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Humanitarian Device Exemption is an approval process provided by the United
States Food and Drug Administration allowing a medical device to be marketed
without requiring evidence of effectiveness. The FDA calls a device approved in this
manner a "Humanitarian Use Device" (HUD).
Requirements
To qualify, the device must be intended to benefit patients with a rare disease or
condition (i.e. fewer than 4,000 people in the US annually).
The applicant must also show that there is no other way that the device could be
brought to market, and that there is no comparable device already available
Standards Agencies,
Regulatory Agencies, and
Allied Organizations
© D. J. McMahon 2014
rev 141203
Standards-Setting Agencies
Determine the safest standards possible
for medical devices, within the limits of
practical design and manufacturing
practices.
Steps to develop a standard:
1) Call for Proposals
2) Report on Proposals
3) Report on Comments
4) Technical Session
5) Council Appeals and Final Issuance of a Document
> Input is from manufacturers, users, and regulators
> Most standards are reviewed and revised every 5 years
International Electrochemical
Commission
(IEC)
International Standards Institute
(ISO)
American National Standards Institute
(ANSI)
Typical ISO standard:
Typical ISO and ANSI icons used on medical devices :
NFPA
(formerly the National Fire Protection Association)
> Over a century old
> ~300 standards covering codes and standards for
buildings, processes, services, design, and installation of
equipment in all disciplines
> Source of the National Electrical Code (NEC)
> Most important publication for biomed is NFPA 99
> Several others relevant to biomed
NFPA 99:
Standard for Healthcare Facilities
Establishes “… criteria to minimize the hazards
of fire, explosion, and electricity in health care
facilities.”
> The primary reference for electrical safety for
Clinical Engineering departments in the U.S.
> Most U.S. states adopt NFPA99 as regulation.
> Reference copy in the NSC library.
NFPA 70 and 99 both set a requirement that an CE
department has the service manual for each model
of patient care equipment:
NFPA 99, 2005: p 99-96: Sec 10.2.8.1
The National Institute of
Standards and Technology
The U.S. official agency for maintaining primary
physical standards and testing to them.
It is NOT a regulatory agency.
Most test equipment is calibrated to a standard that
is ‘traceable to the NIST’.
Nationally Recognized
Testing Laboratories
(NRTL’s)
Private sector organizations that provide product
safety testing and certification services to
manufacturers. The testing and certification are
done to independently test equipment to
standards that are consensus-based.
> 15 listed by OSHA as approved for US manufacturers
> see www.osha.gov/dts/otpca/nrtl/index.html#nrtls
Four NRTL certifications most often
found on medical devices:
Underwriter’s
Laboratories
Intertek Testing Services
(was ETL Laboratories)
Canadian
Standards
Association
TŰV America
part of
The CE mark:
> Mandatory mark of design conformity for
products sold in the European Economic Area
(the ‘European Community’)
> With the increase in international sales of
medical devices, the CE mark will be found on
more equipment in the future. It indicates that
the product meets ISO standards, and is
equivalent to the mark of an NRTL.
Regulatory Agencies
Government agencies, or self-governing
organizations, that foster, monitor, and
enforce compliance with standards for
design and process in health care settings.
Regulates food, biological agents,
pharmaceuticals, cosmetics, medical
devices, radiological devices, and
veterinary products.
FDA’s medical device classifications:
Class I: least regulatory control
- eg bandages, gloves, IV sets, most instruments
Class II: more controls & performance requirements
- eg sterile drapes, most medical electronics, wheelchairs, etc
Class III: tightest controls and pre-market approvals
- eg defibrillators, ventilators, heart valves, artificial joints
FDA Pre-market approvals:
Pre-market approval: The process that manufacturers are
required to pass before selling a product in most countries.
Usually referred to as 510-(K) approval, and includes
medical devices, disposables, re-manufactured disposables,
and test equipment.
“510-(K)” refers to the FDA paperwork form numbers.
The pre-approval process can take many months, especially
if the FDA requires the manufacturer to make design
changes or verify safety more thoroughly.
Safe Medical Devices Act of 1990
(SMDA)
Device user facilities must report device-related deaths
to the FDA and the manufacturer, if known.
Device user facilities must also report device-related
serious injuries to the manufacturer, or to the FDA if the
manufacturer is not known.
Use FDA form 3500:
www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
See
www.fda.gov/Safety/MedWatch/default.htm
Example of FDA recall:
U.S. Occupational Safety &
Health Administration
Assures the safety and health of workers by setting and
enforcing standards; providing training, outreach, and
education; establishing partnerships; and encouraging
continual improvement in workplace safety and health.
