In an endeavor to provide additional resources of information for the Biomed, the California Medical Instrumentation Association (CMIA) offers the following documents, presentations and video.
The sources vary, each may be used by an individual however reproduction and distribution is allowed only if specifically stated in the document. You are encouraged to submit legally reproducible appropriate documents for inclusion in this resource. Send them to [email protected] for review.
Home Use Devices
Who can write a prescription for a medical device?
Each state has laws and regulations that determine who can write a prescription for a medical device in that state. FDA defers to the states on determining who can write a valid prescription.
Do I need a prescription for my device?
Not all medical devices require a prescription; however, many medical devices do require a prescription (for example, contact lenses).
How can I find out if my medical device has been recalled?
You can search FDA’s online public recall database.
I can’t find the instructions for use. Where can I find the information?
If you do not have the instructions, contact your healthcare provider.
What kinds of home use device issues should be reported to FDA?
For information about recognizing and reporting incidents with home use devices, see the following educational tools, which provide examples of device-related incidents likely to occur in the home setting and encourages staff to report them.
- Where do I report a serious injury, death or medical device malfunction?
How do I clean my device?
Follow the manufacturer’s instructions. If you do not have the instructions, contact your healthcare provider.
Where do I dispose hazardous waste, such as needles or tubing?
Dispose of your medical device according to the manufacturer’s instructions. You may also wish to contact your pharmacist, nearest hospital, solid waste company, or state or local government for additional information about proper disposal.
What devices does FDA recommend for home use?
FDA is responsible for regulating companies that manufacture, repackage, re-label, and import medical devices sold in the United States. This is accomplished through scientific review of premarket data submitted by a medical device manufacturer to establish a device’s safety and efficacy and then once on the market, monitoring medical device adverse event reports to detect and correct device-related problems in a timely manner.
It is important to note because the FDA’s scope of work is to regulate the medical device industry, the FDA cannot and does not recommend specific medical devices for use in any setting. Review the instructions for use for a device you plan to use in the home before deciding on the one best for a particular patient population.
I have a patient who lives in a rural area and is being discharged from the hospital. She will be two hours from the nearest clinic. What medical device associated risks should I consider?
There are many risks to consider when caring for a patient who requires a medical device in their home environment, especially in rural areas. It is important to consider:
- What the device needs to operate safely and effectively, (for example: electricity, running water, computer connections, back up supplies)
- Power sources and outlets, (for example: are they compatible with one another?)
- Patient capabilities
FDA has developed a checklist with important questions to ask when considering home use medical devices titled, “Home Healthcare Medical Devices: A Checklist”
Where can I buy home use devices?
Home Use devices are often sold to patients who have a prescription for that given device at hospitals or at pharmacies. Medical devices are also cleared or approved for sale directly to the consumer and these are called Over-the-Counter (OTC) products. Medical devices are also available at many online retailers. If you buy a home use device online, make sure you are buying from a reliable source. Also check the store’s return policy and customer support statement before you place an order.
Who do I contact if my device breaks or doesn’t work properly?
Make sure you have phone numbers for your homecare agency, doctor, or the device manufacturer to call if your device is not working properly. You should also report the problem to your doctor, to the manufacturer of your medical device and to FDA through the MedWatch Reporting Program.
Does the term “Management” in HTM include those who do not manage people?
- Yes. The name of the profession—HTM—provides a professional identity for ALL of the members who make up this community of specialists.
- The term “Management” in “Healthcare Technology Management” refers to the management of technologies rather than the management of people.
- HTM professionals are responsible for the lifecycle management of medical technologies, which includes a wide breadth of responsibilities such as activities that control costs, provide clinical support, and improve patient safety and outcomes.
Is the HTM name new? If so, how is it being shared with others?
Yes, it’s new. Many individuals and organizations are helping to communicate the HTM name. This web site is one way the name is being communicated with others.
What are the core functions of HTM professionals in a hospital setting?
- Selecting safe and effective medical equipment
- Maintaining medical equipment and systems
- Improving patient outcomes
- Educating clinical staff
- Controlling costs
What other hospital departments interface with HTM?
HTM works collaboratively with many other departments within a healthcare organization. This includes, but is not limited to, clinical departments, administration, materials management, risk management, quality& patient safety, facilities management, and IT.
What is the usual reporting chain for HTM professionals within a hospital setting?
Reporting structures vary widely. In many cases, the HTM department reports to the leaders of facilities management, IT, or administration. A successful HTM program may exist anywhere within the organizational structure, so long as there are resources and a strong partnership to support all that a good HTM program can do.
What is considered an HTM profession?
Job titles vary within HTM, and as the profession evolves, so will the titles, roles, and job descriptions. However, common titles within HTM include: clinical engineer, biomedical equipment technician, clinical equipment specialist, biomedical equipment specialist, laboratory technician, and imaging technician.
What do they do?
