology, but they are receiving many requests for use in different locations in the hospital other than in the imaging department. This causes concern about education, training, and monitoring of users who may not be credentialed to read or interpret ultrasound images.

Several respondents emphasize the importance of engaging a wide range of different stakeholders in the organization, particularly end-users in decision-making, as appropriate, and believe that the approach contributes to the quality of decisions and their value analysis programs.

In addition to evaluating and approving devices for purchasing, two respondents mention their team is also responsible for writing a training program, a communication program, and a monitoring program to make sure the device is utilized as projected.

Approach or Philosophy of the Team
There is some variation among respondents when asked about their particular philosophy or the approach used to guide the work of their teams. However, most view safety and cost as the basis for their approach. One respondent says their overlying philosophy has always been to first evaluate the clinical quality of the product, then cost and then the innovation demonstrated by the manufacturer with technology and new products. Most discuss conducting a thorough investigation of a device particularly if it’s new and emphasize the importance of the multidisciplinary team in the process and the value of clinical trials and testing by users. One respondent, whose hospitals are part of a system, mentions the comprehensive evaluation completed by their supply chain organization that helps set and drive standards with staff involvement from each of their facilities. Respondents from another hospital system utilize their procurement and strategic sourcing staff for consulting and providing data to physician teams. Their data gathering and communication helps establish evaluation criteria for decision- making. Many respondents add that another factor considered in the process is whether or not the manufacturer is capable of supplying the numbers of medical products they require.

Devices Evaluated from all Areas of the Hospital
Most teams evaluate devices from all areas of the hospital including specialty areas such as the intensive care units, labor and delivery, operating rooms, catheterization labs, etc. However, some respondents report having one primary value analysis team for devices that are used in multiple areas of the hospital, but have individual value analysis teams for devices that are only used in a certain areas such as interventional radiology.

Leased or Owned Devices
When asked if devices are owned or leased, respondents say their facilities own most of their medical devices. A respondent from a large system of hospitals say they have a philosophy of looking at the total cost of ownership and may go with a more expensive device, because the company may have a better product warranty and better clinical and educational resources. One respondent says they always look at the lease versus buy option and consider the long term cost of ownership. The respondent adds that most times they purchase the device with one exception that involves the clinical laboratory. For example, chemistry analyzers are expensive devices, require high maintenance and may include a reagent purchasing commitment so it’s more prudent to lease the device. In another facility, the decision to lease requires an in-depth financial analysis to demonstrate that it is the better alternative. Additionally, one facility has a combination of owned and leased devices with approximately 75% owned. The reason for leasing may be due to an immediate clinical need. If capital funds are not available at the time, they will lease the device and purchase it later when funds are approved. Another respondent states that leasing may be warranted when the device is very expensive but may only be used a few times a year such as a specialty bed. Most respondents report that contracts for leased devices are usually negotiated every three to five years.

Purchasing Process
There are some commonalities among respondents’ organizations when discussing their purchasing and approval process such as the individuals who are most involved in decision-making, however, many differences also exist. None of the respondents identify a single person as a primary decision-maker, and assert that most decisions may involve several individuals depending on the device and other factors. Most say that final review and approval is needed from senior management for device purchases that involve capital equipment, affect several other hospitals in a system, and/or include a high purchase cost. The differences among respondents’ organizations involve how often meetings are conducted, the particular type of device under review, the amount of time it takes to make decisions, and how devices involving new technology are reviewed and approved. Additionally, a few hospitals report having a formal request process to bring devices to their team while in other hospitals the process is less formal. Table1 provides a comparison of responses about meeting frequency, time frames for decision-making, decision-makers, and other aspects involved in the purchasing process as reported by one or more respondents.

Table 1. Purchasing Process: Meeting Frequency, Decision Time Frame, Primary Decision- Maker as Reported by Respondents

Frequency of MeetingsAverage Time for Decision MakingPrimary Decision MakersOther Factors that May Affect Decisions
Every 18 months based on fiscal year2 monthsTechnology assessment committee (for review of a capital acquisition of $100,000 or more a year)capital allocation committee (senior executives and physicians)
contingency planning committee (department heads, vice presidents, and CEO as needed)
Task force established for review and approval, if needed, during fiscal year; contingency funding is available in most fiscal years;
Monthly2 to 3 weeksFinance and Purchasing DepartmentsDeveloping programs for training, communication and monitoring may extend the time frame of decision making;
MonthlyDuring meetingVAT team(s)key stakeholders senior leadership in financeSome decisions take longer due to organizational initiatives, vendor contracts, utilization;
Monthly ad hoc based on requestsBased on testing, committee review, fiscal year budget for operations and capital equipmentVAT team(s)quality and safety management supply chain organization senior leadership for new technologyDiscretionary funding available, if necessary, to supplement cost;
Every 2 monthsBased on devices/productsVAT team(s)senior executives depending on product and costMeeting frequency may change if the device is a capital expense or involves a risk/benefit analysis;
Quarterly3 to 6 monthsVAT Chairperson
Purchasing and Finance Departments
Quarterly12 to 18 months for large contractsProduct council procurement/strategic sourcing teamSmaller subgroups evaluate applicability and desirability rely on contracting process for pricing, fill rates, supply chain;


Factors or Criteria and other Resources Considered in the Purchasing Process
There are several factors or criteria that respondents say are considered in the purchasing process at their institutions. The following is a list of factors as reported by one or more respondents.

