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Cheat sheet

CHTM Memorization Sheet

Print this and keep it beside you. The CHTM exam rewards recall of the financial formulas, the risk tools and the laws behind them, the operations metrics a department reports, who regulates what, how training is justified and measured, and the labor laws a manager must not break. Every number and name on this sheet is fair game.

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01The exam itself

FactValue
Certifying bodyThe AAMI Credentials Institute (ACI), the credentialing arm of AAMI
CredentialCertified Healthcare Technology Manager (CHTM), for HTM supervisors and managers
Questions100 multiple-choice questions
Time and rules2 hours, closed book; an on-screen calculator and an on-screen notepad are the only tools
DeliveryComputer-based at Kryterion test centers
Testing windowsTwice a year: May 1 to 15 and November 1 to 15
Domain 1Financial Management, 20% of the exam
Domain 2Risk Management, 16% of the exam
Domain 3Operations Management, 40% of the exam
Domain 4Education and Training, 11% of the exam
Domain 5Human Resources, 13% of the exam
Scoring methodA criterion-referenced cut score set by the modified Angoff method; the cut score is not published
ResultsReported as pass or fail, with no numeric score
Fee$490 member, $565 non-member; retake $440 member, $515 non-member
Retake rulesWait 60 days between attempts; at most three attempts in two years, then a one-year wait
RecertificationAt least 30 continuing education units (CEUs) in a three-year cycle, with fees paid by December 31 of the year the credential expires. One CEU is one hour of qualifying activity
Other ACI credentialsCABT for associates entering the field, CBET for technicians, CRES for imaging specialists; the CHTM is the management credential. A CABT alone does not satisfy an eligibility pathway
How the questions readThey ask for the FIRST step, the BEST recommendation, the MOST appropriate report, committee, or document, and now and then the LEAST appropriate action
Eligibility pathwayWhat it requires
1. Current technician or engineer credentialA current CCE, CBET, CRES, or CLES plus at least three years of work as an HTM supervisor or manager in the last five
2. Military trainingThe Department of Defense (DoD) BMET training program plus three years of military or civilian HTM supervisor or manager experience in the last five
3. Associate degreeAn associate degree in biomedical technology, a related healthcare discipline, information technology, or business plus three years as an HTM supervisor or manager in the last five
4. Bachelor's degree or higherA bachelor's degree or higher in biomedical technology, engineering, a related healthcare discipline, information technology, or business plus two years as an HTM manager in the last five
5. Experience aloneSeven years in the HTM field with three years of management experience in the last five
Attestation ruleA pathway without the supervisor or manager title needs confirmation of management duties by self-attestation or third-party attestation
This course's official-format test uses 70%, the same bar as our CBET and CRES courses; ACI publishes no cut score.

02Financial management

Budget or termWhat it means to the manager
Operating budgetNext year's spending on labor, parts, contracts, outside service, calibration, tools and minor equipment, office supplies, travel, memberships, education, and shop meetings
Capital budgetRequests above the hospital's dollar threshold for items with a long useful life: a system, test equipment, a shop expansion. It competes with every other capital request in the hospital
Who approves whatThe manager builds both. The operating budget is approved up the manager's own chain with finance; the capital budget is approved by the capital or technology committee and senior leadership, because capital money is rationed across the whole hospital
When budgets are builtThree to six months before the fiscal year starts
Fiscal yearThe hospital's twelve-month accounting year. It often does not match the calendar year, so know which one a request is aimed at
Cost centerThe numbered account a department's costs post to. Every work order, part, and contract payment should trace to one
Chart of accountsThe hospital's list of cost centers and subaccounts. The HTM budget is reported in those subaccount numbers, not in categories HTM invents
Distributed budgetingHTM holds only shop costs: labor, calibration, training, supplies. Contracts, parts, and outside labor stay with whichever clinical cost center owns the device, which leaves nobody able to see total maintenance cost or hold a vendor to terms
Consolidated budgetingEvery equipment dollar is moved under the HTM cost center, then allocated back to the clinical cost centers from CMMS reports. This is the better model, because the department that pays can withhold payment until service reports arrive
The irregular-cost trapA large cost that recurs on a long interval, such as an eighteen-month part, must be budgeted on its interval. Last year's spend may not contain it at all
Purchase order costRaising one purchase order carries roughly $100 of hospital overhead, so many small orders waste more than the lower part price ever saves
Fiscal agreementConsolidation only works with a written understanding among HTM, the clinical departments, and the chief financial officer on priorities and on how a repair that exceeds the budget still gets done
What you spend money onWhere it posts in the general ledger
Technician and supervisor wagesSalaries, the payroll line
Overtime and on-call paySalaries. Track it as its own line: rising overtime is the first sign of understaffing
Repair parts bought by HTMMaintenance and repairs
Service contracts and vendor laborPurchased maintenance and repair
Shop consumables and small suppliesOffice supplies or medical and surgical inventory, by what the item is
Test equipment calibrationMaintenance and repairs, or a calibration line if the hospital has one
Training tuition, travel, and lodgingTravel and education. Training is an expense because it cannot be depreciated
A replacement monitoring systemCapital, not operating. It is depreciated over its useful life rather than expensed this year
FormulaStatement and worked example
Budget varianceVariance = actual minus budget. $112,000 actual against a $100,000 budget is a $12,000 variance
Variance percentVariance / budget x 100. $12,000 / $100,000 x 100 = 12%. Accounting usually wants a written explanation once a month lands 5% or 10% off its budget
Favorable or unfavorableAn expense that comes in under budget is favorable; over budget is unfavorable. Over-expenditure is what gets the attention
ROI percentROI = (gain minus cost) / cost x 100. A $25,000 school that avoids $90,000 of contract cost: (90,000 minus 25,000) / 25,000 x 100 = 260%
Payback periodPayback = cost / annual savings. A $100,000 project returning $20,000 a year pays back in five years. Shorter is better
Total cost of ownershipTCO = purchase plus installation plus service plus parts plus training plus disposal, across the life of the device. Compare TCO, never the sticker price
Straight-line depreciation(Cost minus salvage value) / useful life, per year. A $1,000,000 system over ten years with no salvage depreciates $100,000 a year
Book valueBook value = cost minus accumulated depreciation. After three years that system books at $700,000, and that number says nothing about remaining useful life or resale value
Cost of service ratioCOSR = annual service cost / acquisition cost x 100. $5,000 a year on a $125,000 system is 4%
Reading a COSRAcross a hospital, 4% to 25% is the normal band. Manufacturer service typically runs 10% to 25%; full in-house service can reach 4% to 6%
COSR on a quoted contractDivide the contract's annual price by the device's purchase price, then compare it with the department's COSR. A $180,000 contract on a $1,000,000 system is 18% against a department running 6%: three times the cost
Statement or accounting termWhat it holds
Balance sheetA snapshot on one day: assets, liabilities, and owner's equity. Assets equal liabilities plus equity
Income statementAlso called the profit and loss statement. It covers a period of a month, quarter, or year: revenue minus expenses equals net income
Cash flow statementCash in and cash out over a period, split into operating, investing, and financing. Reported profit is not money in the bank
GAAPGenerally accepted accounting principles: the standards, conventions, and rules accountants follow when recording transactions and preparing statements
Accounts payableAP is what the hospital owes its vendors. Unpaid service invoices and parts orders sit here
Accounts receivableAR is what the hospital is owed. Revenue from servicing outside clinics sits here until it is collected
Accrual versus cash basisAccrual records an expense when it is incurred; cash basis records it when the payment clears. Hospitals budget on accrual, so a part ordered in June is June's expense
Capital versus expenseA capital item is depreciated over its useful life; an expense lands entirely in this year's budget
Who to know by nameThe chief financial officer and the cost accountant for your cost center. The CFO decides how large irregular costs are carried in the budget
A business justification is written in one order and never another: the problem, the options, the costs, the benefits, the risks, then the recommendation. Say what happens if nothing is funded.

