How to Report a Problem (Medical Devices)

What is Medical Device Reporting (MDR)?

Medical Device Reporting (MDR) is the mechanism for the Food and Drug Administration to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. If you are a consumer or health professional you should use the nearby link to the MedWatch program for reporting significant adverse events or product problems with medical products.

User Facilities and MDR

User Facilities (e.g., hospitals, nursing homes) are required to report suspected medical device related deaths to both the FDA and the manufacturers. User facilities report medical device related serious injuries only to the manufacturer. If the medical device manufacturer is unknown, the serious injury is reported by the facility to FDA. Health professionals within a user-facility should familiarize themselves with their institution procedures for reporting adverse events to the FDA.

There is a guidance for user facilities, “Medical Device Reporting for User Facilities”.  See its nearby link.

Note: Please do not send the actual device to FDA as stated in Block D9 of the MEDWATCH 3500A form. In Block D9 indicate that you are keeping the device or returning it to the manufacturer.

History of MDR Regulation

Legislation requiring device user facility reporting was enacted by Congress to increase the amount of information the Food and Drug Administration (FDA) and device manufacturers receive about problems with medical devices. Although manufacturers and importers of medical devices have been required since 1984 to report to FDA all device-related deaths, serious injuries, and certain malfunctions, numerous reports have shown there is widespread underreporting. A 1986 General Accounting Office (GAO) study showed that less than one percent of device problems occurring in hospitals are reported to FDA, and the more serious the problem with a device, the less likely it was to be reported. A GAO followup study in 1989 concluded that despite full implementation of the Medical Device Reporting (MDR) regulation, serious shortcomings still existed.

Under the 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. In addition, SMDA also required that device user facilities submit to FDA, on a semiannual basis, a summary of all reports submitted during that time period. The device user facility reporting section of SMDA became effective on November 28, 1991.

To implement SMDA, FDA published a tentative final rule in the Federal Register on November 26, 1991, and invited comments on the regulation. Over 300 comments were received by FDA. Then, on June 16, 1992, the President signed into law the Medical Devices Amendments of 1992 (Public Law 102-300; the Amendments of 1992), amending certain provisions (section 519 of the Food, Drug, and Cosmetic Act) relating to reporting of adverse events. The primary impact of the 1992 Amendments on device user facility reporting was to clarify certain terms and to establish a single reporting standard for device user facilities, manufacturers, importers, and distributors. A final rule published in the Federal Register on December 11, 1995, addresses the comments received by the FDA and the changes mandated by the Amendments of 1992.

Reference: http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm

 

What FDA Regulates

FDA is the federal agency responsible for ensuring that foods are safe, wholesome and sanitary; human and veterinary drugs, biological products, and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe. FDA also ensures that these products are honestly, accurately and informatively represented to the public. Some of the agency’s specific responsibilities include:

Biologics

• product and manufacturing establishment licensing
• safety of the nation’s blood supply
• research to establish product standards and develop improved testing methods

Cosmetics

• safety
• labeling

Drugs

• product approvals
• OTC and prescription drug labeling
• drug manufacturing standards

Foods

• labeling
• safety of all food products (except meat and poultry)
• bottled water

Medical Devices

• premarket approval of new devices
• manufacturing and performance standards
• tracking reports of device malfunctioning and serious adverse reactions

Radiation-Emitting Electronic Products

• radiation safety performance standards for microwave ovens, television receivers, diagnostic x-ray equipment, cabinet x-ray systems (such as baggage x-rays at airports), laser products, ultrasonic therapy equipment, mercury vapor lamps, and sunlamps
• accrediting and inspecting mammography facilities

Veterinary Products

• livestock feeds
• pet foods
• veterinary drugs and devices

Source: FDA

Google’s new privacy policy

Q: How will Google’s privacy changes affect users?

A: Google Inc. is combining more than 60 different privacy policies so it will be able to throw all the data it gathers about each of its logged-in users into personal dossiers. The information Google learns about you while you enter requests into its search engine can be culled to suggest videos to watch when you visit the company’s YouTube site.

Users who write a memo on Google’s online word processing program, Docs, might be alerted to the misspelling of the name of a friend or co-worker a user has communicated with on Google’s Gmail. The new policy pools information from all Google-operated services, empowering the company to connect the dots from one service to the next.

Q: Why is Google making these changes?

A: The company, based in Mountain View, Calif., says it is striving for a “beautifully simple, intuitive user experience across Google.” What Google hasn’t spent much time talking about is how being able to draw more revealing profiles about its users will help sell advertising — the main source of its $38 billion in annual revenue.

One reason Google has become such a big advertising network: Its search engine analyzes requests to figure out which people are more likely to be interested in marketing pitches about specific products and services. Targeting the ads to the right audience is crucial because in many cases, Google only gets paid when someone clicks on an ad link. And, of course, advertisers tend to spend more money if Google is bringing them more customers.

Q: Is there a way to prevent Google from combining the personal data it collects from all its services?

A: No, not if you’re a registered user of Gmail, Google Plus, YouTube, or other Google products. But you can minimize the data Google gathers. For starters, make sure you aren’t logged into one of Google’s services when you’re using Google’s search engine, watching a YouTube video or perusing pictures on Picasa. You can get a broad overview of what Google knows about you at http://www.google.com/dashboard , where a Google account login is required. Google also offers the option to delete users’ history of search activity.

It’s important to keep in mind that Google can still track you even when you’re not logged in to one of its services. But the information isn’t quite as revealing because Google doesn’t track you by name, only through a numeric Internet address attached to your computer or an alphanumeric string attached to your Web browser.

Q: Are all Google services covered by the privacy policy?

A: No, a few products, such as Google’s Chrome Web browser and mobile payment processor Wallet, will still be governed by separate privacy policies.

Q: Is Google’s new privacy policy legal?

A: The company has no doubt about it. That’s why it’s repeatedly rebuffed pleas to delay the changes since announcing the planned revisions five weeks ago. But privacy activists and even some legal authorities have several concerns.

The Electronic Privacy Information Center, a privacy rights group, sued the FTC in a federal court in an effort to force the FTC to exercise its powers and block Google’s privacy changes. A federal judge ruled the courts didn’t have the authority to tell the FTC how to regulate Google. The FTC says it is always looking for evidence that one of its consent orders has been violated.

Earlier this week, the French regulatory agency CNIL warned Google CEO Larry Page that the new policy appears to violate the European Union’s strict data-protection rules. Last week, 36 attorneys general in the U.S. and its territories derided the new policy as an “invasion of privacy” in a letter to Page.

One of the major gripes is that registered Google users aren’t being given an option to consent to, or reject, the changes, given that they developed their dependence on the services under different rules. In particular, people who bought smartphones running on Google’s Android software, and signed two-year contracts to use the devices, may have a tough time avoiding the new privacy policy. They could switch to non-Google services, but those typically don’t work as well on Android software. Or they could buy a different smartphone and pay an early-termination penalty.

Q: What regulatory power do government agencies have to change or amend the privacy changes?

A: The U.S. Federal Trade Commission gained greater oversight over Google’s handling of personal information as part of a settlement reached last year. Google submitted to the agreement after exposing its users email contacts when it launched a now-defunct social networking service called Buzz in 2010. The consent order requires Google’s handling of personal information to be audited every other year and forbids misleading or deceptive privacy changes.

Google met with the FTC before announcing the privacy changes. Neither the company nor the FTC has disclosed whether Google satisfied regulators that the revisions comply with the consent order.

 Reference: http://profit.ndtv.com/News/Article/faqs-all-you-should-know-about-google-s-new-privacy-policy-298822?pfrom=home-topstories