• safety and cost (viewed by most as primary drivers; cost includes the total cost of the life expectancy of the device);
• clinical quality;
• design features (ease of use, ability to program);
• problems or concerns reported by users of the device or similar devices;
• feedback from clinical testers;
• feedback from colleagues about whether the manufacturer has been a good partner or not;
• past experiences with manufacturer when problems/concerns have occurred;
• production capability of manufacturer to supply what is needed;
• reliability of the supplier support system;
• innovation, new technology and new products from the manufacturer; and,
• registry data for device, if available.

Additionally, respondents use specific resources for information about devices they’re considering for purchase and identify sources that they typically access first in the process. Table 2 provides a listing of the resources utilized for making decisions as reported by one or more respondents.

Table 2. Resources Used to Obtain Medical Device Information in the Purchasing Process as Reported by Respondents
Initial ResourceSecondary ResourceAdditional Resources
Internal reporting systemFDA recalls database (daily occurrence)Hospital device trials;
Calls to other hospitals; ECRI Institute for their safety scores; Supply chain organization
ECRI Institute evaluation is standard for device comparisons and pricingIndividual vendor technical groupsFDA MAUDE database;
Association for the Advancement of Medical Instrumentation (AAMI);
MedSun Monthly Newsletters
ECRI Institute reportsPubMed Search for clinical trial dataFDA website e.g., advisory report transcripts; inspection reports; Biomedical engineering colleagues; Work with other institutions; Patient concerns network; Manufacturer site visits
ECRI Institute reportsAn online system for clinical and financial device informationFDA Recalls database
ECRI Institute Alert TrackerFDA MAUDE databaseInternal reporting system; Staff feedback from internal device trial; Supply chain organization; American Hospital Association (AHA) subsidiary groups (risk management, materials, etc.)
FDA MAUDE databaseIndividual manufacturerInterviews with other institutions to discuss issues, concerns and problems
ECRI Institute ReportsRegistry data, if availableFDA: MAUDE database, recalls database, clinical trial data,Literature searches


Influence of Budget in the Purchasing Process and Decision-Making
All respondents say that the budget is a major influence in the decision-making and purchasing process for medical devices. However, respondents explain that while cost is always a factor in decision-making, many other aspects are considered when evaluating a device for purchasing particularly patient safety. One respondent says that each device is viewed differently and asserts there is no one single formula for how the budgeting and financials work. Another respondent reports that their multidisciplinary team includes a representative from finance, the leadership team, and the senior executive team and adds that all are involved in making the decision to purchase more expensive devices, but adds that the specific device and its safety are also evaluated carefully. Another respondent adds that past experience of team members with budgeting and device approvals makes a difference in their decision-making particularly when deciding on a less expensive device and there are questions about the quality.

Most respondents believe that devices shouldn’t be purchased solely on price. One respondent mentions they have their sourcing managers negotiate pricing once they’ve decided to purchase a more expensive device. Additionally, other factors considered in the decision are the relationship with the vendor, product warranties, and clinical and education resources.

Typically, capital budget item purchases are reviewed by the hospitals’ CFO and senior leadership team for agreement on choices and pricing. At one hospital, a senior executive financial committee that includes the president, CFO and vice presidents are involved in the purchasing process.

Third Party Purchasers/Group Purchasing Organizations
All respondent hospitals use group purchasing organizations (GPO) and report working closely with them to obtain pricing. Many respondents say they also rely on their GPO for utilization run rates, contractual agreements, comparative pricing, products, equipment, and for setting standards. However, a few respondents report also working directly with specific manufacturers for some products.

Effect of Product Recalls on Purchasing
All respondents have systems in place for receiving notifications from manufacturers about recalls. Three respondents’ hospitals use web-based recall management services and others have internal alert systems for distributing the information to the appropriate individuals upon receipt. In one hospital, the VAT manager is responsible for reviewing all recall notifications.

A few respondents say they routinely check the FDA recalls database when they are involved in new contract negotiations or when they are looking to purchase equipment. However, one respondent adds that a particular recall rarely stops the purchasing process and explains that it depends on whether the problem is hospital or system-wide or if it’s an issue that mostly requires staff awareness and monitoring.

There are two instances, however, that a respondent mentions a recall did have an effect on purchasing. In one situation involving a recall, the hospital could not purchase additional devices because of restrictions placed on the manufacturer. The second occurrence involved a device widely used in the hospital that the company could no longer sell. The respondent believes that removing the device would have created a significant risk to patients so permission from FDA was given to them to keep the device in service under certain conditions and implementation of safety parameters.