03Procurement, contracts, and the lifecycle

Life expectancy questionHow the manager answers it
How is useful life setManufacturer guidance, the AHA useful-life schedule for hospital assets, the department's own failure trends, parts availability, and the declared end of support
What the AHA schedule isAn industry average life expectancy by asset type, widely used to set depreciation. It is an average, not a verdict on the device in front of you
What end of life meansThe manufacturer has decided to stop supporting the model. It does not mean the device is unsafe, unrepairable, or finished
Is support guaranteedNo. No law requires a manufacturer to supply parts or support for any number of years after it declares EOL
What triggers replacementSupport withdrawn, parts no longer available, failure rates climbing, calibration that will not hold, technology overtaken by something safer or more capable, or an annual maintenance cost that has outgrown the device's value
How replacement is forecastRising annual cost per device in the CMMS plus the manufacturer's EOL notices, read years ahead, because replacement runs into millions
Service arrangementWhat it coversWho carries the risk
Full service contractParts, labor, travel, scheduled maintenance, often software supportThe vendor, at a fixed and usually high price
Parts onlyParts at an agreed price; no laborShared: in-house staff do the work
Time and materialsNothing in advance. You pay per call for labor, parts, and travelThe hospital, which is self-insurance. Managed well it can cut cost by as much as 60% against a contract
Shared riskA spending pool or a cap, with savings or overruns divided by formulaShared. Read the formula before you sign it
First lookIn-house staff respond first; the vendor is called only when they cannot finishThe hospital on routine calls, the vendor on the hard ones
Preventive onlyScheduled maintenance; repairs are billed separatelyThe hospital on every failure
Software supportUpdates, patches, remote diagnostics, license renewalThe vendor, but only for what the license actually lists
Point-of-sale or extended warrantyService sold at the moment of purchase, usually with no HTM inputThe hospital, which overpays. The seller's margin on one can run as high as 90%, and they rarely allow cancellation without a penalty
Equipment insurance or asset managementA premium covers scheduled and unscheduled work; you file claimsThe insurer, but the administrative load of claims lands on HTM
In-house serviceYour own staff, tools, test equipment, and partsThe hospital. Usually the lowest cost given volume, training, and stable staff
Contract termWhat to pin down before signing
ScopeExactly which devices, systems, modules, and accessories are covered, by serial or asset number, and during what hours
CostThe annual price, what it buys against the alternatives priced over the same years, and the COSR it works out to on this device
ComplianceWhether the vendor's people are qualified and will supply training and competency records, whether their work will be documented in the CMMS, and whether their intervals meet the plan and the accreditor
Response timeTime to a phone response and time to on-site arrival, stated separately, with what happens when they are missed
Uptime guaranteeThe promised availability, how it is measured, and the remedy when it is not met
PartsWhether parts are included, whether glassware and major assemblies are included, and whether they are new, refurbished, or exchange
LoanersWhether a loaner or backup unit is provided, how fast, and at whose cost
TrainingSeats, level, location, and whether service literature and passwords come with them
ExclusionsThe list that decides your real cost: batteries, accessories, probes, abuse, after-hours maintenance, software, travel
TerminationHow the hospital gets out, how much notice is required, and what penalty applies
Renewal and escalationWhether it renews automatically and how much the price may rise each year
Indemnity and liabilityWho answers for injury, data loss, and damage caused during service
Entire-agreement clauseThe signed contract is the whole deal, and a term can run as long as ten years. Nothing said in a meeting or an email survives it
Where the leverage isBefore signing, and before the capital purchase closes. After the sale the hospital has none

In-house or vendor: the factors that decide

  • Volume: how many of this model the hospital owns, and whether the hours justify a trained technician
  • Skills: who on staff already works at this level, and what happens when that one person is on leave
  • Training cost: tuition, travel, lodging, and the weeks of productivity lost while a technician is away
  • Test equipment: what the model requires, what it costs, and who calibrates it
  • Parts access: whether the manufacturer sells parts, service keys, and software to equipment owners at all
  • Risk: the consequence of a long outage on this device, and whether a backup unit exists
  • Response time: how long a vendor takes to arrive against how long your own staff take to walk down the hall
Acquisition or disposal choiceWhat the manager does with it
PurchaseCapital money, depreciated over the useful life. The hospital owns the asset and all of its downstream cost
LeaseOperating money spread over the term. Read who maintains it, who insures it, and what happens at the end
Fair market valueWhat a willing buyer would pay today. It is not book value and not replacement cost, and policy should say who determines it
Trade-inConvenient, and usually the lowest value the hospital can get. Price the open market before accepting it
ResaleUsed-equipment companies and broker sites will bid. After the labor to list, negotiate, and load, it is often close to break-even
DonationA charity may deploy the device abroad. Policy must say who selects the charity and who may donate instead of sell
Environmental disposalBatteries, mercury, sealed sources, refrigerants, and electronics follow environmental rules, not the loading dock
Data wiping before disposalAny device that stored patient information is wiped or has its media destroyed before it leaves. Selling or donating a device holding PHI is a HIPAA violation, and often only HTM knows the data is there
DocumentationA disposal record naming the asset, the method, the date, the wipe, and the signature closes the asset out of the inventory and the ledger
Order of preferenceRedistribute inside the organization or to a simulation center, then sell, then donate, then recycle. Disposing of an asset still being depreciated takes a hit for the remaining book value, so finance agrees first

