----- Original Message -----
From: Michael Patterson
To: FDA CDRH Ombudsman
Subject: Request to clarify Federal and FDA jurisdiction, and to notify local and state authorities regarding legal issues and Jurisdiction over the regulation of Federal law regarding FDA approved medical devices.

As we discussed today, here is my

Request to clarify Federal and FDA jurisdiction, and to notify local and state authorities regarding legal issues and Jurisdiction over the regulation of FDA approved medical devices.

I believe that the working group and petitions I have sent in to the FDA may be the last opportunity the FDA will have to protect the public health from the misuse of these FDA approved medical devices.  The issues I'm discussing with the FDA extend to the reuse and reprocessing of ALL FDA approved medical devices.  My requests, petitions and emails do Not ask the FDA to do anything more or anything less than to regulate the SAME types of users and practitioners (medical Doctors and their technicians) that the FDA has in fact regulated before these Devices were approved.  The same problems the FDA pointed out that occured before devices were FDA approved and before clinical trials are in fact occuring with the same or similar FDA approved medical devices. 

Read more: Jurisdiction

Does the FDA do anything if the users of these FDA approved Class I medical devices do not follow the Operator Manual procedures (see Exhibit D, including sterilization and cleaning off of debris)? 


"Hansatome Microkeratome DRAFT 12-14-2000 Operator's Manual"

Is the new sterilization method is to use EtO which is stringent enough?  Is it followed for all components that come into contact with highly infectious tissue (the cornea and blood) during LASIK?  "he stated that the elimination of EtO sterilization only referred to the components for the tray and that the blades and tubing will continue to be EtO sterilized."



EtO uses low heat instead of autoclaving.



p.17 "26.  Warning  It is important to follow proper surgical procedure and carefully drape the eyelids and lashes.  Failure to do so could result in possible serious permanent patient injury."

"31.... NOTE: Any tissue lodged in the Hansatome microkeratome head should be removed immediately.  This will prevent the tissue from hardening or becoming lodged in the cavity of the Hansatome microkeratome head."

"34. Warning  The Hansatome microkeratome must be cleaned, disinfected and/or sterilized according to the instructions provided in this manual.  Failure to properly clean, disinfect, and sterilize equipment could result in possible serious permanent patient injury."

"36. Warning  Any delay in cleaning can allow residual debris from the procedure to adhere to the Hansatome microkeratome.  Such debris could clog the Hansatome microkeratome and during sterilization, could harden and become permanently lodged.  Debris allowed to build up on the Hansatome microkeratome components could affect the performance of the system resulting in system malfunction and possible permenant patient injury."

"43.  Warning  Do not sterilize the Hansatome microkeratome head with the AccuGlide blade installed.  This could result in the blade becoming wedged in the head or result in damage to the head.  Damage of this nature could result in possible serious permanent patient injury."

p.3-1 indicates using Alcohol for cleaning which apparently changed with the new 510K dated 2001.

The following Exhibits were presented to the FDA and are presented here as evidence that reusing Blades for LASIK surgery is within the jurisdiction of the FDA and the Federal government to investigate. 

The FDA knows that many Doctors are reusing the blades even contrary to what the FDA approved as "safe".  see http://www.lasikliberty.com/index.php?option=com_content&task=view&id=15&Itemid=1

Apparently, two Doctors in CA admitted to reusing a single blade on multiple patients and were placed on probation by the medical board, and I believe the penalty should be higher than this decision.

"LaserVue reused microkeratome blades among patients rather than sterilizing or replacing them.  Former patients may have been exposed to infectious diseases such as HIV or Hepatitis. "

"Class Action o/b/o 2,700 former LaserVue patients. In a settlement to an investigation brought by Medical Board of California (MBC), defendants admitted that their protocol was to rinse and reuse a blade on up to 4 eyes.  MBC concluded that defendants departed from standard of care and placed them on probation." (see http://www.lasikinfocenter.net/Webpages/Ongoing%20Litigation%20Against%20RS%20Webpage.htm).

If the FDA has No jurisdiction to regulate an already approved medical device that is known to be used unsafely and contrary to the public health, then what's the point of approving these devices as safe in the first place? What do they actually review during the medical device reviews?

How many people would resist saving over $1million by taking some extra risk (for someone else, not themself) if no one would do anything about it?

Read more: Exhibit List

The FDA indicates that the physician license is provided by Federal law under Title 21, but the FDA Office of Criminal Investigations stated that the ONLY jurisdiction to enforce Title 21 is State and local (I believe this is Incorrect).

Read more: Hansatome Manual

Please contact your local and Federal Representatives to ask them to investigate and pass new laws to regulate the obviously unsafe use of all FDA approved medical devices.  The House has investigated and there have been discussions of new legislation.

In general, the reuse or reprocessing of single use devices on multiple patients is a serious concern (see http://reform.house.gov/UploadedFiles/121605\%20FDA\%20Medical\%20Device\%20Letters.pdf )."

The House of representatives has investigated the FDA regarding allowing these harmful practices (as reported in the Washington Post).

"If there is the remotest possibility that a catheter might be used twice, that you could potentially harm a patient, you should not use it," he said. "It's common sense."
"The Washington Post examined thousands of pages of documents, including FDA records, court filings and internal company reports, and was able to document dozens of cases of patient injuries and device malfunctions after single-use devices were reused over the past decade"

Microkeratome blades get duller every time they are reused which causes irregular flaps made in the cornea, less smooth flaps, epithelial ingrowth, keratitis, and other serious problems.

For every LASIK surgery, every patient MUST have new microkeratome components (e.g., blades and cannulas).  Reusing microkeratome components that come into contact with blood or the cornea on multiple patients is not within the practice of medicine for patients in the United States let alone within the standard of care for any Medical Doctor (for any medical procedure including LASIK).  There is NO patient benefit for reuse and there is a very high risk of harm to the patient. 

Based on my review of the risks associated with reusing microkeratome blades or cannulas on multiple patients (especially without proper sterilization), this practice can spread infectious diseases (e.g., DLK, HIV, hepatitis, CJD, etc.) as well as corneal infections (a complication that does lead to loss of eye and blindness).  Proper sterilization of the microkeratome blades with regard to CJD prions is not practical and the blades do come into contact with the eye and blood (which are considered highly infectious tissue).  The microkeratome then inserts the tissue into the eye of any other patients it comes into contact with.