Medical Device Training
A Medical Device can be defined as "An instrument, apparatus, implant, in-vitro agent, or other similar/related article or component, used in the prevention, diagnosis, treatment and/or care of disease."
The Medical Device Data System (MDDS)
A medical device data system (MDDS) is a device intended to provide one or more of the following uses:
- The electronic transfer or exchange of medical device data from a medical device, without altering the function or parameters of any connected devices.
- The electronic storage and retrieval of medical device data, without altering the function or parameters of connected devices.
- The electronic display of medical device data, without altering the function or parameters of connected devices.
- The electronic conversion of medical device data from one format to another, in accordance with preset specifications.
Classified as Class III systems, the FDA is now considering reclassifying these systems as Class I systems, which means many more vendors and providers will now be brought under the compliance umbrella. If you're looking for more information about the FDA's proposed MDDS Rule; and to understand its implications for currently regulated and unregulated vendors and providers, Read More >>
Medical Device Reporting (MDR)
Medical Device Reporting (MDR) is a mechanism developed by the FDA to receive reports on significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly.
For startup companies entering the medical device field for the first time, it is important to be aware of the extant registration, listing, labeling, reporting, corrections and removals regulations. To understand the essentials of the FDA's Medical Device regulations, Read More >>
Premarket Approval (PMA)
The Premarket Approval (PMA) is an application submitted to the FDA to request clearance to market or to continue marketing of a Class III medical device. PMA is the most stringent type of device marketing application required by the FDA. Most Class III devices require PMA before marketing the device in the USA.
PMA requires everything noted under 'requirements' in 510(K), along with information regarding manufacturing:
- Critical/non-critical device status
- Organization (sufficient to describe QA program including training)
- QA program
- Quality audits (written quality audit procedures)
- Facilities (description, procedures, rationales)
- Equipment (list of equipment, general calibration procedure, examples of calibration records)
- Methods to control components
- Production and process controls (process flow and production procedures, identification and validation of significant processes and testing procedures)
To explore modular options of filing a PMA, and to understand the benefits this sort of filing offers to companies needing to go through the PMA process, Read More >>
Medical Device Recalls
Medical Device Recalls are either corrections or removals, depending on where the action is applied. The FDA posts consumer information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could cause serious health problems or death.
Despite the great care taken during the development of medical devices, errors can still occur. The important thing, therefore, is to establish proactive practices to determine 'recall readiness' after launching of a medical device product. To explore the impact of managing the decision-making process of a recall (if you ever have to face one), Read More >>
Who Recalls Medical Devices?
In most cases, a company (manufacturer, distributor, or other responsible party) recalls a medical device on its own (voluntarily). When a company learns that it has a product that violates FDA law, it:
- Recalls the device (through correction or removal)
- Notifies the FDA
The FDA can legally require a company to recall a device. Recalls can be disruptive, and well-managed recalls are not accidental - they are the result of extensive preparation well ahead of time. Recall teams with the right abilities and experience need to be assembled. Adequate risk management practices have to be implemented. To further explore the practices to establish appropriate degrees of 'recall readiness', Read More >>
Reporting Complaints: Information required
The following information must be provided when reporting a complaint:
- The name, address (including zip code), and telephone number (including area code) of the complainant
- A clear, brief description of the complaint, illness or injury
- A complete description of the product(s), including brand, product name, size, code(s) or lot number(s)
- Name and location where purchased
- Product manufacturer's name and address
For insight into the complaints process and to understand FDA regulations and requirements, Read More >>
Medical Device Failure
Medical device failure often means that patients being treated using the device are either injured or face the possibility of injury. When this occurs, the immediate actions to be taken are:
- Removing the device from service immediately
- Gathering all disposables/accessories and placing them in a plastic bag with the device
- Locking up device; allowing only Clinical Engineering and Risk Management access to the equipment
Effective risk communication of medical device failures facilitates appropriate decision-making - important, as these decisions directly impact patient health and safety. To explore the types of risk communications during medical device failures (both pre and post-marketing stages in the medical device lifecycle), Read More >>
Minimal Labeling Requirements in the US
The minimal labeling requirements on the package label include:
- Name and place of manufacturer, packer or distributor
- Street address, city, state and zip code
- Adequate directions for use
A prescription device is exempt from 'adequate directions for use', provided:
- The device is in possession of a licensed practitioner
- The labeling has an Rx statement
- The labeling includes information for use
- All labeling other than labels and cartons includes the date of issuance or date of the latest revision
- Common use is known to the ordinary individual
The required information must be displayed prominently on the device label. Exemptions to prominence may be granted if device labeling lacks sufficient space. Labeling must be in English, and there are more specific labeling requirements for specific devices under 21 CFR 801.403.
To explore the cleaning and labeling requirements, especially when reprocessing reusable medical devices; and the understand the regulatory requirements including cleaning and sterilization methods and validations, Read More >>
International Labeling Standards
International labeling standards are as follows:
- The CE Mark must appear in a visible, legible and indelible form on the device or its sterile pack and on the instructions for use.
- As far as practical and appropriate, information needed to use the device safely must be on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging (MDD).
- Instructions for use must be included in the packaging for every device.
- Where appropriate, the information should take the form of symbols
What is the 'CE' Mark?
The CE Mark is present on a wide array of medical and other devices. The letters 'CE' are the abbreviation of the French phrase "Conformité Européene" which literally means "European Conformity".
Compliant medical devices must bear the 'CE' Mark to be admitted to the 29-member EU. For a detailed explanation, in layman's terms, of the various routes to CE marking of medical devices (with a focus on the Medical Device Directive MDD 93/42/EEC) Read More >>
GMP Requirements for Medical Device Suppliers
Medical device manufacturers must comply with FDA Good Manufacturing Practices (GMPs) specific to Medical Devices and, to a varied extent, GMPs apply to their suppliers as well.
Medical Devices Manufacturers are required to comply with regulations FDA 21 CFR - part 820 GMPs. To understand international GMPs for medication devices (USA, Europe, Canada, Japan, etc) and for valuable assistance in compliance with domestic and international regulations for quality systems, Read More >>