04Risk management

Risk categoryWhat it looks like in an HTM department
Patient safety riskA device that shocks, burns, delivers the wrong dose, or reads out of calibration and leads to a misdiagnosis
Operations riskDowntime on the only device of its kind; a procedure canceled; a surgeon who takes cases to another hospital
Financial riskUnplanned repairs that blow the budget, a contract signed without review, regulatory fines, the cost of a lawsuit
Emergency preparedness riskA utility failure, a network outage, or a disaster that leaves clinicians without working equipment and no documented workaround
Regulatory riskA survey finding on maintenance records, an unreported adverse event, equipment in an alternative program that is not eligible for it
How risk and cost tradeRisk and cost move in opposite directions. Almost any risk can be driven near zero if the hospital pays enough, and cost comes down only by accepting more risk. The hospital's risk management department decides how much is acceptable
Scoring inputHow it shapes the maintenance strategy
Equipment functionWhat the device does: life support, therapeutic, diagnostic, analytical, or support. Life support scores highest
Physical riskThe harm a failure could cause: death, injury, a wrong diagnosis, or an inconvenience
Likelihood of failureHow often this model actually fails, from the hospital's own history or credible outside data
Maintenance requirementHow much scheduled work the device truly needs: filters, batteries, calibration, moving parts, or almost nothing
Incident historyThe number, frequency, and nature of past failures and service requests on identical or very similar equipment
How the score is usedThe inputs combine into one number. High scores get full scheduled maintenance at the manufacturer's interval; low scores get a longer interval or less work
Run to failureA low-risk, inexpensive device whose failure harms nobody may be repaired or replaced only when it fails, under a documented alternative equipment maintenance program
Risk toolThe steps, in order
Root cause analysisDefine the event, gather the facts, ask why until the causes stop being symptoms (the five whys), map contributing causes on a fishbone, agree corrective actions with owners and dates, then verify the fix held
What RCA is forEvents that already happened. It works backward from the nearest cause to the root, which is often the organization rather than the person at the bedside
FMEAPick the process, list every step, list how each step can fail, score severity, occurrence, and detection, multiply them into a risk priority number, act on the highest, then rescore. Use it on failures that have not happened yet
Risk priority numberRPN = severity x occurrence x detection. Severity 8 x occurrence 3 x detection 5 = 120. Rank the list and work from the top
Incident investigationSecure the device, its accessories, and its disposables where they are; preserve settings and switch positions; photograph everything; interview the witnesses; pull error logs; document names, dates, and sequence; then report
What not to doDo not clean, repair, re-calibrate, update, or return the device to service, and do not let the trash be emptied: lot numbers of disposables live in it
Where the report goesThe complete report goes to the risk manager, which is what makes it work product. Discuss its contents with no one else. A near miss is investigated the same way
Law, program, or reportWhat it obligates
Safe Medical Devices Act of 1990 (SMDA)Made adverse-event reporting mandatory for device user facilities: hospitals, ambulatory surgical facilities, nursing homes, and outpatient diagnostic and treatment facilities
DeathReport to the FDA and to the manufacturer no later than 10 work days after becoming aware. Where the manufacturer cannot be identified, the report goes to the agency alone
Serious injuryReport to the manufacturer no later than 10 work days, or to the agency instead when the manufacturer cannot be identified. Copying the agency on every suspected serious injury is recommended practice
Serious injury, definedLife-threatening, or causing permanent impairment of a body function or permanent damage to a body structure, or requiring medical or surgical intervention to prevent that permanent harm
Annual user facility reportSubmitted to the FDA on Form FDA 3419 by January 1 of each year, identifying the facility and the reports it filed
MDR event filesA user facility must keep written reporting procedures and must retain the event file for 2 years from the date of the event, available to an FDA investigator
How reports are filedMandatory reports go in on Form FDA 3500A through MedWatch. Form FDA 3500 is the voluntary form for clinicians and the public
MAUDEThe public database of device reports. Search it before buying and during an investigation to see whether others have reported the same failure
Sentinel eventA patient safety event that reaches a patient and results in death, permanent harm, or severe temporary harm. It triggers a full root cause analysis and an action plan, and accrediting bodies publish alerts on the patterns they see
Recall classificationThe FDA assigns a recall the numeral I, II, or III to show the relative degree of health hazard the violative product presents
Class I recallThe worst case: there is a reasonable probability that using or being exposed to the product will cause serious harm to health, or death. Act on it immediately
Class II recallUsing or being exposed to the product may cause health consequences that are temporary or medically reversible, or the chance of serious harm is remote
Class III recallUsing or being exposed to the product is not likely to harm health at all, but it still breaks a requirement and must be corrected
Recall workflowReceive the notice, locate every affected asset in the CMMS by model and serial range, quarantine or correct, notify the users and the committee, document each unit, verify the vendor's correction, then close the recall with a record
Hazard and safety advisoriesManufacturer notices, ECRI alerts, and FDA safety communications. Someone must own the inbox, log each notice, and record the action taken even when the action is none
Data and cybersecurity topicWhat the manager must hold
PACSStores and moves images with patient identifiers. Treat the archive as patient data, not as a file server
EMR and EHRThe record inside one organization and the record shared across organizations. Networked devices feed them directly or through middleware
HITECHExtended the HIPAA rules: breach notification, direct obligations on business associates, and stronger enforcement
IntegrityData that arrives at the record unchanged and attached to the right patient. A wrong-patient vital sign is a safety event, not a clerical error
BackupsScheduled, verified, stored away from the system they protect, and restored in a test before you need them in anger
Access controlUnique named accounts, least privilege, multi-factor authentication where it is supported, and shared service passwords retired
EncryptionProtect data at rest on the device and in transit across the network, by the manufacturer's supported method
Patching and updatesOnly on the manufacturer's validated schedule. An unvalidated patch can take a cleared device out of its cleared configuration
HardeningTurn off unused ports and services, change default credentials, and remove software the clinical function does not need
SegmentationPut devices that cannot be patched on their own network segment with tight rules, and document who approves exceptions
AntivirusOnly where the manufacturer allows it, and only with the exclusions they specify
MDS2The manufacturer disclosure statement for medical device security. Require it before purchase; it is the inventory of what the device can and cannot protect
Operating system life expectancyAsk how long the embedded operating system will be supported. A device with a long clinical life running an operating system whose support ends far sooner is a known future problem, not a surprise
Wireless Medical Telemetry ServiceProtected spectrum for patient telemetry, licensed and coordinated under FCC rules. Someone must register the hospital's WMTS use and keep other transmitters out of the band
Why the FCC mattersIt licenses and manages the radio spectrum. An unmanaged transmitter in a telemetry band means dropped waveforms on monitored patients

Emergency preparedness

  • Downtime procedures in writing for every clinical system: what staff do when the network, the record, or the device is gone, and who declares downtime
  • Utility failure: know what is on emergency power, which outlets are on the generator, and which devices must be moved when they are not
  • Generator and UPS inventory: which devices have internal batteries, how long they last, and when each battery was last tested and replaced
  • Critical equipment lists: the devices whose failure threatens life, maintained whether or not they sit in an alternative maintenance program
  • Disaster plans: surge capacity, where reserve equipment is stored, how it is kept charged and tested, and who releases it