> Specific issues for healthcare workers
Washington State
Department of Health
In all states, DOH inspects all healthcare facilities
for compliance with state and federal standards,
and practice standards set by specific medical
specialties.
> Typically inspect hospitals every 2 years
Centers for Medicare &
Medicaid Services
Federal agency that administers federal healthcare
services through the states.
In December of 2012, issued a ruling requiring all
medical devices to be maintained only be the OEM
service guidelines. Caused a huge backlash in
the HTM community, resulting in a revision:
CMS Memorandum of December, 2013
• S&C 12-07-Hospital Superceded: We are updating previously provided
guidance to clarify:
-- Hospital facilities, supplies and equipment must be maintained to ensure an
acceptable level of safety and quality.
-- A hospital may adjust its maintenance, inspection, and testing frequency and
activities for facility and medical equipment from what is recommended by the
manufacturer, based on a risk-based assessment by qualified personnel, unless:
--- Other Federal or state law; or hospital Conditions of Participation (CoPs)
require adherence to manufacturer’s recommendations and/or set specific
requirements. For example, all imaging/radiologic equipment must be maintained
per manufacturer’s recommendations; or
--- The equipment is a medical laser device; or
--- New equipment without a sufficient amount of maintenance history has been
acquired.
--- Hospitals electing to adjust facility or medical equipment maintenance must
develop policies and procedures and maintain documentation supporting their
Alternate Equipment Management (AEM) program. They must adhere strictly to
the AEM activities and/or frequencies they establish.
HIPAA:
The Health Insurance Portability &
Accountability Act of 1996
HIPAA required the Department of Health and Human
Services (HHS) to publish new rules that will ensure:
> Standardization of electronic patient health, administrative and
financial data
> Unique health identifiers for individuals, employers, health plans
and health care providers
> Protecting the confidentiality and integrity of "individually
identifiable health information," past, present or future
“PHI” : “Protected Health Information”
Implications of HIPAA for all healthcare employees:
> You may be asked to sign a confidentiality agreement
> HIPAA applies to patients and co-workers.
> Patient privacy is the key element: No information can be
shared without the patient’s knowledge and consent.
> HIPAA includes information about a patient’s health,
family, address, contact info, etc.
Implications of HIPAA for all healthcare employees:
> Patient information should only be accessed as part of your
duties.
HTM techs rarely need PHI.
> HIPAA does not prohibit accessing your own PHI
> Employees may be allowed to access their own PHI,
depending on employer policy.
> Violations can result in employer reprimand, suspension,
or termination.
> Violations can result in federal prosecution.
Allied Agencies
and Organizations
The Joint Commission on the
Accreditation of Hospital
Organizations
‘JCAHO’
Now referred to as ‘The Joint Commission’.
Composed of AHA, ANA, AMA, etc.
Inspects hospitals every 3 years, or unannounced.
JCAHO accreditation is not required, but is very
important for federal reimbursements and for a
hospital’s insurance coverage.
When surveyed by TJC, the Clinical
Engineering department must be in compliance
with two sections of the standard:
“Environment of Care” (EC) and
“Human Resources” (HR)
Each section is divided into “elements of performance”
(EP’s) that specify expectations.
“The Joint Commission inspector
has a question for you…”
“Sentinel Event”:
Defined by The Joint Commission as any
unanticipated event resulting in death or serious
physical or psychological injury to a patient,
not related to the natural course of the
patient's illness.
Alternative accreditation agencies :
Center for Improvement of
Healthcare Quality
Healthcare Facilities
Accreditation Program
DNV (Det Norske Veritas)
- Norway - US offices
American Society of
Hospital Engineers
Organization for Facilities Engineers
Concerned with compliance with codes for
maintenance, construction, and remodeling of
the physical plant.
Association for the
Advancement of Medical
Instrumentation
Consortium of the clinical users, manufacturers,
and regulators of medical devices.
Also sets standards jointly with ANSI/ISO
Host organization in the US for the Biomed
Certification Exams
ECRI Institute
The “Consumer Reports” type agency for
medical devices.
Publishes a monthly journal, quarterlies for
specialty areas, advises on safety issues,
advises on purchasing, etc.
ECRI’S TECHNOLOGY HAZARDS LIST
FOR 2014
1. Alarm hazards
2. Infusion pump medication errors
3. CT radiation exposures in pediatric patients
4. Data integrity failures in EHRs and other health IT systems
5. Occupational radiation hazards in hybrid ORs
6. Inadequate reprocessing of endoscopes and surgical instruments
7. Neglecting change management for networked devices and systems
8. Risks to pediatric patients from “adult” technologies
9. Robotic surgery complications due to insufficient training
10. Retained devices and unretrieved fragments