Product Performance that does not meet Expectations
Respondents provide several examples when their value analysis team received feedback that a device wasn’t working as expected and a change was necessary. Most have a process in place for determining what the problems or concerns are and quickly try to resolve the issues or find replacement devices. Generally, they say the vendors are very understanding about pulling the product line without any kind of penalty.

Radio-frequency Identification, Real-time Location, Tracking and Inventory Systems
Two respondents report using radio-frequency identification (RFID) systems and use it for device tagging on most of their major moveable patient care equipment. The respondents add that the system provides information about distribution, how often equipment cycles through cleaning, usage, and for retrieving devices involved in recalls. The other respondents say their hospitals use inventory management systems, barcode scanners or their own internal systems for locating devices, tracking usage and for projecting future device usage.

How FDA can help with Decision-making
When asked how FDA could aid their decisions, respondents offer the following suggestions and comments:

• A better method of device classification in a database that provides detail and is easy to use would be very helpful to hospitals.
• Accessing the MAUDE database is not easy; a universal device nomenclature would be helpful for conducting searches.
• A database of collective information would be valuable for comparing manufacturers (a side by side comparison) that includes the clinical efficacy of devices. A suggestion is to start with the types of devices that could impact clinical outcomes such as orthopedic and spinal implants. Other devices such as patient care plastic products would not need to be included in the database.
• More information is needed for devices that are not high risk and don’t require clinical testing. Hospitals have to rely only on feedback from users of the devices. For devices that are clinically trialed, many have not had human factors testing, although it seems manufacturers are getting better with providing human factors testing information.
• There is very little data on new products and new technology and if there is information available, it’s very anecdotal and unconvincing. Information about which devices are in the pipeline at FDA would be very useful.
• Even though ECRI provides great data about devices that our physician committee reviews, the product may be new to the market (e.g., for only a month) and there may be no independent studies to help in the evaluation of the device. The manufacturer has data about how good their product is compared to others, but it would be good to have an independent perspective and additional information to support decisions.
• It would be helpful to have something similar to ECRI for making purchasing decisions where a hospital can query the marketplace for a specific device. The information could provide the device manufacturers, the specifications, user feedback, cost information, the number of recalls, alerts, sanctions, etc.

Summary
The survey findings provide insight about how health care providers approach the process of evaluating and purchasing devices for their institutions. All respondents report that safety (prevention of patient harm) and cost are the primary drivers of their decisions and rely on a variety of other criteria and resources for additional information. All respondents involve a multidisciplinary team in the evaluation process and believe it is essential to obtaining important input and feedback about the clinical quality and performance of the device. Participation, particularly from physicians and other end-users on the teams, is viewed as critical to the success of the process.

All respondents’ hospitals have a GPO that provides services such as, medical product information, comparative pricing, contractual agreements, and product standards. Also, respondents believe budget always has a role in decision-making. Approval processes vary among their institutions according to factors such as the cost of the device, type of device, clinical evaluation, projected usage, and available funding.

Survey respondents say they would like more information from FDA and other sources to make more effective and efficient decisions about devices they evaluate and consider for purchase. Most respondents believe that having access to comparisons about device quality among manufacturers that includes factors such as cost, device specifications, safety and performance reports, recalls, inspection reports, warning letters, etc. will assist their internal value analysis processes. Subsequently, the information contributes to increased knowledge and more comprehensive and informed decisions for purchasing high-quality, safe and effective devices that can mitigate health risks to patients.

Survey Limitations
Although the findings add to FDA’s knowledge of health care provider experiences and perspectives involved in the process of evaluation, decision-making and purchasing of medical products, there are several limitations to the survey methodology. These include the small convenience sample of respondents, the variability in roles and responsibilities of teams among the hospitals, and the differences noted among smaller size hospitals, larger hospitals and hospitals that are part of a system. In view of these limitations, the respondents’ perspectives may not represent the perspectives of all health care providers.

Therefore, these findings represent only one piece of information. No conclusions can be made about the decision-making or purchasing process to foster device quality in the broader clinical environment based on this report alone. Instead, the report should be considered along with other information that may include input from other key stakeholders, both internal and external, publications, and other data sources that are part of FDA’s activities for monitoring and promoting device quality, safety and performance.

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Surveying device users is one of many tools the FDA uses to evaluate the public health impact of the potential problems associated with the use of medical devices. Typically, small sample surveys are used to collect qualitative information on postmarket experiences of clinicians and obtain their perspectives as device users. Survey respondents are selected based on their experience with the topic or device, their availability and their willingness to participate.

FDA scientific, medical, nursing and engineering staff is made aware of the survey findings as needed. FDA will work with the manufacturers and health care professional organizations to make important information known to the clinical community. Additionally, FDA continues to work with manufacturers to ensure the development, testing and promulgation of methods for reducing the risk associated with devices and to minimize the complications from adverse events that may occur in the course of normal usage. If the results of any survey raise serious concerns about the device safety, effectiveness and quality, FDA may convene a group of clinical, scientific and regulatory experts to discuss further actions.

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Updated October 22, 2014

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