05Service operations and metrics

Work order stageWhat has to happen
RequestCaptured once, with the device asset number, location, caller, and the problem in the caller's words
TriageRanked by clinical impact, not by order of arrival. A life-support device beats a convenience item every time
AssignmentTo a technician with the competency and the parts, with the clinical user told who is coming and when
RepairThe work itself, with time and parts recorded as they happen rather than from memory at the end of the week
VerificationPerformance and safety checks that prove the device meets specification before it goes back to the patient
ClosureProblem code, cause, action, parts, labor hours, and the condition on return, all in the CMMS
Customer feedbackTell the user what was wrong and what was done, then measure satisfaction on a survey you do not change year to year, so the numbers compare
What a complete record holdsAsset number, date and time in and out, who did the work, the reported problem, what was found, what was done, parts used with cost, labor hours, test results, and the return-to-service decision
Problem codes that matterUse error and cannot duplicate. Both are real work and neither is an equipment failure. Trend them or you will mistake a training problem for a reliability problem
Outside vendorsEvery visit by a vendor or manufacturer is logged in the CMMS too. Make check-in and a service report within 24 hours a condition of payment
CMMS contentWhy it is there
Asset inventoryEvery medical device in the building, whether the hospital bought it, leases it, rents it, has it on loan, or borrowed it, and regardless of who maintains it
Standard nomenclatureOne agreed name per device type, manufacturer, and model, so like items can be compared. UMDNS from ECRI is the common free standard
Granularity ruleInventory anything carrying a serial number, because serial ranges are what recalls name. Give one shared number to the cheap, numerous, low-consequence items nobody would track one by one
Original costPrice paid for every asset. Without it no cost of service ratio can be calculated and no cost can be fairly allocated to a cost center
Work ordersEvery scheduled and unscheduled job, open and closed, with hours and parts against the asset
Service historyThe full life of the asset, including work done by vendors, so trends and repeat problems are visible
PartsWhat is on the shelf, what it cost, what it fits, and what is on order
Recalls and advisoriesWhich notice hit which asset, what was done, and when it closed
End of life and support datesSo replacement planning starts years before the device stops being serviceable
Maintenance term or taskWhat it means
Preventive maintenanceScheduled work on parts that wear: filters, fans, lubrication, batteries, and components with a known life
Performance verificationConfirming the device still meets specification. If it does, nothing is changed
Safety testingMeasuring leakage current, ground resistance, and where applicable isolation, with a safety analyzer
Scheduled maintenanceThe umbrella term: any mix of safety testing, performance verification, and preventive maintenance done on a schedule
How PM is scheduledBy month. Each asset lands in one of the twelve months of the year, and the year is balanced around a short February, summer vacations, and the holidays
The flexibility windowThe Joint Commission allows 30 days either side of the scheduled date for annual scheduled maintenance, which is what makes the plan workable
PM completion rateCompleted / due x 100. Monitor it daily, not at month end, because at month end it is too late to fix
The compliance reportCompletion rate by month and by department, the list of misses, the reason for each, and the date each was completed
Documenting a missed PMName the asset, why it was missed, where the device was, what the clinical risk was, and when it was finished. A missed PM with a documented reason is a finding you can answer
What a surveyor asks forThe inventory, the plan, the completion rate, the misses and their explanations, the critical equipment list, which assets sit in an alternative program, and the evidence behind putting them there
Metric the department reportsHow it is read
PM completion rateCompleted / due x 100. The number a surveyor asks for first and the one administration understands
Repeat repairsRepairs that come back within 30 days of the first one. A falling count means the fixes are holding; a rising one points at a bad device, a bad part, or a technician who needs training
Mean time to repairMTTR is the average hands-on repair time. It measures the technician and the parts supply
Total time to repairThe clock the clinician feels: from the call to return to service, including waiting for parts, vendors, and access. Always longer than MTTR, and the one to report
UptimeThe share of time a device was available for use. Report it on critical devices, where downtime cancels cases
Customer satisfactionA periodic survey of contactability, response speed, completion, technical competence, communication, and overall effectiveness, kept unchanged so results compare across years
Cost of service ratioCOSR by hospital, department, modality, equipment type, and manufacturer. The drill-down is where the savings are found
Labor hours per deviceTotal documented hours divided by assets supported. Useful inside one hospital and dangerous as a comparison between hospitals
OvertimeHours and dollars. Sustained overtime is a staffing request waiting to be written
BacklogOpen work orders and overdue scheduled maintenance, with age. A growing backlog is the earliest honest warning
Which KPIs leadership seesA short monthly set: completion rate, backlog, total time to repair, satisfaction, and cost. Pick the KPI set once and keep reporting the same one
Staffing questionHow to answer it
Devices per technicianHistorically one technician per roughly 1,200 to 2,000 inventoried items. It ignores complexity, contracts, and how the inventory was counted
Hours per deviceBuild the workload from the bottom up: scheduled hours per model times quantity, plus historical unscheduled hours, plus travel
Workload by riskLife-support and critical devices need more hours per unit than support equipment. Weight the count, do not just take it
Full-time equivalentOne FTE is one full-time position of roughly 2,080 paid hours a year. Express partial coverage in tenths
A worked caseA system leaves warranty. The quoted contract is $60,000 a year; a junior technician costs less than that. The new position absorbs 0.4 FTE of the system and returns 0.6 FTE to the maintenance schedule
SchedulingCover the hours clinicians work, not the hours the shop prefers. A second shift beats overtime when the volume is steady
On-callA written rotation, a defined response time, documented pay, and a rule about who may be called and for what

Resources the department has to keep current

  • PPE and the training to use it: gloves, eye protection, hearing protection, lockout devices, and whatever the hazard assessment for each area requires
  • Hand tools and specialty tools per equipment type, accounted for and replaced when worn
  • Test equipment: safety analyzers, simulators, meters, and gas and flow analyzers matched to the inventory
  • Calibration of test equipment on a schedule, traceable to the national standards kept by NIST, with certificates on file
  • Supplies and PM kits ordered before the month they are needed, so work is not held waiting on parts
  • Technical information: service manuals, operator manuals, software, passwords, and updates, obtained in writing at purchase
  • Training: model-specific schools, refreshers, and the competency records that prove them

