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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).

RequirementsTo 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 ElectrochemicalCommission

(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

Underwriter’s Laboratories

Canadian Standards

Association

Intertek Testing Services

(was ETL Laboratories)

TŰV America

part of

Four NRTL certifications most often found on medical devices:

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:

• 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.

CMS Memorandum of December, 2013

HIPAA required the Department of Health and HumanServices (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

HIPAA:The Health Insurance Portability &

Accountability Act of 1996

“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.

> 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.

Implications of HIPAA for all healthcare employees:

Allied Agencies

and Organizations

The Joint Commission on the Accreditation of Hospital

Organizations

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.

‘JCAHO’

When surveyed by TJC, the ClinicalEngineering 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 seriousphysical or psychological injury to a patient,not related to the natural course of thepatient's illness.

Alternative accreditation agencies :

DNV (Det Norske Veritas) - Norway - US offices

Healthcare Facilities Accreditation Program

Center for Improvement of Healthcare Quality

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