- Plan, select, manage, and repair medical devices and technologies
- Ensure a high standard of performance of medical devices and systems through preventive maintenance (PM) or corrective maintenance (CM) checks or quality inspections
- Provide clinical staff with on-call technical assistance and device training
- Help facilities provide safe, cost-effective, and well-maintained healthcare technologies that improve clinical outcomes
How does HTM interact with Information Technology?
The relationship between IT and HTM varies depending on the employer’s organizational structure. IT professionals focus on the technologies that store, share, and analyze health information (i.e., computer hardware, software). HTM professionals focus on clinical technology. IT and HTM professionals must work with one another on network management, wireless strategies, device integration, systems planning, and the like.
What impact does the name of the HTM profession have on job titles?
The name of the profession—HTM—does not affect individual job titles. Similar to other professions, such as Nursing, Human Resources (HR) or Information Technology (IT), the HTM profession is comprised of specialists in different fields within HTM. Efforts are underway by HTM leaders and AAMI to standardize job descriptions and job titles for HTM professionals. Ultimately, it is the employer who establishes job titles.
- Dos and Don’ts of Interviewing
- Career Resources: Interview Guide
- Exploring Career Advancement Opportunities for HTM Professionals
- Certification: A Rewarding Endeavor
- Average Salary of Biomedical Equipment Technician Jobs
- Where Do I Go from Here Climbing the Ladder to Management
- Survival Guide for HTM Millennials
- Career Resources: Five Tips for a Strong Phone Interview
- Networking is Key to Career Advancement
What Type of Person Could Be a Future BMET?
Future BMETs should be endowed with a variety of attributes. On the technical side are the abilities to reason, solve problems and enjoy challenges. Communication skills are extremely important, not only with your peers but with those who use the equipment from doctors to nurses and laboratory technicians and other support departments as purchasing, IT and accounting. The person should be self-motivated, be dedicated to customer service and improving themselves, have the ability to work independently or on a team, and be capable of setting priorities.
What Will BMETs Learn in School?
They will obtain a basic understanding of health sciences physiology and anatomy and their terminology. Preparation also includes math, physics and electronics and the ability to navigate schematics. Classes cover the basics of sensors and rudiments of data acquisition. A cooperative education (co-op) or internship periods expose students to the realities of current equipment.
Is Special Education Required?
Typically one obtains an Associates degree in BMET from a community college or if in the Military Service, completing the Sheppard Air Force Base’s Department of Defense BMET School course. Others receive on-the-job-training (OJT) and attend manufacturer’s classes after receiving formal training in electronics. After employment continuing education for certification (CBET), manufacturer’s classes or completion of a BS degree offer paths for advancement and increased salary.
How Many BMETs Are There?
In 2000 the U.S. Bureau of Labor Statistics’ Occupational Outlook Handbook estimated there were 11,000 positions equivalent to a BMET. However, 2006-7 edition reports 29,000 an almost 3 fold increase in 6 years.
What Are the Job Opportunities?
Most BMETs are hospital employees of a department called Clinical Engineering or Biomedical Engineering or hired by an organization contracted to perform these services. These department’s responsibilities vary between institutions and may service thousands of devices from beds and scales to large X-ray systems and digital imaging networks. Few institutions have the staff to support everything so responsibility for some is contracted out to the equipment manufacturers or thirds party service organizations. They, in turn, hire BMETs a Field Service Engineers to maintain unique equipment for many institutions in an area or even country-wide.
What is a BMET or Biomed?
A: Biomedical Equipment Technicians (BMET) are responsible for the performance and maintenance of a hospital’s patient care equipment. Their duties include maintenance (returning equipment to operational status), preventative maintenance (periodically ensuring each of the hospital’s thousands of devices are functioning properly), and assisting with the procurement of new devices and contracts, training users in the operation and care of equipment and evaluating failures. With such a variety of equipment and tasks, there are opportunities for advancement and diversity while knowing that you are a significant member of the health care delivery team.
What is the Salary of a BMET?
As of Feb 28, 2019, the average annual pay for a Biomedical Equipment Technician in the United States is $51,125 a year.
While ZipRecruiter is seeing annual salaries as high as $77,000 and as low as $22,000, the majority of Biomedical Equipment Technician salaries currently range between $40,500 (25th percentile) to $60,500 (75th percentile) across the United States. The average pay range for a Biomedical Equipment Technician varies little (about $20,000), which suggests that regardless of location, there are not many opportunities for increased pay or advancement, even with several years of experience.
Based on recent job postings on ZipRecruiter, the Biomedical Equipment Technician job market in both Oceanside, CA and the surrounding area is very active. People working as a Biomedical Equipment Technician in your area are making on average $50,027 per year or $1,098 (2%) less than the national average annual salary of $51,125. California ranks number 1 out of 50 states nationwide for Biomedical Equipment Technician salaries.
Are There Opportunities for Advancement?
Advancement can occur along many paths. There are hundreds of equipment types around the hospital for one to be an expert on all. However, by expressing an interest in various equipment types your value increases. Much of today’s equipment is connected via networks so capability in IT and connectivity plus medical devices allows advancement opportunities in either camp. Medium and large hospitals require many BMETs which results in management opportunities. This usually requires continuing education or management training. Additional growth in the field increases with chains or outsourcing organizations.