Data management the department owns

  • Backups of the CMMS and of device configurations, on a schedule, stored away from the machine they protect
  • Restore tests, performed and documented, because a backup nobody has restored is a hope and not a plan
  • Security of the CMMS: named accounts, role-based rights, and removal of accounts when people leave
  • Patching on the manufacturer's validated schedule, recorded against the asset
  • Updates and software versions tracked in the inventory, so a recall or a vulnerability can be matched to real devices
Alternative equipment maintenance questionThe answer
What an AEM program isA program that changes how often maintenance, inspection, and testing happen and what they include, away from the manufacturer's recommendations, on the strength of a risk assessment by qualified personnel
What CMS allowsThe change itself, where no other federal or state law and no condition of participation requires the manufacturer's schedule
What may NOT be includedImaging and radiologic equipment, whether diagnostic or therapeutic; medical laser devices; and new equipment without enough maintenance history to support a risk-based decision
New equipmentMaintained to the manufacturer's recommendations until there is enough history, from the hospital, its contractor, or nationally recognized sources, to support a change
Who may make the decisionQualified personnel, hospital employees or contractors. The hospital must be able to show how it assures that contractors use qualified people
Evidence requiredThe equipment's function and the consequences of failure, how serious the likely harm is, likelihood of failure, maintenance requirements, availability of alternative or backup devices, and documented incident history of identical or very similar equipment
DocumentationWritten policies and procedures, the risk methodology, the evidence held per equipment type, and the activities and frequencies chosen
AdherenceA hospital must follow the alternative activities and frequencies it set, strictly. An AEM program is not permission to improvise
IdentificationEquipment in the program must be readily identifiable as such, and so must critical equipment. Surveyors focus on the critical equipment inside the program

06Policy, regulators, and accreditation

Medical equipment management plan sectionWhat it must say
ScopeWhich equipment and which locations the plan covers, and who maintains what between HTM, clinical staff, contractors, and manufacturers
Inventory criteriaWhat gets an asset number, what is grouped, what is excluded, and how leased, rented, loaned, and patient-owned equipment is handled
Risk and maintenance strategiesHow risk is scored, which strategies exist, and how each equipment type is assigned to one
Scheduled maintenance and inspectionIntervals, procedures, who performs them, and the flexibility window the plan uses
Incident responseHow a device involved in an event is secured, investigated, reported, and released
Recalls and advisoriesWho receives notices, how affected assets are found, and how actions are documented and closed
Emergency proceduresClinical downtime procedures, utility failures, and how staff get a replacement device
TrainingWho trains HTM staff, who trains operators, and how competency is assessed and recorded
Performance monitoringThe metrics the plan reports, to whom, and how often
Annual evaluationA yearly review of the plan's scope, objectives, performance, and effectiveness, with the findings reported to the committee
Compliance statementThe plan must stand up against federal, state, and local requirements, be specific enough to show how each equipment type is maintained, and reference the organization's other policies rather than repeat them

The policy library a department needs

  • A copy of the organization's MEMP, with the department's own procedures written to support it rather than contradict it
  • Inventory procedures: what is inventoried, incoming inspection of new equipment, and removal from inventory
  • Scheduled maintenance: assigning procedures, the risk-based or alternative strategy, frequencies, responsibility, and workload balancing
  • Work order documentation, including scheduled, unscheduled, use error, and non-HTM work
  • Repair parts, purchase orders, service contracts, and the escalation policy
  • Safety: electrical, radiological, biological, and OSHA requirements, plus infection control for devices
  • Information security and patient privacy, telemetry and wireless spectrum management, and coordination with IT
  • The environment of care manual: the organization's binder of plans, which holds the MEMP beside safety, security, hazardous materials, fire, and utilities
  • SOPs are living documents. They are updated as scope changes, used to orient new staff, and referenced in daily work rather than filed and forgotten
CommitteeWhat HTM brings to it
Environment of care committee (EOC)Equipment inventory and completion rates, incidents and recalls, the annual plan evaluation, and utility and construction impacts
Patient safetyDevice-related events and near misses, use error trends, alarm issues, and the actions taken
Risk managementIncident investigation reports, device holds, exposure from pending claims, and reportable events
Performance improvementMetrics with targets and trends, improvement projects, and the results of corrective actions
Radiation safetyImaging and therapy equipment performance, service records, survey results, and the radiation-producing device inventory
Infection controlDevice cleaning and disinfection between patients and before service, water systems, sterilizers, and loaner handling
How to report to any of themA short written report with the number, the trend, what caused it, what is being done, and what you need from the committee
Regulator or bodyWhat it controls
CMSThe Centers for Medicare and Medicaid Services pays for most hospital care and sets the conditions of participation a hospital must meet to be paid
Conditions of participationThe federal requirements behind hospital surveys. Several CoPs reach equipment maintenance and documentation directly
Deemed statusCMS lets approved accrediting organizations survey on its behalf, so a hospital accredited by one of them is deemed to meet the conditions
The Joint Commission (TJC)The most common hospital accreditor, with standards for the equipment management plan, maintenance intervals, and competency assessment
DNVAn accrediting organization for hospitals whose program integrates a quality management system with the CMS requirements
AABBAccredits blood banks and transfusion services, with equipment testing requirements often stricter than the manufacturer's
CAP and CLIACAP accredits laboratories against detailed checklists; CLIA is the federal program through which CMS regulates clinical laboratory testing
FDARegulates medical devices: clearance for market, manufacturing and performance, medical device reporting, and recalls
CDRHThe FDA center responsible for devices and radiation-emitting products, including mandatory performance standards and recall authority
FCCLicenses and manages the radio spectrum, including the Wireless Medical Telemetry Service bands hospitals use for patient telemetry
NRCLicenses and inspects the use of radioactive materials, including nuclear medicine, and enforces its requirements
OSHARequires the employer to keep the workplace safe and healthful, with hazard communication, PPE, lockout, and electrical safety rules
HIPAAProtects the privacy and security of identifiable health information, by rules on privacy and on administrative, physical, and technical safeguards. It reaches every device that stores or sends patient data
State agenciesThe state health department and licensing bodies, plus the state's adopted building, fire, and electrical codes. State rules can be stricter than federal ones
NFPAPublishes consensus codes that become law only where a state adopts them. NFPA 99 is the health care facilities code and NFPA 70 is the electrical code
IECInternational standards used throughout the field, including the 60601 series for medical electrical equipment and the 80001 series for risk management of networks carrying devices
ECRIAn independent nonprofit that tests devices, publishes hazard and recall alerts, and maintains the nomenclature many inventories use

Surviving a survey

  • Prepare the evidence in advance and keep it current year-round: inventory, plan, completion rates, the misses with explanations, competency records, the critical equipment list, and the alternative program with its evidence
  • Host the surveyor yourself: answer the question asked, show the record, and let the record speak. Do not speculate and do not volunteer problems you have not fixed
  • Expect tracers: a surveyor picks a device in a unit and follows it through the inventory, the schedule, the history, and the competency of whoever serviced it
  • Answer a finding with a corrective action plan: what was wrong, the root cause, the action, the owner, the completion date, and how you will show it held

07Projects, capital planning, and stakeholders

Capital request elementWhat HTM supplies
The request itselfWhat is being bought, how many, for whom, and when it is needed, in the hospital's capital request format
Clinical needThe clinical problem the device solves, stated by the department that will use it, with the consequence of not funding it
FeasibilityWhether the hospital can actually run and service it: staff, skills, parts, and vendor presence
SpaceFootprint, clearances, doorways and elevator access, and the room it displaces
Site preparationConstruction, shielding, floor loading, ventilation, water, gases, drains, and who pays for them
PowerLoad, receptacle type, emergency versus normal branch, and whether the device needs conditioned power or a UPS
NetworkAddresses, ports, segment, bandwidth, interfaces to the record, and the agreement with IT in writing
Total cost of ownershipPurchase plus installation plus service plus parts plus training plus disposal over the life, not the quoted price
Service strategyIn-house, contract, or time and materials, priced for the life of the device, with the training and test equipment each option needs
StandardizationWhether this matches models already owned, and what a new model adds in training, parts, and procedures
CybersecurityThe MDS2, the operating system and how long it is supported, the patching method, authentication, and encryption
The recommendationOne clear recommendation with the options compared against it, so the committee decides rather than deliberates

Can the hospital sustain this device

  • Parts: are they sold to equipment owners, at what price, and for how many years
  • Training: is service training available to the hospital at all, where, how long, and at what cost
  • Service manuals, software, passwords, and diagnostic access, confirmed in writing before the order
  • Life expectancy: how long the model is expected to serve and when the manufacturer plans to end support
  • MAUDE history: what other facilities have already reported about this model
  • Operating system life expectancy, and what happens to the device when that support ends
Project stageWhat the manager produces
CharterThe scope, the objective, the sponsor, the budget, the deadline, and what is explicitly out of scope
PlanTasks, owners, dependencies, and the decisions that must be made before work starts
ScheduleDates with the long-lead items identified: construction, shielding, network drops, and delivery windows
BudgetCapital and operating lines, with site preparation and training named rather than assumed
StakeholdersEveryone who must be consulted or informed, named, with what each needs and when
RisksWhat could delay or break the project, how likely it is, and the mitigation, reviewed as the project moves
CommunicationWho reports what to whom on what day, agreed at the start so nobody learns about a change from the hallway
Acceptance testingThe incoming inspection and performance test the device must pass before the hospital accepts delivery and pays
Sustainment planAsset in the inventory, schedule assigned, parts stocked, service strategy live, training delivered, and support contacts recorded
Close-outFinal cost against budget, lessons learned, the old asset retired in the inventory, and the sponsor told it is done
Lifecycle stageHTM's job in it
AcquisitionBring the cost history, failure data, and support-withdrawal notices, then compare total cost of ownership, serviceability, standardization, security, and clinical fit, filtering out marketing claims
ContractingNegotiate price, training, manuals, parts discounts, response times, and exclusions while there is still leverage
InstallationCoordinate site preparation, power, network, delivery, and the pre-acceptance inspection, then inspect, test, tag, record cost and ownership, and assign the maintenance schedule
TrainingDeliver operator and service training before clinical use, record competency, and keep the materials where staff can find them
SustainmentScheduled and unscheduled maintenance, parts, recalls, upgrades, patching, and cost tracking, with cost per year and failure rate watched so the replacement is seen coming years out
DisposalWipe the data, remove it from the inventory, settle the book value, and document the method

Construction, utilities, and change

  • Attend the planning and design meetings. Equipment decisions made in a drawing become construction costs nobody budgeted
  • Read utility interruption notices as clinical events: which rooms, which devices, how long, and what runs on battery
  • Publish the downtime procedures before the interruption and confirm the clinical units have them
  • Use formal change management for network changes, patches, and configuration changes to clinical devices

Stakeholders and how to stay in front of them

  • Senior leadership: scheduled meetings and short written reports with the number, the trend, the cause, and the decision you need. Never a surprise
  • Nursing: daily rounding in the units, a named contact, and visible follow-up on the thing they reported last week
  • IT and informatics: joint ownership of networked devices, shared change windows, and an agreed incident path
  • Facilities: power, water, gases, ventilation, and construction schedules that affect clinical equipment
  • Materials management: purchase orders, receiving, consumables, and withholding payment when terms are not met
  • Vendors: check-in and check-out, service reports within 24 hours, and a scorecard you can show them
  • Technicians: shop meetings, daily huddles on the backlog, and a clear escalation path when they are blocked

08Education and training

Needs analysis inputThe question it answers
CostWhat the training costs in tuition, travel, lodging, and the weeks of productivity lost while the technician is away
Return on investmentWhat the hospital avoids in contract, vendor labor, and downtime once the technician is trained, accumulated across four, five, and six years
OperationsWhich backlog, response time, or completion problem this training actually fixes
Technical requirementsWhat the equipment demands: proprietary software, calibration, service keys, or a certificate to open it legally
CompetencyWhich assessed gaps exist today, by person and by equipment type
Customer requirementsWhat the clinical departments have asked for, and what they will stop calling the vendor for once staff are trained
ResourcesWhether the test equipment, tools, manuals, and parts access exist to use the training once it is delivered
Asset inventoryHow many of the model the hospital owns, where they are, and whether the count justifies a trained technician at all
Effectiveness measureWhat it should do after training
CostVendor labor, contract spend, and parts cost for that equipment type should fall
Failure ratesRepeat repairs on the trained equipment should drop, because the fix is now the right fix
Total time to repairThe clinician's clock should shorten, because the first responder can finish the job
Staff competenciesDocumented assessments move from gap to competent, recorded per person and per model
Skill setMore models covered in-house, with at least two people competent on every critical one
User satisfactionSurvey scores for technical competence and responsiveness should rise in the departments involved
Training typeWhat it is and how it is obtained
Technical and model-specificService-level training on one model. Start with the maker of the device, then price independent trainers, who are often cheaper and sometimes teach more
Manufacturer-provided, negotiatedNegotiate training into the purchase: seats, level, location, travel, and lodging, delivered inside the warranty period or the warranty extended until it is. After the sale there is no leverage left
SafetyElectrical safety, lockout, radiation and laser areas, hazard communication, lifting, and infection control for device handling
Soft skillsCustomer service, written communication, conflict handling, and how to explain a technical answer to a clinician
Regulatory and code complianceWhat the accreditor and the conditions of participation require, how records are kept, and what a surveyor asks
Internal policyThe department's own SOPs, the CMMS, documentation standards, escalation, and on-call rules
OrientationA new technician gets a mentor, the SOP manual, the MEMP, supervised work, and a documented sign-off before working alone
CertificationTie steps in the career ladder to a credential and pay for achieving it. Trained, certified staff stay with employers who value them
Competency assessmentRequired by the accreditor. Test, self-assessment spot-checked by the manager, observed scheduled maintenance, or review of repeat repairs, documented either way

Operator training: when HTM teaches clinicians

  • Failure trending: when a model generates work orders that are not failures, the training need is in the unit, not the shop
  • Use error: identify it on the service call, code it, trend it by department, model, and shift, then take in-service education to the pattern on every shift
  • New equipment: operator training before first clinical use, on every shift that will touch it, with attendance recorded
  • New clinical applications: a new procedure on an old device is new training
  • New staff and rotating students: a spike in use errors often follows an intake of residents or travelers
  • Database management: record who was trained, on what, by whom, and when, because the accreditor will ask and the pattern tells you where to go next