Can You Describe a Typical Day on the Job?
Over a period of a year, half your time is spent performing PMs. Much of the remainder of the day is spent repairing unplanned equipment failures. If life support equipment failed you may become a sleuth to determine what went wrong. The remainder may be on the phone answering questions about equipment use or issues, performing in-service training or evening recommending a product or service for purchase.
General Biomed Information
Professional Challenges in a New Health Care World
Mary Logan, President of the Association for the Advancement of Medical Instrumentation (AAMI) provided a glimpse into the future of Biomeds and clinical engineering; skill set requirements and the need to ensure corporate management is aware of the importance of the Biomed.
The Healthcare Environment Medical Equipment Management
George Mills, Senior Engineer of The Joint Commission’s Standard Interpretation Group defines new scoring procedures and their effect on Biomedical/Clinical Engineering departments.
Biomed Certification Study Guide
Dave Harrington compiled the Biomed Certification Study Guide for classes in the Northeast, using some of the material for his ICC prep column in 24 X 7 and over 40 years of experience in the field.
What are the Responsibilities of a Hospital’s Biomedical Engineering Department and its Biomeds?
Paul Kelley, former CMIA Board Chairperson, answered that question to the Board of Directors of Washington Hospital in Fremont, CA. Paul covers the beginnings of biomedical engineering technology, what is happening in today’s modern department, who they serve, and their responsibilities.
BMETs are known by many titles
Although job titles vary widely in the industry, the following job titles and descriptions are typical of those employed in ranking personnel.
BMET I—An entry-level or junior biomedical equipment technician (BMET). Works under close supervision. Performs skilled work on preventive maintenance (PM), repair, safety testing, and recording functional test data. Not certified. Usually has less than four years of experience.
BMET II—A BMET usually has a two-year degree or higher. Has good knowledge of schematics and works independently on repairs, safety testing, and preventive maintenance. Maintains records, writes reports, and coordinates outside repairs. Average experience is eight years.
BMET III—A highly experienced or specialized BMET who usually has a two-year degree or higher. Has substantial experience and may be certified. Does highly skilled work of considerable difficulty. Has comprehensive knowledge of practices, procedures, and types of equipment. Average experience is 12 years.
Equipment Specialist—A highly specialized BMET having special training or equivalent experience in lab equipment (LES) or radiology equipment (RES). Usually has a two-year degree or higher. Performs highly skilled work of considerable difficulty and may hold certification as CLES or CRES.
BMET Supervisor—A BMET who supervises others. Has a significant amount of training or education or equivalent experience. Most have a four-year degree or higher. Schedules and assigns work to subordinates, but also continues to do highly skilled repairs. Has comprehensive knowledge of practices, procedures, and types of equipment. Average experience is 13 years.
Clinical / Biomedical Engineer—A graduate engineer holding a BS, MS, or PhD. Performs engineering-level work of considerable difficulty. Has the ability to modify devices, and conduct analysis of devices and systems.
Clinical / Biomedical Engineering Supervisor—A clinical engineer (CE) who supervises BMET/peer/ subordinate CEs; may also supervise equipment specialists. Usually degreed engineer at BA, MS, or PhD level. Average experience is 21 years.
Director/Department Manager—Most are educated or experienced as clinical engineers or BMET, but others may be trained in administration or business or have extensive healthcare supervisory experience. Most have a significant amount of technical or management experience, and have the skills to select acquire, maintain, and repair high-tech equipment. Supervises BMETs, CEs, and support personnel. May also be the chief technology officer or vice president for healthcare technology.
- Biomed Certification Study Guide
For What Equipment is a BMET Responsible?
A large community general hospital may have 10,000 devices. All must be uniquely defined and records maintained of their maintenance and performance history. This is a large task itself, requiring dedicated computer database applications. A random list of equipment includes: Electrocardiographs, Electroencephalographs, X-ray , MRI, Blood warmers, infusion pumps, humidifiers, cell counters, cell washers, dialysis machines, physiological mentoring systems, anesthesia machines, hospital beds, microscopes, lasers, ultrasonic imaging, sterilizers, blood gas analyzers, ventilators, surgical lamps, clinical lab analyzers, electrosurgical unit, resuscitators, The industry organizations ECRI maintains a categorized list of over 6,000 types.
- Proposition 65 Requires California Hospitals to Notify Patients of Harmful Chemicals and Materials Used in Medical Devices An ECRI Health Devices
HIPAA and Securing the Healthcare IT Environment
A 40 side presentation by Jim Rizzo of General Electric explaining the need for patient data security and the responsibility of the Biomed.
Investigation and Litigation of Medical Injuries
What Biomeds Should Know About Incident Investigation, Documentation and Court Procedures. This is an outline for a presentation given to the CMIA San Diego Chapter by Jerome T. Anderson, C.B.E.T., C.C.E. of Biomedical Consulting Services. Mr. Anderson has over 30 years of experience in clinical engineering.