Materials: what the department keeps and who keeps it current

  • Service manuals per model, obtained at purchase, kept where technicians can reach them on and off shift
  • Operations manuals, including the copies the clinical units need, because a unit's lost manual becomes a service call
  • Software, firmware images, service keys, and passwords, stored securely and retrievable when the one person who knew them leaves
  • Training media: recordings, slides, job aids, and quick reference cards made after each school, so one seat teaches the whole shop
  • A written purchase requirement that manuals, software, passwords, updates, and support are supplied for as long as the device stays in service, with payment withheld until they arrive
  • One named owner for the library and a review date, so superseded versions come out and nobody works from an obsolete procedure

Partners who train with you

  • Infection prevention: cleaning and disinfection between patients, what HTM may handle, and how devices are decontaminated before service
  • Facilities management: power, emergency branch, water, gases, ventilation, and who responds to what at two in the morning
  • Materials management: purchase orders, receiving and incoming inspection, consumables, and vendor terms
  • IT: addresses, segments, patching windows, interface failures, and the joint incident path

09Human resources and labor law

Employee lifecycle stageWhat the manager produces
Job descriptionDuties, required education and experience, certification expectations, physical requirements, and the pay grade. Keep a full ladder of levels and steps: nobody can be promoted into a job that does not exist, and even a two-person department needs at least eight
SelectionScreening against the written description, the same interview questions for every candidate, reference and credential verification, and a documented reason for the choice
OrientationA mentor, the SOP manual, the MEMP, the CMMS, safety training, and supervised work with a documented sign-off before solo assignments
EvaluationThe annual review, which should contain nothing the employee is hearing for the first time. Feedback is the manager's job all year
Development planWhat the employee wants to be able to do next, the training that gets them there, and the date it is reviewed
RetentionThe direct manager is the biggest single factor in whether staff stay. Interesting work, involvement, feedback, training, and respect hold people
Why turnover hurtsRecruiting and training a replacement is estimated to exceed 1.5 times annual salary, before counting the clinical cost of equipment nobody can repair
Performance improvement planSpecific deficiencies, specific expectations, specific dates, the support offered, and a clear statement that it is an opportunity rather than an automatic exit
TerminationThe last step of a documented path, done with the human resources department present and with every prior conversation already on paper
Performance and engagement topicWhat the manager does
CompensationKnow the local and national market for each grade, and get a real survey done rather than relying on self-reported numbers
Organizational valuesTie department goals to the hospital's stated priorities, so the request speaks the language the budget is written in
EngagementBring staff into goal setting. A plan the shop helped write gets implemented; a plan dropped on the shop gets resisted
GoalsDepartment goals covering financial performance, scheduled maintenance completion, customer satisfaction, response time, repeat repairs, and use errors, shared with everyone
CoachingContinuous and specific, in the moment, with the behavior named and the better alternative shown
MentoringPair a new technician with an experienced one, with time protected for it rather than assumed
RecognitionFinancial incentives are hard to get in a hospital. Recognition and a real say in the department's direction often matter more to technicians
What managers get wrongManagers rank salary, bonuses, vacation, retirement, and perks first. Employees rank interesting work, involvement in decisions, feedback, training, and respect first, with the money items last
ConflictAddress it early, with the people involved, on the facts, and document what was agreed
Documenting improvement opportunitiesWrite it down when it happens, in neutral language, with dates and specifics, so the record exists before you need it
Recommendations to human resourcesBring human resources in before you act, not after. They own the process, the consistency, and the legal exposure
Staffing and pay itemThe number or the rule
Staffing levelsOne technician per roughly 1,200 to 2,000 inventoried items as a first pass, refined by inventory value, equipment complexity, risk mix, number of sites, and travel
Cost of a biomedSalary / 2,080 hours plus benefits plus supervision and unproductive time. Under $100,000 a year is under $50 an hour, about $72 an hour fully loaded, which is below any vendor rate and below most contract labor
IncentivesPay differentials for certification, on-call, shift, and specialty skills, where the hospital's compensation policy allows
Overtime and on-call payBudgeted, tracked as its own line, and governed by a written rotation. Sustained overtime is cheaper to fix with a position than to keep paying
Pay equityWhatever criteria the employer applies when it sets wages must be free of any influence from sex or race, and comparable work inside the department should be paid comparably. Review it regularly
Certification as a differentiatorMake certification a requirement at defined steps in the ladder and reward it. It is proof of competence and a retention tool, not a resignation risk
Law or agencyWhat a manager must not get wrong
ADAThe Americans with Disabilities Act prohibits discrimination against people with disabilities and requires reasonable accommodation. A disability is a physical or mental impairment that substantially limits a major life activity, a record of one, or being regarded as having one
EEOCThe Equal Employment Opportunity Commission enforces the federal bans on discrimination by race, color, religion, sex including pregnancy, gender identity, and sexual orientation, national origin, age of 40 or older, disability, and genetic information
EEOC coverageThe rules reach most employers of 15 or more people, and 20 or more in age discrimination cases. Retaliation against someone who complains or takes part in an investigation is itself illegal
FMLAThe Family and Medical Leave Act gives eligible employees 12 workweeks of unpaid, job-protected leave in a 12-month period for a birth, an adoption or foster placement, a serious health condition of the employee or a spouse, child, or parent, or a qualifying military exigency, with group health coverage continued
FMLA military caregiver leaveUp to 26 workweeks in a single 12-month period to care for a covered servicemember with a serious injury or illness
NLRAThe National Labor Relations Act protects employees' rights to organize, to bargain collectively, and to engage in concerted activity about terms and conditions of employment, whether or not a union is present
OSHAThe employer owes every worker a workplace that is safe and healthful. For HTM that means hazard assessment, PPE, electrical safety, lockout and tagout, hazard communication, and the right to report hazards without retaliation
Hearings and investigationsHuman resources present, the facts gathered the same way every time, comparable cases treated comparably, and contemporaneous documentation. The same rule applied the same way to every employee is what keeps the hospital out of court
Facilitating change: explain why before what, involve the people who will do the work, train them before the switch, measure what happened, then recognize the staff who made it work. A change explained is implemented; a change announced is resisted.

10Acronyms

Every acronym used in this course, 72 in all.

AcronymStands forMeaning
AABBAssociation for the Advancement of Blood and BiotherapiesThe body that accredits blood banks and transfusion services.
AAMIAssociation for the Advancement of Medical InstrumentationThe standards body for medical equipment and the sponsor of the HTM credentials.
ACIAAMI Credentials InstituteThe body inside AAMI that writes and administers the certification exams.
ADAAmericans with Disabilities ActThe civil rights law that bars disability discrimination and requires reasonable accommodation.
AEMAlternative equipment maintenanceA program that adjusts maintenance intervals and activities away from the manufacturer's recommendations, based on risk.
AHAAmerican Hospital AssociationThe hospital trade association that publishes the useful-life schedule for hospital assets.
APAccounts payableWhat the organization owes its vendors and has not yet paid.
ARAccounts receivableWhat the organization is owed by others and has not yet collected.
BMETBiomedical equipment technicianThe technician who inspects, maintains, and repairs patient care equipment.
CABTCertified Associate in Biomedical TechnologyThe entry-level ACI credential for people beginning a career in medical equipment service.
CAPCollege of American PathologistsThe body that accredits clinical laboratories against detailed discipline-specific checklists.
CAPACorrective and preventive actionThe paired fix: correct this cause, and prevent the same cause from acting elsewhere.
CBETCertified Biomedical Equipment TechnicianThe ACI credential for technicians who service general patient care equipment.
CCECertified Clinical EngineerThe clinical engineering credential, awarded outside the technician certification family.
CDRHCenter for Devices and Radiological HealthThe FDA center responsible for medical devices and radiation-emitting products.
CEUContinuing education unitOne hour of qualifying educational or professional activity, counted toward recertification.
CFOChief financial officerThe executive who owns the hospital's finances, budgets, and capital decisions.
CHTMCertified Healthcare Technology ManagerThe ACI credential for HTM supervisors and managers: 100 questions, 2 hours, offered in May and November.
CLESCertified Laboratory Equipment SpecialistThe specialist credential for people who service clinical laboratory instruments.
CLIAClinical Laboratory Improvement AmendmentsThe federal program through which CMS regulates clinical laboratory testing on humans.
CMMSComputerized maintenance management systemThe database that holds the equipment inventory, work orders, costs, and service history.
CMSCenters for Medicare and Medicaid ServicesThe federal agency that pays for most hospital care and sets the conditions of participation.
CoPCondition of participationA federal requirement a hospital must meet to be paid by Medicare and Medicaid.
COSRCost of service ratioAnnual service cost divided by acquisition cost, as a percent; the field's main cost benchmark.
CRESCertified Radiology Equipment SpecialistThe specialist credential for people who service imaging and radiologic equipment.
DNVDNV HealthcareAn accrediting organization for hospitals whose program joins a quality management system to the CMS rules.
DoDDepartment of DefenseThe federal department whose biomedical equipment training program is a recognized eligibility pathway.
ECGElectrocardiographThe device that records the heart's electrical activity, used here only as an inventory example.
ECRIECRI InstituteAn independent nonprofit that tests medical devices and publishes hazard and recall alerts.
EEOCEqual Employment Opportunity CommissionThe agency that enforces the federal bans on employment discrimination.
EHRElectronic health recordThe patient record shared across organizations, as opposed to the record inside one of them.
EMRElectronic medical recordThe patient record held inside one organization.
EOCEnvironment of careThe accreditation program covering the physical environment, including medical equipment.
EOLEnd of lifeThe date a manufacturer stops supporting a model, which is not the date the device stops working.
FCCFederal Communications CommissionThe agency that licenses and manages the radio spectrum, including the medical telemetry bands.
FDAFood and Drug AdministrationThe agency that regulates medical devices, from market clearance through reporting and recalls.
FMEAFailure mode and effects analysisA forward-looking method: list how each step of a process can fail, then act on the worst.
FMLAFamily and Medical Leave ActThe law giving eligible employees unpaid, job-protected leave for family and medical reasons.
FTEFull-time equivalentOne full-time position, roughly 2,080 paid hours a year; partial coverage is expressed in tenths.
GAAPGenerally accepted accounting principlesThe standards, conventions, and rules accountants follow when recording and presenting financial statements.
HFAPHealthcare Facilities Accreditation ProgramA hospital accreditation program that has held federal authority to accredit hospitals.
HIPAAHealth Insurance Portability and Accountability ActThe law that protects the privacy and the security of identifiable health information.
HITECHHealth Information Technology for Economic and Clinical Health ActThe law that extended the HIPAA rules with breach notification and stronger enforcement.
HTMHealthcare technology managementThe profession and the department that manages a hospital's medical equipment across its whole life.
HVACHeating, ventilation, and air conditioningThe building system that holds temperature and humidity inside the limits equipment needs.
IECInternational Electrotechnical CommissionThe international standards body behind the medical electrical equipment and network risk standards.
ITInformation technologyThe group that owns the network, servers, and enterprise systems the devices depend on.
KPIKey performance indicatorA measure a department reports to show whether it is performing.
MAUDEManufacturer and User Facility Device ExperienceThe FDA's public database of medical device adverse event reports.
MDRMedical device reportingThe federal requirement that user facilities, manufacturers, and importers report device-related adverse events.
MDS2Manufacturer disclosure statement for medical device securityThe standard form on which a manufacturer discloses a device's security capabilities.
MEMPMedical equipment management planThe organization-wide written plan for how medical equipment is maintained and monitored.
MTTRMean time to repairThe average hands-on time to complete a repair.
NFPANational Fire Protection AssociationThe nonprofit that publishes consensus codes which become law only where a state adopts them.
NISTNational Institute of Standards and TechnologyThe federal institute that keeps the national measurement standards test equipment is traced to.
NLRANational Labor Relations ActThe law protecting employees' rights to organize, bargain collectively, and act together on working conditions.
NRCNuclear Regulatory CommissionThe agency that licenses and inspects the use of radioactive materials, including nuclear medicine.
OSHAOccupational Safety and Health AdministrationThe labor agency requiring employers to provide a safe and healthful workplace.
PACSPicture archiving and communication systemThe system that stores and moves medical images along with the patient identifiers attached to them.
PHIProtected health informationAny identifiable health information, including what sits on a medical device's storage.
PMPreventive maintenanceScheduled work on the parts of a device that wear, done before they cause a failure.
PPEPersonal protective equipmentThe gloves, eye and hearing protection, and other gear a hazard assessment requires.
RCARoot cause analysisA backward-looking method: work from the event to the cause underneath it, then fix that.
ROIReturn on investmentThe gain from an investment minus its cost, divided by the cost, as a percent.
RPNRisk priority numberSeverity times occurrence times detection, the number that ranks failure modes in an FMEA.
SMDASafe Medical Devices Act of 1990The law that made adverse event reporting mandatory for hospitals and other device user facilities.
SOPStandard operating procedureA written departmental procedure that says how a recurring task is actually done.
TCOTotal cost of ownershipEverything a device costs across its life, not the price on the quote.
TJCThe Joint CommissionThe most common hospital accreditor in the United States.
UMDNSUniversal Medical Device Nomenclature SystemA free device naming standard, widely used to keep an equipment inventory consistent.
UPSUninterruptible power supplyA battery-backed supply that carries a device through a power interruption.
WMTSWireless Medical Telemetry ServiceProtected radio spectrum reserved for patient telemetry, coordinated under FCC rules.